79C3C34C52B45572883A05D425EB0F82
Health Service Executive National Consent Policy, Part 3
https://www.hse.ie/eng/about/who/qid/other-quality-improvement-programmes/consent/national-consent-policy-hse-v1-3-june-2019.pdf
http://leaux.net/URLS/ConvertAPI Text Files/F4170D42684D2DBAC6CA678E1EBE6FF2.en.txt
Examining the file media/Synopses/F4170D42684D2DBAC6CA678E1EBE6FF2.html:
This file was generated: 2020-12-01 06:00:08
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114: Part Three—Research
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p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
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p.000114: 5.3 People in dependent or unequal relationships
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p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
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Political / criminal
Searching for indicator criminal:
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p.000114: on openness, trust and good communication. Almost every health and social care intervention involves decisions
p.000114: made by service users and those providing theircare.
p.000114: Good decision making requires a dialogue between parties that recognises and acknowledges the service user’s goals,
p.000114: values and preferences as well as the specialist knowledge, experience and clinical judgment of health and social care
p.000114: professionals.
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p.000114: 1.4 Consent in Irish law
p.000114:
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p.000114: It is a basic rule at common law that consent must be obtained for medical examination, treatment,
p.000114: service or investigation. This is well established in Irish case law and ethical standards. The requirement for consent
p.000114: is also recognised in international and European human rights law and under the Irish Constitution.
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p.000114: Page 21
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part One—General Principles
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p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
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p.000114: 1.5 Age of consent in Irish law
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p.000114: The age of consent in Ireland is outlined in the following Acts:
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p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114: Part One—General Principles
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p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
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p.000114: 7.8 Advance refusal of treatment
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p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
p.000114: including advance refusal of medical treatment. There is no Irish legislation confirming the enforceability of such
p.000114: advance refusals. However, such an advance plan should be respected on condition that:
p.000114: • The decision was an informed choice, according to the principles discussed in Sections 2-5
p.000114: • The decision specifically covers the situation that has arisen, and
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p.000114: • There is no evidence that the service user has changed their mind since the advance plan was made.
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p.000114: 14 As specified in the Act
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
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p.000114: If there is reasonable doubt about the existence of an advance treatment plan, the service user’s capacity at the
p.000114: time of making the treatment plan or whether it still applies in the present circumstances, treatment
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p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
p.000114: child and the authorisation of a second consultant psychiatrist before medication which has been
p.000114: prescribed to a child for a continuous period of three months can be continued. Electroconvulsive therapy or
p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
p.000114: requires any other treatment or intervention not related to their mental health, the general principles of consent
p.000114: apply as discussed in this policy.
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p.000114: 10. Sexual health services
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p.000114: Under Irish law it is a criminal offence to engage or attempt to engage in a sexual act with a child under 17 years of
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
p.000114: law, a girl under the age of 17 who has sexual intercourse may not be convicted of an offence on
p.000114: that ground alone. This exemption from prosecution does not apply to boys of the same age.
p.000114: There is no specific provision in law regarding the age at which contraceptive advice and treatment and
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part Two—Children and Minors
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p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
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p.000114: 23 or any other relevant legislation or national guidelines
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
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Political / displaced
Searching for indicator displaced:
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p.000114:
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p.000114: Part Two Children and Minors
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p.000114: National Consent Policy HSE V.1.3
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p.000114: Part Two—Children and Minors
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p.000114: 1. Introduction
p.000114:
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p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
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p.000114: 7. DNAR decisions and children
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p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
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p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
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p.000114: Page 110
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
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Political / person in detention center
Searching for indicator detained:
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p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
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p.000114: Page 60
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: The 2001 Act also contains certain provisions in relation to the treatment of a detained child. Section
p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
p.000114: child and the authorisation of a second consultant psychiatrist before medication which has been
p.000114: prescribed to a child for a continuous period of three months can be continued. Electroconvulsive therapy or
p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
p.000114: requires any other treatment or intervention not related to their mental health, the general principles of consent
p.000114: apply as discussed in this policy.
p.000114:
p.000114:
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p.000114: 10. Sexual health services
p.000114:
p.000114:
p.000114: Under Irish law it is a criminal offence to engage or attempt to engage in a sexual act with a child under 17 years of
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
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Political / person under arrest
Searching for indicator arrest:
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p.000091:
p.000091: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000091: validation against the controlled version
p.000091:
p.000091: National Consent Policy HSE V.1.3
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p.000091:
p.000091: Table of contents
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p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
p.000098: 2. Definition and scope of resuscitation decisions 99
p.000098: 2.1 Do not attempt resuscitation or do not resuscitate
p.000099: 99
p.000099: 2.2 Scope of DNAR orders
p.000099: 99
p.000099: 3. General principles
p.000100: 100
p.000100: 3.1 Need for individual decision making
p.000100: 100
p.000100: 3.2 Involving the individual in discussions regarding CPR
p.000101: 101
p.000101: 3.3 Involving family or friends in discussions regarding CPR 101
p.000101: 3.4 Decision-making capacity
p.000102: 102
p.000102: 3.5 Provision of information
p.000102: 102
p.000102: 3.6 Decision-making regarding CPR and DNAR orders 102
p.000102: 4. When should CPR and DNAR decisions be considered? 103
p.000102: 4.1 Cardiorespiratory arrest is considered unlikely
p.000103: 103
p.000103: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable 104
p.000103: 4.3 Cardiorespiratory arrest is considered possible or likely 104
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p.000103: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000103: validation against the controlled version
p.000103:
p.000103: National Consent Policy HSE V.1.3
p.000103: Table of contents
p.000103: Page
p.000103: 5. Presumption in favour of providing CPR 105
p.000103: 6. Balancing the benefits and risks of providing CPR 106
p.000103: 6.1 Respecting an individual’s refusal of CPR
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
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p.000113: Bibliography
p.000114: 114
p.000114:
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p.000114: National Consent Advisory Group Membership 124
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p.000114: Glossary
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p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
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p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
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p.000114: Autonomy
p.000114: The capacity to make decisions and take actions that are in keeping with one’s values and beliefs.
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p.000114: Bioethics
p.000114: A multidisciplinary activity dealing with the ethical implications of biological research and medicine.
p.000114:
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p.000114: Biobank
p.000114: A centralised archive of human biological material from which materials are made available for research purposes.
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p.000114: Capacity
p.000114: The ability to understand the nature and consequences of a decision in the context of available choices at the time the
p.000114: decision is to be made.
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p.000114: Cardiopulmonary resuscitation (CPR)
p.000114: Cardiopulmonary resuscitation (CPR) is an attempt to restore breathing (sometimes with support) and spontaneous
p.000114: circulation in an individual in cardiorespiratory arrest. CPR usually includes chest compressions,
p.000114: attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs.
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p.000114: Page 12
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114: Glossary
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p.000114: Cardiorespiratory arrest
p.000114: Cardiac arrest is the cessation of cardiac contraction. Respiratory arrest is the cessation of effective
p.000114: oxygenation and ventilation. Cardiorespiratory arrest is a combination of cardiac and respiratory arrest.
p.000114:
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p.000114: Child
p.000114: A person under the age of 18 years, unless that person has attained full age through marriage.
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p.000114: Coercion/Duress
p.000114: Forcing someone to behave in a particular way by use of threats or intimidation or some other form of pressure or
p.000114: force.
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p.000114: Consent
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation in
p.000114: research following a process of communication in which the service user has received sufficient
p.000114: information to enable him/her to understand the nature, potential risks and benefits of the proposed intervention or
p.000114: service.
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p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
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p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
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p.000114: Intervention
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p.000114: Part Four
p.000114: Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR), including chest compressions, defibrillation (with electric shocks), the
p.000114: injection of drugs and ventilation of the lungs, is an important and potentially life- saving intervention for victims
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergency situation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
p.000114: relating to resuscitation procedures; therefore, such issues are not dealt with in this policy.
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: 2. Definition and scope of resuscitation decisions
p.000114:
p.000114:
p.000114: 2.1 Do not attempt resuscitation or do not resuscitate
p.000114:
p.000114:
p.000114: Throughout this document the term “do not attempt resuscitation” (DNAR) orders will be used as opposed to “do not
p.000114: resuscitate” (DNR) orders. This change has been made in an effort to underscore the uncertainty surrounding
p.000114: the success of CPR: “do not resuscitate” may imply that resuscitation would likely be successful if it
p.000114: were undertaken, whereas “do not attempt resuscitation” emphasises that the success of any resuscitation
p.000114: intervention is less clear cut and situation dependent.
p.000114:
p.000114:
p.000114: 2.2 Scope of DNAR orders
p.000114:
p.000114:
p.000114: A decision not to attempt CPR applies only to CPR. It does not apply to any other aspect of treatment
p.000114: and all other treatments and care that are appropriate for the individual should continue. If a
p.000114: decision is made to restrict the nature or extent of CPR, this should be carefully documented and
p.000114: communicated effectively to all members of the healthcare team caring for the individual.
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
...
p.000114: training, knowledge and communication skills to coordinate this process. In general, this duty rests with the
p.000114: most senior healthcare professional with responsibility for an individual’s treatment and care, which would be a
p.000114: consultant or registrar in the hospital setting or the individual’s GP in other healthcare settings. He/she
p.000114: should usually consult with other healthcare professionals who may have helpful insights into the individual’s
p.000114: condition.
p.000114:
p.000114: 31 See Part One section 5.5. for further provisions on the assessment of capacity
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: Situations may arise where a decision regarding CPR has to be made quickly and the most senior healthcare professional
p.000114: is unavailable. In such circumstances, decision-making responsibility can be delegated to other less senior
p.000114: healthcare professionals, who should notify and discuss with their senior colleague as soon as possible.
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p.000114: 4. When should CPR and DNAR decisions be considered?
p.000114:
p.000114:
p.000114: Advance care planning, including making decisions about CPR, is an important part of good clinical care
p.000114: for those at risk of cardiorespiratory arrest and is preferable to making decisions only after a crisis has arisen.
p.000114: Hence, the likelihood of cardiorespiratory arrest occurring should be taken into account when determining
p.000114: how, when and if to consider the need for CPR/DNAR discussions or decisions for an individual. Three
p.000114: broad groups can be identified based on the likelihood of cardiorespiratory arrest within the foreseeable
p.000114: future:
p.000114: • Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114: • Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114: • Cardiorespiratory arrest is considered possible or likely.
p.000114:
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p.000114: 4.1 Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114:
p.000114: For most people, within the general population, the likelihood of cardiorespiratory arrest within a given period is
p.000114: very small. In general, these would be healthy individuals for whom cardiorespiratory arrest
p.000114: would represent an unanticipated emergency situation. Moreover, given the low likelihood of arrest, it is unlikely that
p.000114: the issues of CPR and DNAR orders would have been raised previously with such individuals since healthcare
p.000114: professionals are not required to discuss every possible eventuality with every individual. Instead, the
p.000114: general presumption in favour of CPR should operate in the unlikely event of an arrest. However, if an individual
p.000114: indicates that he/ she wishes to discuss CPR, then this should be respected.
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114:
p.000114: However, a small cohort of individuals within the general population may have prepared an advance
p.000114: healthcare directive refusing CPR under specific circumstances. The wishes of such individuals should be
p.000114: respected if the directive is considered valid and applicable to the situation that has arisen32.
p.000114:
p.000114: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114:
p.000114: Some individuals may be so unwell that death is considered to be imminent and unavoidable. For such
p.000114: individuals, cardiorespiratory arrest may represent the terminal event in their illness and the provision of CPR
p.000114: would not be clinically indicated (i.e. would not restart the heart and maintain breathing for a
p.000114: sustained period). Attempting CPR in such circumstances may cause harm to the individual, increase his/her
p.000114: suffering and/or result in a traumatic and undignified death. In many cases, a sensitive but open discussion of
p.000114: end-of-life care will be possible in which individuals should be helped to understand the severity of their condition.
p.000114: However, it should be emphasised that this does not necessarily require explicit discussion of CPR or an ‘offer’ of
p.000114: CPR. Implementing a DNAR order for those close to death does not equate to “doing nothing”; all care provided should
p.000114: follow a palliative approach and focus on easing that individual’s suffering and making him/her as comfortable as
p.000114: possible.
p.000114:
p.000114:
p.000114: 4.3 Cardiorespiratory arrest is considered possible or likely
p.000114:
p.000114:
p.000114: For certain individuals there may be an identifiable risk of cardiorespiratory arrest occurring as a result of their
p.000114: clinical condition. These include individuals with acute severe illness and those with severe or multiple coexisting
p.000114: medical conditions or diseases.
p.000114: Advance care planning, including consideration of issues such as CPR/DNAR is often appropriate for such individuals and
p.000114: should occur in the context of a general discussion about the individual’s prognosis and the likelihood that CPR would
p.000114: be successful, as well as his/her values, concerns, expectations and goals of care.
p.000114:
p.000114: 32 There is currently no specific legislation pertaining to advance healthcare directives in Ireland. However, the
p.000114: Irish courts have established that an individual with capacity has the right to refuse treatment to facilitate a
p.000114: natural death. The weight of legal opinion has been interpreted to mean that an advance healthcare directive made by an
p.000114: individual, when he/she had capacity, would be upheld. In addition, the Medical Council Guide to Professional Conduct
p.000114: and Ethics for Registered Practitioners (2009) also recognises advance healthcare directives
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p.000114: Most CPR discussions and decisions will occur in this group. However, it must be emphasised that this is not a
p.000114: homogenous group, as the likelihood of success from CPR varies widely, and this necessarily influences how
p.000114: discussions are conducted.
p.000114:
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p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
p.000114: In some instances where CPR has been started, additional information may subsequently become available which makes
p.000114: continued CPR inappropriate, for example clinical information which indicates that CPR is unlikely to
p.000114: be successful, or information regarding the individual’s preferences.
p.000114: As was discussed in Section 4.2, there will be some individuals for whom no formal DNAR decision has been made, but
p.000114: where attempting CPR is clearly inappropriate because death is imminent and unavoidable, for example, in the final
p.000114: stages of a terminal illness. In these circumstances, it is reasonable for healthcare professionals not to
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: 6. Balancing the benefits and risks of providing CPR
p.000114:
p.000114:
p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
p.000114: acknowledging the uncertainty inherent in many medical predictions, healthcare professionals still have an
p.000114: obligation to provide an opinion, based on their expertise.
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: Principles to be applied in reaching a decision about CPR33
p.000114:
p.000114: • Decisions about CPR must be made on the basis of an individual assessment of each person’s case.
p.000114: • The likely clinical outcome of attempting CPR should be considered, including the likelihood of
p.000114: successfully re-starting the individual’s heart and breathing for a sustained period, and the level of recovery
p.000114: that can reasonably be expected after successful CPR.
p.000114: • Advance care planning, including making decisions about CPR, is an important part of good clinical care for
p.000114: those at risk of cardiorespiratory arrest.
p.000114: • Communication and the provision of information in a sensitive manner are central to discussions about CPR
p.000114: and should be undertaken by the most senior healthcare professional available.
p.000114: • It is not necessary to initiate a discussion about CPR with an individual if there is no reason to believe
p.000114: that he/she is likely to suffer a cardiorespiratory arrest.
p.000114: • Where no explicit decision has been made in advance there should be an initial presumption in
p.000114: favour of CPR.
p.000114: • Where the expected benefit of attempted CPR may be outweighed by the risks, the individual’s informed
p.000114: views are of paramount importance. If the individual lacks decision-making capacity those close to him/her
p.000114: should be involved in discussions to explore his/her wishes, feelings, beliefs and values.
p.000114: • If an individual with decision-making capacity refuses CPR, or an individual lacking decision-making
p.000114: capacity has a valid and applicable advance healthcare directive refusing CPR, this should be respected.
p.000114: • DNAR decisions apply only to CPR and not to any other aspects of treatment and care.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 33 This information has been modified from: Lannon R and O’Keeffe ST (2010). Cardiopulmonary resuscitation in older
p.000114: people – a review. Reviews in Clinical Gerontology 20: 20–29;
p.000114: British Medical Association, Resuscitation Council (UK) and Royal College of Nursing (2007). Decisions relating to
p.000114: cardiopulmonary resuscitation: A joint statement from the British Medical Association, the Resuscitation Council (UK)
p.000114: and the Royal College of Nursing. British Medical Association, London, 24p
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p.000114: 6.5 Where an individual does not want to discuss CPR and DNAR orders
p.000114:
p.000114:
p.000114: Situations may arise where an individual does not want to discuss CPR/DNAR orders. In some cases such
p.000114: refusals may be linked to the timing of the discussion and the individual should be given the opportunity
p.000114: to defer the discussion and revisit the issues of CPR and DNAR orders at a later time. However, if an individual
p.000114: refuses to participate in the discussion, his/her wishes should be respected. If the individual would prefer that the
p.000114: healthcare professional discuss the decision with somebody else such as a relative, partner or friend, this should be
p.000114: respected. However, it should be emphasised that the role of those close to the individual is not to
p.000114: make the final decision relating to CPR, but rather to help the senior healthcare professional to make the most
p.000114: appropriate decision.
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p.000114: 6.6 DNAR orders and readily reversible cardiorespiratory arrests
p.000114:
p.000114:
p.000114: In certain situations, an individual with a DNAR order may suffer a cardiorespiratory arrest from a
p.000114: readily reversible cause unconnected to his/her underlying illness. In such cases CPR would be appropriate,
p.000114: while the reversible cause of arrest is treated. For example, choking restricts an individual’s intake of
p.000114: oxygen, which could potentially lead to a cardiorespiratory arrest if not treated promptly. The initial response should
p.000114: concentrate on removing the cause of the tracheal blockage, but in the event of a subsequent cardiorespiratory arrest,
p.000114: CPR should be provided.
p.000114: Where an individual with a DNAR order in place is to undergo a medical or surgical procedure, it may be appropriate
p.000114: to review the DNAR order given the potential for cardiorespiratory arrest to occur under anaesthesia. In such
p.000114: situations, should a cardiorespiratory arrest occur, there should be a presumption in favour of
p.000114: providing CPR. Therefore, in advance of procedures involving anaesthesia it may be advisable to temporarily
p.000114: suspend an individual’s DNAR order. The process of reviewing the DNAR order should involve discussion with
p.000114: the individual as part of the consent process in advance of the procedure. If the DNAR order is to be suspended this
p.000114: decision should be clearly documented as well as the time at which the DNAR order is to be
p.000114: re-instated. If an individual wishes his/her DNAR order to remain valid during the procedure, despite the
p.000114: increased likelihood of cardiorespiratory arrest, this might significantly increase the overall level of risk
p.000114: associated with the procedure. This issue of elevated risk should be highlighted to the individual, by his/her
p.000114: healthcare team, as part of the overall discussion regarding the procedure. However, if the individual is willing to
p.000114: accept the additional risk then the healthcare professional should continue with the procedure.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
p.000114:
p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
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p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
p.000114: be in the child’s best interests and a DNAR order should be put in place.
p.000114: Given the additional complexity and the emotionally-demanding nature of decisions relating to CPR for
p.000114: children this process should be underpinned by a number of fundamental guiding principles:
p.000114: • Parent(s)/legal guardian(s) and the healthcare team should work in partnership when deciding about
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
...
p.002003: and the Law 2nd Ed (Bloomsbury, 2011)
p.002003: Mason and Kenyon Mason and McCall Smith’s Law and Medical Ethics 7thed(OUP, 2006)
p.002003:
p.002003: McKenchie L, Gill AB. Consent for Neonatal Research. Archives of Disease in Childhood Fetal & Neonatal Edition (2006),
p.002003: 91(5): F374-376
p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003: O’Brien M and O’Keeffe ST (2009).Resuscitation decisions in Irish long-stay units. Irish Journal of Medical Science
p.002003: 178(4): 423-425
p.002003: O’Keeffe ST (2001). Development and implementation of resuscitation guidelines: a personal experience. Age
p.002003: and Ageing 30(1): 19-25
p.002003: O’ Keeffe ‘A Clinician’s Perspective: Issues of Capacity in Care’ (2008) 14 Medico-Legal Journal of Ireland 41
p.002003: Peberdy MA, Kaye W, Ornato JP, Larkin GL, Nadkarni V, Mancini ME, Berg RA, Nichol G and Lane- Trultt T (2003).
p.002003: Cardiopulmonary resuscitation of adults in the hospital: A report of 14720 cardiac arrests from the National Registry
p.002003: of Cardiopulmonary Resuscitation. Resuscitation 58(3): 297-308
p.002003: Sandroni C, Nolan J, Cavallaro P and Antonelli M (2007). In-hospital cardiac arrest: incidence, prognosis
p.002003: and possible measures to improve survival. Intensive Care Medicine 33(2): 237–245
p.002003: Smith GB, Poplett N and Williams D (2005).Staff awareness of a ‘Do Not Attempt Resuscitation’ policy in a
p.002003: District General Hospital. Resuscitation 65(2): 159-165
p.002003: Staunton ‘The Development of Healthcare Planning in Ireland’ (2009) 15 Medico-Legal Journal of Ireland 74
p.002003: Whelan Mental Health Law and Policy (Thompson Roundhall, 2009)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: National Consent Advisory Group Membership
p.002003:
p.002003:
p.002003: Name
p.002003: Title
p.002003: Organisation
p.002003: Role
p.002003:
p.002003:
p.002003: Deirdre Madden Angela Hughes Ann Duffy
p.002003: Anne Marie Loftus
p.002003:
p.002003:
p.002003: Austin Warters Bill Ebbitt
p.002003: Caoimhe Gleeson
p.002003: Senior Lecturer, Faculty of Law National Quality Lead
p.002003: Clinical Risk Advisor Clinical
p.002003: Indemnity Scheme
p.002003:
p.002003: Director of Nursing and Midwifery, Sligo General Hospital
p.002003:
p.002003: Manager of Older Persons Services
p.002003: General Manager, National Disability Unit
p.002003:
...
Political / political affiliation
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p.000114: If a consent form is used and the service user is unable to write, a mark on the form to indicate consent is
p.000114: sufficient. It is good practice for the mark to be witnessed by a person other than the clinician seeking consent, and
p.000114: for the fact that the service user has chosen to make their mark in this way to be recorded in the healthcare record.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.6 Confidentiality and data protection
p.000114:
p.000114:
p.000114: Service users have a right to expect that information about them will be held in confidence by those who provide health
p.000114: and social care services to them. Confidentiality is central to trust in this relationship. Staff are expected to
p.000114: comply with the provisions of the Data Protection Acts 1988 and 2003 which state that personal
p.000114: information obtained from service users for the purposes of informing care, treatment or service provision
p.000114: should not be disclosed to a third party unless the service user has consented or unless the specific
p.000114: requirements of the legislation are complied with11. (The legislation distinguishes between “sensitive” and
p.000114: “non-sensitive” data. For non-sensitive data, information may be shared (“processed”) where it is necessary to prevent
p.000114: injury or other damage to the health of the data subject. For sensitive data, information may be shared where it is
p.000114: necessary for medical purposes and is undertaken by a medical professional).
p.000114: This also applies if a third party, such as a family member, makes a complaint regarding the care of a service user:
p.000114: it is essential in these circumstances to ensure that the service user has consented to their personal
p.000114: information being made available for any internal investigations/ reviews.
p.000114: Sharing of information on a strict ‘need to know’ basis between staff involved in a service user’s care is essential to
p.000114: the provision of safe and effective care. Similarly, an integral component of modern health and social care is the use
p.000114: of audit and quality assurance programmes to ensure that the care provided is of the highest quality when
p.000114: benchmarked against national and international standards. Consent from the service user is not
p.000114: usually sought in these circumstances except where identifiable data is being made available to a third party.
p.000114: However, it is good practice to make service users aware that such practices occur and that safeguards exist to ensure
p.000114: that their personal information is protected. For example, this could be done in hospitals by providing
p.000114: such information on admission.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 11 See Part Three section 9 for provisions relating to confidentiality and data protection in the context of research
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.7 When consent is refused
p.000114:
p.000114:
p.000114: If an adult with capacity to make an informed decision makes a voluntary and appropriately informed
p.000114: decision to refuse treatment or service, this decision must be respected, even where the service user’s decision may
p.000114: result in his or her death. In such cases it is particularly important to accurately document the discussions with the
p.000114: service user, including the procedure that has been offered, the service user’s decision to decline and the
p.000114: fact that the implications of this decision have been fully outlined.
p.000114: Those who provide health and social care services should also consider and discuss with the service user
...
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
p.000114: to consent must also have the capacity to refuse. However, courts in other jurisdictions have held that
p.000114: there is a clear practical distinction to be made between consent to and refusal of medical treatment in
p.000114: that consent involves acceptance of what is an experienced medical view whereas refusal rejects that
p.000114: experience from a position of comparatively limited knowledge. Consequently, it is argued that the implications
p.000114: of refusal may be more serious and, in extreme cases, may even result in death.
p.000114: Section 23 of the Non-Fatal Offences Against the Person Act 1997, while it allows the young person aged
p.000114: 16-18 to give consent to medical treatment, does not include an express entitlement to refuse such treatment.
p.000114: This policy proposes that in cases where an individual between the age of 16 and 18 refuses a treatment or service, in
p.000114: general such refusal should be respected in the same way as for adults. However, if the refusal relates to life
p.000114: sustaining treatment, or other decisions which may have profound, irreversible consequences for him or her, reasonable
p.000114: efforts must be made to discuss the young person’s refusal with all the relevant parties, including the involvement of
p.000114: the HSE Advocacy services and/or a third party mediator where appropriate, in an attempt to reach
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
p.000114: As noted in Section 2, parent(s)/legal guardian(s) are generally considered best placed to safeguard the
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
...
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
...
p.000114: information regarding what will happen to material/data should be provided.
p.000114: • Information about who is organising and funding the research.
p.000114:
p.000114: • A description of any reasonably foreseeable risk, discomfort or disadvantages.
p.000114:
p.000114: • A description of any benefits to the participant or to others which may reasonably be expected from the
p.000114: research, avoiding inappropriate expectations.
p.000114: • A disclosure of appropriate alternative procedures for treatment/diagnosis, if any, that might be advantageous
p.000114: to the participant.
p.000114: • A statement describing the procedures adopted for ensuring data protection/ confidentiality/privacy including
p.000114: duration of storage of personal data.
p.000114: • A description of how incidental findings are to be handled.
p.000114:
p.000114: • A description of any planned genetic tests, including whether results will be disseminated to research
p.000114: participants.
p.000114: • An explanation as to whether there are any treatments or compensation if injury occurs (where relevant) and,
p.000114: if so, what they consist of, or where further information may be obtained. Insurance coverage should be
p.000114: mentioned.
p.000114: • Contact details to access information about the research and research participants' rights.
p.000114:
p.000114: • An explanation of what will happen with the material/data at the end of the research and if the material/data
p.000114: are retained or sent/sold to a third party for further research.
p.000114: • Information about what will happen to the results of the research.
p.000114:
p.000114: • A statement regarding the potential commercialisation of the research (where applicable).
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.2 Who should seek consent?
p.000114:
p.000114:
p.000114: The person obtaining consent should have sufficient knowledge about the research and be capable of
p.000114: answering questions from prospective participants.
p.000114: Depending on the circumstances, prospective research participants may be approached directly (e.g. by advertisement) or
p.000114: indirectly (e.g. by the individual’s GP). Where researchers are not also the service provider, best practice and
p.000114: data protection considerations require that the service provider should act as a gatekeeper and make the initial
p.000114: contact with the prospective participant and provide him/her with the contact details of the research team.
p.000114: There may be situations where the researcher is also directly involved in providing care or support to
p.000114: the individual. Where this is the case, it is essential that any conflict of interest that might arise as a result of
p.000114: the original relationship be acknowledged and that any possibility that the individual might feel obliged to
...
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
p.000114: create a need for alternative life decisions, including those concerning reproductive choices or those with the
p.000114: potential to improve health e.g. dietary modification or career choices.
p.000114: When participants or their relatives are to be informed about genetic data that may be important for their health or
p.000114: lifestyle choices, the disclosure strategy should provide access to genetic and clinical advice/counselling, or
p.000114: clearly recommend to participants that they seek these services. Advice about the results of genetic
p.000114: research needs to include a clear explanation of the difference between research and clinical testing,
p.000114: and to clarify any need for the clinical confirmation of research results by an accredited laboratory.
p.000114: Where people are asked to consent to the collection of their genetic material or data for research, they
p.000114: should be advised:
p.000114: • That, by its nature, genetic material is in principle identifiable, even if personal identifiers are not
p.000114: collected or are removed
p.000114: • That they are free to decline participation without giving reasons
p.000114:
p.000114: • About arrangements to ensure the privacy and confidentiality of their genetic data with regard to both
p.000114: family members and others
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114: 13.2 Payment
p.000114:
p.000114:
p.000114: There may be instances where research participants will be paid for any inconvenience and time given to the study.
p.000114: Payment may be financial (not limited to reimbursement, compensation or nominal levels) or non-financial e.g.
p.000114: entry into prize draws, gift vouchers, book tokens. Payment that is disproportionate to the time involved or is likely
p.000114: to encourage participants to take risks, is ethically unacceptable. The timing of payments must be such that they do
p.000114: not constitute undue inducement.
p.000114: Where researchers wish to offer payment to prospective research participants, they must justify to a REC their
p.000114: reasons as well as the amount/reward being offered. Payments or rewards that undermine a person’s ability
p.000114: to exercise free choice would be deemed to invalidate his/her consent.
p.000114:
p.000114:
p.000114:
p.000114: 14. Audit
p.000114:
p.000114:
p.000114: In general, audit does not require informed consent. If audit is to be conducted by those involved in the care of the
p.000114: individual or their support staff (e.g. clinical audit staff) then explicit consent is not required provided that the
p.000114: individual:
p.000114: • has access to information outlining the possibility that their personal data may be disclosed for local
p.000114: clinical audit; and
p.000114: • has been given an opportunity to opt out.
p.000114:
p.000114: Where clinical audit is to be conducted by an external third party, then the data must be de-
p.000114: identified (therefore no consent would be required). In cases where identifiable data is necessary for clinical audit
p.000114: purposes, the data may only be disclosed to third parties with the explicit consent of the individuals
p.000114: concerned.
p.000114:
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There are a number of key differences between audit and research:
p.000114:
p.000114: Research Audit
p.000114:
p.000114:
p.000114: Purpose
p.000114: To provide new knowledge e.g. to set or change clinical standards.
p.000114: To measure practice against evidence- based standards.
p.000114:
p.000114:
p.000114:
p.000114: Methodology
p.000114: Addresses clearly defined questions/hypotheses using systematic and rigorous processes. Designed so that it can be
p.000114: replicated and results can be generalised to other groups.
p.000114: Addresses clearly defined audit questions using a robust methodology, usually asking whether a specific standard has
p.000114: been met. Results are specific and local.
p.000114:
p.000114:
p.000114: Data Analysis
p.000114: Requires data analysis (i.e. quantitative/ qualitative) to make inferences.
p.000114: Simple statistics (e.g. means, frequencies) to compare audit cycles.
p.000114:
p.000114: Ethical Approval
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Political / vulnerable
Searching for indicator vulnerable:
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p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
p.000075: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
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p.000091:
p.000091:
...
p.000114: While there are no legal provisions relating to the duration of consent, for major interventions it is good practice
p.000114: where possible to seek the service user’s consent to the proposed procedure well in advance, when there
p.000114: is time to respond to the service user’s questions and provide adequate information. Clinicians should then
p.000114: check, before the procedure starts, that the service user has no questions or concerns and still consents to proceed.
p.000114: If there is a significant time-lapse between the initial seeking and giving of consent and the actual date of an
p.000114: intervention, it is helpful to check if the service user can remember the treatment information given
p.000114: previously and if they have any questions in relation to that information. If the service user isn’t satisfied that he
p.000114: or she can remember the earlier information or if he or she has cognitive difficulties that might interfere with his or
p.000114: her recollection of the earlier discussion or there is a change in the service users condition or in the
p.000114: information about the proposed intervention which may result in a change in the nature, purpose or risks
p.000114: associated with the procedure, a fresh consent following provision of appropriate information should be sought.
p.000114: Asking a service user to provide consent just before the procedure is due to start, at a time when they may be feeling
p.000114: particularly vulnerable, or seeking consent from someone who is sedated, in pain or anxious, creates doubt as to the
p.000114: validity of the consent. In particular, service users should not be given routine pre-operative medication before being
p.000114: asked for their consent to proceed with a treatment.
p.000114:
p.000114:
p.000114: 7.4 Types of consent
p.000114:
p.000114:
p.000114: The validity of consent does not depend on the form in which it is given. Service users may indicate
p.000114: consent orally, in writing or in certain limited circumstances by implication (such as where a service user
p.000114: holds out their arm for a blood pressure reading). In all situations, common courtesy and respect for the service user
p.000114: is required.
p.000114:
p.000114:
p.000114:
p.000114: Page 39
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Before accepting a service user’s consent, those who provide health and social care services must consider whether the
p.000114: service user has been given the information they want or need, and how well they understand what is proposed.
p.000114:
p.000114:
...
p.000114: adult lacking decision-making capacity must be obtained from the person’s legal representative, as defined
p.000114: above.
p.000114: Refusal to participate in a research project by an individual lacking decision-making capacity should be
p.000114: respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 29 In July 2012 the European Commission published a proposal to repeal the Clinical Trials Directive 2001/20/EC and for
p.000114: new legislation relating to the conduct of clinical trials on Medicinal Products for Human Use. The new legislation,
p.000114: which is expected to come into effect in 2016, will take the form of a Regulation which will ensure that, in the main,
p.000114: the rules governing clinical trials will be identical throughout Europe . Other aspects, such as the structure and
p.000114: function of RECs and eligibility for the role of legal representative will be decided at a national level
p.000114: 30 It is also important to note that the European Commission is in the process of reviewing EU legal frameworks
p.000114: relating to medical devices and on the protection of personal data
p.000114:
p.000114: Page 77
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
...
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
...
p.002003: Children (2012)
p.002003: Dublin Hospitals Group Risk Management Forum (2010).Matters for consideration regarding Do Not Attempt to Resuscitate
p.002003: Orders for Adult Patients
p.002003: European Union Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric
p.002003: Population (2008)
p.002003: General Medical Council (2010) Treatment and care towards the end of life: good practice in decision
p.002003: making. General Medical Council, London
p.002003: Hospice Friendly Hospitals Programme and the National Council on Ageing and Older People (2008).End-of-Life
p.002003: Care for Older People in Acute and Long-Stay Care Settings in Ireland Joint Statement Dublin
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline Clinical Investigation of Medicinal
p.002003: Products in the Pediatric Population E11 (2000)
p.002003: Irish Council for Bioethics Human Biological Material: Recommendations for Collection, Use and Storage in Research
p.002003: (2005)
p.002003: Law Reform Commission Report on Vulnerable Adults and the Law (LRC 83 -2006) (available at www.lawreform.ie)
p.002003: Law Reform Commission Report on Advance Care Directives (LRC 94–2009) (available at
p.002003: www.lawreform.ie)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 119
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th Ed) (2009)
p.002003: (available at www.medicalcouncil.ie)
p.002003: Medical Research Council (MRC).MRC Ethics Guide.Medical Research Involving Children (2004).
p.002003:
p.002003: Medical Research Council (MRC).MRC Ethics Guide. Medical Research Involving Adults who cannot Consent (2007)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
...
Searching for indicator vulnerability:
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p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
p.000114: Page 73
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
...
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
...
p.000114: function of RECs and eligibility for the role of legal representative will be decided at a national level
p.000114: 30 It is also important to note that the European Commission is in the process of reviewing EU legal frameworks
p.000114: relating to medical devices and on the protection of personal data
p.000114:
p.000114: Page 77
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
...
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.000114: retain the information. Sensitive issues should be discussed in an appropriate location to ensure that the service
p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 26
p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
...
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 29
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5. Has the service user the capacity to make the decision?
p.000114:
p.000114:
p.000114: 5.1 General principles
p.000114:
p.000114:
p.000114: Best practice favours a ‘functional’ or decision-specific approach to defining decision-making capacity: that
p.000114: capacity is to be judged in relation to a particular decision to be made, at the time it is to be made - in other words
p.000114: it should be issue specific and time specific – and depends upon the ability of an individual to comprehend,
p.000114: reason with and express a choice with regard to information about the specific decision. The “functional”
p.000114: approach recognises that there is a hierarchy of complexity in decisions and also that cognitive
p.000114: deficits are only relevant if they actually impact on decision making.
p.000114:
p.000114:
p.000114: 5.2 Duty to maximise capacity
p.000114:
p.000114:
p.000114: Best practice and international human rights standards favour “supported decision-making” where possible. This
p.000114: requires that efforts must be made to support individuals in making decisions for themselves where this is possible. A
p.000114: service user’s ability to make decisions may depend on the nature and severity of their condition, or the
p.000114: difficulty or complexity of the decision. Some service users will always be able to make simple decisions, but may
p.000114: have difficulty if the decision is complex or involves a number of options. Other service users may be able to make
p.000114: decisions at certain times but not at other times, because of fluctuations in their condition or because factors such
p.000114: as confusion, panic, shock, fatigue, pain or medication temporarily affect their ability to understand,
p.000114: retain or weigh up information, or communicate their wishes.
p.000114:
p.000114:
p.000114: It is important to give those who may have difficulty making decisions the time and support they need to maximise their
p.000114: ability to make decisions for themselves.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 30
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Approaches that may be helpful in this regard include:
p.000114:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations, or having written or audio information about their condition
p.000114: • Speak to those close to the service user and to other health and social care staff about the best ways
p.000114: of communicating with the service user, taking account of confidentiality issues.
p.000114:
p.000114:
p.000114: 5.3 Presumption of capacity
p.000114:
p.000114:
p.000114: Those who provide health and social care services must work on the presumption that every adult service
p.000114: user has the capacity to make decisions about their care, and to decide whether to agree to, or refuse, an examination,
p.000114: investigation or treatment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of their age, disability,
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 31
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.4 When to consider incapacity
p.000114:
p.000114:
p.000114: An important implication of the presumption of capacity is that this presumption should not be challenged unless an
p.000114: adequate “trigger” exists. All service users may experience temporary lack of capacity due to severe illness, loss of
p.000114: consciousness or other similar circumstances.
p.000114:
p.000114:
p.000114: The possibility of incapacity and the need to assess capacity formally should only be considered,
p.000114: if, having been given all appropriate help and support, a service user:
p.000114:
p.000114: • is unable to communicate a clear and consistent choice or
p.000114:
p.000114: • is obviously unable to understand and use the information and choices provided.
p.000114:
p.000114:
p.000114: 5.5 Assessing capacity to consent
p.000114:
p.000114:
p.000114: Capacity to consent should be assessed if there is sufficient reason, as indicated in Section 5.4, to question the
p.000114: presumption of capacity. This involves assessing whether:
p.000114: • The service user understands in broad terms and believes the reasons for and nature of the
p.000114: decision to be made
p.000114: • The service user has sufficient understanding of the principal benefits and risks of an intervention and
p.000114: relevant alternative options after these have been explained to them in a manner and in a language appropriate
p.000114: to their individual level of cognitive functioning
p.000114: • The service user understands the relevance of the decision, appreciates the advantages
p.000114: and disadvantages in relation to the choices open to them and is able to retain this knowledge long enough to make a
p.000114: voluntary choice.
p.000114: The fact that a person may not, in their current situation have sufficient understanding or appreciation
p.000114: regarding a decision should in the first instance signal a requirement for the provision of supports in
p.000114: order to ensure that the decision-making capacity of the individual is enhanced to the greatest degree
p.000114: possible, rather than an inevitable finding of incapacity to make that decision.
p.000114:
p.000114: Page 32
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.6 Making decisions if capacity is absent
p.000114:
p.000114:
p.000114: There is currently no legislative framework to govern how a decision about treatment and care should be made for those
p.000114: who lack capacity to make that decision themselves.
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
p.000114: capacity, the health and social care professional should determine what is in their best interests, which is decided by
p.000114: reference to their values and preferences if known.
p.000114:
p.000114:
p.000114: The health and social care professional should:
p.000114:
p.000114: • Consider whether the service user's lack of capacity is temporary or permanent. In those with
p.000114: fluctuating cognitive impairment, it may be possible to make use of lucid periods to obtain consent
p.000114: • Consider which options for treatment would provide overall clinical benefit for the service user
p.000114: • Consider which option, including the option not to treat, would be least restrictive of the service user's
p.000114: future choices
p.000114: • Support and encourage service users to be involved, as far as they want to and are able, in decisions
p.000114: about their treatment and care
p.000114: • Seek any evidence of the service user's previously expressed preferences, such as an advance statement
p.000114: or decision, and of the service user’s previous wishes and beliefs
p.000114: • Consider the views of anyone the service user asks you to consult
p.000114:
p.000114: • Consider the views of people who have a close, ongoing, personal relationship with the service user such
p.000114: as family or friends
p.000114: • Consider involving an advocate to support the service user who lacks capacity to participate in the
p.000114: decision making process around consent. This may be particularly helpful in difficult situations such
p.000114: as when service users with no family or friends have to make a complex decision; or when there is
p.000114: significant disagreement regarding the best course of action.
p.000114:
p.000114:
p.000114: Page 33
p.000114:
...
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.3 When should consent be sought?
p.000114:
p.000114:
p.000114: The provision of information and the seeking and giving of consent should involve a continuing process of keeping
p.000114: service users up to date with any changes in their condition and the interventions proposed. It
p.000114: should not be a once-off, sometimes ‘eleventh hour’ event, exemplified by getting a hurried signature
p.000114: on a consent form.
p.000114: While there are no legal provisions relating to the duration of consent, for major interventions it is good practice
p.000114: where possible to seek the service user’s consent to the proposed procedure well in advance, when there
p.000114: is time to respond to the service user’s questions and provide adequate information. Clinicians should then
p.000114: check, before the procedure starts, that the service user has no questions or concerns and still consents to proceed.
p.000114: If there is a significant time-lapse between the initial seeking and giving of consent and the actual date of an
p.000114: intervention, it is helpful to check if the service user can remember the treatment information given
p.000114: previously and if they have any questions in relation to that information. If the service user isn’t satisfied that he
p.000114: or she can remember the earlier information or if he or she has cognitive difficulties that might interfere with his or
p.000114: her recollection of the earlier discussion or there is a change in the service users condition or in the
p.000114: information about the proposed intervention which may result in a change in the nature, purpose or risks
p.000114: associated with the procedure, a fresh consent following provision of appropriate information should be sought.
p.000114: Asking a service user to provide consent just before the procedure is due to start, at a time when they may be feeling
p.000114: particularly vulnerable, or seeking consent from someone who is sedated, in pain or anxious, creates doubt as to the
p.000114: validity of the consent. In particular, service users should not be given routine pre-operative medication before being
p.000114: asked for their consent to proceed with a treatment.
p.000114:
p.000114:
p.000114: 7.4 Types of consent
p.000114:
p.000114:
p.000114: The validity of consent does not depend on the form in which it is given. Service users may indicate
p.000114: consent orally, in writing or in certain limited circumstances by implication (such as where a service user
p.000114: holds out their arm for a blood pressure reading). In all situations, common courtesy and respect for the service user
p.000114: is required.
p.000114:
p.000114:
p.000114:
p.000114: Page 39
p.000114:
...
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 3.2 Involving the individual in discussions regarding CPR
p.000114:
p.000114:
p.000114: Decisions pertaining to CPR and DNAR orders should be made in the context of the likelihood of success and the
p.000114: potential risks as well as the individual’s overall goals and preferences for his/her treatment and care.
p.000114: Determination of the former requires discussion with the individual him/ herself.
p.000114: Decisions relating to CPR and DNAR orders are complex and potentially emotive therefore, it is important for such
p.000114: issues to be dealt with in an open, honest and sensitive manner.
p.000114: On-going communication between individuals, those close to them (where appropriate) and healthcare
p.000114: professionals is essential in achieving this goal (see also Section 6.5).
p.000114:
p.000114:
p.000114: 3.3 Involving family or friends in discussions regarding CPR
p.000114:
p.000114:
p.000114: If the individual wishes to have the support or involvement of others, such as family or friends, in decision making,
p.000114: this should be respected. If a person has decision-making capacity then his/her family or friends should only be
p.000114: involved in discussions regarding his/her treatment and care with that individual’s consent. If the individual is
p.000114: unable to participate in discussions due to his/her physical or cognitive condition, those with a close,
p.000114: on-going, personal relationship with the individual may have insight into his/her previously expressed
p.000114: preferences, wishes and beliefs. They may also have their own views as to the appropriateness or
p.000114: otherwise of interventions, based on their knowledge of the individual’s circumstances. In general, the closer the
p.000114: relationship to the individual, the greater weight should attach to such views. However, the role of those close to
p.000114: the individual is not to make the final decision regarding CPR, but rather to help the senior
p.000114: healthcare professional to make the most appropriate decision. Where CPR is judged inappropriate,
p.000114: it is good practice to inform those close to the patient, but there is no need to seek their ‘permission’ not to
p.000114: perform CPR in these circumstance (see also Part One Section 5.6.1).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 101
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 3.4 Decision-making capacity
p.000114:
p.000114:
p.000114: Best practice utilises a functional approach to defining decision-making capacity whereby capacity
...
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p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
...
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
...
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p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 26
p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 28
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
...
p.000114: possible, rather than an inevitable finding of incapacity to make that decision.
p.000114:
p.000114: Page 32
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.6 Making decisions if capacity is absent
p.000114:
p.000114:
p.000114: There is currently no legislative framework to govern how a decision about treatment and care should be made for those
p.000114: who lack capacity to make that decision themselves.
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
p.000114: capacity, the health and social care professional should determine what is in their best interests, which is decided by
p.000114: reference to their values and preferences if known.
p.000114:
p.000114:
p.000114: The health and social care professional should:
p.000114:
p.000114: • Consider whether the service user's lack of capacity is temporary or permanent. In those with
p.000114: fluctuating cognitive impairment, it may be possible to make use of lucid periods to obtain consent
p.000114: • Consider which options for treatment would provide overall clinical benefit for the service user
p.000114: • Consider which option, including the option not to treat, would be least restrictive of the service user's
p.000114: future choices
p.000114: • Support and encourage service users to be involved, as far as they want to and are able, in decisions
p.000114: about their treatment and care
p.000114: • Seek any evidence of the service user's previously expressed preferences, such as an advance statement
p.000114: or decision, and of the service user’s previous wishes and beliefs
p.000114: • Consider the views of anyone the service user asks you to consult
p.000114:
p.000114: • Consider the views of people who have a close, ongoing, personal relationship with the service user such
p.000114: as family or friends
p.000114: • Consider involving an advocate to support the service user who lacks capacity to participate in the
p.000114: decision making process around consent. This may be particularly helpful in difficult situations such
p.000114: as when service users with no family or friends have to make a complex decision; or when there is
p.000114: significant disagreement regarding the best course of action.
p.000114:
p.000114:
p.000114: Page 33
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
Health / Comatose
Searching for indicator coma:
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p.000114: capacity
p.000114: 7 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: 8 See section 5.5 for provisions relating to the assessment of capacity
p.000114: Page 34
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5.6.3 Non-emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In non-emergency situations, a distinction can be made between those service users who, depending on the
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
...
Health / Drug Dependence
Searching for indicator dependency:
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p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
...
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000114: • Participants should be advised of the risks of re-identification in the event of data security breaches.
p.000114:
p.000114:
p.000114: 2.1.4 Commercialisation
p.000114:
p.000114:
p.000114: • Researchers should clearly explain to research participants whether or not they will receive payment
p.000114: (either financial or non-financial) for participating in the research project or have their expenses covered.
p.000114: • Research participants should be made aware that they will not be entitled to a share of any
p.000114: profits that may arise from use of their material/data or products derived from it.
p.000114: • Researchers should disclose any conflict of interest they may have e.g. a financial interest in the
p.000114: study.
p.000114: (See Figure 1 for a list of sample information which might be included in a consent form)
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 69
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Figure 1.
p.000114:
p.000114: • A statement that the study involves research participants and an explanation of the purposes of the research.
p.000114: • The expected duration of the participant's involvement.
p.000114:
p.000114: • A description of the procedures to be followed/drug to be tested, and an identification of any procedures
p.000114: which are experimental.
p.000114: • A statement that participation is voluntary including a statement offering the participant the opportunity to
p.000114: ask questions and to withdraw at any time from the research without consequences. In the case of withdrawal,
p.000114: information regarding what will happen to material/data should be provided.
p.000114: • Information about who is organising and funding the research.
p.000114:
p.000114: • A description of any reasonably foreseeable risk, discomfort or disadvantages.
p.000114:
p.000114: • A description of any benefits to the participant or to others which may reasonably be expected from the
p.000114: research, avoiding inappropriate expectations.
p.000114: • A disclosure of appropriate alternative procedures for treatment/diagnosis, if any, that might be advantageous
p.000114: to the participant.
p.000114: • A statement describing the procedures adopted for ensuring data protection/ confidentiality/privacy including
p.000114: duration of storage of personal data.
p.000114: • A description of how incidental findings are to be handled.
p.000114:
p.000114: • A description of any planned genetic tests, including whether results will be disseminated to research
p.000114: participants.
p.000114: • An explanation as to whether there are any treatments or compensation if injury occurs (where relevant) and,
p.000114: if so, what they consist of, or where further information may be obtained. Insurance coverage should be
p.000114: mentioned.
p.000114: • Contact details to access information about the research and research participants' rights.
...
Searching for indicator influence:
(return to top)
p.000035: 6.1 Emergency situations
p.000036: 36
p.000036: 6.2 Where the service user declines information
p.000036: 36
p.000036: 7. Specific issues relating consent
p.000037: 37
p.000037: 7.1 Scope of consent
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
p.000042: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Page 6
p.000055:
p.000055: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000055: validation against the controlled version
p.000055:
...
p.000114: usually enough for staff to seek consent to proceed after a brief description of the intervention.
p.000114: Refusal of permission, especially if it may be harmful to the service user or a request for additional
p.000114: information should trigger additional discussion.
p.000114: Although service users may be provided with standardised informational material, they should be told if their
p.000114: particular circumstances might modify the risks or benefits as stated in such material.
p.000114: Service users should be asked if they have understood the information they have been given, and whether or not they
p.000114: would like more information before making a decision. Questions should be answered honestly and, as far as practical,
p.000114: as fully as the service users wishes.
p.000114:
p.000114:
p.000114: 3.3 What information about risks and side effects of an intervention should be provided?
p.000114:
p.000114:
p.000114: The amount of information about risk that staff should share with service users will depend on the individual service
p.000114: user and what they want or need to know. Although most service users will be aware that no physical procedure or
p.000114: medication is entirely risk free, they may not be as familiar with the potential risks of common
p.000114: procedures such as the administration of blood products or radiographic procedures. Factors such as service
p.000114: users’ occupations or lifestyles may influence those risks that they consider significant or particularly undesirable.
p.000114: A general rule is to provide information that a reasonable person in the service user’s situation would expect to be
p.000114: told. This is in line with ethical and professional standards as well as the legal standard applied by the Irish
p.000114: courts. Such information includes the likelihood of:
p.000114: • side effects or complications of an intervention;
p.000114:
p.000114: • failure of an intervention to achieve the desired aim; and
p.000114:
p.000114: • the risks associated with taking no action or with taking an alternative approach.
p.000114:
p.000114: A risk may be seen as material/significant if a reasonable person in the patient's position if warned of
p.000114: the risk would attach significance to it. Such risks must be disclosed to the patient.
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
...
p.000114:
p.000114:
p.000114: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the Mental Health Act 2001
p.000114:
p.000114:
p.000114: Where the service user has been involuntarily admitted to an approved centre under the Mental Health Act 2001, the
p.000114: procedures in respect of treatment must comply with the provisions of that Act. In some limited cases, the Act
p.000114: allows mental health treatment to be provided even if the service user is unwilling or unable to consent
p.000114: provided that the requirements of the Act are met. However, this does not remove the ethical imperative to seek the
p.000114: consent of the service user and to make every effort to ensure that the treatment is acceptable to the service user.
p.000114:
p.000114: Nor does the Mental Health Act 2001 remove the ethical obligation to maximise service user capacity and
p.000114: to involve service users lacking capacity in the decision-making process to the greatest extent possible.
p.000114: All care given to the service user should be explained to him/her once their condition improves.
p.000114: Where the service user who has been admitted under the 2001 Act requires any other treatment or intervention not
p.000114: related to their mental health, the general principles of consent apply as discussed in this policy.
p.000114:
p.000114:
p.000114: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of Garda investigations into driving under
p.000114: the influence of alcohol and/or drugs
p.000114:
p.000114:
p.000114: The general principles regarding consent apply when testing for intoxicants. When such testing is clinically indicated,
p.000114: the urgency of the situation in which such testing commonly occurs means that explicit discussion of the pros and cons
p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
p.000114: Page 43
p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
p.000114:
p.000114:
p.000114: 7.8 Advance refusal of treatment
p.000114:
p.000114:
p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
p.000114: including advance refusal of medical treatment. There is no Irish legislation confirming the enforceability of such
...
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
...
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There are a number of key differences between audit and research:
p.000114:
p.000114: Research Audit
p.000114:
p.000114:
p.000114: Purpose
p.000114: To provide new knowledge e.g. to set or change clinical standards.
p.000114: To measure practice against evidence- based standards.
p.000114:
p.000114:
p.000114:
p.000114: Methodology
p.000114: Addresses clearly defined questions/hypotheses using systematic and rigorous processes. Designed so that it can be
p.000114: replicated and results can be generalised to other groups.
p.000114: Addresses clearly defined audit questions using a robust methodology, usually asking whether a specific standard has
p.000114: been met. Results are specific and local.
p.000114:
p.000114:
p.000114: Data Analysis
p.000114: Requires data analysis (i.e. quantitative/ qualitative) to make inferences.
p.000114: Simple statistics (e.g. means, frequencies) to compare audit cycles.
p.000114:
p.000114: Ethical Approval
p.000114: Required.
p.000114: May not be required.
p.000114:
p.000114:
p.000114: New Treatments
p.000114: May involve a completely new treatment or practice.
p.000114: Will never involve a completely new treatment or practice.
p.000114:
p.000114:
p.000114: Randomisation
p.000114: May involve allocating individuals randomly to different treatment groups.
p.000114: Will never involve allocating individuals randomly to different treatment groups.
p.000114:
p.000114: Sample Size
p.000114: Statistically powered calculation.
p.000114: Sufficient number of cases to influence practice based on findings.
p.000114:
p.000114:
p.000114: Outcome
p.000114: Improved knowledge.
p.000114: Strategies in place to improve clinical practice.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 94
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 95
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.000114: researcher must divulge this information to the appropriate authorities. This should occur only following
p.000114: discussion with the child. The child and his/her parent(s)/legal guardian(s) should be informed of this
p.000114: obligation during the consent/assent process and it should be highlighted in participant information leaflets. A
p.000114: strategy for information disclosure should be submitted to and approved by the REC in advance of the
p.000114: research being commenced.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 74
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000114: users’ occupations or lifestyles may influence those risks that they consider significant or particularly undesirable.
p.000114: A general rule is to provide information that a reasonable person in the service user’s situation would expect to be
p.000114: told. This is in line with ethical and professional standards as well as the legal standard applied by the Irish
p.000114: courts. Such information includes the likelihood of:
p.000114: • side effects or complications of an intervention;
p.000114:
p.000114: • failure of an intervention to achieve the desired aim; and
p.000114:
p.000114: • the risks associated with taking no action or with taking an alternative approach.
p.000114:
p.000114: A risk may be seen as material/significant if a reasonable person in the patient's position if warned of
p.000114: the risk would attach significance to it. Such risks must be disclosed to the patient.
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
p.000114: Information about risk should be given in a balanced way. Service users may understand information about
p.000114: risk differently from those providing health and social care. This is particularly true when using descriptive terms
p.000114: such as ‘often’ or ‘uncommon’. Potential biases related to how risks are ‘framed’ are important: a 1 in a thousand risk
p.000114: of a complication also means that 999 out of a thousand service users will not experience that complication.
p.000114: In order to best support service users in assessing the risks and benefits of various interventions/ course of action
p.000114: consideration should be given to:
p.000114: • Designing and employing communications that use plain language
p.000114:
p.000114:
p.000114: • Avoid explaining risks in purely descriptive terms (such as low risk), try to supplement with numerical
p.000114: data
p.000114: • Use absolute numbers or percentages; avoid using relative risk or percentage improvements
p.000114: • Use visual aids e.g. pictographs wherever possible, to maximise understanding.
p.000114:
p.000114:
p.000114: 3.4 How and when information should be provided
p.000114:
p.000114:
p.000114: The manner in which the health and social care options are discussed with a service user is as important as the
p.000114: information itself. The following measures are often helpful:
...
p.000114: retain the information. Sensitive issues should be discussed in an appropriate location to ensure that the service
p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
...
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Approaches that may be helpful in this regard include:
p.000114:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations, or having written or audio information about their condition
p.000114: • Speak to those close to the service user and to other health and social care staff about the best ways
p.000114: of communicating with the service user, taking account of confidentiality issues.
p.000114:
p.000114:
p.000114: 5.3 Presumption of capacity
p.000114:
p.000114:
p.000114: Those who provide health and social care services must work on the presumption that every adult service
p.000114: user has the capacity to make decisions about their care, and to decide whether to agree to, or refuse, an examination,
p.000114: investigation or treatment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of their age, disability,
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.4 When to consider incapacity
p.000114:
p.000114:
...
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
...
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
p.000114: • the minor’s views are stable and a true reflection of his or her core values and beliefs,
p.000114: taking into account his or her physical and mental health and any other factors that affect his or her
p.000114: ability to exercise independent judgement;
p.000114: • the nature, purpose and usefulness of the treatment or social care intervention;
p.000114:
p.000114: • the risks and benefits involved in the treatment or social care intervention, and
p.000114:
p.000114: • any other specific welfare, protection or public health considerations, in respect of which relevant
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 54
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
...
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
p.000114: create a need for alternative life decisions, including those concerning reproductive choices or those with the
p.000114: potential to improve health e.g. dietary modification or career choices.
p.000114: When participants or their relatives are to be informed about genetic data that may be important for their health or
p.000114: lifestyle choices, the disclosure strategy should provide access to genetic and clinical advice/counselling, or
p.000114: clearly recommend to participants that they seek these services. Advice about the results of genetic
p.000114: research needs to include a clear explanation of the difference between research and clinical testing,
...
p.000114: the participant. Incidental findings and/or research results (especially in the case of genetic research)
p.000114: should be confirmed by an accredited laboratory.
p.000114: In cases where incidental findings are regarded to be of vital and immediate clinical significance (e.g. tumours,
p.000114: blood clots, aneurysms), the researcher involved has a duty of care to that individual. Prospective
p.000114: research participants must be advised that such a duty of care exists during the consent process.
p.000114: Researchers should be especially aware of their obligations to protect the confidentiality of research
p.000114: participants when releasing data to third parties. For instance, in the case of genetic research, family
p.000114: members may need to be informed of potential genetic risks. Similarly, data may be of interest to other researchers or
p.000114: biobanks.
p.000114: Provided that consent is in place, transfer of identifiable data to such third parties is permissible and provided a
p.000114: comparable level of security and protection of privacy can be ensured. (For more information on Consent and controlling
p.000114: access to data see Section 9).
p.000114: The Disability Act 2005 (Part 4) provides that insurers cannot request, take into account or process the
p.000114: results of genetic tests (for a more in-depth discussion of genetic research see Section 6.1).
p.000114: Certain types of information may be made available to public health officials for important purposes, for
p.000114: example, the reporting of infectious diseases, without the explicit consent of the individual.
p.000114:
p.000114:
p.000114:
p.000114: 9. Consent and controlling access to data
p.000114:
p.000114:
p.000114: Research participants who have given appropriate consent have a right to expect that identifiable data about
p.000114: themselves, either provided or discovered in the course of research, will not be shared with others without their
p.000114: consent.
p.000114:
p.000114:
p.000114:
p.000114: Page 89
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Anonymous data is beyond the scope of the Data Protection Acts, therefore, consent is not required in
p.000114: order to conduct research using this form of data. However, use of anonymous data is not always possible, or indeed
...
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergency situation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
p.000114: relating to resuscitation procedures; therefore, such issues are not dealt with in this policy.
p.000114:
p.000114:
p.000114:
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...
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
p.000114: In particular, individuals are the best judges of their own quality of life; healthcare professionals and families
p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 3.2 Involving the individual in discussions regarding CPR
p.000114:
p.000114:
p.000114: Decisions pertaining to CPR and DNAR orders should be made in the context of the likelihood of success and the
p.000114: potential risks as well as the individual’s overall goals and preferences for his/her treatment and care.
p.000114: Determination of the former requires discussion with the individual him/ herself.
p.000114: Decisions relating to CPR and DNAR orders are complex and potentially emotive therefore, it is important for such
p.000114: issues to be dealt with in an open, honest and sensitive manner.
...
p.002003: Law Reform Commission Report on Advance Care Directives (LRC 94–2009) (available at
p.002003: www.lawreform.ie)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 119
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th Ed) (2009)
p.002003: (available at www.medicalcouncil.ie)
p.002003: Medical Research Council (MRC).MRC Ethics Guide.Medical Research Involving Children (2004).
p.002003:
p.002003: Medical Research Council (MRC).MRC Ethics Guide. Medical Research Involving Adults who cannot Consent (2007)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
p.002003: National Disability Authority, Ethical Guidance for Research with People with Disabilities (October 2009)
p.002003: National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee.
p.002003: National Statement on Ethical Conduct in Human Research (2007)
p.002003: National Health and Medical Research Council (Australia) Biobank Information Paper (2010)
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
p.002003:
p.002003: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.002003: Subjects (1964 – 2008)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 120
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Academic Commentary
p.002003:
...
p.002003: and possible measures to improve survival. Intensive Care Medicine 33(2): 237–245
p.002003: Smith GB, Poplett N and Williams D (2005).Staff awareness of a ‘Do Not Attempt Resuscitation’ policy in a
p.002003: District General Hospital. Resuscitation 65(2): 159-165
p.002003: Staunton ‘The Development of Healthcare Planning in Ireland’ (2009) 15 Medico-Legal Journal of Ireland 74
p.002003: Whelan Mental Health Law and Policy (Thompson Roundhall, 2009)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
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p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: National Consent Advisory Group Membership
p.002003:
p.002003:
p.002003: Name
p.002003: Title
p.002003: Organisation
p.002003: Role
p.002003:
p.002003:
p.002003: Deirdre Madden Angela Hughes Ann Duffy
p.002003: Anne Marie Loftus
p.002003:
p.002003:
p.002003: Austin Warters Bill Ebbitt
p.002003: Caoimhe Gleeson
p.002003: Senior Lecturer, Faculty of Law National Quality Lead
p.002003: Clinical Risk Advisor Clinical
p.002003: Indemnity Scheme
p.002003:
p.002003: Director of Nursing and Midwifery, Sligo General Hospital
p.002003:
p.002003: Manager of Older Persons Services
p.002003: General Manager, National Disability Unit
p.002003:
p.002003: National Specialist in Accessibility & Equality Officer
p.002003: University College Cork
p.002003:
p.002003: HSE, Quality & Patient Safety Division
p.002003:
p.002003: State Claims Agency
p.002003:
p.002003: Irish Association of Directors of Nursing and Midwifery
p.002003:
p.002003: HSE
p.002003:
p.002003: HSE, Integrated Services Division
p.002003:
p.002003: HSE, Advocacy Unit, Quality & Patient Safety
p.002003: Chair
p.002003:
p.002003: Programme Lead, Deputy Chair
p.002003:
p.002003: Member Member Member
p.002003: Member
p.002003:
p.002003:
p.002003: Member
p.002003:
p.002003:
p.002003: Catherine Whelan Gary Davis
p.002003: Kevin Kelleher
p.002003: Director, Independent Hospitals Association Ireland
p.002003:
p.002003: Deputy Data Protection Officer
p.002003:
p.002003: Assistant National Director Pop- ulation Health - Health Protec- tion
p.002003: Independent Hospitals Association Ireland
p.002003:
p.002003: Office of the Data Protection Commissioner
p.002003:
p.002003: HSE
p.002003: Member Member Member
p.002003:
p.002003: Mary Donnelly Mary Dowling Mary O’Meara
p.002003: Senior Lecturer, Faculty of Law Clinical Risk Manager
p.002003: Senior Medical Officer
p.002003: University College Cork
p.002003:
p.002003: HSE, St. Lukes General Hospital, Kilkenny
p.002003: National Immunisation Office
p.002003: Member Member Member
p.002003:
p.002003: Mary Vasseghi
p.002003:
p.002003: Phil Garland Samantha Hughes
p.002003: Shane Brennan Shaun O’Keeffe
p.002003: Service User
p.002003:
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
p.000030: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
p.000034: 5.6.2 Emergency situations involving service users who lack capacity 34
p.000034: 5.6.3 Non-emergency situations involving service users who lack capacity 35
p.000034: 5.7 Wards of court
p.000035: 35
p.000035: 6. Is it always necessary to seek consent from a service user? 36
p.000035: 6.1 Emergency situations
p.000036: 36
p.000036: 6.2 Where the service user declines information
p.000036: 36
p.000036: 7. Specific issues relating consent
p.000037: 37
p.000037: 7.1 Scope of consent
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
...
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Page 8
p.000091:
p.000091:
p.000091: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000091: validation against the controlled version
p.000091:
p.000091: National Consent Policy HSE V.1.3
p.000091:
p.000091:
p.000091: Table of contents
p.000091:
p.000091:
p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
p.000098: 2. Definition and scope of resuscitation decisions 99
p.000098: 2.1 Do not attempt resuscitation or do not resuscitate
p.000099: 99
p.000099: 2.2 Scope of DNAR orders
p.000099: 99
p.000099: 3. General principles
p.000100: 100
p.000100: 3.1 Need for individual decision making
p.000100: 100
p.000100: 3.2 Involving the individual in discussions regarding CPR
p.000101: 101
p.000101: 3.3 Involving family or friends in discussions regarding CPR 101
p.000101: 3.4 Decision-making capacity
p.000102: 102
p.000102: 3.5 Provision of information
p.000102: 102
p.000102: 3.6 Decision-making regarding CPR and DNAR orders 102
p.000102: 4. When should CPR and DNAR decisions be considered? 103
p.000102: 4.1 Cardiorespiratory arrest is considered unlikely
p.000103: 103
p.000103: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable 104
p.000103: 4.3 Cardiorespiratory arrest is considered possible or likely 104
p.000103: Page 9
p.000103: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000103: validation against the controlled version
p.000103:
p.000103: National Consent Policy HSE V.1.3
p.000103: Table of contents
p.000103: Page
p.000103: 5. Presumption in favour of providing CPR 105
p.000103: 6. Balancing the benefits and risks of providing CPR 106
p.000103: 6.1 Respecting an individual’s refusal of CPR
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
...
p.000114: service.
p.000114:
p.000114:
p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
p.000114:
p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 13
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
p.000114: A person who is less than 18 years of age, who is not or has not been married.
p.000114:
p.000114:
p.000114: Personal data
p.000114: Data relating to a living individual who is or can be identified either from the data or from the data in conjunction
p.000114: with other information that is in, or is likely to come into, the possession of the data controller.
p.000114:
p.000114:
p.000114: Reasonable person
p.000114: A person who exercises average care, skill, caution and judgement.
p.000114:
p.000114:
p.000114: Service provider
p.000114: Any person, organisation or part of an organisation delivering health and social care services.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 15
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
...
p.000114: made by service users and those providing theircare.
p.000114: Good decision making requires a dialogue between parties that recognises and acknowledges the service user’s goals,
p.000114: values and preferences as well as the specialist knowledge, experience and clinical judgment of health and social care
p.000114: professionals.
p.000114:
p.000114:
p.000114: 1.4 Consent in Irish law
p.000114:
p.000114:
p.000114: It is a basic rule at common law that consent must be obtained for medical examination, treatment,
p.000114: service or investigation. This is well established in Irish case law and ethical standards. The requirement for consent
p.000114: is also recognised in international and European human rights law and under the Irish Constitution.
p.000114:
p.000114:
p.000114:
p.000114: Page 21
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
...
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 28
p.000114:
...
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursing home if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 29
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5. Has the service user the capacity to make the decision?
p.000114:
p.000114:
p.000114: 5.1 General principles
p.000114:
p.000114:
p.000114: Best practice favours a ‘functional’ or decision-specific approach to defining decision-making capacity: that
p.000114: capacity is to be judged in relation to a particular decision to be made, at the time it is to be made - in other words
...
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
p.000114: capacity, the health and social care professional should determine what is in their best interests, which is decided by
p.000114: reference to their values and preferences if known.
p.000114:
p.000114:
p.000114: The health and social care professional should:
p.000114:
p.000114: • Consider whether the service user's lack of capacity is temporary or permanent. In those with
p.000114: fluctuating cognitive impairment, it may be possible to make use of lucid periods to obtain consent
p.000114: • Consider which options for treatment would provide overall clinical benefit for the service user
p.000114: • Consider which option, including the option not to treat, would be least restrictive of the service user's
p.000114: future choices
p.000114: • Support and encourage service users to be involved, as far as they want to and are able, in decisions
p.000114: about their treatment and care
p.000114: • Seek any evidence of the service user's previously expressed preferences, such as an advance statement
p.000114: or decision, and of the service user’s previous wishes and beliefs
p.000114: • Consider the views of anyone the service user asks you to consult
p.000114:
p.000114: • Consider the views of people who have a close, ongoing, personal relationship with the service user such
p.000114: as family or friends
p.000114: • Consider involving an advocate to support the service user who lacks capacity to participate in the
p.000114: decision making process around consent. This may be particularly helpful in difficult situations such
p.000114: as when service users with no family or friends have to make a complex decision; or when there is
p.000114: significant disagreement regarding the best course of action.
p.000114:
p.000114:
p.000114: Page 33
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114: 5.6.1 Role of the family
p.000114:
p.000114:
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service6 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so7.
p.000114: However, it may be helpful to include those who have a close, ongoing, personal relationship with the
p.000114: service user, in particular anyone chosen by the service user to be involved in treatment decisions, in the
p.000114: discussion and decision-making process pertaining to health and social care interventions.
p.000114: Their role in such situations is not to make the final decision, but rather to provide greater insight into his/her
p.000114: previously expressed views and preferences and to outline what they believe the individual would have
p.000114: wanted. In some cases, involvement of those close to the service user will facilitate the service user in reaching a
p.000114: decision in conjunction with health/social care providers.
p.000114:
p.000114:
p.000114: 5.6.2 Emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In emergency situations where a service user is deemed to lack capacity8 consent is not necessary.
p.000114: The health and social care professional may treat the service user provided the treatment is immediately
...
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.6 Confidentiality and data protection
p.000114:
p.000114:
p.000114: Service users have a right to expect that information about them will be held in confidence by those who provide health
p.000114: and social care services to them. Confidentiality is central to trust in this relationship. Staff are expected to
p.000114: comply with the provisions of the Data Protection Acts 1988 and 2003 which state that personal
p.000114: information obtained from service users for the purposes of informing care, treatment or service provision
p.000114: should not be disclosed to a third party unless the service user has consented or unless the specific
p.000114: requirements of the legislation are complied with11. (The legislation distinguishes between “sensitive” and
p.000114: “non-sensitive” data. For non-sensitive data, information may be shared (“processed”) where it is necessary to prevent
p.000114: injury or other damage to the health of the data subject. For sensitive data, information may be shared where it is
p.000114: necessary for medical purposes and is undertaken by a medical professional).
p.000114: This also applies if a third party, such as a family member, makes a complaint regarding the care of a service user:
p.000114: it is essential in these circumstances to ensure that the service user has consented to their personal
p.000114: information being made available for any internal investigations/ reviews.
p.000114: Sharing of information on a strict ‘need to know’ basis between staff involved in a service user’s care is essential to
p.000114: the provision of safe and effective care. Similarly, an integral component of modern health and social care is the use
p.000114: of audit and quality assurance programmes to ensure that the care provided is of the highest quality when
p.000114: benchmarked against national and international standards. Consent from the service user is not
p.000114: usually sought in these circumstances except where identifiable data is being made available to a third party.
p.000114: However, it is good practice to make service users aware that such practices occur and that safeguards exist to ensure
p.000114: that their personal information is protected. For example, this could be done in hospitals by providing
p.000114: such information on admission.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 11 See Part Three section 9 for provisions relating to confidentiality and data protection in the context of research
p.000114:
p.000114: Page 41
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
...
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
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p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
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p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
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p.000114:
p.000114: Part Three Research
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Research has the potential to promote scientific advances, improve health services and contribute
p.000114: to the wellbeing of individuals and society as a whole. It allows policymakers and service providers to
p.000114: prepare for and respond to the risks posed by e.g. disease or environmental hazards and to verify that drugs and
p.000114: medical devices etc. are safe and effective. It has the potential to feed into the formation of policy
p.000114: and is concerned with a range of human experiences, perspectives and needs e.g. health, education,
p.000114: housing, family and community services as well as the social institutions created to meet those needs. Research is a
p.000114: regular part of the work undertaken by many HSE staff. There are various types of research which cover a
p.000114: range of activities, from laboratory research, clinical trials, observational studies and
p.000114: epidemiological investigations to surveys and interviews. Research can also assist the HSE with organising and
p.000114: providing services.
p.000114: A number of international codes and standards as well as national and international legal instruments
p.000114: aimed at protecting research participants and ensuring high quality research have been developed in recent
p.000114: decades and these have been taken into account in formulating this policy24.
p.000114: Participation in research has the potential to offer participants direct benefits (e.g. improvements in health and
p.000114: well-being) and indirect benefits (e.g. greater access to professional care and support). The potential
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
...
p.000114: • Consent for participation must be sought from the person’s legal representative
p.000114:
p.000114: • A REC must approve the participation of adults lacking decision-making capacity in research taking all of
p.000114: the above factors into consideration
p.000114: • The explicit wish of a participant to refuse participation in or to be withdrawn from the study should be
p.000114: respected.
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where a prospective research participant lacks decision-making capacity but has some ability to understand the
p.000114: significance of the research, the researcher should ascertain the wishes of that individual with respect to
p.000114: his/her participation.
p.000114: Under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations
p.000114: 200429,30, consent for research participation on behalf of an adult lacking decision- making capacity must
p.000114: be obtained from the person’s legal representative. A legal representative has been defined as a person not connected
p.000114: with the conduct of the trial who by virtue of his/her family relationship with that adult, is suitable to act as the
p.000114: legal representative and is willing and able to do so or (if there is no such individual) a person who is not connected
p.000114: with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114: Outside of clinical trials, there is currently no legal framework for a person who lacks decision-
p.000114: making capacity to participate in research. In the absence of any such legal regulations, it is
p.000114: recommended that as a matter of best practice the same principles should apply to both clinical trials and other
p.000114: forms of research. This means that consent for participation in any form of research on behalf of an
p.000114: adult lacking decision-making capacity must be obtained from the person’s legal representative, as defined
p.000114: above.
p.000114: Refusal to participate in a research project by an individual lacking decision-making capacity should be
p.000114: respected.
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p.000114:
p.000114:
p.000114: 29 In July 2012 the European Commission published a proposal to repeal the Clinical Trials Directive 2001/20/EC and for
p.000114: new legislation relating to the conduct of clinical trials on Medicinal Products for Human Use. The new legislation,
p.000114: which is expected to come into effect in 2016, will take the form of a Regulation which will ensure that, in the main,
...
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
p.000114: the terminally ill) is valuable, their reliance on medical treatment may impact on their willingness to consent to
p.000114: research participation and this raises significant ethical issues. Therefore, such research should only be
p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
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p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
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p.000114: validation against the controlled version
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
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p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
p.000114: create a need for alternative life decisions, including those concerning reproductive choices or those with the
p.000114: potential to improve health e.g. dietary modification or career choices.
p.000114: When participants or their relatives are to be informed about genetic data that may be important for their health or
p.000114: lifestyle choices, the disclosure strategy should provide access to genetic and clinical advice/counselling, or
p.000114: clearly recommend to participants that they seek these services. Advice about the results of genetic
p.000114: research needs to include a clear explanation of the difference between research and clinical testing,
p.000114: and to clarify any need for the clinical confirmation of research results by an accredited laboratory.
p.000114: Where people are asked to consent to the collection of their genetic material or data for research, they
p.000114: should be advised:
p.000114: • That, by its nature, genetic material is in principle identifiable, even if personal identifiers are not
p.000114: collected or are removed
p.000114: • That they are free to decline participation without giving reasons
p.000114:
p.000114: • About arrangements to ensure the privacy and confidentiality of their genetic data with regard to both
p.000114: family members and others
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Whether the research may reveal information of potential importance to their future health, or the future
p.000114: health of their blood relatives
p.000114: • That a genetic test may reveal unexpected relationships, such as non-paternity (i.e. a different biological
p.000114: father); and
p.000114: • That, if it is proposed to approach blood relatives, consent to do so will first be sought from the
p.000114: participant.
p.000114: Identifiers of genetic material or related data:
p.000114:
p.000114: • Should not be removed without the consent of participants, if removal would make it difficult to
p.000114: communicate personal results; and
p.000114: • Should be removed if participants request it, provided they have been informed that the material or data
p.000114: would remain potentially identifiable
p.000114: • Researchers should not transfer genetic material or related data to any researcher not engaged in the
p.000114: research project unless:
p.000114: ◇ where the material or data is identifiable, participants have been informed about the transfer and have
p.000114: explicitly consented to it; or
p.000114: ◇ a REC has judged that the conditions for transfer have been met (for more information on consent and
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p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: The plan should identify the circumstances under which research results would warrant disclosure,
p.000114: a strategy for managing such disclosure, and include arrangements for appropriate medical advice or referral
p.000114: when disclosure is made. Disclosure of research results should be done in a sensitive manner with the consent of
p.000114: the participant. Incidental findings and/or research results (especially in the case of genetic research)
p.000114: should be confirmed by an accredited laboratory.
p.000114: In cases where incidental findings are regarded to be of vital and immediate clinical significance (e.g. tumours,
p.000114: blood clots, aneurysms), the researcher involved has a duty of care to that individual. Prospective
p.000114: research participants must be advised that such a duty of care exists during the consent process.
p.000114: Researchers should be especially aware of their obligations to protect the confidentiality of research
p.000114: participants when releasing data to third parties. For instance, in the case of genetic research, family
p.000114: members may need to be informed of potential genetic risks. Similarly, data may be of interest to other researchers or
p.000114: biobanks.
p.000114: Provided that consent is in place, transfer of identifiable data to such third parties is permissible and provided a
p.000114: comparable level of security and protection of privacy can be ensured. (For more information on Consent and controlling
p.000114: access to data see Section 9).
p.000114: The Disability Act 2005 (Part 4) provides that insurers cannot request, take into account or process the
p.000114: results of genetic tests (for a more in-depth discussion of genetic research see Section 6.1).
p.000114: Certain types of information may be made available to public health officials for important purposes, for
p.000114: example, the reporting of infectious diseases, without the explicit consent of the individual.
p.000114:
p.000114:
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p.000114: 9. Consent and controlling access to data
p.000114:
p.000114:
p.000114: Research participants who have given appropriate consent have a right to expect that identifiable data about
p.000114: themselves, either provided or discovered in the course of research, will not be shared with others without their
p.000114: consent.
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p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
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p.000114: 3.2 Involving the individual in discussions regarding CPR
p.000114:
p.000114:
p.000114: Decisions pertaining to CPR and DNAR orders should be made in the context of the likelihood of success and the
p.000114: potential risks as well as the individual’s overall goals and preferences for his/her treatment and care.
p.000114: Determination of the former requires discussion with the individual him/ herself.
p.000114: Decisions relating to CPR and DNAR orders are complex and potentially emotive therefore, it is important for such
p.000114: issues to be dealt with in an open, honest and sensitive manner.
p.000114: On-going communication between individuals, those close to them (where appropriate) and healthcare
p.000114: professionals is essential in achieving this goal (see also Section 6.5).
p.000114:
p.000114:
p.000114: 3.3 Involving family or friends in discussions regarding CPR
p.000114:
p.000114:
p.000114: If the individual wishes to have the support or involvement of others, such as family or friends, in decision making,
p.000114: this should be respected. If a person has decision-making capacity then his/her family or friends should only be
p.000114: involved in discussions regarding his/her treatment and care with that individual’s consent. If the individual is
p.000114: unable to participate in discussions due to his/her physical or cognitive condition, those with a close,
p.000114: on-going, personal relationship with the individual may have insight into his/her previously expressed
p.000114: preferences, wishes and beliefs. They may also have their own views as to the appropriateness or
p.000114: otherwise of interventions, based on their knowledge of the individual’s circumstances. In general, the closer the
p.000114: relationship to the individual, the greater weight should attach to such views. However, the role of those close to
p.000114: the individual is not to make the final decision regarding CPR, but rather to help the senior
p.000114: healthcare professional to make the most appropriate decision. Where CPR is judged inappropriate,
p.000114: it is good practice to inform those close to the patient, but there is no need to seek their ‘permission’ not to
p.000114: perform CPR in these circumstance (see also Part One Section 5.6.1).
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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Health / Physically Disabled
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p.000113: Bibliography
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p.000114: National Consent Advisory Group Membership 124
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
p.000114:
p.000114:
p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
p.000114:
p.000114:
p.000114: Autonomy
p.000114: The capacity to make decisions and take actions that are in keeping with one’s values and beliefs.
p.000114:
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p.000114: child that will be delivered.
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursing home if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
...
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Approaches that may be helpful in this regard include:
p.000114:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations, or having written or audio information about their condition
p.000114: • Speak to those close to the service user and to other health and social care staff about the best ways
p.000114: of communicating with the service user, taking account of confidentiality issues.
p.000114:
p.000114:
p.000114: 5.3 Presumption of capacity
p.000114:
p.000114:
p.000114: Those who provide health and social care services must work on the presumption that every adult service
p.000114: user has the capacity to make decisions about their care, and to decide whether to agree to, or refuse, an examination,
p.000114: investigation or treatment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of their age, disability,
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.4 When to consider incapacity
p.000114:
p.000114:
p.000114: An important implication of the presumption of capacity is that this presumption should not be challenged unless an
p.000114: adequate “trigger” exists. All service users may experience temporary lack of capacity due to severe illness, loss of
p.000114: consciousness or other similar circumstances.
p.000114:
p.000114:
p.000114: The possibility of incapacity and the need to assess capacity formally should only be considered,
p.000114: if, having been given all appropriate help and support, a service user:
p.000114:
p.000114: • is unable to communicate a clear and consistent choice or
p.000114:
p.000114: • is obviously unable to understand and use the information and choices provided.
p.000114:
p.000114:
p.000114: 5.5 Assessing capacity to consent
p.000114:
p.000114:
p.000114: Capacity to consent should be assessed if there is sufficient reason, as indicated in Section 5.4, to question the
p.000114: presumption of capacity. This involves assessing whether:
p.000114: • The service user understands in broad terms and believes the reasons for and nature of the
p.000114: decision to be made
p.000114: • The service user has sufficient understanding of the principal benefits and risks of an intervention and
p.000114: relevant alternative options after these have been explained to them in a manner and in a language appropriate
p.000114: to their individual level of cognitive functioning
p.000114: • The service user understands the relevance of the decision, appreciates the advantages
...
p.000114: the rules governing clinical trials will be identical throughout Europe . Other aspects, such as the structure and
p.000114: function of RECs and eligibility for the role of legal representative will be decided at a national level
p.000114: 30 It is also important to note that the European Commission is in the process of reviewing EU legal frameworks
p.000114: relating to medical devices and on the protection of personal data
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
...
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR), including chest compressions, defibrillation (with electric shocks), the
p.000114: injection of drugs and ventilation of the lungs, is an important and potentially life- saving intervention for victims
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergency situation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
p.000114: relating to resuscitation procedures; therefore, such issues are not dealt with in this policy.
p.000114:
p.000114:
p.000114:
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p.000114: professionals are not required to discuss every possible eventuality with every individual. Instead, the
p.000114: general presumption in favour of CPR should operate in the unlikely event of an arrest. However, if an individual
p.000114: indicates that he/ she wishes to discuss CPR, then this should be respected.
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: However, a small cohort of individuals within the general population may have prepared an advance
p.000114: healthcare directive refusing CPR under specific circumstances. The wishes of such individuals should be
p.000114: respected if the directive is considered valid and applicable to the situation that has arisen32.
p.000114:
p.000114: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114:
p.000114: Some individuals may be so unwell that death is considered to be imminent and unavoidable. For such
p.000114: individuals, cardiorespiratory arrest may represent the terminal event in their illness and the provision of CPR
p.000114: would not be clinically indicated (i.e. would not restart the heart and maintain breathing for a
p.000114: sustained period). Attempting CPR in such circumstances may cause harm to the individual, increase his/her
p.000114: suffering and/or result in a traumatic and undignified death. In many cases, a sensitive but open discussion of
p.000114: end-of-life care will be possible in which individuals should be helped to understand the severity of their condition.
p.000114: However, it should be emphasised that this does not necessarily require explicit discussion of CPR or an ‘offer’ of
p.000114: CPR. Implementing a DNAR order for those close to death does not equate to “doing nothing”; all care provided should
p.000114: follow a palliative approach and focus on easing that individual’s suffering and making him/her as comfortable as
p.000114: possible.
p.000114:
p.000114:
p.000114: 4.3 Cardiorespiratory arrest is considered possible or likely
p.000114:
p.000114:
p.000114: For certain individuals there may be an identifiable risk of cardiorespiratory arrest occurring as a result of their
p.000114: clinical condition. These include individuals with acute severe illness and those with severe or multiple coexisting
p.000114: medical conditions or diseases.
p.000114: Advance care planning, including consideration of issues such as CPR/DNAR is often appropriate for such individuals and
p.000114: should occur in the context of a general discussion about the individual’s prognosis and the likelihood that CPR would
p.000114: be successful, as well as his/her values, concerns, expectations and goals of care.
p.000114:
p.000114: 32 There is currently no specific legislation pertaining to advance healthcare directives in Ireland. However, the
p.000114: Irish courts have established that an individual with capacity has the right to refuse treatment to facilitate a
p.000114: natural death. The weight of legal opinion has been interpreted to mean that an advance healthcare directive made by an
p.000114: individual, when he/she had capacity, would be upheld. In addition, the Medical Council Guide to Professional Conduct
p.000114: and Ethics for Registered Practitioners (2009) also recognises advance healthcare directives
p.000114: Page 104
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Most CPR discussions and decisions will occur in this group. However, it must be emphasised that this is not a
p.000114: homogenous group, as the likelihood of success from CPR varies widely, and this necessarily influences how
p.000114: discussions are conducted.
p.000114:
p.000114:
p.000114:
p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
p.000114: In some instances where CPR has been started, additional information may subsequently become available which makes
p.000114: continued CPR inappropriate, for example clinical information which indicates that CPR is unlikely to
p.000114: be successful, or information regarding the individual’s preferences.
p.000114: As was discussed in Section 4.2, there will be some individuals for whom no formal DNAR decision has been made, but
p.000114: where attempting CPR is clearly inappropriate because death is imminent and unavoidable, for example, in the final
p.000114: stages of a terminal illness. In these circumstances, it is reasonable for healthcare professionals not to
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: 6. Balancing the benefits and risks of providing CPR
p.000114:
p.000114:
p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
p.000114: acknowledging the uncertainty inherent in many medical predictions, healthcare professionals still have an
...
p.000114:
p.000114:
p.000114: Situations may arise where an individual does not want to discuss CPR/DNAR orders. In some cases such
p.000114: refusals may be linked to the timing of the discussion and the individual should be given the opportunity
p.000114: to defer the discussion and revisit the issues of CPR and DNAR orders at a later time. However, if an individual
p.000114: refuses to participate in the discussion, his/her wishes should be respected. If the individual would prefer that the
p.000114: healthcare professional discuss the decision with somebody else such as a relative, partner or friend, this should be
p.000114: respected. However, it should be emphasised that the role of those close to the individual is not to
p.000114: make the final decision relating to CPR, but rather to help the senior healthcare professional to make the most
p.000114: appropriate decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 6.6 DNAR orders and readily reversible cardiorespiratory arrests
p.000114:
p.000114:
p.000114: In certain situations, an individual with a DNAR order may suffer a cardiorespiratory arrest from a
p.000114: readily reversible cause unconnected to his/her underlying illness. In such cases CPR would be appropriate,
p.000114: while the reversible cause of arrest is treated. For example, choking restricts an individual’s intake of
p.000114: oxygen, which could potentially lead to a cardiorespiratory arrest if not treated promptly. The initial response should
p.000114: concentrate on removing the cause of the tracheal blockage, but in the event of a subsequent cardiorespiratory arrest,
p.000114: CPR should be provided.
p.000114: Where an individual with a DNAR order in place is to undergo a medical or surgical procedure, it may be appropriate
p.000114: to review the DNAR order given the potential for cardiorespiratory arrest to occur under anaesthesia. In such
p.000114: situations, should a cardiorespiratory arrest occur, there should be a presumption in favour of
p.000114: providing CPR. Therefore, in advance of procedures involving anaesthesia it may be advisable to temporarily
p.000114: suspend an individual’s DNAR order. The process of reviewing the DNAR order should involve discussion with
p.000114: the individual as part of the consent process in advance of the procedure. If the DNAR order is to be suspended this
p.000114: decision should be clearly documented as well as the time at which the DNAR order is to be
p.000114: re-instated. If an individual wishes his/her DNAR order to remain valid during the procedure, despite the
...
p.002003: Beach MC and Morrison RS (2002).The Effect of Do-Not-Resuscitate Orders on Physician Decision- Making.Journal of the
p.002003: American Geriatrics Society 50(12): 2057-2061
p.002003: Brazier and Cave Medicine, Patients and the Law (Penguin, 2007)
p.002003:
p.002003: British Medical Association, Resuscitation Council (UK) and Royal College of Nursing
p.002003: (2007).Decisions relating to cardiopulmonary resuscitation: A joint statement from the British Medical
p.002003: Association, the Resuscitation Council (UK) and the Royal College of Nursing. British Medical Association,
p.002003: London, 24p
p.002003: Butler MW, Saaidin N, Sheikh AA and Fennell JS (2006). Dissatisfaction with Do Not Attempt Resuscitation
p.002003: Orders: A nationwide study of Irish consultant physician practices. Irish Medical Journal 99(7): 208-210
p.002003: Burns JP, Edwards J, Johnson J, Cassem NH and Truog RD (2003). Do-not-resuscitate order after 25 years. Critical Care
p.002003: Medicine 31(5): 1543-1550
p.002003: Canadian Medical Association (1995).Joint Statement on Resuscitative Interventions (Update
p.002003: 1995).Canadian Medical Association Journal 153(11): 1652A-1652F
p.002003: Cherniak EP (2002). Increasing use of DNR orders in the elderly worldwide: whose choice is it?
p.002003: Journal of Medical Ethics 28(5): 303-307
p.002003:
p.002003: Clayton JM, Hancock KM, Butow PN, Tattersall MHN and Currow DC (2007).Clinical practice guidelines for
p.002003: communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their
p.002003: caregivers. The Medical Journal of Australia 186(12): S77-S108
p.002003: Desch K, Li J, Kim S, Laventhal N, Metzger k, Siemieniak D, Ginsburg D. Analysis of Informed Consent
p.002003: Document Utilization in a Minimal-Risk Genetic Study. Annals of Internal Medicine (2011), 155(5): p316-322
p.002003:
p.002003:
p.002003:
p.002003: Page 121
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Diem SJ, Lantos JD and Tulsky JA (1996). Cardiopulmonary Resuscitation on Television: Miracles and Misinformation. The
p.002003: New England Journal of Medicine 334(24): 1578-1582
p.002003: Donnelly Healthcare Decision-Making and the Law: Autonomy, Capacity and the Limits of Liberalism (Cambridge University
p.002003: Press, 2010)
p.002003: Donnelly ‘The Right of Autonomy in Irish Law’ (2008) 14 Medico-Legal Journal of Ireland 34
p.002003:
p.002003: Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA and Stapleton RD (2009). Epidemiologic Study of
p.002003: In-Hospital Cardiopulmonary Resuscitation in the Elderly. The New England Journal of Medicine 361(1): 22-31
p.002003: Ferguson RP, Phelan T, Haddad T, Hinduja A and Dubin NH (2008). Survival After In-Hospital Cardiopulmonary
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
p.000114: Participants who regain capacity (or their legal representatives once located) should be given all the relevant
p.000114: information and their consent to continued participation should be obtained as soon as is reasonably possible. The
p.000114: option to withdraw and to seek the destruction of any biological material or data collected as part of the study should
p.000114: also be given.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5.2 People highly dependent on medical care
p.000114:
p.000114:
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
p.000114: the terminally ill) is valuable, their reliance on medical treatment may impact on their willingness to consent to
p.000114: research participation and this raises significant ethical issues. Therefore, such research should only be
p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
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p.000091:
p.000091:
p.000091: Table of contents
p.000091:
p.000091:
p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
p.000098: 2. Definition and scope of resuscitation decisions 99
p.000098: 2.1 Do not attempt resuscitation or do not resuscitate
p.000099: 99
p.000099: 2.2 Scope of DNAR orders
p.000099: 99
p.000099: 3. General principles
p.000100: 100
p.000100: 3.1 Need for individual decision making
p.000100: 100
p.000100: 3.2 Involving the individual in discussions regarding CPR
p.000101: 101
p.000101: 3.3 Involving family or friends in discussions regarding CPR 101
p.000101: 3.4 Decision-making capacity
p.000102: 102
p.000102: 3.5 Provision of information
p.000102: 102
p.000102: 3.6 Decision-making regarding CPR and DNAR orders 102
p.000102: 4. When should CPR and DNAR decisions be considered? 103
p.000102: 4.1 Cardiorespiratory arrest is considered unlikely
p.000103: 103
p.000103: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable 104
p.000103: 4.3 Cardiorespiratory arrest is considered possible or likely 104
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p.000103: validation against the controlled version
p.000103:
p.000103: National Consent Policy HSE V.1.3
p.000103: Table of contents
p.000103: Page
p.000103: 5. Presumption in favour of providing CPR 105
p.000103: 6. Balancing the benefits and risks of providing CPR 106
p.000103: 6.1 Respecting an individual’s refusal of CPR
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
...
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Situations may arise where a decision regarding CPR has to be made quickly and the most senior healthcare professional
p.000114: is unavailable. In such circumstances, decision-making responsibility can be delegated to other less senior
p.000114: healthcare professionals, who should notify and discuss with their senior colleague as soon as possible.
p.000114:
p.000114:
p.000114:
p.000114: 4. When should CPR and DNAR decisions be considered?
p.000114:
p.000114:
p.000114: Advance care planning, including making decisions about CPR, is an important part of good clinical care
p.000114: for those at risk of cardiorespiratory arrest and is preferable to making decisions only after a crisis has arisen.
p.000114: Hence, the likelihood of cardiorespiratory arrest occurring should be taken into account when determining
p.000114: how, when and if to consider the need for CPR/DNAR discussions or decisions for an individual. Three
p.000114: broad groups can be identified based on the likelihood of cardiorespiratory arrest within the foreseeable
p.000114: future:
p.000114: • Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114: • Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114: • Cardiorespiratory arrest is considered possible or likely.
p.000114:
p.000114:
p.000114: 4.1 Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114:
p.000114: For most people, within the general population, the likelihood of cardiorespiratory arrest within a given period is
p.000114: very small. In general, these would be healthy individuals for whom cardiorespiratory arrest
p.000114: would represent an unanticipated emergency situation. Moreover, given the low likelihood of arrest, it is unlikely that
p.000114: the issues of CPR and DNAR orders would have been raised previously with such individuals since healthcare
p.000114: professionals are not required to discuss every possible eventuality with every individual. Instead, the
p.000114: general presumption in favour of CPR should operate in the unlikely event of an arrest. However, if an individual
p.000114: indicates that he/ she wishes to discuss CPR, then this should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: However, a small cohort of individuals within the general population may have prepared an advance
p.000114: healthcare directive refusing CPR under specific circumstances. The wishes of such individuals should be
p.000114: respected if the directive is considered valid and applicable to the situation that has arisen32.
p.000114:
p.000114: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114:
p.000114: Some individuals may be so unwell that death is considered to be imminent and unavoidable. For such
p.000114: individuals, cardiorespiratory arrest may represent the terminal event in their illness and the provision of CPR
p.000114: would not be clinically indicated (i.e. would not restart the heart and maintain breathing for a
p.000114: sustained period). Attempting CPR in such circumstances may cause harm to the individual, increase his/her
p.000114: suffering and/or result in a traumatic and undignified death. In many cases, a sensitive but open discussion of
p.000114: end-of-life care will be possible in which individuals should be helped to understand the severity of their condition.
p.000114: However, it should be emphasised that this does not necessarily require explicit discussion of CPR or an ‘offer’ of
p.000114: CPR. Implementing a DNAR order for those close to death does not equate to “doing nothing”; all care provided should
p.000114: follow a palliative approach and focus on easing that individual’s suffering and making him/her as comfortable as
p.000114: possible.
p.000114:
p.000114:
p.000114: 4.3 Cardiorespiratory arrest is considered possible or likely
p.000114:
p.000114:
p.000114: For certain individuals there may be an identifiable risk of cardiorespiratory arrest occurring as a result of their
p.000114: clinical condition. These include individuals with acute severe illness and those with severe or multiple coexisting
p.000114: medical conditions or diseases.
p.000114: Advance care planning, including consideration of issues such as CPR/DNAR is often appropriate for such individuals and
...
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Most CPR discussions and decisions will occur in this group. However, it must be emphasised that this is not a
p.000114: homogenous group, as the likelihood of success from CPR varies widely, and this necessarily influences how
p.000114: discussions are conducted.
p.000114:
p.000114:
p.000114:
p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
p.000114: In some instances where CPR has been started, additional information may subsequently become available which makes
p.000114: continued CPR inappropriate, for example clinical information which indicates that CPR is unlikely to
p.000114: be successful, or information regarding the individual’s preferences.
p.000114: As was discussed in Section 4.2, there will be some individuals for whom no formal DNAR decision has been made, but
p.000114: where attempting CPR is clearly inappropriate because death is imminent and unavoidable, for example, in the final
p.000114: stages of a terminal illness. In these circumstances, it is reasonable for healthcare professionals not to
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: 6. Balancing the benefits and risks of providing CPR
p.000114:
p.000114:
p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
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p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
p.000114: Participants who regain capacity (or their legal representatives once located) should be given all the relevant
p.000114: information and their consent to continued participation should be obtained as soon as is reasonably possible. The
p.000114: option to withdraw and to seek the destruction of any biological material or data collected as part of the study should
p.000114: also be given.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 78
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5.2 People highly dependent on medical care
p.000114:
p.000114:
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
p.000114: the terminally ill) is valuable, their reliance on medical treatment may impact on their willingness to consent to
p.000114: research participation and this raises significant ethical issues. Therefore, such research should only be
p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
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p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
p.000114:
p.000114:
p.000114: 7.8 Advance refusal of treatment
p.000114:
p.000114:
p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
p.000114: including advance refusal of medical treatment. There is no Irish legislation confirming the enforceability of such
p.000114: advance refusals. However, such an advance plan should be respected on condition that:
p.000114: • The decision was an informed choice, according to the principles discussed in Sections 2-5
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p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
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p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
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p.000091:
p.000091:
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p.000091: validation against the controlled version
p.000091:
p.000091: National Consent Policy HSE V.1.3
p.000091:
p.000091:
p.000091: Table of contents
p.000091:
p.000091:
p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
...
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
p.000114:
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p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 6. Is it always necessary to seek service user consent?
p.000114:
p.000114:
p.000114: The general principles of consent apply to all decisions about care: from the treatment of minor and self-limiting
p.000114: conditions, to major interventions with significant risks or side effects. However, while the agreement of the
p.000114: service user should always be sought, there are a number of situations where the amount of information
p.000114: provided about an intervention may legitimately be abbreviated. These include:
p.000114: • Emergency situations
p.000114:
p.000114: • Where the service user declines information.
p.000114:
p.000114:
p.000114: 6.1 Emergency situations
p.000114:
p.000114:
...
p.000114: There is consensus that covert research should not be undertaken routinely, rather it should occur only where it can
p.000114: provide a unique form of evidence that cannot be gathered in any other way or where important issues of sociological
p.000114: significance are being addressed. While serious ethical and legal issues arise in relation to covert research,
p.000114: the use of covert methods may be justified in certain circumstances. For example, difficulties arise when
p.000114: research participants change their behaviour because they know they are being observed.
p.000114: Where consent has not been obtained prior to the research it should, where possible, be obtained at a later time. In
p.000114: cases where participants who are asked to give retrospective consent express concerns about their inclusion in a
p.000114: project, the researcher should give them the option of removing their data from the study.
p.000114: For research where identifiable data (e.g. images, video recordings) is being collected, then the consent
p.000114: of prospective research participants must be sought.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6.4 Research in public health emergencies
p.000114:
p.000114:
p.000114: The requirement for consent might be waived in public health emergencies, where a health threat and possible
p.000114: treatments/alleviations must be identified as quickly as possible. For instance, a waiver may be permissible,
p.000114: where a delay caused by the time needed to obtain consent from a person suffering from a new strain of
p.000114: pandemic influenza or other biological, chemical, radiological or nuclear agent, might not only
p.000114: jeopardise his/her health but also the health of others within the population.
p.000114:
p.000114:
p.000114: 6.5 Multi-jurisdictional research
p.000114:
p.000114:
p.000114: When multi-jurisdiction research is being undertaken, additional ethical considerations might arise. While
p.000114: researchers should be cognisant of the local research ethics requirements, they should comply with this
p.000114: policy and act in accordance with Irish legislation.
p.000114: When multi-jurisdictional research is to be conducted, local cultural values should be
p.000114: acknowledged in the design and conduct of the research. Irrespective of cultural traditions, consent must
p.000114: always be given by the prospective research participant. In certain cases it may be appropriate to seek the
p.000114: agreement of a person(s) invested with a certain authority within the community.
p.000114: Researchers must do their utmost to communicate information accurately and in a
...
p.000114: changes occur in the conditions or the procedures of a study, researchers should once again seek the consent of the
p.000114: participants. It is imperative that research participants be informed when there is new information that might
p.000114: affect their willingness to continue participation. There are a number of reasons why reconsent may be required
p.000114: which include but are not limited to cases where:
p.000114: • the research protocol has been substantially altered;
p.000114:
p.000114: • new safety information has come to light;
p.000114:
p.000114: • alternative treatments have become available;
p.000114:
p.000114: • a child participant reaches legal maturity (i.e. 18 years or 16 years in the case of clinical trials);
p.000114: • a formerly incapacitated adult has regained capacity; or
p.000114:
p.000114: • a substantial period of time has elapsed since the original consent was obtained (e.g. longitudinal study).
p.000114: A strategy for reconsenting participants should be presented to the REC responsible for reviewing and approving the
p.000114: study.
p.000114:
p.000114:
p.000114:
p.000114: 12. Research where consent may not be required
p.000114:
p.000114:
p.000114: As noted above, certain types of research may not require the consent of the research participant by virtue of a legal
p.000114: basis (e.g. research in public health emergencies) or because a REC has waived the requirement for consent (e.g.
p.000114: population based research). It should be noted that in the latter case, the waiver applies only to de-identified
p.000114: material/data.
p.000114: Waiver of consent is to be regarded as an exception to the rule and studies seeking waiver of consent
p.000114: must receive REC approval. Before a waiver of consent may be granted the researcher must satisfy the REC
p.000114: that:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • the overall benefit to research is real and substantial
p.000114:
p.000114: • the benefits from the research justify any risks of harm associated with not seeking consent;
p.000114: • it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records);
p.000114: • there is no known or likely reason for thinking that participants would not have consented if they had been
p.000114: asked;
...
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p.000114:
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Part Four
p.000114: Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR), including chest compressions, defibrillation (with electric shocks), the
p.000114: injection of drugs and ventilation of the lungs, is an important and potentially life- saving intervention for victims
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergency situation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
...
p.000114: for those at risk of cardiorespiratory arrest and is preferable to making decisions only after a crisis has arisen.
p.000114: Hence, the likelihood of cardiorespiratory arrest occurring should be taken into account when determining
p.000114: how, when and if to consider the need for CPR/DNAR discussions or decisions for an individual. Three
p.000114: broad groups can be identified based on the likelihood of cardiorespiratory arrest within the foreseeable
p.000114: future:
p.000114: • Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114: • Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114: • Cardiorespiratory arrest is considered possible or likely.
p.000114:
p.000114:
p.000114: 4.1 Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114:
p.000114: For most people, within the general population, the likelihood of cardiorespiratory arrest within a given period is
p.000114: very small. In general, these would be healthy individuals for whom cardiorespiratory arrest
p.000114: would represent an unanticipated emergency situation. Moreover, given the low likelihood of arrest, it is unlikely that
p.000114: the issues of CPR and DNAR orders would have been raised previously with such individuals since healthcare
p.000114: professionals are not required to discuss every possible eventuality with every individual. Instead, the
p.000114: general presumption in favour of CPR should operate in the unlikely event of an arrest. However, if an individual
p.000114: indicates that he/ she wishes to discuss CPR, then this should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: However, a small cohort of individuals within the general population may have prepared an advance
p.000114: healthcare directive refusing CPR under specific circumstances. The wishes of such individuals should be
p.000114: respected if the directive is considered valid and applicable to the situation that has arisen32.
p.000114:
p.000114: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114:
p.000114: Some individuals may be so unwell that death is considered to be imminent and unavoidable. For such
...
Health / visual impairment
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p.000011:
p.000011:
p.000011: Table of contents
p.000011:
p.000011:
p.000011: Page
p.000011: Glossary
p.000011: 11
p.000011: Part One – General Principles 19
p.000011: 1. Introduction
p.000020: 20
p.000020: 1.1 Scope of this policy
p.000020: 20
p.000020: 1.2 Ethical issues regarding consent
p.000020: 20
p.000020: 1.3 Health and social care decision-making
p.000021: 21
p.000021: 1.4 Consent in Irish law
p.000021: 21
p.000021: 1.5 Age of consent in Irish law
p.000022: 22
p.000022: 2. What is valid and genuine consent? 23
p.000022: 3. Providing information and discussing treatment options 23
p.000022: 3.1 Importance of individual circumstances
p.000024: 24
p.000024: 3.2 What information should be provided about interventions? 24
p.000024: 3.3 What information about risks and side effects of an intervention should be 25
p.000024: provided?
p.000024: 3.4 How and when information should be provided 26
p.000024: 3.4.1 Service users with limited English proficiency 27
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
p.000030: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
...
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 28
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
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p.000114: users’ occupations or lifestyles may influence those risks that they consider significant or particularly undesirable.
p.000114: A general rule is to provide information that a reasonable person in the service user’s situation would expect to be
p.000114: told. This is in line with ethical and professional standards as well as the legal standard applied by the Irish
p.000114: courts. Such information includes the likelihood of:
p.000114: • side effects or complications of an intervention;
p.000114:
p.000114: • failure of an intervention to achieve the desired aim; and
p.000114:
p.000114: • the risks associated with taking no action or with taking an alternative approach.
p.000114:
p.000114: A risk may be seen as material/significant if a reasonable person in the patient's position if warned of
p.000114: the risk would attach significance to it. Such risks must be disclosed to the patient.
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
p.000114: Information about risk should be given in a balanced way. Service users may understand information about
p.000114: risk differently from those providing health and social care. This is particularly true when using descriptive terms
p.000114: such as ‘often’ or ‘uncommon’. Potential biases related to how risks are ‘framed’ are important: a 1 in a thousand risk
p.000114: of a complication also means that 999 out of a thousand service users will not experience that complication.
p.000114: In order to best support service users in assessing the risks and benefits of various interventions/ course of action
p.000114: consideration should be given to:
p.000114: • Designing and employing communications that use plain language
p.000114:
p.000114:
p.000114: • Avoid explaining risks in purely descriptive terms (such as low risk), try to supplement with numerical
p.000114: data
p.000114: • Use absolute numbers or percentages; avoid using relative risk or percentage improvements
p.000114: • Use visual aids e.g. pictographs wherever possible, to maximise understanding.
p.000114:
p.000114:
p.000114: 3.4 How and when information should be provided
p.000114:
p.000114:
p.000114: The manner in which the health and social care options are discussed with a service user is as important as the
p.000114: information itself. The following measures are often helpful:
...
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p.000011:
p.000011: Page
p.000011: Glossary
p.000011: 11
p.000011: Part One – General Principles 19
p.000011: 1. Introduction
p.000020: 20
p.000020: 1.1 Scope of this policy
p.000020: 20
p.000020: 1.2 Ethical issues regarding consent
p.000020: 20
p.000020: 1.3 Health and social care decision-making
p.000021: 21
p.000021: 1.4 Consent in Irish law
p.000021: 21
p.000021: 1.5 Age of consent in Irish law
p.000022: 22
p.000022: 2. What is valid and genuine consent? 23
p.000022: 3. Providing information and discussing treatment options 23
p.000022: 3.1 Importance of individual circumstances
p.000024: 24
p.000024: 3.2 What information should be provided about interventions? 24
p.000024: 3.3 What information about risks and side effects of an intervention should be 25
p.000024: provided?
p.000024: 3.4 How and when information should be provided 26
p.000024: 3.4.1 Service users with limited English proficiency 27
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
p.000030: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
p.000034: 5.6.2 Emergency situations involving service users who lack capacity 34
...
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
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Social / Access to Social Goods
Searching for indicator access:
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p.000075: Page 7
p.000075: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Page 8
p.000091:
p.000091:
p.000091: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000091: validation against the controlled version
p.000091:
p.000091: National Consent Policy HSE V.1.3
p.000091:
p.000091:
p.000091: Table of contents
p.000091:
p.000091:
p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
p.000098: 2. Definition and scope of resuscitation decisions 99
p.000098: 2.1 Do not attempt resuscitation or do not resuscitate
p.000099: 99
p.000099: 2.2 Scope of DNAR orders
p.000099: 99
p.000099: 3. General principles
p.000100: 100
p.000100: 3.1 Need for individual decision making
p.000100: 100
p.000100: 3.2 Involving the individual in discussions regarding CPR
p.000101: 101
p.000101: 3.3 Involving family or friends in discussions regarding CPR 101
...
p.000114: Forcing someone to behave in a particular way by use of threats or intimidation or some other form of pressure or
p.000114: force.
p.000114:
p.000114:
p.000114: Consent
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation in
p.000114: research following a process of communication in which the service user has received sufficient
p.000114: information to enable him/her to understand the nature, potential risks and benefits of the proposed intervention or
p.000114: service.
p.000114:
p.000114:
p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
p.000114:
p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 13
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
...
p.000114: is also recognised in international and European human rights law and under the Irish Constitution.
p.000114:
p.000114:
p.000114:
p.000114: Page 21
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2 For discussion of these exceptional circumstances see chapter one section 6
p.000114: 3 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 4 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
...
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 54
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
...
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
p.000114: Page 59
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
...
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Research has the potential to promote scientific advances, improve health services and contribute
p.000114: to the wellbeing of individuals and society as a whole. It allows policymakers and service providers to
p.000114: prepare for and respond to the risks posed by e.g. disease or environmental hazards and to verify that drugs and
p.000114: medical devices etc. are safe and effective. It has the potential to feed into the formation of policy
p.000114: and is concerned with a range of human experiences, perspectives and needs e.g. health, education,
p.000114: housing, family and community services as well as the social institutions created to meet those needs. Research is a
p.000114: regular part of the work undertaken by many HSE staff. There are various types of research which cover a
p.000114: range of activities, from laboratory research, clinical trials, observational studies and
p.000114: epidemiological investigations to surveys and interviews. Research can also assist the HSE with organising and
p.000114: providing services.
p.000114: A number of international codes and standards as well as national and international legal instruments
p.000114: aimed at protecting research participants and ensuring high quality research have been developed in recent
p.000114: decades and these have been taken into account in formulating this policy24.
p.000114: Participation in research has the potential to offer participants direct benefits (e.g. improvements in health and
p.000114: well-being) and indirect benefits (e.g. greater access to professional care and support). The potential
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
p.000114: • Beneficence - maximising the potential benefits of the research and minimising the risks;
p.000114: • Justice - the duty to neither neglect nor discriminate against individuals or groups who may benefit from
p.000114: research and to avoid placing an unfair burden of research participation on particular groups; and
p.000114:
p.000114:
p.000114: 24 These documents are referred to in the bibliography
p.000114:
p.000114: Page 66
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • Respect for persons – the notion that individuals should be treated as autonomous agents and that
...
p.000114:
p.000114:
p.000114: 2.1.2 Explanation of the risks and benefits
p.000114:
p.000114:
p.000114: • Prospective research participants should be given an account of the foreseeable risks and benefits
p.000114: associated with participating in the research study. They should be assured that they can withdraw from the research
p.000114: study at any time and that their decision will not have any negative repercussions.
p.000114: (For more information see Section 10 on Withdrawal of Consent). The contact details of researchers should be
p.000114: provided to the research participant should s/he require clarification on any issue relating to the
p.000114: research.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 68
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.1.3 Confidentiality
p.000114:
p.000114:
p.000114: • Participants should be informed what information will be collected and for what purposes.
p.000114: • Participants should also be told in what form the data will be stored (e.g. de- identified)
p.000114: and what measures the researchers will put in place to ensure confidentiality for the full
p.000114: life-cycle of the study.
p.000114: • Research participants should be told which persons will have access to their data including
p.000114: third parties outside the jurisdiction.
p.000114: • Participants should be advised in relation to the fate of their data at the end of the study.
p.000114: • Participants should be advised of the risks of re-identification in the event of data security breaches.
p.000114:
p.000114:
p.000114: 2.1.4 Commercialisation
p.000114:
p.000114:
p.000114: • Researchers should clearly explain to research participants whether or not they will receive payment
p.000114: (either financial or non-financial) for participating in the research project or have their expenses covered.
p.000114: • Research participants should be made aware that they will not be entitled to a share of any
p.000114: profits that may arise from use of their material/data or products derived from it.
p.000114: • Researchers should disclose any conflict of interest they may have e.g. a financial interest in the
p.000114: study.
p.000114: (See Figure 1 for a list of sample information which might be included in a consent form)
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 69
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Figure 1.
p.000114:
p.000114: • A statement that the study involves research participants and an explanation of the purposes of the research.
p.000114: • The expected duration of the participant's involvement.
p.000114:
...
p.000114: which are experimental.
p.000114: • A statement that participation is voluntary including a statement offering the participant the opportunity to
p.000114: ask questions and to withdraw at any time from the research without consequences. In the case of withdrawal,
p.000114: information regarding what will happen to material/data should be provided.
p.000114: • Information about who is organising and funding the research.
p.000114:
p.000114: • A description of any reasonably foreseeable risk, discomfort or disadvantages.
p.000114:
p.000114: • A description of any benefits to the participant or to others which may reasonably be expected from the
p.000114: research, avoiding inappropriate expectations.
p.000114: • A disclosure of appropriate alternative procedures for treatment/diagnosis, if any, that might be advantageous
p.000114: to the participant.
p.000114: • A statement describing the procedures adopted for ensuring data protection/ confidentiality/privacy including
p.000114: duration of storage of personal data.
p.000114: • A description of how incidental findings are to be handled.
p.000114:
p.000114: • A description of any planned genetic tests, including whether results will be disseminated to research
p.000114: participants.
p.000114: • An explanation as to whether there are any treatments or compensation if injury occurs (where relevant) and,
p.000114: if so, what they consist of, or where further information may be obtained. Insurance coverage should be
p.000114: mentioned.
p.000114: • Contact details to access information about the research and research participants' rights.
p.000114:
p.000114: • An explanation of what will happen with the material/data at the end of the research and if the material/data
p.000114: are retained or sent/sold to a third party for further research.
p.000114: • Information about what will happen to the results of the research.
p.000114:
p.000114: • A statement regarding the potential commercialisation of the research (where applicable).
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.2 Who should seek consent?
p.000114:
p.000114:
p.000114: The person obtaining consent should have sufficient knowledge about the research and be capable of
p.000114: answering questions from prospective participants.
p.000114: Depending on the circumstances, prospective research participants may be approached directly (e.g. by advertisement) or
p.000114: indirectly (e.g. by the individual’s GP). Where researchers are not also the service provider, best practice and
p.000114: data protection considerations require that the service provider should act as a gatekeeper and make the initial
p.000114: contact with the prospective participant and provide him/her with the contact details of the research team.
...
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
p.000114: create a need for alternative life decisions, including those concerning reproductive choices or those with the
p.000114: potential to improve health e.g. dietary modification or career choices.
p.000114: When participants or their relatives are to be informed about genetic data that may be important for their health or
p.000114: lifestyle choices, the disclosure strategy should provide access to genetic and clinical advice/counselling, or
p.000114: clearly recommend to participants that they seek these services. Advice about the results of genetic
p.000114: research needs to include a clear explanation of the difference between research and clinical testing,
p.000114: and to clarify any need for the clinical confirmation of research results by an accredited laboratory.
p.000114: Where people are asked to consent to the collection of their genetic material or data for research, they
p.000114: should be advised:
p.000114: • That, by its nature, genetic material is in principle identifiable, even if personal identifiers are not
p.000114: collected or are removed
p.000114: • That they are free to decline participation without giving reasons
p.000114:
p.000114: • About arrangements to ensure the privacy and confidentiality of their genetic data with regard to both
p.000114: family members and others
p.000114:
p.000114:
p.000114: Page 81
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Whether the research may reveal information of potential importance to their future health, or the future
p.000114: health of their blood relatives
p.000114: • That a genetic test may reveal unexpected relationships, such as non-paternity (i.e. a different biological
p.000114: father); and
p.000114: • That, if it is proposed to approach blood relatives, consent to do so will first be sought from the
p.000114: participant.
p.000114: Identifiers of genetic material or related data:
p.000114:
p.000114: • Should not be removed without the consent of participants, if removal would make it difficult to
p.000114: communicate personal results; and
p.000114: • Should be removed if participants request it, provided they have been informed that the material or data
p.000114: would remain potentially identifiable
p.000114: • Researchers should not transfer genetic material or related data to any researcher not engaged in the
p.000114: research project unless:
p.000114: ◇ where the material or data is identifiable, participants have been informed about the transfer and have
p.000114: explicitly consented to it; or
p.000114: ◇ a REC has judged that the conditions for transfer have been met (for more information on consent and
p.000114: controlling access to data see Section 9).
p.000114:
p.000114:
p.000114: 6.2 Epidemiological research
p.000114:
p.000114:
p.000114: A REC may waive the requirement for consent if the expected benefit of the research is real and substantial. Such
p.000114: waivers may also be approved when the existence of a signed consent form would be an unjustified threat to
p.000114: the subject's confidentiality.
p.000114: Categories of epidemiological research for which consent might be waived include:
p.000114:
p.000114: • The use of anonymous material/data
p.000114:
p.000114: • Studies using health-related registries that are authorised for such use; and
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 82
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Cluster randomised trials (i.e. where groups are randomised as opposed to individuals).
p.000114: For example, villages, hospitals, families or classrooms may be randomised. Reasons for performing
p.000114: cluster randomised trials vary. Sometimes the intervention can only be administered to a group, for example
p.000114: an addition to the water supply (fluoride) or a public education campaign.
p.000114:
p.000114:
p.000114: 6.3 Covert research
p.000114:
p.000114:
...
p.000114: researchers should be cognisant of the local research ethics requirements, they should comply with this
p.000114: policy and act in accordance with Irish legislation.
p.000114: When multi-jurisdictional research is to be conducted, local cultural values should be
p.000114: acknowledged in the design and conduct of the research. Irrespective of cultural traditions, consent must
p.000114: always be given by the prospective research participant. In certain cases it may be appropriate to seek the
p.000114: agreement of a person(s) invested with a certain authority within the community.
p.000114: Researchers must do their utmost to communicate information accurately and in a
p.000114: comprehensible and appropriate way. Where formal written consent from the participant is not possible, the following
p.000114: should be observed:
p.000114: • a community representative trained by the research team should be made available; and
p.000114: • the oral approval should be witnessed by the trained and independent community representative. S/he will
p.000114: verify that the purpose of the research has been explained to the participant and that that the consent was freely
p.000114: given.
p.000114: Researchers should be mindful that in some countries, participating in research may be the only way that individuals
p.000114: can access healthcare and they must ensure that this circumstance does not act as an undue inducement to research
p.000114: participation.
p.000114:
p.000114:
p.000114:
p.000114: Page 84
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6.6 Research involving archival material
p.000114:
p.000114:
p.000114: Researchers may want to use biological material or data that was previously accumulated for clinical
p.000114: purposes or that was collected by other researchers. This raises privacy issues, such as whether the
p.000114: archival material or data contains personal identifiers, or whether it can be linked to such identifiers and, if so, by
p.000114: whom. If consent was required for the original collection or use of the archival material or data then secondary uses
p.000114: may be constrained by the conditions specified in the initial consent. Consequently, it is essential that the
p.000114: consent process anticipate, where feasible, any foreseeable plans for future research using the material or data.
p.000114: There are, however, certain circumstances under which archival biological material or data may be used for research
p.000114: purposes where consent is not required. For instance, where archival biological material or data was
...
p.000114: may waive the consent requirement subject to conditions outlined below.
p.000114: Researchers who have not obtained consent from participants for secondary use of their archival material or data should
p.000114: only use such material or data if they can satisfy a REC that:
p.000114: • The use of the material/data without the participants’ consent is unlikely to adversely affect the welfare
p.000114: of individuals involved
p.000114: • The researchers will take appropriate measures to protect the privacy of individuals, and to safeguard the
p.000114: material/data
p.000114: • The researchers will comply with any known preferences previously expressed by individuals about any use of
p.000114: their material/data
p.000114: • It is impossible or impracticable to seek consent from individuals to whom the material/data relates; and
p.000114: It is important to note that the word “impracticable” refers to excessive difficulty or onerousness that jeopardises
p.000114: the conduct of the research as opposed to inconvenience.
p.000114:
p.000114:
p.000114: Page 85
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: As a condition of access, archival biological material or data should be de-identified by the data controller (for more
p.000114: information see Section 9 Consent and controlling access to data).
p.000114:
p.000114:
p.000114: 6.7 Research involving deceased people
p.000114:
p.000114:
p.000114: Human biological material obtained during the course of a post-mortem examination can prove extremely valuable for
p.000114: research purposes. An individual may provide prior consent for the use of his/her biological material for research that
p.000114: will be carried out after his/her death. However, this scenario is uncommon, therefore, the consent form furnished to
p.000114: the next-of-kin prior to a post- mortem examination should include a section which allows relatives of the deceased to
p.000114: give or refuse consent for the use of any retained tissue and/or organs for research purposes.
p.000114: A designated person with training in bereavement should be made available to speak to relatives and explain the
p.000114: procedures involved in an understandable and sympathetic manner. Families must be assured that their decision
p.000114: will be respected.
p.000114:
p.000114:
p.000114:
p.000114: 7. Consent for future uses
p.000114:
p.000114:
p.000114: It is important that consent documentation allows prospective participants to make a decision whether or not to
p.000114: allow their material or data to be used in the future. In order for such decisions to be as fully
p.000114: informed as possible, prospective research participants should be presented with a multiple choice or
...
p.000114: without further consent being required.
p.000114: Where prospective research participants are to be recruited in a clinical setting, a clear distinction should be made
p.000114: between consent for any clinical procedures or tests and consent to research participation. In practice,
p.000114: this means separate discussions should take place and separate consent documentation should be provided.
p.000114: Research participants should be informed of the extent to which confidentiality will reasonably be maintained during
p.000114: future research. If prospective research participants refuse to consent to the biobanking or future use of their
p.000114: material or data, then the material or data should be destroyed on completion of the planned research
p.000114: project.
p.000114: In order to protect the interests of research participants whose material or data might be stored, institutions and
p.000114: researchers that maintain biobanks must:
p.000114: • ensure that they have or use appropriate facilities, equipment, policies and procedures
p.000114: to store human biological materials safely and securely; and
p.000114: • establish appropriate physical, administrative and technical safeguards to protect human
p.000114: biological materials and any information about participants from unauthorised access.
p.000114: Biobank custodians have an obligation to respect an individual’s expressed preferences. Where an individual does not
p.000114: want biological materials used for future research, custodians should remove these biological materials and/or
p.000114: data from any collections used or made available for research.
p.000114: Research participants whose biological material is (or is intended to be) stored in a biobank must be informed of
p.000114: their right to withdraw their material and/or data without any negative repercussions. It is
p.000114: recommended that researchers offer prospective research participants a set of graded options for withdrawal, such
p.000114: as, no further contact from researchers or complete withdrawal.
p.000114: • No further contact: participants would no longer be contacted by the researchers or data controllers but
p.000114: their previously provided biological material/data would still be available for use in the current research and/or
p.000114: future research.
p.000114:
p.000114: Page 87
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Limited further use: participants’ biological material would be destroyed but the previously
p.000114: collected data derived from that material would be available for further use in the current research and/or future
p.000114: research. Participants might also be given the option to identify the types of research they would or would
p.000114: not want their material/data to be used for.
...
p.000114: when disclosure is made. Disclosure of research results should be done in a sensitive manner with the consent of
p.000114: the participant. Incidental findings and/or research results (especially in the case of genetic research)
p.000114: should be confirmed by an accredited laboratory.
p.000114: In cases where incidental findings are regarded to be of vital and immediate clinical significance (e.g. tumours,
p.000114: blood clots, aneurysms), the researcher involved has a duty of care to that individual. Prospective
p.000114: research participants must be advised that such a duty of care exists during the consent process.
p.000114: Researchers should be especially aware of their obligations to protect the confidentiality of research
p.000114: participants when releasing data to third parties. For instance, in the case of genetic research, family
p.000114: members may need to be informed of potential genetic risks. Similarly, data may be of interest to other researchers or
p.000114: biobanks.
p.000114: Provided that consent is in place, transfer of identifiable data to such third parties is permissible and provided a
p.000114: comparable level of security and protection of privacy can be ensured. (For more information on Consent and controlling
p.000114: access to data see Section 9).
p.000114: The Disability Act 2005 (Part 4) provides that insurers cannot request, take into account or process the
p.000114: results of genetic tests (for a more in-depth discussion of genetic research see Section 6.1).
p.000114: Certain types of information may be made available to public health officials for important purposes, for
p.000114: example, the reporting of infectious diseases, without the explicit consent of the individual.
p.000114:
p.000114:
p.000114:
p.000114: 9. Consent and controlling access to data
p.000114:
p.000114:
p.000114: Research participants who have given appropriate consent have a right to expect that identifiable data about
p.000114: themselves, either provided or discovered in the course of research, will not be shared with others without their
p.000114: consent.
p.000114:
p.000114:
p.000114:
p.000114: Page 89
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Anonymous data is beyond the scope of the Data Protection Acts, therefore, consent is not required in
p.000114: order to conduct research using this form of data. However, use of anonymous data is not always possible, or indeed
p.000114: desirable, in a research context.
p.000114: De-identifying data (i.e. where identifiable information is substituted with a code to which only the data controller
p.000114: would have the key) is another way of protecting confidentiality. In order to safeguard a research participant’s
p.000114: rights to privacy, data should be de-identified by the data controller as early as possible. In the case of
p.000114: HSE-run facilities, the HSE is the data controller.
p.000114: In cases where research is to be undertaken by external third parties (e.g. researchers who are not directly involved
p.000114: in the care of the prospective research participants), where identifiable information will be used then the
...
Searching for indicator access to information:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 13.2 Payment
p.000114:
p.000114:
p.000114: There may be instances where research participants will be paid for any inconvenience and time given to the study.
p.000114: Payment may be financial (not limited to reimbursement, compensation or nominal levels) or non-financial e.g.
p.000114: entry into prize draws, gift vouchers, book tokens. Payment that is disproportionate to the time involved or is likely
p.000114: to encourage participants to take risks, is ethically unacceptable. The timing of payments must be such that they do
p.000114: not constitute undue inducement.
p.000114: Where researchers wish to offer payment to prospective research participants, they must justify to a REC their
p.000114: reasons as well as the amount/reward being offered. Payments or rewards that undermine a person’s ability
p.000114: to exercise free choice would be deemed to invalidate his/her consent.
p.000114:
p.000114:
p.000114:
p.000114: 14. Audit
p.000114:
p.000114:
p.000114: In general, audit does not require informed consent. If audit is to be conducted by those involved in the care of the
p.000114: individual or their support staff (e.g. clinical audit staff) then explicit consent is not required provided that the
p.000114: individual:
p.000114: • has access to information outlining the possibility that their personal data may be disclosed for local
p.000114: clinical audit; and
p.000114: • has been given an opportunity to opt out.
p.000114:
p.000114: Where clinical audit is to be conducted by an external third party, then the data must be de-
p.000114: identified (therefore no consent would be required). In cases where identifiable data is necessary for clinical audit
p.000114: purposes, the data may only be disclosed to third parties with the explicit consent of the individuals
p.000114: concerned.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 93
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There are a number of key differences between audit and research:
p.000114:
p.000114: Research Audit
p.000114:
p.000114:
p.000114: Purpose
p.000114: To provide new knowledge e.g. to set or change clinical standards.
p.000114: To measure practice against evidence- based standards.
p.000114:
p.000114:
p.000114:
p.000114: Methodology
p.000114: Addresses clearly defined questions/hypotheses using systematic and rigorous processes. Designed so that it can be
p.000114: replicated and results can be generalised to other groups.
...
Searching for indicator freedomXofXinformation:
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p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 54
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
p.000114: Page 55
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
p.000114: to consent must also have the capacity to refuse. However, courts in other jurisdictions have held that
p.000114: there is a clear practical distinction to be made between consent to and refusal of medical treatment in
p.000114: that consent involves acceptance of what is an experienced medical view whereas refusal rejects that
...
Social / Age
Searching for indicator age:
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p.000011: completion of the policy and supporting documentation. I am also grateful to Dr Philip Crowley, John Kenny
p.000011: and Wini Ryan for their help and support during this project.
p.000011: Finally sincere thanks to all of the staff, service users and members of the public who made
p.000011: submissions during the consultation phase of this work and who were significant stakeholders in the development of this
p.000011: Policy.
p.000011: Dr Deirdre Madden
p.000011:
p.000011: Chair, National Consent Advisory Group.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Page 3
p.000011:
p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Table of contents
p.000011:
p.000011:
p.000011: Page
p.000011: Glossary
p.000011: 11
p.000011: Part One – General Principles 19
p.000011: 1. Introduction
p.000020: 20
p.000020: 1.1 Scope of this policy
p.000020: 20
p.000020: 1.2 Ethical issues regarding consent
p.000020: 20
p.000020: 1.3 Health and social care decision-making
p.000021: 21
p.000021: 1.4 Consent in Irish law
p.000021: 21
p.000021: 1.5 Age of consent in Irish law
p.000022: 22
p.000022: 2. What is valid and genuine consent? 23
p.000022: 3. Providing information and discussing treatment options 23
p.000022: 3.1 Importance of individual circumstances
p.000024: 24
p.000024: 3.2 What information should be provided about interventions? 24
p.000024: 3.3 What information about risks and side effects of an intervention should be 25
p.000024: provided?
p.000024: 3.4 How and when information should be provided 26
p.000024: 3.4.1 Service users with limited English proficiency 27
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
p.000030: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
p.000042: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Page 6
p.000055:
p.000055: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
...
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: National Consent Advisory Group Membership 124
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 10
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 11
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
...
p.000114:
p.000114:
p.000114: Capacity
p.000114: The ability to understand the nature and consequences of a decision in the context of available choices at the time the
p.000114: decision is to be made.
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR)
p.000114: Cardiopulmonary resuscitation (CPR) is an attempt to restore breathing (sometimes with support) and spontaneous
p.000114: circulation in an individual in cardiorespiratory arrest. CPR usually includes chest compressions,
p.000114: attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Cardiorespiratory arrest
p.000114: Cardiac arrest is the cessation of cardiac contraction. Respiratory arrest is the cessation of effective
p.000114: oxygenation and ventilation. Cardiorespiratory arrest is a combination of cardiac and respiratory arrest.
p.000114:
p.000114:
p.000114: Child
p.000114: A person under the age of 18 years, unless that person has attained full age through marriage.
p.000114:
p.000114:
p.000114: Coercion/Duress
p.000114: Forcing someone to behave in a particular way by use of threats or intimidation or some other form of pressure or
p.000114: force.
p.000114:
p.000114:
p.000114: Consent
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation in
p.000114: research following a process of communication in which the service user has received sufficient
p.000114: information to enable him/her to understand the nature, potential risks and benefits of the proposed intervention or
p.000114: service.
p.000114:
p.000114:
p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
p.000114:
p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 13
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
...
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
p.000114: A person who is less than 18 years of age, who is not or has not been married.
p.000114:
p.000114:
p.000114: Personal data
p.000114: Data relating to a living individual who is or can be identified either from the data or from the data in conjunction
p.000114: with other information that is in, or is likely to come into, the possession of the data controller.
p.000114:
p.000114:
p.000114: Reasonable person
p.000114: A person who exercises average care, skill, caution and judgement.
p.000114:
p.000114:
p.000114: Service provider
p.000114: Any person, organisation or part of an organisation delivering health and social care services.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Service user
p.000114: For the purpose of this document the term ‘service user’ means a person who uses health and social care services.
p.000114: In some instances the term ‘patient’, ‘individual’ or ‘participant’ is used in this document instead of ‘service user’
p.000114: where it is considered more appropriate.
p.000114:
p.000114:
p.000114: Significant/Material risk
p.000114: A risk may be seen as significant/material if a reasonable person in the patient's position would attach significance
p.000114: to it.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
...
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2 For discussion of these exceptional circumstances see chapter one section 6
p.000114: 3 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 4 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 2. What is valid and genuine consent?
p.000114:
p.000114:
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation
p.000114: in research following a process of communication about the proposed intervention. The process of
p.000114: communication begins at the initial contact and continues through to the end of the service user’s involvement in the
...
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Approaches that may be helpful in this regard include:
p.000114:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations, or having written or audio information about their condition
p.000114: • Speak to those close to the service user and to other health and social care staff about the best ways
p.000114: of communicating with the service user, taking account of confidentiality issues.
p.000114:
p.000114:
p.000114: 5.3 Presumption of capacity
p.000114:
p.000114:
p.000114: Those who provide health and social care services must work on the presumption that every adult service
p.000114: user has the capacity to make decisions about their care, and to decide whether to agree to, or refuse, an examination,
p.000114: investigation or treatment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of their age, disability,
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: Page 31
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
...
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
...
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: Page 50
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
...
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
p.000114: Page 52
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
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p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
...
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
p.000114: to consent must also have the capacity to refuse. However, courts in other jurisdictions have held that
p.000114: there is a clear practical distinction to be made between consent to and refusal of medical treatment in
p.000114: that consent involves acceptance of what is an experienced medical view whereas refusal rejects that
p.000114: experience from a position of comparatively limited knowledge. Consequently, it is argued that the implications
p.000114: of refusal may be more serious and, in extreme cases, may even result in death.
p.000114: Section 23 of the Non-Fatal Offences Against the Person Act 1997, while it allows the young person aged
p.000114: 16-18 to give consent to medical treatment, does not include an express entitlement to refuse such treatment.
p.000114: This policy proposes that in cases where an individual between the age of 16 and 18 refuses a treatment or service, in
p.000114: general such refusal should be respected in the same way as for adults. However, if the refusal relates to life
p.000114: sustaining treatment, or other decisions which may have profound, irreversible consequences for him or her, reasonable
p.000114: efforts must be made to discuss the young person’s refusal with all the relevant parties, including the involvement of
p.000114: the HSE Advocacy services and/or a third party mediator where appropriate, in an attempt to reach
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
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p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
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p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
p.000114: requires any other treatment or intervention not related to their mental health, the general principles of consent
p.000114: apply as discussed in this policy.
p.000114:
p.000114:
p.000114:
p.000114: 10. Sexual health services
p.000114:
p.000114:
p.000114: Under Irish law it is a criminal offence to engage or attempt to engage in a sexual act with a child under 17 years of
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
p.000114: law, a girl under the age of 17 who has sexual intercourse may not be convicted of an offence on
p.000114: that ground alone. This exemption from prosecution does not apply to boys of the same age.
p.000114: There is no specific provision in law regarding the age at which contraceptive advice and treatment and
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
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p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
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p.000114: validation against the controlled version
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p.000114: National Consent Policy HSE V.1.3
p.000114:
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p.000114: explained and that the consent was freely given. A video/audio tape recording of the consent interview might also
p.000114: be made with the permission of the research participant, however, researchers using this method must be
p.000114: mindful of their obligations to protect the confidentiality of the participant.
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3. Children
p.000114:
p.000114:
p.000114: Children should not be denied the possible benefits of research participation but instead should be afforded the
p.000114: opportunity to participate in research on matters that might affect them. Neither should children be exploited or
p.000114: inappropriately enrolled in research because they lack the capacity to consent to participation26.
p.000114: For the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own
p.000114: behalf27. For all other research, the person must be over the age of 18 years in order to provide consent.
p.000114: The following principles should be adhered to when conducting research involving children:
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
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p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
...
p.000114: • No further contact: participants would no longer be contacted by the researchers or data controllers but
p.000114: their previously provided biological material/data would still be available for use in the current research and/or
p.000114: future research.
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Limited further use: participants’ biological material would be destroyed but the previously
p.000114: collected data derived from that material would be available for further use in the current research and/or future
p.000114: research. Participants might also be given the option to identify the types of research they would or would
p.000114: not want their material/data to be used for.
p.000114: • No further use: all biological material/data previously collected could no longer be used by researchers
p.000114: but would instead be destroyed.
p.000114: Whatever option is selected by an individual should be adhered to. It is important to note that the subsequent use
p.000114: of biological material or data collected for a specified purpose may not proceed without first receiving REC
p.000114: approval.
p.000114: In the case of longitudinal studies, children who are recruited as research participants should be asked for consent
p.000114: to their continued participation in research on reaching the age of maturity (i.e. 18 years). (For more
p.000114: information on Reconsent see Section 11 ).
p.000114:
p.000114:
p.000114:
p.000114: 8. Consent and incidental findings
p.000114:
p.000114:
p.000114: The term “incidental findings” refers to the unanticipated discoveries made in the course of research but
p.000114: that are outside the scope of the research. Medically relevant incidental findings are findings that have been
p.000114: interpreted as having significant implications for the participant, whether health-related, psychological or social.
p.000114: As part of the consent process, prospective research participants should be provided with the option of
p.000114: whether or not they wish to have medically relevant incidental findings disclosed to them. Should
p.000114: prospective participants indicate a desire not to be given medically relevant information, then this decision
p.000114: should be documented and respected.
p.000114: When medically relevant incidental findings are likely, researchers should develop a plan indicating how
p.000114: they will disclose such findings to participants and submit this plan for REC review.
p.000114:
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p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
...
p.000114: As noted above, certain types of research may not require the consent of the research participant by virtue of a legal
p.000114: basis (e.g. research in public health emergencies) or because a REC has waived the requirement for consent (e.g.
p.000114: population based research). It should be noted that in the latter case, the waiver applies only to de-identified
p.000114: material/data.
p.000114: Waiver of consent is to be regarded as an exception to the rule and studies seeking waiver of consent
p.000114: must receive REC approval. Before a waiver of consent may be granted the researcher must satisfy the REC
p.000114: that:
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • the overall benefit to research is real and substantial
p.000114:
p.000114: • the benefits from the research justify any risks of harm associated with not seeking consent;
p.000114: • it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records);
p.000114: • there is no known or likely reason for thinking that participants would not have consented if they had been
p.000114: asked;
p.000114: • there is sufficient protection of their privacy; and
p.000114:
p.000114: • there is an adequate plan to protect the confidentiality of data.
p.000114:
p.000114: It is important to note that the word “impracticable” refers to excessive difficulty or onerousness that jeopardises
p.000114: the conduct of the research as opposed to inconvenience.
p.000114:
p.000114:
p.000114:
p.000114: 13. Remuneration of research participants
p.000114:
p.000114:
p.000114: 13.1 Reimbursement
p.000114:
p.000114:
p.000114: Research participants may be reimbursed for lost earnings, travel costs and other expenses incurred.
p.000114: Another acceptable form of reimbursement might be the provision of free medical services. Compensation for
p.000114: the time and inconvenience involved in research participation (e.g. payment at minimum wage levels) might also
p.000114: be permissible as research participants should not be expected to bear the costs that relate to taking part in a
p.000114: study. However, it is important to note that compensation is understood to mean a recompense for losses sustained
p.000114: e.g. time away from work.
p.000114: Any reimbursements or compensation that might be offered to prospective participants should first be approved
p.000114: by a REC in order to ensure that they are reasonable and do not reflect any undue inducement by
p.000114: encouraging people to act against their better judgment or take unnecessary risks.
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
p.000114: In particular, individuals are the best judges of their own quality of life; healthcare professionals and families
p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
p.000114:
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p.000114: validation against the controlled version
p.000114:
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 3.2 Involving the individual in discussions regarding CPR
p.000114:
p.000114:
p.000114: Decisions pertaining to CPR and DNAR orders should be made in the context of the likelihood of success and the
p.000114: potential risks as well as the individual’s overall goals and preferences for his/her treatment and care.
p.000114: Determination of the former requires discussion with the individual him/ herself.
p.000114: Decisions relating to CPR and DNAR orders are complex and potentially emotive therefore, it is important for such
...
p.000114: this policy
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
...
p.002003: Reviews in Clinical Gerontology 20: 20–29
p.002003:
p.002003: Lippert FK, Raffay V, Georgiou M, Steen PA and Bossaert L (2010). European Resuscitation Council Guidelines for
p.002003: Resuscitation 2010, Section 10. The ethics of resuscitation and end-of-life decisions. Resuscitation
p.002003: 81(10): 1445–1451
p.002003: Loertscher L, Reed DA, Bannon MP and Mueller PS (2010). Cardiopulmonary Resuscitation and Do
p.002003: -Not-Resuscitate Orders: A Guide for Clinicians. The American Journal of Medicine 123(1): 4-9 Madden Medicine, Ethics
p.002003: and the Law 2nd Ed (Bloomsbury, 2011)
p.002003: Mason and Kenyon Mason and McCall Smith’s Law and Medical Ethics 7thed(OUP, 2006)
p.002003:
p.002003: McKenchie L, Gill AB. Consent for Neonatal Research. Archives of Disease in Childhood Fetal & Neonatal Edition (2006),
p.002003: 91(5): F374-376
p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003: O’Brien M and O’Keeffe ST (2009).Resuscitation decisions in Irish long-stay units. Irish Journal of Medical Science
p.002003: 178(4): 423-425
p.002003: O’Keeffe ST (2001). Development and implementation of resuscitation guidelines: a personal experience. Age
p.002003: and Ageing 30(1): 19-25
p.002003: O’ Keeffe ‘A Clinician’s Perspective: Issues of Capacity in Care’ (2008) 14 Medico-Legal Journal of Ireland 41
p.002003: Peberdy MA, Kaye W, Ornato JP, Larkin GL, Nadkarni V, Mancini ME, Berg RA, Nichol G and Lane- Trultt T (2003).
p.002003: Cardiopulmonary resuscitation of adults in the hospital: A report of 14720 cardiac arrests from the National Registry
p.002003: of Cardiopulmonary Resuscitation. Resuscitation 58(3): 297-308
p.002003: Sandroni C, Nolan J, Cavallaro P and Antonelli M (2007). In-hospital cardiac arrest: incidence, prognosis
p.002003: and possible measures to improve survival. Intensive Care Medicine 33(2): 237–245
p.002003: Smith GB, Poplett N and Williams D (2005).Staff awareness of a ‘Do Not Attempt Resuscitation’ policy in a
p.002003: District General Hospital. Resuscitation 65(2): 159-165
p.002003: Staunton ‘The Development of Healthcare Planning in Ireland’ (2009) 15 Medico-Legal Journal of Ireland 74
p.002003: Whelan Mental Health Law and Policy (Thompson Roundhall, 2009)
p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: National Consent Advisory Group Membership
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p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
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p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
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p.000055: validation against the controlled version
p.000055:
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p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
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p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: National Consent Advisory Group Membership 124
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
p.000114:
p.000114:
p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
p.000114:
p.000114:
p.000114: Autonomy
p.000114: The capacity to make decisions and take actions that are in keeping with one’s values and beliefs.
p.000114:
p.000114:
p.000114: Bioethics
p.000114: A multidisciplinary activity dealing with the ethical implications of biological research and medicine.
p.000114:
p.000114:
p.000114: Biobank
p.000114: A centralised archive of human biological material from which materials are made available for research purposes.
p.000114:
p.000114:
p.000114: Capacity
p.000114: The ability to understand the nature and consequences of a decision in the context of available choices at the time the
p.000114: decision is to be made.
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR)
p.000114: Cardiopulmonary resuscitation (CPR) is an attempt to restore breathing (sometimes with support) and spontaneous
p.000114: circulation in an individual in cardiorespiratory arrest. CPR usually includes chest compressions,
p.000114: attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Cardiorespiratory arrest
p.000114: Cardiac arrest is the cessation of cardiac contraction. Respiratory arrest is the cessation of effective
p.000114: oxygenation and ventilation. Cardiorespiratory arrest is a combination of cardiac and respiratory arrest.
p.000114:
p.000114:
p.000114: Child
p.000114: A person under the age of 18 years, unless that person has attained full age through marriage.
p.000114:
p.000114:
p.000114: Coercion/Duress
p.000114: Forcing someone to behave in a particular way by use of threats or intimidation or some other form of pressure or
p.000114: force.
p.000114:
p.000114:
p.000114: Consent
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation in
p.000114: research following a process of communication in which the service user has received sufficient
p.000114: information to enable him/her to understand the nature, potential risks and benefits of the proposed intervention or
p.000114: service.
p.000114:
p.000114:
p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
p.000114:
p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
...
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2 For discussion of these exceptional circumstances see chapter one section 6
p.000114: 3 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 4 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 2. What is valid and genuine consent?
p.000114:
p.000114:
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation
p.000114: in research following a process of communication about the proposed intervention. The process of
p.000114: communication begins at the initial contact and continues through to the end of the service user’s involvement in the
...
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
...
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
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p.000114:
p.000114:
p.000114: Part Two Children and Minors
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: As a corollary to the rights given to parents as legal guardians of their children, there are also
p.000114: duties imposed on them to act in the best interests of their children. In the health and social care context this
p.000114: requires parents and legal guardians to engage with health and social care service providers to ensure that
p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
p.000114: Page 52
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
p.000114: Page 53
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
...
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
p.000114: Page 55
p.000114:
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...
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 56
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
p.000114: As noted in Section 2, parent(s)/legal guardian(s) are generally considered best placed to safeguard the
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
p.000114: for children and have expertise in the particular needs of their child. Parent(s)/legal guardian(s) are
p.000114: entitled to be treated with courtesy and respect and to be provided with adequate information and support in relation
p.000114: to the provision of health and social care services to their children (see further Part One Section 3).
p.000114: It is important for service providers to recognise the role of the parent(s)/legal guardian(s) in
p.000114: deciding together with health and social care professionals what is in the best interests of the child. Case
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 57
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
p.000114: parent(s)/legal guardian(s) about the decision they are making in relation to their child and carry out
p.000114: an assessment of the minor as outlined in Section 3 above. If appropriate, the maternal grandparents might
p.000114: also be asked to participate in this discussion with the consent of the minor parent/legal guardian. Failing
p.000114: resolution, it is recommended that legal advice is sought.
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
p.000114: In relation to children who are subject to interim and emergency care orders, an application can be made to the
p.000114: District Court pursuant to the Child Care Act 1991 in regard to medical treatment.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 58
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to children who are subject to a full care order, although it is good practice to seek the consent of the
p.000114: parent/legal guardian, the HSE is authorised pursuant to Section 18 of the 1991 Childcare Act to consent to any
p.000114: necessary medical or psychiatric treatment, assessment or examination. However, different procedures apply to
p.000114: admission and treatment under the Mental Health Act 2001 (see Section 9).
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
p.000114: control over the child as if they were the child’s parent/legal guardian provided that:
p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
p.000114: Page 59
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
p.000114:
p.000114:
p.000114: Page 60
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: The 2001 Act also contains certain provisions in relation to the treatment of a detained child. Section
p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
p.000114: child and the authorisation of a second consultant psychiatrist before medication which has been
p.000114: prescribed to a child for a continuous period of three months can be continued. Electroconvulsive therapy or
p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
p.000114: requires any other treatment or intervention not related to their mental health, the general principles of consent
p.000114: apply as discussed in this policy.
p.000114:
p.000114:
p.000114:
p.000114: 10. Sexual health services
p.000114:
p.000114:
p.000114: Under Irish law it is a criminal offence to engage or attempt to engage in a sexual act with a child under 17 years of
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
p.000114: law, a girl under the age of 17 who has sexual intercourse may not be convicted of an offence on
p.000114: that ground alone. This exemption from prosecution does not apply to boys of the same age.
p.000114: There is no specific provision in law regarding the age at which contraceptive advice and treatment and
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
...
p.000114: inappropriately enrolled in research because they lack the capacity to consent to participation26.
p.000114: For the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own
p.000114: behalf27. For all other research, the person must be over the age of 18 years in order to provide consent.
p.000114: The following principles should be adhered to when conducting research involving children:
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 26 Researchers should refer to the Department of Children and Youth Affairs document Guidance for Developing Research
p.000114: Projects Involving Children which was published in April 2012
p.000114: 27 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI no 190 of 2004,
p.000114: section 4
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There is an international consensus that children should not be exposed to more than minimal risk in the absence of
p.000114: direct benefit to the participants themselves. The standard of minimal risk requires that the probability and
p.000114: magnitude of the possible harms posed by participating in research are no greater than those encountered by
p.000114: participants in their everyday life or during the performance of routine physical or psychological examinations or
p.000114: tests.
p.000114: Where the research entails only minimal risk, it is sufficient if the research offers the prospect of benefits either
p.000114: to the participants directly or to the group which is the focus of the research and to which the participants belong.
p.000114: Where the research poses more than minimal risk, it should aim to generate new knowledge of sufficient importance for
p.000114: addressing the participants’ conditions/needs. Such research should offer the prospect of direct benefits for
p.000114: the participants themselves and be commensurate with the level of foreseeable risk. The benefit-to-risk ratio presented
p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
...
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
p.000114: Therefore, it is essential that researchers should be aware of the possibility of parental therapeutic
p.000114: misconceptions when determining how to explain the potential benefits and risks of research participation during the
p.000114: consent process.
p.000114: In certain circumstances, it will not be possible for the researcher to guarantee confidentiality to the child due
p.000114: to mandatory reporting obligations. For instance, if a child reveals that they or others are at significant
p.000114: risk of harm, or the researcher observes or receives evidence of incidents likely to cause serious harm, the
p.000114: researcher must divulge this information to the appropriate authorities. This should occur only following
p.000114: discussion with the child. The child and his/her parent(s)/legal guardian(s) should be informed of this
p.000114: obligation during the consent/assent process and it should be highlighted in participant information leaflets. A
p.000114: strategy for information disclosure should be submitted to and approved by the REC in advance of the
p.000114: research being commenced.
p.000114:
p.000114:
p.000114:
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
p.000114: In accordance with the functional approach to capacity (see Part One), there may be instances where a person might have
p.000114: limited capacity and may require assistance in deciding whether or not to participate in research. In such cases,
p.000114: researchers must ensure that efforts are made to assist people in reaching their decision and that they are provided
p.000114: with the appropriate tools to maximise their decision-making ability.
p.000114: The objectives as well as the potential risks and benefits of the research should be explained as fully as possible to
p.000114: the prospective participant given their level of understanding. The information should be provided using easily
p.000114: comprehensible language and the prospective participant should be informed of the right to withdraw from the
...
p.000114: material or personal data.
p.000114: In the case of anonymous biological material/data, prospective research participants should be informed during the
p.000114: consent process that it will not be possible to withdraw their material and/ or data.
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 11. Reconsent
p.000114:
p.000114:
p.000114: The consent process should consist of a continued exchange of information for the duration of a study. When substantial
p.000114: changes occur in the conditions or the procedures of a study, researchers should once again seek the consent of the
p.000114: participants. It is imperative that research participants be informed when there is new information that might
p.000114: affect their willingness to continue participation. There are a number of reasons why reconsent may be required
p.000114: which include but are not limited to cases where:
p.000114: • the research protocol has been substantially altered;
p.000114:
p.000114: • new safety information has come to light;
p.000114:
p.000114: • alternative treatments have become available;
p.000114:
p.000114: • a child participant reaches legal maturity (i.e. 18 years or 16 years in the case of clinical trials);
p.000114: • a formerly incapacitated adult has regained capacity; or
p.000114:
p.000114: • a substantial period of time has elapsed since the original consent was obtained (e.g. longitudinal study).
p.000114: A strategy for reconsenting participants should be presented to the REC responsible for reviewing and approving the
p.000114: study.
p.000114:
p.000114:
p.000114:
p.000114: 12. Research where consent may not be required
p.000114:
p.000114:
p.000114: As noted above, certain types of research may not require the consent of the research participant by virtue of a legal
p.000114: basis (e.g. research in public health emergencies) or because a REC has waived the requirement for consent (e.g.
p.000114: population based research). It should be noted that in the latter case, the waiver applies only to de-identified
p.000114: material/data.
p.000114: Waiver of consent is to be regarded as an exception to the rule and studies seeking waiver of consent
p.000114: must receive REC approval. Before a waiver of consent may be granted the researcher must satisfy the REC
p.000114: that:
p.000114:
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p.000114: providing CPR. Therefore, in advance of procedures involving anaesthesia it may be advisable to temporarily
p.000114: suspend an individual’s DNAR order. The process of reviewing the DNAR order should involve discussion with
p.000114: the individual as part of the consent process in advance of the procedure. If the DNAR order is to be suspended this
p.000114: decision should be clearly documented as well as the time at which the DNAR order is to be
p.000114: re-instated. If an individual wishes his/her DNAR order to remain valid during the procedure, despite the
p.000114: increased likelihood of cardiorespiratory arrest, this might significantly increase the overall level of risk
p.000114: associated with the procedure. This issue of elevated risk should be highlighted to the individual, by his/her
p.000114: healthcare team, as part of the overall discussion regarding the procedure. However, if the individual is willing to
p.000114: accept the additional risk then the healthcare professional should continue with the procedure.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
p.000114:
p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
p.000114:
p.000114: Page 110
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
p.000114: be in the child’s best interests and a DNAR order should be put in place.
p.000114: Given the additional complexity and the emotionally-demanding nature of decisions relating to CPR for
p.000114: children this process should be underpinned by a number of fundamental guiding principles:
p.000114: • Parent(s)/legal guardian(s) and the healthcare team should work in partnership when deciding about
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: • Therefore, children should be informed and listened to and their ascertainable views and preferences should
p.000114: be taken into consideration
p.000114: • The final decision reached should be in the best interests of the child.
p.000114:
p.000114: In some instances, consensus may be reached on a child’s proposed treatment and care plan following a
p.000114: detailed discussion about his/her condition and prognosis, the likelihood of CPR being successful as well as the
p.000114: benefits and risks associated with CPR. However, disagreements with parent(s)/legal guardian(s) may be more
p.000114: likely to arise where a healthcare professional considers that the provision of CPR would be clinically
p.000114: inappropriate. In such cases continued communication and obtaining a second opinion from an
p.000114: independent senior healthcare professional may help to resolve the disagreement. Nonetheless, if the
p.000114: disagreement persists, healthcare professionals should seek ethical and legal advice and court involvement
p.000114: may ultimately be required to reach a solution.
p.000114:
p.000114:
p.000114:
p.000114: 8. Documenting and communicating CPR/DNAR decisions
p.000114:
p.000114:
p.000114: A decision whether or not to attempt CPR should be clearly and accurately documented in the individual’s healthcare
p.000114: record, along with how the decision was made, the date of the decision, the rationale for it, and who was involved in
p.000114: discussing the decision.
p.000114: It is recommended that service providers should develop specific mechanisms for the documentation
p.000114: and dissemination of decisions relating to resuscitation35.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 35 For example, the development of a standardised and colour-coded DNAR card, to be included in an individual’s
...
p.000114: European Commission, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
p.000114: protection of individuals with regard to the processing of personal data and on the free movement of such data
p.000114: European Commission, Proposal for a Regulation of the European Parliament and of the Council on clinical trials on
p.000114: medicinal products for human use, and repealing Directive 2001/20/EC. 17th July 2012
p.000114: European Convention on Human Rights and Fundamental Freedoms 1953 Health Act 1947
p.000114:
p.000114:
p.000114: Page 117
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Bibliography
p.000114:
p.000114:
p.000114: Mental Health Act 2001
p.000114:
p.000114: Mental Health Act 2001 (Approved Centres) Regulations 2006(SI 551 of 2006)
p.000114:
p.000114: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
p.000114: medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC,
p.000114: Directive 2001/83/EC and Regulation (EC) No 726/2004.
p.000114: Road Traffic Act 2010
p.000114:
p.000114: UNESCO Universal Declaration on Bioethics and Human Rights 2005 UNESCO International Declaration on Human Genetic Data
p.002003: 2003
p.002003: UNESCO Universal Declaration on the Human Genome and Human Rights 1997 United Nations Convention on the Rights of
p.002003: Persons with Disabilities 2006 United Nations Convention on the Rights of the child 1989
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Reports/Guidance
p.002003:
p.002003: Association of Anaesthetists of Great Britain and Ireland (2009) Do Not Attempt Resuscitation (DNAR)
p.002003: Decisions in the Perioperative Period. Association of Anaesthetists of Great Britain and Ireland, London
p.002003: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and
p.002003: Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for
p.002003: Research Involving Humans (December 2010)
p.002003: Council on Ethical and Judicial Affairs, American Medical Association (1991) CEJA Report D – I-90. Guidelines for the
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
p.002003:
p.002003:
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p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
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p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Reader Information
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Corporate Responsibility:
p.000011: HSE National Quality Improvement Team, Chief Clinical Office
p.000011:
p.000011:
p.000011:
p.000011: Title:
p.000011:
p.000011: Document Reference Number: Version Number:
p.000011: Author:
p.000011: National Consent Policy HSE V.1.3
p.000011: V. 1.3
p.000011:
p.000011: National Consent Advisory Group
p.000011:
p.000011:
p.000011: Approval Date:
p.000011: April 2013
p.000011:
p.000011:
p.000011: Published Date:
p.000011: May 2013
p.000011:
p.000011:
p.000011: Superseded Documents: Changes to V.1
p.000011: Changes to V.1.1
p.000011:
p.000011:
p.000011: Changes to V.1.2
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Revision Date: Contact Details:
p.000011: National Consent Policy V1 (2013)
p.000011:
p.000011: Text added to Part 2 Children and Minors Page 49—2 Role of Parent(s) and Legal Guardian(s)
p.000011: Text changed on Part 2 Children and Minors Page 49—2.1 What is legal guardianship?
p.000011: Text added to Part 1, General Principles, Section 3.5 Consent and pregnancy.
p.000011: Text deleted to Part 1, General Principles, Section 7.7.1 Refusal of treatment in pregnancy.
p.000011: Text added to Part 1, General Principles, Section 7.10 Refusal of treatment in pregnancy.
p.000011: May 2016, June 2019 Marie Tighe
p.000011: Project Manager- Consent
p.000011: HSE National Office for Assisted Decision Making and Consent
p.000011: Email: marie.tighe1@hse.ie
p.000011:
p.000011: Web: www.hse.ie
p.000011:
p.000011:
p.000011: ISBN: 978-1-906218-63-8
p.000011:
p.000011:
p.000011:
p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011: I would like to acknowledge the hard work, guidance and patience of the members of the National Consent
p.000011: Advisory Group and our sub-groups whose expertise and experience was critical to the development of this
p.000011: Policy.
p.000011: I would also like to express my sincere thanks to Angela Hughes and Larraine Gilligan of the Quality
p.000011: and Patient Safety Division of the HSE for their hard work, diligence, and support in ensuring the
p.000011: completion of the policy and supporting documentation. I am also grateful to Dr Philip Crowley, John Kenny
...
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
p.000042: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
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p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
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p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
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p.000102: 4.1 Cardiorespiratory arrest is considered unlikely
p.000103: 103
p.000103: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable 104
p.000103: 4.3 Cardiorespiratory arrest is considered possible or likely 104
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p.000103: Table of contents
p.000103: Page
p.000103: 5. Presumption in favour of providing CPR 105
p.000103: 6. Balancing the benefits and risks of providing CPR 106
p.000103: 6.1 Respecting an individual’s refusal of CPR
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
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p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
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p.000114: National Consent Advisory Group Membership 124
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
...
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
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p.000114: 2 For discussion of these exceptional circumstances see chapter one section 6
p.000114: 3 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 4 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 2. What is valid and genuine consent?
p.000114:
p.000114:
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation
p.000114: in research following a process of communication about the proposed intervention. The process of
...
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
...
p.000114: Section 1.4 of this Policy.
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p.000114:
p.000114: National Consent Policy HSE V.1.3
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
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p.000114: Part Two Children and Minors
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
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p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
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p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
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p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: As a corollary to the rights given to parents as legal guardians of their children, there are also
p.000114: duties imposed on them to act in the best interests of their children. In the health and social care context this
p.000114: requires parents and legal guardians to engage with health and social care service providers to ensure that
p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
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p.000114: 16 See Part One section 6.1
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p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
...
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
p.000114: Page 53
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
p.000114: • the minor’s views are stable and a true reflection of his or her core values and beliefs,
p.000114: taking into account his or her physical and mental health and any other factors that affect his or her
p.000114: ability to exercise independent judgement;
p.000114: • the nature, purpose and usefulness of the treatment or social care intervention;
p.000114:
p.000114: • the risks and benefits involved in the treatment or social care intervention, and
p.000114:
p.000114: • any other specific welfare, protection or public health considerations, in respect of which relevant
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
p.000114: Page 55
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
p.000114: to consent must also have the capacity to refuse. However, courts in other jurisdictions have held that
p.000114: there is a clear practical distinction to be made between consent to and refusal of medical treatment in
p.000114: that consent involves acceptance of what is an experienced medical view whereas refusal rejects that
p.000114: experience from a position of comparatively limited knowledge. Consequently, it is argued that the implications
p.000114: of refusal may be more serious and, in extreme cases, may even result in death.
p.000114: Section 23 of the Non-Fatal Offences Against the Person Act 1997, while it allows the young person aged
p.000114: 16-18 to give consent to medical treatment, does not include an express entitlement to refuse such treatment.
p.000114: This policy proposes that in cases where an individual between the age of 16 and 18 refuses a treatment or service, in
p.000114: general such refusal should be respected in the same way as for adults. However, if the refusal relates to life
p.000114: sustaining treatment, or other decisions which may have profound, irreversible consequences for him or her, reasonable
p.000114: efforts must be made to discuss the young person’s refusal with all the relevant parties, including the involvement of
p.000114: the HSE Advocacy services and/or a third party mediator where appropriate, in an attempt to reach
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
p.000114: As noted in Section 2, parent(s)/legal guardian(s) are generally considered best placed to safeguard the
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
p.000114: for children and have expertise in the particular needs of their child. Parent(s)/legal guardian(s) are
p.000114: entitled to be treated with courtesy and respect and to be provided with adequate information and support in relation
p.000114: to the provision of health and social care services to their children (see further Part One Section 3).
p.000114: It is important for service providers to recognise the role of the parent(s)/legal guardian(s) in
p.000114: deciding together with health and social care professionals what is in the best interests of the child. Case
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
...
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
p.000114: parent(s)/legal guardian(s) about the decision they are making in relation to their child and carry out
p.000114: an assessment of the minor as outlined in Section 3 above. If appropriate, the maternal grandparents might
p.000114: also be asked to participate in this discussion with the consent of the minor parent/legal guardian. Failing
p.000114: resolution, it is recommended that legal advice is sought.
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
p.000114: In relation to children who are subject to interim and emergency care orders, an application can be made to the
p.000114: District Court pursuant to the Child Care Act 1991 in regard to medical treatment.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to children who are subject to a full care order, although it is good practice to seek the consent of the
p.000114: parent/legal guardian, the HSE is authorised pursuant to Section 18 of the 1991 Childcare Act to consent to any
p.000114: necessary medical or psychiatric treatment, assessment or examination. However, different procedures apply to
p.000114: admission and treatment under the Mental Health Act 2001 (see Section 9).
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
p.000114: control over the child as if they were the child’s parent/legal guardian provided that:
p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: The 2001 Act also contains certain provisions in relation to the treatment of a detained child. Section
p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
p.000114: child and the authorisation of a second consultant psychiatrist before medication which has been
p.000114: prescribed to a child for a continuous period of three months can be continued. Electroconvulsive therapy or
p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
...
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
p.000114:
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p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
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p.000114: National Consent Policy HSE V.1.3
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p.000114: consent for research).
p.000114: There may be certain circumstances where it is not possible for a prospective participant to provide
p.000114: written consent due to e.g. literacy levels or physical inability. In such cases a witness who is
p.000114: independent of the research should be present during the entire consent process and should sign the consent
p.000114: form. By signing the consent form, the witness acknowledges that the information provided to the individual was
p.000114: explained and that the consent was freely given. A video/audio tape recording of the consent interview might also
p.000114: be made with the permission of the research participant, however, researchers using this method must be
p.000114: mindful of their obligations to protect the confidentiality of the participant.
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3. Children
p.000114:
p.000114:
p.000114: Children should not be denied the possible benefits of research participation but instead should be afforded the
p.000114: opportunity to participate in research on matters that might affect them. Neither should children be exploited or
p.000114: inappropriately enrolled in research because they lack the capacity to consent to participation26.
p.000114: For the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own
p.000114: behalf27. For all other research, the person must be over the age of 18 years in order to provide consent.
p.000114: The following principles should be adhered to when conducting research involving children:
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 26 Researchers should refer to the Department of Children and Youth Affairs document Guidance for Developing Research
p.000114: Projects Involving Children which was published in April 2012
p.000114: 27 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI no 190 of 2004,
p.000114: section 4
p.000114:
p.000114: Page 72
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There is an international consensus that children should not be exposed to more than minimal risk in the absence of
p.000114: direct benefit to the participants themselves. The standard of minimal risk requires that the probability and
p.000114: magnitude of the possible harms posed by participating in research are no greater than those encountered by
p.000114: participants in their everyday life or during the performance of routine physical or psychological examinations or
p.000114: tests.
p.000114: Where the research entails only minimal risk, it is sufficient if the research offers the prospect of benefits either
p.000114: to the participants directly or to the group which is the focus of the research and to which the participants belong.
p.000114: Where the research poses more than minimal risk, it should aim to generate new knowledge of sufficient importance for
p.000114: addressing the participants’ conditions/needs. Such research should offer the prospect of direct benefits for
p.000114: the participants themselves and be commensurate with the level of foreseeable risk. The benefit-to-risk ratio presented
p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
p.000114: Page 73
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
p.000114: Therefore, it is essential that researchers should be aware of the possibility of parental therapeutic
p.000114: misconceptions when determining how to explain the potential benefits and risks of research participation during the
p.000114: consent process.
p.000114: In certain circumstances, it will not be possible for the researcher to guarantee confidentiality to the child due
p.000114: to mandatory reporting obligations. For instance, if a child reveals that they or others are at significant
p.000114: risk of harm, or the researcher observes or receives evidence of incidents likely to cause serious harm, the
p.000114: researcher must divulge this information to the appropriate authorities. This should occur only following
p.000114: discussion with the child. The child and his/her parent(s)/legal guardian(s) should be informed of this
p.000114: obligation during the consent/assent process and it should be highlighted in participant information leaflets. A
p.000114: strategy for information disclosure should be submitted to and approved by the REC in advance of the
p.000114: research being commenced.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 74
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
...
p.000114: study at any time without there being any negative repercussions.
p.000114: There may be some instances where the capacity to consent to research participation is lacking. Adults who lack
p.000114: decision-making capacity must neither be unfairly excluded from the potential benefits of research participation,
p.000114: nor may their lack of capacity to consent be used to inappropriately include them in research. However,
p.000114: special measures should be taken to protect their rights and interests.
p.000114: The following principles should be adhered to when conducting research involving adults lacking decision-making
p.000114: capacity:
p.000114: • The research should only be undertaken if the required knowledge cannot be obtained by
p.000114: conducting research involving adults with decision-making capacity
p.000114: • The research is expected to provide a direct benefit to the participants or to provide
p.000114: knowledge about the cause or treatment of the impairing or similar condition. Where there is no prospect
p.000114: of direct benefit for participants, the risks involved should be no more than minimal (For more
p.000114: information on minimal risk see Section 3 on Children)
p.000114: • Consent for participation must be sought from the person’s legal representative
p.000114:
p.000114: • A REC must approve the participation of adults lacking decision-making capacity in research taking all of
p.000114: the above factors into consideration
p.000114: • The explicit wish of a participant to refuse participation in or to be withdrawn from the study should be
p.000114: respected.
p.000114:
p.000114: Page 76
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where a prospective research participant lacks decision-making capacity but has some ability to understand the
p.000114: significance of the research, the researcher should ascertain the wishes of that individual with respect to
p.000114: his/her participation.
p.000114: Under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations
p.000114: 200429,30, consent for research participation on behalf of an adult lacking decision- making capacity must
p.000114: be obtained from the person’s legal representative. A legal representative has been defined as a person not connected
...
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
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p.000114:
...
p.000114: recommended that researchers offer prospective research participants a set of graded options for withdrawal, such
p.000114: as, no further contact from researchers or complete withdrawal.
p.000114: • No further contact: participants would no longer be contacted by the researchers or data controllers but
p.000114: their previously provided biological material/data would still be available for use in the current research and/or
p.000114: future research.
p.000114:
p.000114: Page 87
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Limited further use: participants’ biological material would be destroyed but the previously
p.000114: collected data derived from that material would be available for further use in the current research and/or future
p.000114: research. Participants might also be given the option to identify the types of research they would or would
p.000114: not want their material/data to be used for.
p.000114: • No further use: all biological material/data previously collected could no longer be used by researchers
p.000114: but would instead be destroyed.
p.000114: Whatever option is selected by an individual should be adhered to. It is important to note that the subsequent use
p.000114: of biological material or data collected for a specified purpose may not proceed without first receiving REC
p.000114: approval.
p.000114: In the case of longitudinal studies, children who are recruited as research participants should be asked for consent
p.000114: to their continued participation in research on reaching the age of maturity (i.e. 18 years). (For more
p.000114: information on Reconsent see Section 11 ).
p.000114:
p.000114:
p.000114:
p.000114: 8. Consent and incidental findings
p.000114:
p.000114:
p.000114: The term “incidental findings” refers to the unanticipated discoveries made in the course of research but
p.000114: that are outside the scope of the research. Medically relevant incidental findings are findings that have been
p.000114: interpreted as having significant implications for the participant, whether health-related, psychological or social.
p.000114: As part of the consent process, prospective research participants should be provided with the option of
p.000114: whether or not they wish to have medically relevant incidental findings disclosed to them. Should
p.000114: prospective participants indicate a desire not to be given medically relevant information, then this decision
p.000114: should be documented and respected.
p.000114: When medically relevant incidental findings are likely, researchers should develop a plan indicating how
p.000114: they will disclose such findings to participants and submit this plan for REC review.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 88
p.000114:
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p.000114: validation against the controlled version
p.000114:
...
p.000114: to review the DNAR order given the potential for cardiorespiratory arrest to occur under anaesthesia. In such
p.000114: situations, should a cardiorespiratory arrest occur, there should be a presumption in favour of
p.000114: providing CPR. Therefore, in advance of procedures involving anaesthesia it may be advisable to temporarily
p.000114: suspend an individual’s DNAR order. The process of reviewing the DNAR order should involve discussion with
p.000114: the individual as part of the consent process in advance of the procedure. If the DNAR order is to be suspended this
p.000114: decision should be clearly documented as well as the time at which the DNAR order is to be
p.000114: re-instated. If an individual wishes his/her DNAR order to remain valid during the procedure, despite the
p.000114: increased likelihood of cardiorespiratory arrest, this might significantly increase the overall level of risk
p.000114: associated with the procedure. This issue of elevated risk should be highlighted to the individual, by his/her
p.000114: healthcare team, as part of the overall discussion regarding the procedure. However, if the individual is willing to
p.000114: accept the additional risk then the healthcare professional should continue with the procedure.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
p.000114:
p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
p.000114:
p.000114: Page 110
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
p.000114: be in the child’s best interests and a DNAR order should be put in place.
p.000114: Given the additional complexity and the emotionally-demanding nature of decisions relating to CPR for
p.000114: children this process should be underpinned by a number of fundamental guiding principles:
p.000114: • Parent(s)/legal guardian(s) and the healthcare team should work in partnership when deciding about
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: • Therefore, children should be informed and listened to and their ascertainable views and preferences should
p.000114: be taken into consideration
p.000114: • The final decision reached should be in the best interests of the child.
p.000114:
p.000114: In some instances, consensus may be reached on a child’s proposed treatment and care plan following a
p.000114: detailed discussion about his/her condition and prognosis, the likelihood of CPR being successful as well as the
p.000114: benefits and risks associated with CPR. However, disagreements with parent(s)/legal guardian(s) may be more
p.000114: likely to arise where a healthcare professional considers that the provision of CPR would be clinically
p.000114: inappropriate. In such cases continued communication and obtaining a second opinion from an
p.000114: independent senior healthcare professional may help to resolve the disagreement. Nonetheless, if the
p.000114: disagreement persists, healthcare professionals should seek ethical and legal advice and court involvement
p.000114: may ultimately be required to reach a solution.
p.000114:
p.000114:
p.000114:
p.000114: 8. Documenting and communicating CPR/DNAR decisions
p.000114:
p.000114:
p.000114: A decision whether or not to attempt CPR should be clearly and accurately documented in the individual’s healthcare
p.000114: record, along with how the decision was made, the date of the decision, the rationale for it, and who was involved in
p.000114: discussing the decision.
...
p.002003: Decisions in the Perioperative Period. Association of Anaesthetists of Great Britain and Ireland, London
p.002003: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and
p.002003: Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for
p.002003: Research Involving Humans (December 2010)
p.002003: Council on Ethical and Judicial Affairs, American Medical Association (1991) CEJA Report D – I-90. Guidelines for the
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 118
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
p.002003: Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector
p.002003: (2007)
p.002003:
p.002003: Department of Children and Youth Affairs, Guidance for Developing Ethical Research Projects Involving
p.002003: Children (2012)
p.002003: Dublin Hospitals Group Risk Management Forum (2010).Matters for consideration regarding Do Not Attempt to Resuscitate
p.002003: Orders for Adult Patients
p.002003: European Union Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric
p.002003: Population (2008)
p.002003: General Medical Council (2010) Treatment and care towards the end of life: good practice in decision
p.002003: making. General Medical Council, London
p.002003: Hospice Friendly Hospitals Programme and the National Council on Ageing and Older People (2008).End-of-Life
p.002003: Care for Older People in Acute and Long-Stay Care Settings in Ireland Joint Statement Dublin
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline Clinical Investigation of Medicinal
p.002003: Products in the Pediatric Population E11 (2000)
p.002003: Irish Council for Bioethics Human Biological Material: Recommendations for Collection, Use and Storage in Research
p.002003: (2005)
p.002003: Law Reform Commission Report on Vulnerable Adults and the Law (LRC 83 -2006) (available at www.lawreform.ie)
p.002003: Law Reform Commission Report on Advance Care Directives (LRC 94–2009) (available at
p.002003: www.lawreform.ie)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 119
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th Ed) (2009)
p.002003: (available at www.medicalcouncil.ie)
p.002003: Medical Research Council (MRC).MRC Ethics Guide.Medical Research Involving Children (2004).
p.002003:
p.002003: Medical Research Council (MRC).MRC Ethics Guide. Medical Research Involving Adults who cannot Consent (2007)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
p.002003: National Disability Authority, Ethical Guidance for Research with People with Disabilities (October 2009)
p.002003: National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee.
p.002003: National Statement on Ethical Conduct in Human Research (2007)
p.002003: National Health and Medical Research Council (Australia) Biobank Information Paper (2010)
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
...
p.002003: University College Cork
p.002003:
p.002003: HSE, Quality & Patient Safety Division
p.002003:
p.002003: State Claims Agency
p.002003:
p.002003: Irish Association of Directors of Nursing and Midwifery
p.002003:
p.002003: HSE
p.002003:
p.002003: HSE, Integrated Services Division
p.002003:
p.002003: HSE, Advocacy Unit, Quality & Patient Safety
p.002003: Chair
p.002003:
p.002003: Programme Lead, Deputy Chair
p.002003:
p.002003: Member Member Member
p.002003: Member
p.002003:
p.002003:
p.002003: Member
p.002003:
p.002003:
p.002003: Catherine Whelan Gary Davis
p.002003: Kevin Kelleher
p.002003: Director, Independent Hospitals Association Ireland
p.002003:
p.002003: Deputy Data Protection Officer
p.002003:
p.002003: Assistant National Director Pop- ulation Health - Health Protec- tion
p.002003: Independent Hospitals Association Ireland
p.002003:
p.002003: Office of the Data Protection Commissioner
p.002003:
p.002003: HSE
p.002003: Member Member Member
p.002003:
p.002003: Mary Donnelly Mary Dowling Mary O’Meara
p.002003: Senior Lecturer, Faculty of Law Clinical Risk Manager
p.002003: Senior Medical Officer
p.002003: University College Cork
p.002003:
p.002003: HSE, St. Lukes General Hospital, Kilkenny
p.002003: National Immunisation Office
p.002003: Member Member Member
p.002003:
p.002003: Mary Vasseghi
p.002003:
p.002003: Phil Garland Samantha Hughes
p.002003: Shane Brennan Shaun O’Keeffe
p.002003: Service User
p.002003:
p.002003: Assistant National Director, Children & Families Services
p.002003: Team Lead, Clinical Audit & Research Team
p.002003: Quality & Clinical Programmes Communications
p.002003:
p.002003: Consultant Geriatrician
p.002003:
p.002003:
p.002003: HSE
p.002003: HSE, Dublin Mid Leinster HSE
p.002003: HSE, Galway University Hospitals
p.002003: Member
p.002003:
p.002003: Member Member
p.002003:
p.002003:
p.002003: Member
p.002003:
p.002003: Siobhan O’Sullivan
p.002003:
p.002003: Winifred Ryan
p.002003: Chief Bioethics Officer
p.002003:
p.002003: Head of Standards and Guidance
p.002003: Department of Health
p.002003: HSE, Quality & Patient Safety Division
p.002003: Member
p.002003: Deputy Chair until March 2012
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
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p.002003:
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p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.002003: obtained in the Perinatal Period. Journal of Perniatology (2004), 24(7): p409-415
p.002003: Ballard HO, Shook LA, Locono J, Bernard P, Hayes D. Parents’ Understanding and Recall of Informed
p.002003: Consent Information for Neonatal Research. IRB: Ethics & Human Research (May-June 2011), p12-19
p.002003: Beach MC and Morrison RS (2002).The Effect of Do-Not-Resuscitate Orders on Physician Decision- Making.Journal of the
p.002003: American Geriatrics Society 50(12): 2057-2061
p.002003: Brazier and Cave Medicine, Patients and the Law (Penguin, 2007)
p.002003:
p.002003: British Medical Association, Resuscitation Council (UK) and Royal College of Nursing
p.002003: (2007).Decisions relating to cardiopulmonary resuscitation: A joint statement from the British Medical
p.002003: Association, the Resuscitation Council (UK) and the Royal College of Nursing. British Medical Association,
p.002003: London, 24p
p.002003: Butler MW, Saaidin N, Sheikh AA and Fennell JS (2006). Dissatisfaction with Do Not Attempt Resuscitation
p.002003: Orders: A nationwide study of Irish consultant physician practices. Irish Medical Journal 99(7): 208-210
p.002003: Burns JP, Edwards J, Johnson J, Cassem NH and Truog RD (2003). Do-not-resuscitate order after 25 years. Critical Care
p.002003: Medicine 31(5): 1543-1550
p.002003: Canadian Medical Association (1995).Joint Statement on Resuscitative Interventions (Update
p.002003: 1995).Canadian Medical Association Journal 153(11): 1652A-1652F
p.002003: Cherniak EP (2002). Increasing use of DNR orders in the elderly worldwide: whose choice is it?
p.002003: Journal of Medical Ethics 28(5): 303-307
p.002003:
p.002003: Clayton JM, Hancock KM, Butow PN, Tattersall MHN and Currow DC (2007).Clinical practice guidelines for
p.002003: communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their
p.002003: caregivers. The Medical Journal of Australia 186(12): S77-S108
p.002003: Desch K, Li J, Kim S, Laventhal N, Metzger k, Siemieniak D, Ginsburg D. Analysis of Informed Consent
p.002003: Document Utilization in a Minimal-Risk Genetic Study. Annals of Internal Medicine (2011), 155(5): p316-322
p.002003:
p.002003:
p.002003:
p.002003: Page 121
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Diem SJ, Lantos JD and Tulsky JA (1996). Cardiopulmonary Resuscitation on Television: Miracles and Misinformation. The
p.002003: New England Journal of Medicine 334(24): 1578-1582
p.002003: Donnelly Healthcare Decision-Making and the Law: Autonomy, Capacity and the Limits of Liberalism (Cambridge University
p.002003: Press, 2010)
p.002003: Donnelly ‘The Right of Autonomy in Irish Law’ (2008) 14 Medico-Legal Journal of Ireland 34
p.002003:
p.002003: Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA and Stapleton RD (2009). Epidemiologic Study of
p.002003: In-Hospital Cardiopulmonary Resuscitation in the Elderly. The New England Journal of Medicine 361(1): 22-31
p.002003: Ferguson RP, Phelan T, Haddad T, Hinduja A and Dubin NH (2008). Survival After In-Hospital Cardiopulmonary
p.002003: Resuscitation. Southern Medical Journal 101(10): 1007-1011
p.002003: Fritz Z and Fuld J (2010). Ethical issues surrounding do not attempt resuscitation orders: decisions, discussions and
p.002003: deleterious effects. Journal of Medical Ethics 36(10): 593-597.
p.002003: Herring Medical Law and Ethics (2nd Ed)(OUP, 2009)
p.002003:
p.002003: Hogan and Whyte JM Kelly: The Irish Constitution (4th Ed) (Lexis NexisButterworths, 2003) Jackson Medical Law: Texts,
p.002003: Cases and Materials (2nd Ed) (OUP, 2009)
p.002003: Lannon R and O’Keeffe ST (2010).Cardiopulmonary resuscitation in older people – a review.
p.002003: Reviews in Clinical Gerontology 20: 20–29
p.002003:
p.002003: Lippert FK, Raffay V, Georgiou M, Steen PA and Bossaert L (2010). European Resuscitation Council Guidelines for
p.002003: Resuscitation 2010, Section 10. The ethics of resuscitation and end-of-life decisions. Resuscitation
p.002003: 81(10): 1445–1451
p.002003: Loertscher L, Reed DA, Bannon MP and Mueller PS (2010). Cardiopulmonary Resuscitation and Do
p.002003: -Not-Resuscitate Orders: A Guide for Clinicians. The American Journal of Medicine 123(1): 4-9 Madden Medicine, Ethics
p.002003: and the Law 2nd Ed (Bloomsbury, 2011)
p.002003: Mason and Kenyon Mason and McCall Smith’s Law and Medical Ethics 7thed(OUP, 2006)
p.002003:
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 28
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursing home if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
...
Searching for indicator neonates:
(return to top)
p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
p.000075: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
...
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
...
Social / In Nursing Home
Searching for indicator nursing home:
(return to top)
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursing home if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 29
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5. Has the service user the capacity to make the decision?
p.000114:
p.000114:
p.000114: 5.1 General principles
p.000114:
p.000114:
p.000114: Best practice favours a ‘functional’ or decision-specific approach to defining decision-making capacity: that
p.000114: capacity is to be judged in relation to a particular decision to be made, at the time it is to be made - in other words
p.000114: it should be issue specific and time specific – and depends upon the ability of an individual to comprehend,
p.000114: reason with and express a choice with regard to information about the specific decision. The “functional”
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
p.000114:
p.000114: Page 35
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 6. Is it always necessary to seek service user consent?
p.000114:
p.000114:
p.000114: The general principles of consent apply to all decisions about care: from the treatment of minor and self-limiting
p.000114: conditions, to major interventions with significant risks or side effects. However, while the agreement of the
...
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
p.000114: Page 53
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
...
p.000114: manner that is comprehensible to him or her about the nature, purpose, benefits and risks of an intervention.
p.000114: The meaning of sufficient information will depend both on the individual circumstances of the service user and on the
p.000114: nature and extent of the intervention. Ensuring that information is provided in a manner that is comprehensible to the
p.000114: service user requires consideration of the quality of the communication between service provider and service user both
p.000114: in terms of the content of the information to be provided and of how that information should be provided. This will be
p.000114: explained in further detail in Sections 3.1 - 3.3.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 23
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 3.1 Importance of individual circumstances
p.000114:
p.000114:
p.000114: How much information service users want and require will vary depending on their individual circumstances.
p.000114: Discussions with service users should as much as possible be tailored according to:
p.000114: • Their needs, wishes and priorities
p.000114:
p.000114: • Their level of knowledge about, and understanding of, their condition, prognosis and the treatment options
p.000114: • Their ability to understand the information provided/language used
p.000114:
p.000114: • The nature of their condition.
p.000114:
p.000114:
p.000114: 3.2 What information should be provided about interventions?
p.000114:
p.000114:
p.000114: The amount of information to be provided about an intervention will depend on the urgency, complexity,
p.000114: nature and level of risk associated with the intervention.
p.000114: Choosing whether to undergo or to forego medical investigation and treatment or whether to agree or not to
p.000114: a major lifestyle change such as admission to residential care often requires the service user to balance the
p.000114: potential risks and benefits of both approaches. In these circumstances, service users need adequate
p.000114: information about:
p.000114: • Their diagnosis and prognosis including any uncertainties about the diagnosis or prognosis
p.000114: • Options for treating or managing the condition, including the option not to treat
p.000114: • The purpose of any proposed intervention and what it will involve
p.000114: • The potential benefits, risks and the likelihood of success of a proposed intervention, as well as that
p.000114: of any available alternative
p.000114: • Whether a proposed investigation or treatment is experimental or part of a research project
p.000114: • If relevant, that costs will have to be paid and how and where information about these costs may be
p.000114: obtained.
p.000114:
p.000114:
p.000114: Page 24
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
...
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
p.000114: Information about risk should be given in a balanced way. Service users may understand information about
p.000114: risk differently from those providing health and social care. This is particularly true when using descriptive terms
p.000114: such as ‘often’ or ‘uncommon’. Potential biases related to how risks are ‘framed’ are important: a 1 in a thousand risk
p.000114: of a complication also means that 999 out of a thousand service users will not experience that complication.
p.000114: In order to best support service users in assessing the risks and benefits of various interventions/ course of action
p.000114: consideration should be given to:
p.000114: • Designing and employing communications that use plain language
p.000114:
p.000114:
p.000114: • Avoid explaining risks in purely descriptive terms (such as low risk), try to supplement with numerical
p.000114: data
p.000114: • Use absolute numbers or percentages; avoid using relative risk or percentage improvements
p.000114: • Use visual aids e.g. pictographs wherever possible, to maximise understanding.
p.000114:
p.000114:
p.000114: 3.4 How and when information should be provided
p.000114:
p.000114:
p.000114: The manner in which the health and social care options are discussed with a service user is as important as the
p.000114: information itself. The following measures are often helpful:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information. Sensitive issues should be discussed in an appropriate location to ensure that the service
p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 26
p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
...
p.000114: adequate “trigger” exists. All service users may experience temporary lack of capacity due to severe illness, loss of
p.000114: consciousness or other similar circumstances.
p.000114:
p.000114:
p.000114: The possibility of incapacity and the need to assess capacity formally should only be considered,
p.000114: if, having been given all appropriate help and support, a service user:
p.000114:
p.000114: • is unable to communicate a clear and consistent choice or
p.000114:
p.000114: • is obviously unable to understand and use the information and choices provided.
p.000114:
p.000114:
p.000114: 5.5 Assessing capacity to consent
p.000114:
p.000114:
p.000114: Capacity to consent should be assessed if there is sufficient reason, as indicated in Section 5.4, to question the
p.000114: presumption of capacity. This involves assessing whether:
p.000114: • The service user understands in broad terms and believes the reasons for and nature of the
p.000114: decision to be made
p.000114: • The service user has sufficient understanding of the principal benefits and risks of an intervention and
p.000114: relevant alternative options after these have been explained to them in a manner and in a language appropriate
p.000114: to their individual level of cognitive functioning
p.000114: • The service user understands the relevance of the decision, appreciates the advantages
p.000114: and disadvantages in relation to the choices open to them and is able to retain this knowledge long enough to make a
p.000114: voluntary choice.
p.000114: The fact that a person may not, in their current situation have sufficient understanding or appreciation
p.000114: regarding a decision should in the first instance signal a requirement for the provision of supports in
p.000114: order to ensure that the decision-making capacity of the individual is enhanced to the greatest degree
p.000114: possible, rather than an inevitable finding of incapacity to make that decision.
p.000114:
p.000114: Page 32
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.6 Making decisions if capacity is absent
p.000114:
p.000114:
p.000114: There is currently no legislative framework to govern how a decision about treatment and care should be made for those
p.000114: who lack capacity to make that decision themselves.
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
...
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
p.000114:
p.000114:
p.000114: Page 60
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
p.000114: Page 73
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
p.000114: Therefore, it is essential that researchers should be aware of the possibility of parental therapeutic
p.000114: misconceptions when determining how to explain the potential benefits and risks of research participation during the
p.000114: consent process.
p.000114: In certain circumstances, it will not be possible for the researcher to guarantee confidentiality to the child due
p.000114: to mandatory reporting obligations. For instance, if a child reveals that they or others are at significant
...
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
p.000114: In accordance with the functional approach to capacity (see Part One), there may be instances where a person might have
p.000114: limited capacity and may require assistance in deciding whether or not to participate in research. In such cases,
p.000114: researchers must ensure that efforts are made to assist people in reaching their decision and that they are provided
p.000114: with the appropriate tools to maximise their decision-making ability.
p.000114: The objectives as well as the potential risks and benefits of the research should be explained as fully as possible to
p.000114: the prospective participant given their level of understanding. The information should be provided using easily
p.000114: comprehensible language and the prospective participant should be informed of the right to withdraw from the
p.000114: study at any time without there being any negative repercussions.
p.000114: There may be some instances where the capacity to consent to research participation is lacking. Adults who lack
p.000114: decision-making capacity must neither be unfairly excluded from the potential benefits of research participation,
p.000114: nor may their lack of capacity to consent be used to inappropriately include them in research. However,
p.000114: special measures should be taken to protect their rights and interests.
p.000114: The following principles should be adhered to when conducting research involving adults lacking decision-making
p.000114: capacity:
p.000114: • The research should only be undertaken if the required knowledge cannot be obtained by
p.000114: conducting research involving adults with decision-making capacity
p.000114: • The research is expected to provide a direct benefit to the participants or to provide
p.000114: knowledge about the cause or treatment of the impairing or similar condition. Where there is no prospect
p.000114: of direct benefit for participants, the risks involved should be no more than minimal (For more
...
Social / Literacy
Searching for indicator literacy:
(return to top)
p.000114: information itself. The following measures are often helpful:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information. Sensitive issues should be discussed in an appropriate location to ensure that the service
p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 26
p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
...
p.000114: contact with the prospective participant and provide him/her with the contact details of the research team.
p.000114: There may be situations where the researcher is also directly involved in providing care or support to
p.000114: the individual. Where this is the case, it is essential that any conflict of interest that might arise as a result of
p.000114: the original relationship be acknowledged and that any possibility that the individual might feel obliged to
p.000114: participate be averted. This might be achieved by having the consent either obtained or witnessed by a person who is
p.000114: independent of the research.
p.000114:
p.000114:
p.000114: 2.3 How should consent be documented?
p.000114:
p.000114:
p.000114: For the majority of cases, prospective research participants should provide written consent. However, in
p.000114: cases where decision-making capacity is lacking, the research team should seek consent from the person’s
p.000114: legal representative (for a more in–depth discussion see Section 4 on Adults lacking decision-making capacity and
p.000114: consent for research).
p.000114: There may be certain circumstances where it is not possible for a prospective participant to provide
p.000114: written consent due to e.g. literacy levels or physical inability. In such cases a witness who is
p.000114: independent of the research should be present during the entire consent process and should sign the consent
p.000114: form. By signing the consent form, the witness acknowledges that the information provided to the individual was
p.000114: explained and that the consent was freely given. A video/audio tape recording of the consent interview might also
p.000114: be made with the permission of the research participant, however, researchers using this method must be
p.000114: mindful of their obligations to protect the confidentiality of the participant.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 71
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3. Children
p.000114:
p.000114:
p.000114: Children should not be denied the possible benefits of research participation but instead should be afforded the
p.000114: opportunity to participate in research on matters that might affect them. Neither should children be exploited or
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
p.000114: A person who is less than 18 years of age, who is not or has not been married.
p.000114:
p.000114:
p.000114: Personal data
p.000114: Data relating to a living individual who is or can be identified either from the data or from the data in conjunction
p.000114: with other information that is in, or is likely to come into, the possession of the data controller.
p.000114:
p.000114:
p.000114: Reasonable person
p.000114: A person who exercises average care, skill, caution and judgement.
p.000114:
p.000114:
p.000114: Service provider
p.000114: Any person, organisation or part of an organisation delivering health and social care services.
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Service user
p.000114: For the purpose of this document the term ‘service user’ means a person who uses health and social care services.
p.000114: In some instances the term ‘patient’, ‘individual’ or ‘participant’ is used in this document instead of ‘service user’
p.000114: where it is considered more appropriate.
p.000114:
p.000114:
p.000114: Significant/Material risk
p.000114: A risk may be seen as significant/material if a reasonable person in the patient's position would attach significance
p.000114: to it.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 2 For discussion of these exceptional circumstances see chapter one section 6
p.000114: 3 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 4 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: Page 22
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 2. What is valid and genuine consent?
p.000114:
p.000114:
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation
p.000114: in research following a process of communication about the proposed intervention. The process of
p.000114: communication begins at the initial contact and continues through to the end of the service user’s involvement in the
p.000114: treatment process, provision of social care or research study. Seeking consent is not merely getting a consent form
...
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
...
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
...
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7. Specific Issues relating to consent
p.000114:
p.000114:
p.000114: 7.1 Scope of consent
p.000114:
p.000114:
p.000114: The need for consent, and the application of the general principles in this policy, extends to all interventions
p.000114: conducted by or on behalf of the HSE on service users in all locations. Thus, it includes social as
p.000114: well as health care interventions and applies to those receiving care and treatment in hospitals, in the
p.000114: community and in residential care settings. How the principles are applied, such as the amount of information
p.000114: provided and the degree of discussion needed to obtain valid consent, will vary with the particular
p.000114: situation. In some situations, permission, as matter of common courtesy and of respect for the service
p.000114: user, rather than consent may be required e.g. to enter a person’s home, and should be obtained in
p.000114: keeping with relevant HSE codes of conduct10.
p.000114: Provision of health and social care to a service user during a single episode often involves a number
p.000114: of interventions. This is particularly true during acute hospital admissions. A useful approach to consent
p.000114: in this context is to consider what a reasonable person in the service user’s situation would consider appropriate.
p.000114: Thus, for example, it might be judged that someone facing potentially hazardous surgery would more likely prefer to
p.000114: focus on the risks of the surgical procedure than on the much smaller risks associated with the ancillary
p.000114: antibiotic treatment. However, individual preferences remain important in these circumstances: if
p.000114: service users have a strong preference for detailed information and for involvement in all aspects of
p.000114: decision-making, this should be respected as far as possible.
p.000114: Those who provide health and social care services should discuss with service users the possibility of additional
p.000114: problems arising during an intervention or treatment when they may not be in a position to make a decision about
p.000114: how to proceed.
p.000114: If there is a significant risk of a particular problem arising, the service user should be asked in
p.000114: advance what they would like the health and social care professional to do if the difficulty occurs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 10 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 37
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
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p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
p.000114: relating to resuscitation procedures; therefore, such issues are not dealt with in this policy.
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: The aim of the national policy is to provide a decision-making framework that will facilitate the advance discussion of
p.000114: personal preferences regarding CPR and DNAR orders and to ensure that decisions relating to CPR and DNAR orders are
p.000114: made consistently, transparently and in line with best practice. Where a decision is made to attempt CPR, it should be
p.000114: performed competently and any decision to restrict the extent and/or duration of the CPR attempt should be
p.000114: based on balancing the benefits and risks of continuing CPR. Unethical and inappropriate practices such as
p.000114: “slow-coding” and “sham resuscitations” where a full resuscitation is deliberately not attempted must not be performed.
p.000114: This policy document should be read in conjunction with other relevant guidance, including the Medical Council’s, Guide
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p.000114: consent of the service user and to make every effort to ensure that the treatment is acceptable to the service user.
p.000114:
p.000114: Nor does the Mental Health Act 2001 remove the ethical obligation to maximise service user capacity and
p.000114: to involve service users lacking capacity in the decision-making process to the greatest extent possible.
p.000114: All care given to the service user should be explained to him/her once their condition improves.
p.000114: Where the service user who has been admitted under the 2001 Act requires any other treatment or intervention not
p.000114: related to their mental health, the general principles of consent apply as discussed in this policy.
p.000114:
p.000114:
p.000114: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of Garda investigations into driving under
p.000114: the influence of alcohol and/or drugs
p.000114:
p.000114:
p.000114: The general principles regarding consent apply when testing for intoxicants. When such testing is clinically indicated,
p.000114: the urgency of the situation in which such testing commonly occurs means that explicit discussion of the pros and cons
p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
p.000114: Page 43
p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
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p.002003: Smith GB, Poplett N and Williams D (2005).Staff awareness of a ‘Do Not Attempt Resuscitation’ policy in a
p.002003: District General Hospital. Resuscitation 65(2): 159-165
p.002003: Staunton ‘The Development of Healthcare Planning in Ireland’ (2009) 15 Medico-Legal Journal of Ireland 74
p.002003: Whelan Mental Health Law and Policy (Thompson Roundhall, 2009)
p.002003:
p.002003:
p.002003:
p.002003:
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p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: National Consent Advisory Group Membership
p.002003:
p.002003:
p.002003: Name
p.002003: Title
p.002003: Organisation
p.002003: Role
p.002003:
p.002003:
p.002003: Deirdre Madden Angela Hughes Ann Duffy
p.002003: Anne Marie Loftus
p.002003:
p.002003:
p.002003: Austin Warters Bill Ebbitt
p.002003: Caoimhe Gleeson
p.002003: Senior Lecturer, Faculty of Law National Quality Lead
p.002003: Clinical Risk Advisor Clinical
p.002003: Indemnity Scheme
p.002003:
p.002003: Director of Nursing and Midwifery, Sligo General Hospital
p.002003:
p.002003: Manager of Older Persons Services
p.002003: General Manager, National Disability Unit
p.002003:
p.002003: National Specialist in Accessibility & Equality Officer
p.002003: University College Cork
p.002003:
p.002003: HSE, Quality & Patient Safety Division
p.002003:
p.002003: State Claims Agency
p.002003:
p.002003: Irish Association of Directors of Nursing and Midwifery
p.002003:
p.002003: HSE
p.002003:
p.002003: HSE, Integrated Services Division
p.002003:
p.002003: HSE, Advocacy Unit, Quality & Patient Safety
p.002003: Chair
p.002003:
p.002003: Programme Lead, Deputy Chair
p.002003:
p.002003: Member Member Member
p.002003: Member
p.002003:
p.002003:
p.002003: Member
p.002003:
p.002003:
p.002003: Catherine Whelan Gary Davis
p.002003: Kevin Kelleher
p.002003: Director, Independent Hospitals Association Ireland
p.002003:
p.002003: Deputy Data Protection Officer
p.002003:
p.002003: Assistant National Director Pop- ulation Health - Health Protec- tion
p.002003: Independent Hospitals Association Ireland
p.002003:
p.002003: Office of the Data Protection Commissioner
p.002003:
p.002003: HSE
p.002003: Member Member Member
p.002003:
p.002003: Mary Donnelly Mary Dowling Mary O’Meara
p.002003: Senior Lecturer, Faculty of Law Clinical Risk Manager
p.002003: Senior Medical Officer
p.002003: University College Cork
p.002003:
p.002003: HSE, St. Lukes General Hospital, Kilkenny
p.002003: National Immunisation Office
p.002003: Member Member Member
p.002003:
p.002003: Mary Vasseghi
p.002003:
p.002003: Phil Garland Samantha Hughes
p.002003: Shane Brennan Shaun O’Keeffe
p.002003: Service User
p.002003:
p.002003: Assistant National Director, Children & Families Services
p.002003: Team Lead, Clinical Audit & Research Team
p.002003: Quality & Clinical Programmes Communications
p.002003:
p.002003: Consultant Geriatrician
p.002003:
p.002003:
p.002003: HSE
p.002003: HSE, Dublin Mid Leinster HSE
p.002003: HSE, Galway University Hospitals
p.002003: Member
p.002003:
p.002003: Member Member
p.002003:
p.002003:
p.002003: Member
p.002003:
p.002003: Siobhan O’Sullivan
p.002003:
p.002003: Winifred Ryan
p.002003: Chief Bioethics Officer
p.002003:
p.002003: Head of Standards and Guidance
p.002003: Department of Health
p.002003: HSE, Quality & Patient Safety Division
p.002003: Member
p.002003: Deputy Chair until March 2012
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
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Social / Presence of Coercion
Searching for indicator coerced:
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p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
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Social / Property Ownership
Searching for indicator home:
(return to top)
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 13
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
...
p.000114: in research following a process of communication about the proposed intervention. Consent must be
p.000114: obtained before starting treatment or investigation, or providing personal or social care for a service user or
p.000114: involving a service user in teaching and research (all defined as ‘interventions’ for the purpose of this
p.000114: policy). This requirement is consistent with fundamental ethical principles, with good practice in
p.000114: communication and decision-making and with national health and social care policy. The need for consent is also
p.000114: recognised in Irish and international law.
p.000114:
p.000114:
p.000114: 1.1 Scope of this policy
p.000114:
p.000114:
p.000114: The need for consent, and the application of the general principles in this policy, extends to all interventions
p.000114: conducted by or on behalf of the HSE on service users in all locations. Thus, it includes social as
p.000114: well as health care interventions and applies to those receiving care and treatment in hospitals, in the
p.000114: community and in residential care settings. How the principles are applied, such as the amount of information
p.000114: provided and the degree of discussion needed to obtain valid consent, will vary with the particular
p.000114: situation. In some situations, permission, as matter of common courtesy and of respect for the service
p.000114: user, rather than consent may be required e.g. to enter a person’s home, and should be obtained in
p.000114: keeping with relevant HSE codes of conduct1. Knowledge of the importance of obtaining consent is expected
p.000114: of all staff employed or contracted by the HSE.
p.000114:
p.000114:
p.000114: 1.2 Ethical issues regarding consent
p.000114:
p.000114:
p.000114: The ethical rationale behind the importance of consent is the need to respect the service user’s right to
p.000114: self-determination (or autonomy) – their right to control their own life and to decide what happens to
p.000114: their own body.
p.000114:
p.000114:
p.000114:
p.000114: 1 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 20
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Those providing health and social care can often claim greater expertise in decisions regarding the ‘means’ to
p.000114: achieve the ‘end’ of better health, such as what medication will best treat blood pressure or whether admission to
p.000114: long-term care is advisable, although service users retain ultimate decision-making authority and must consent
p.000114: to the intervention.
...
p.000114: nature and level of risk associated with the intervention.
p.000114: Choosing whether to undergo or to forego medical investigation and treatment or whether to agree or not to
p.000114: a major lifestyle change such as admission to residential care often requires the service user to balance the
p.000114: potential risks and benefits of both approaches. In these circumstances, service users need adequate
p.000114: information about:
p.000114: • Their diagnosis and prognosis including any uncertainties about the diagnosis or prognosis
p.000114: • Options for treating or managing the condition, including the option not to treat
p.000114: • The purpose of any proposed intervention and what it will involve
p.000114: • The potential benefits, risks and the likelihood of success of a proposed intervention, as well as that
p.000114: of any available alternative
p.000114: • Whether a proposed investigation or treatment is experimental or part of a research project
p.000114: • If relevant, that costs will have to be paid and how and where information about these costs may be
p.000114: obtained.
p.000114:
p.000114:
p.000114: Page 24
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: By contrast, the nature and effect of some interventions, such as removal of a dressing or provision of
p.000114: assisted personal care in the home, are often self-evident and relatively risk-free. In these circumstances, it is
p.000114: usually enough for staff to seek consent to proceed after a brief description of the intervention.
p.000114: Refusal of permission, especially if it may be harmful to the service user or a request for additional
p.000114: information should trigger additional discussion.
p.000114: Although service users may be provided with standardised informational material, they should be told if their
p.000114: particular circumstances might modify the risks or benefits as stated in such material.
p.000114: Service users should be asked if they have understood the information they have been given, and whether or not they
p.000114: would like more information before making a decision. Questions should be answered honestly and, as far as practical,
p.000114: as fully as the service users wishes.
p.000114:
p.000114:
p.000114: 3.3 What information about risks and side effects of an intervention should be provided?
p.000114:
p.000114:
p.000114: The amount of information about risk that staff should share with service users will depend on the individual service
p.000114: user and what they want or need to know. Although most service users will be aware that no physical procedure or
p.000114: medication is entirely risk free, they may not be as familiar with the potential risks of common
p.000114: procedures such as the administration of blood products or radiographic procedures. Factors such as service
...
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursing home if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 29
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5. Has the service user the capacity to make the decision?
p.000114:
p.000114:
p.000114: 5.1 General principles
p.000114:
p.000114:
p.000114: Best practice favours a ‘functional’ or decision-specific approach to defining decision-making capacity: that
p.000114: capacity is to be judged in relation to a particular decision to be made, at the time it is to be made - in other words
p.000114: it should be issue specific and time specific – and depends upon the ability of an individual to comprehend,
p.000114: reason with and express a choice with regard to information about the specific decision. The “functional”
p.000114: approach recognises that there is a hierarchy of complexity in decisions and also that cognitive
...
p.000114: need or are entitled to know.
p.000114:
p.000114: 9 Further details on the documentation of consent are provided at 7.5
p.000114:
p.000114: Page 36
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7. Specific Issues relating to consent
p.000114:
p.000114:
p.000114: 7.1 Scope of consent
p.000114:
p.000114:
p.000114: The need for consent, and the application of the general principles in this policy, extends to all interventions
p.000114: conducted by or on behalf of the HSE on service users in all locations. Thus, it includes social as
p.000114: well as health care interventions and applies to those receiving care and treatment in hospitals, in the
p.000114: community and in residential care settings. How the principles are applied, such as the amount of information
p.000114: provided and the degree of discussion needed to obtain valid consent, will vary with the particular
p.000114: situation. In some situations, permission, as matter of common courtesy and of respect for the service
p.000114: user, rather than consent may be required e.g. to enter a person’s home, and should be obtained in
p.000114: keeping with relevant HSE codes of conduct10.
p.000114: Provision of health and social care to a service user during a single episode often involves a number
p.000114: of interventions. This is particularly true during acute hospital admissions. A useful approach to consent
p.000114: in this context is to consider what a reasonable person in the service user’s situation would consider appropriate.
p.000114: Thus, for example, it might be judged that someone facing potentially hazardous surgery would more likely prefer to
p.000114: focus on the risks of the surgical procedure than on the much smaller risks associated with the ancillary
p.000114: antibiotic treatment. However, individual preferences remain important in these circumstances: if
p.000114: service users have a strong preference for detailed information and for involvement in all aspects of
p.000114: decision-making, this should be respected as far as possible.
p.000114: Those who provide health and social care services should discuss with service users the possibility of additional
p.000114: problems arising during an intervention or treatment when they may not be in a position to make a decision about
p.000114: how to proceed.
p.000114: If there is a significant risk of a particular problem arising, the service user should be asked in
p.000114: advance what they would like the health and social care professional to do if the difficulty occurs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 10 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 37
p.000114:
...
p.000114:
p.000114: Page 41
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.7 When consent is refused
p.000114:
p.000114:
p.000114: If an adult with capacity to make an informed decision makes a voluntary and appropriately informed
p.000114: decision to refuse treatment or service, this decision must be respected, even where the service user’s decision may
p.000114: result in his or her death. In such cases it is particularly important to accurately document the discussions with the
p.000114: service user, including the procedure that has been offered, the service user’s decision to decline and the
p.000114: fact that the implications of this decision have been fully outlined.
p.000114: Those who provide health and social care services should also consider and discuss with the service user
p.000114: whether an alternative treatment/measure is acceptable to the service user.
p.000114: For example in the case of a service user who is refusing a blood transfusion for religious reasons, the service user
p.000114: should be referred for a haematology consultation to ascertain whether any alternative treatment would be
p.000114: acceptable.
p.000114: In the context of social care, for example, where a frail older person is assessed to require home supports in order
p.000114: to keep them safe refuses these services, alternative measures should be discussed with the service user.
p.000114: If there is uncertainty about the service user’s capacity to make a decision, the guidance in Section
p.000114: 5.5 should be followed.
p.000114: There are some circumstances in which a valid refusal of consent raises additional issues:
p.000114:
p.000114: 7.7.1 Refusal of isolation for infectious disease
p.000114:
p.000114:
p.000114: The consent of service users with infectious diseases is required for all health and social care
p.000114: interventions, including treatment of the infection. The refusal of a competent person to receive treatment for an
p.000114: infection, even if medically unwise, should be respected. However, under the provisions of the Health Act
p.000114: 1947 such a person may be isolated in order to prevent the spread of the disease13.
p.000114: In practice, detention and isolation is most likely to occur when someone with an infectious disease,
p.000114: such as tuberculosis, refuses treatment that would render them non-infectious and, hence, no longer a
p.000114: risk to others. In these circumstances, while treatment cannot be provided without the consent of the service
p.000114: user, the health and social care professional should explain the possible consequences of the refusal of treatment,
p.000114: including potential detention and isolation.
p.000114: Page 42
p.000114:
...
p.000114: to involve service users lacking capacity in the decision-making process to the greatest extent possible.
p.000114: All care given to the service user should be explained to him/her once their condition improves.
p.000114: Where the service user who has been admitted under the 2001 Act requires any other treatment or intervention not
p.000114: related to their mental health, the general principles of consent apply as discussed in this policy.
p.000114:
p.000114:
p.000114: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of Garda investigations into driving under
p.000114: the influence of alcohol and/or drugs
p.000114:
p.000114:
p.000114: The general principles regarding consent apply when testing for intoxicants. When such testing is clinically indicated,
p.000114: the urgency of the situation in which such testing commonly occurs means that explicit discussion of the pros and cons
p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
p.000114: Page 43
p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
...
p.000114:
p.000114:
p.000114: 2.2 Scope of DNAR orders
p.000114:
p.000114:
p.000114: A decision not to attempt CPR applies only to CPR. It does not apply to any other aspect of treatment
p.000114: and all other treatments and care that are appropriate for the individual should continue. If a
p.000114: decision is made to restrict the nature or extent of CPR, this should be carefully documented and
p.000114: communicated effectively to all members of the healthcare team caring for the individual.
p.000114:
p.000114: Page 99
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
p.000114: In particular, individuals are the best judges of their own quality of life; healthcare professionals and families
p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 100
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000114: such information on admission.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 11 See Part Three section 9 for provisions relating to confidentiality and data protection in the context of research
p.000114:
p.000114: Page 41
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.7 When consent is refused
p.000114:
p.000114:
p.000114: If an adult with capacity to make an informed decision makes a voluntary and appropriately informed
p.000114: decision to refuse treatment or service, this decision must be respected, even where the service user’s decision may
p.000114: result in his or her death. In such cases it is particularly important to accurately document the discussions with the
p.000114: service user, including the procedure that has been offered, the service user’s decision to decline and the
p.000114: fact that the implications of this decision have been fully outlined.
p.000114: Those who provide health and social care services should also consider and discuss with the service user
p.000114: whether an alternative treatment/measure is acceptable to the service user.
p.000114: For example in the case of a service user who is refusing a blood transfusion for religious reasons, the service user
p.000114: should be referred for a haematology consultation to ascertain whether any alternative treatment would be
p.000114: acceptable.
p.000114: In the context of social care, for example, where a frail older person is assessed to require home supports in order
p.000114: to keep them safe refuses these services, alternative measures should be discussed with the service user.
p.000114: If there is uncertainty about the service user’s capacity to make a decision, the guidance in Section
p.000114: 5.5 should be followed.
p.000114: There are some circumstances in which a valid refusal of consent raises additional issues:
p.000114:
p.000114: 7.7.1 Refusal of isolation for infectious disease
p.000114:
p.000114:
p.000114: The consent of service users with infectious diseases is required for all health and social care
p.000114: interventions, including treatment of the infection. The refusal of a competent person to receive treatment for an
p.000114: infection, even if medically unwise, should be respected. However, under the provisions of the Health Act
p.000114: 1947 such a person may be isolated in order to prevent the spread of the disease13.
p.000114: In practice, detention and isolation is most likely to occur when someone with an infectious disease,
p.000114: such as tuberculosis, refuses treatment that would render them non-infectious and, hence, no longer a
...
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
...
Social / Soldier
Searching for indicator military:
(return to top)
p.002003:
p.002003: Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th Ed) (2009)
p.002003: (available at www.medicalcouncil.ie)
p.002003: Medical Research Council (MRC).MRC Ethics Guide.Medical Research Involving Children (2004).
p.002003:
p.002003: Medical Research Council (MRC).MRC Ethics Guide. Medical Research Involving Adults who cannot Consent (2007)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
p.002003: National Disability Authority, Ethical Guidance for Research with People with Disabilities (October 2009)
p.002003: National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee.
p.002003: National Statement on Ethical Conduct in Human Research (2007)
p.002003: National Health and Medical Research Council (Australia) Biobank Information Paper (2010)
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
p.002003:
p.002003: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.002003: Subjects (1964 – 2008)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 120
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Academic Commentary
p.002003:
p.002003: Ballard HO, Shook LA, Desai NS, Anand KJS. Neonatal research and the Validity of Informed Consent
p.002003: obtained in the Perinatal Period. Journal of Perniatology (2004), 24(7): p409-415
p.002003: Ballard HO, Shook LA, Locono J, Bernard P, Hayes D. Parents’ Understanding and Recall of Informed
p.002003: Consent Information for Neonatal Research. IRB: Ethics & Human Research (May-June 2011), p12-19
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000114: • That a genetic test may reveal unexpected relationships, such as non-paternity (i.e. a different biological
p.000114: father); and
p.000114: • That, if it is proposed to approach blood relatives, consent to do so will first be sought from the
p.000114: participant.
p.000114: Identifiers of genetic material or related data:
p.000114:
p.000114: • Should not be removed without the consent of participants, if removal would make it difficult to
p.000114: communicate personal results; and
p.000114: • Should be removed if participants request it, provided they have been informed that the material or data
p.000114: would remain potentially identifiable
p.000114: • Researchers should not transfer genetic material or related data to any researcher not engaged in the
p.000114: research project unless:
p.000114: ◇ where the material or data is identifiable, participants have been informed about the transfer and have
p.000114: explicitly consented to it; or
p.000114: ◇ a REC has judged that the conditions for transfer have been met (for more information on consent and
p.000114: controlling access to data see Section 9).
p.000114:
p.000114:
p.000114: 6.2 Epidemiological research
p.000114:
p.000114:
p.000114: A REC may waive the requirement for consent if the expected benefit of the research is real and substantial. Such
p.000114: waivers may also be approved when the existence of a signed consent form would be an unjustified threat to
p.000114: the subject's confidentiality.
p.000114: Categories of epidemiological research for which consent might be waived include:
p.000114:
p.000114: • The use of anonymous material/data
p.000114:
p.000114: • Studies using health-related registries that are authorised for such use; and
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 82
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Cluster randomised trials (i.e. where groups are randomised as opposed to individuals).
p.000114: For example, villages, hospitals, families or classrooms may be randomised. Reasons for performing
p.000114: cluster randomised trials vary. Sometimes the intervention can only be administered to a group, for example
p.000114: an addition to the water supply (fluoride) or a public education campaign.
p.000114:
p.000114:
p.000114: 6.3 Covert research
p.000114:
p.000114:
p.000114: Covert research cannot, by definition, involve obtaining consent in advance because informing potential
p.000114: participants would render the research overt and may change its outcome e.g. observation of
p.000114: teenagers’ drinking habits. A distinction should be made between covert research and deception. Covert research
...
p.000114: the use of covert methods may be justified in certain circumstances. For example, difficulties arise when
p.000114: research participants change their behaviour because they know they are being observed.
p.000114: Where consent has not been obtained prior to the research it should, where possible, be obtained at a later time. In
p.000114: cases where participants who are asked to give retrospective consent express concerns about their inclusion in a
p.000114: project, the researcher should give them the option of removing their data from the study.
p.000114: For research where identifiable data (e.g. images, video recordings) is being collected, then the consent
p.000114: of prospective research participants must be sought.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 83
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6.4 Research in public health emergencies
p.000114:
p.000114:
p.000114: The requirement for consent might be waived in public health emergencies, where a health threat and possible
p.000114: treatments/alleviations must be identified as quickly as possible. For instance, a waiver may be permissible,
p.000114: where a delay caused by the time needed to obtain consent from a person suffering from a new strain of
p.000114: pandemic influenza or other biological, chemical, radiological or nuclear agent, might not only
p.000114: jeopardise his/her health but also the health of others within the population.
p.000114:
p.000114:
p.000114: 6.5 Multi-jurisdictional research
p.000114:
p.000114:
p.000114: When multi-jurisdiction research is being undertaken, additional ethical considerations might arise. While
p.000114: researchers should be cognisant of the local research ethics requirements, they should comply with this
p.000114: policy and act in accordance with Irish legislation.
p.000114: When multi-jurisdictional research is to be conducted, local cultural values should be
p.000114: acknowledged in the design and conduct of the research. Irrespective of cultural traditions, consent must
p.000114: always be given by the prospective research participant. In certain cases it may be appropriate to seek the
p.000114: agreement of a person(s) invested with a certain authority within the community.
p.000114: Researchers must do their utmost to communicate information accurately and in a
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000114: R (Burke) v the General Medical Council and Others [2004] EWHC 1879 (Admin)
p.000114:
p.000114: Re A (Medical Treatment: Male Sterilisation) [2000] 1 FCR 193
p.000114:
p.000114: Re AK (Medical Treatment: Consent) [2001] 1 FLR 129
p.000114:
p.000114: Re An Application by the Midland Health Board [1988] ILRM 251
p.000114:
p.000114: Re a Ward of Court [1996] 2 IR 79
p.000114:
p.000114: Re C (adult: refusal of medical treatment) [1994] 1 WLR 290
p.000114:
p.000114: Re F (Mental Patient: Sterilisation) [1990] 2 A.C. 1
p.000114:
p.000114: Re K unreported High Court, Abbot J, 21 September 2006 (ex tempore) Re MB [1997] Fam Law 542
p.000114: Re T (adult: refusal of treatment) [1992] 3 WLR 782
p.000114:
p.000114: Re Y (Mental Patient: Bone Marrow Donation) [1997] Fam 110 Schloendorff v Society of New York Hospital (1914) 211 N.Y.
p.000114: 125: S v HSE [2009] IEHC 106
p.000114: St George's Healthcare NHS Trust v S; R v Collins and others, ex parte S [1998] 3 WLR 936
p.000114:
p.000114: Storck v Germany [2005] ECHR 406
p.000114:
p.000114: Tysiac v Poland [2007] 45 EHRR 42
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 116
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Bibliography
p.000114:
p.000114:
p.000114: Legislation/Conventions/Treaties
p.000114:
p.000114: Bunreacht na hEireann/Constitution of Ireland 1937
p.000114:
p.000114: Charter of Fundamental Rights of the European Union (2000)
p.000114:
p.000114: Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical
p.000114: practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of
p.000114: the manufacturing or importation of such products.
p.000114: Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000114: Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo (1997)
p.000114: Council of Europe Additional Protocol to the Convention of Human Rights and Biomedicine Concerning
p.000114: Biomedical Research (2005)
p.000114: Data Protection Act (1988)
p.000114:
p.000114: Data Protection (Amendment) Act (2003)
p.000114:
p.000114: European Commission, Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
p.000114: approximation of the laws, regulations and administrative provisions of the Member States relating to the
p.000114: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
p.000114: European Commission, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000114: Community code relating to medicinal products for human use
p.000114: European Commission, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
p.000114: protection of individuals with regard to the processing of personal data and on the free movement of such data
...
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 118
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
p.002003: Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector
p.002003: (2007)
p.002003:
p.002003: Department of Children and Youth Affairs, Guidance for Developing Ethical Research Projects Involving
p.002003: Children (2012)
p.002003: Dublin Hospitals Group Risk Management Forum (2010).Matters for consideration regarding Do Not Attempt to Resuscitate
p.002003: Orders for Adult Patients
p.002003: European Union Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric
p.002003: Population (2008)
p.002003: General Medical Council (2010) Treatment and care towards the end of life: good practice in decision
p.002003: making. General Medical Council, London
p.002003: Hospice Friendly Hospitals Programme and the National Council on Ageing and Older People (2008).End-of-Life
p.002003: Care for Older People in Acute and Long-Stay Care Settings in Ireland Joint Statement Dublin
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline Clinical Investigation of Medicinal
p.002003: Products in the Pediatric Population E11 (2000)
p.002003: Irish Council for Bioethics Human Biological Material: Recommendations for Collection, Use and Storage in Research
p.002003: (2005)
p.002003: Law Reform Commission Report on Vulnerable Adults and the Law (LRC 83 -2006) (available at www.lawreform.ie)
p.002003: Law Reform Commission Report on Advance Care Directives (LRC 94–2009) (available at
p.002003: www.lawreform.ie)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 119
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
p.000114: Page 61
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
p.000114:
p.000114: Page 62
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
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p.000114:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000042: Page 5
p.000042: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Page 6
p.000055:
p.000055: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
p.000075: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
...
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
p.000114: A person who is less than 18 years of age, who is not or has not been married.
p.000114:
p.000114:
p.000114: Personal data
p.000114: Data relating to a living individual who is or can be identified either from the data or from the data in conjunction
p.000114: with other information that is in, or is likely to come into, the possession of the data controller.
p.000114:
p.000114:
p.000114: Reasonable person
p.000114: A person who exercises average care, skill, caution and judgement.
p.000114:
p.000114:
p.000114: Service provider
p.000114: Any person, organisation or part of an organisation delivering health and social care services.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 15
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Service user
p.000114: For the purpose of this document the term ‘service user’ means a person who uses health and social care services.
p.000114: In some instances the term ‘patient’, ‘individual’ or ‘participant’ is used in this document instead of ‘service user’
p.000114: where it is considered more appropriate.
p.000114:
p.000114:
p.000114: Significant/Material risk
p.000114: A risk may be seen as significant/material if a reasonable person in the patient's position would attach significance
p.000114: to it.
p.000114:
p.000114:
p.000114:
...
p.000114: medication is entirely risk free, they may not be as familiar with the potential risks of common
p.000114: procedures such as the administration of blood products or radiographic procedures. Factors such as service
p.000114: users’ occupations or lifestyles may influence those risks that they consider significant or particularly undesirable.
p.000114: A general rule is to provide information that a reasonable person in the service user’s situation would expect to be
p.000114: told. This is in line with ethical and professional standards as well as the legal standard applied by the Irish
p.000114: courts. Such information includes the likelihood of:
p.000114: • side effects or complications of an intervention;
p.000114:
p.000114: • failure of an intervention to achieve the desired aim; and
p.000114:
p.000114: • the risks associated with taking no action or with taking an alternative approach.
p.000114:
p.000114: A risk may be seen as material/significant if a reasonable person in the patient's position if warned of
p.000114: the risk would attach significance to it. Such risks must be disclosed to the patient.
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
p.000114: Information about risk should be given in a balanced way. Service users may understand information about
p.000114: risk differently from those providing health and social care. This is particularly true when using descriptive terms
p.000114: such as ‘often’ or ‘uncommon’. Potential biases related to how risks are ‘framed’ are important: a 1 in a thousand risk
p.000114: of a complication also means that 999 out of a thousand service users will not experience that complication.
p.000114: In order to best support service users in assessing the risks and benefits of various interventions/ course of action
p.000114: consideration should be given to:
p.000114: • Designing and employing communications that use plain language
p.000114:
p.000114:
p.000114: • Avoid explaining risks in purely descriptive terms (such as low risk), try to supplement with numerical
p.000114: data
p.000114: • Use absolute numbers or percentages; avoid using relative risk or percentage improvements
p.000114: • Use visual aids e.g. pictographs wherever possible, to maximise understanding.
p.000114:
p.000114:
p.000114: 3.4 How and when information should be provided
p.000114:
p.000114:
...
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visually impaired service users
p.000114:
...
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
p.000114:
p.000114: Page 35
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 6. Is it always necessary to seek service user consent?
p.000114:
p.000114:
p.000114: The general principles of consent apply to all decisions about care: from the treatment of minor and self-limiting
p.000114: conditions, to major interventions with significant risks or side effects. However, while the agreement of the
p.000114: service user should always be sought, there are a number of situations where the amount of information
p.000114: provided about an intervention may legitimately be abbreviated. These include:
p.000114: • Emergency situations
p.000114:
p.000114: • Where the service user declines information.
p.000114:
p.000114:
p.000114: 6.1 Emergency situations
p.000114:
p.000114:
p.000114: In an emergency life-threatening situation where the service user lacks capacity to consent or where the
p.000114: urgency of the relevant intervention imposes time limitations on the ability of the service user to
p.000114: appreciate what treatment is required, the necessary treatment may be administered in the absence of
p.000114: the expressed consent of the service user. The application of this exception is limited to situations where the
p.000114: treatment is immediately necessary to save the life or preserve the health of the service user.
p.000114:
p.000114:
p.000114: 6.2 Where the service user declines information
p.000114:
p.000114:
p.000114: Some service users do not want to know in detail about their condition or the treatment. While this should be respected
p.000114: if possible, it is important that some basic information be provided about major interventions in order that consent
...
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
p.000114: Page 52
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
p.000114: Page 53
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
p.000114: • the minor’s views are stable and a true reflection of his or her core values and beliefs,
p.000114: taking into account his or her physical and mental health and any other factors that affect his or her
p.000114: ability to exercise independent judgement;
p.000114: • the nature, purpose and usefulness of the treatment or social care intervention;
p.000114:
p.000114: • the risks and benefits involved in the treatment or social care intervention, and
p.000114:
p.000114: • any other specific welfare, protection or public health considerations, in respect of which relevant
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 54
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
p.000114: Page 55
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
...
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 57
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
p.000114: parent(s)/legal guardian(s) about the decision they are making in relation to their child and carry out
p.000114: an assessment of the minor as outlined in Section 3 above. If appropriate, the maternal grandparents might
p.000114: also be asked to participate in this discussion with the consent of the minor parent/legal guardian. Failing
p.000114: resolution, it is recommended that legal advice is sought.
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
...
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
p.000114:
p.000114: Page 62
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
...
Searching for indicator youth:
(return to top)
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 26 Researchers should refer to the Department of Children and Youth Affairs document Guidance for Developing Research
p.000114: Projects Involving Children which was published in April 2012
p.000114: 27 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI no 190 of 2004,
p.000114: section 4
p.000114:
p.000114: Page 72
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There is an international consensus that children should not be exposed to more than minimal risk in the absence of
p.000114: direct benefit to the participants themselves. The standard of minimal risk requires that the probability and
p.000114: magnitude of the possible harms posed by participating in research are no greater than those encountered by
p.000114: participants in their everyday life or during the performance of routine physical or psychological examinations or
p.000114: tests.
p.000114: Where the research entails only minimal risk, it is sufficient if the research offers the prospect of benefits either
p.000114: to the participants directly or to the group which is the focus of the research and to which the participants belong.
...
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
p.000114: Page 73
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
...
p.002003: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and
p.002003: Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for
p.002003: Research Involving Humans (December 2010)
p.002003: Council on Ethical and Judicial Affairs, American Medical Association (1991) CEJA Report D – I-90. Guidelines for the
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
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p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
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p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
p.002003: Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector
p.002003: (2007)
p.002003:
p.002003: Department of Children and Youth Affairs, Guidance for Developing Ethical Research Projects Involving
p.002003: Children (2012)
p.002003: Dublin Hospitals Group Risk Management Forum (2010).Matters for consideration regarding Do Not Attempt to Resuscitate
p.002003: Orders for Adult Patients
p.002003: European Union Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric
p.002003: Population (2008)
p.002003: General Medical Council (2010) Treatment and care towards the end of life: good practice in decision
p.002003: making. General Medical Council, London
p.002003: Hospice Friendly Hospitals Programme and the National Council on Ageing and Older People (2008).End-of-Life
p.002003: Care for Older People in Acute and Long-Stay Care Settings in Ireland Joint Statement Dublin
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline Clinical Investigation of Medicinal
p.002003: Products in the Pediatric Population E11 (2000)
p.002003: Irish Council for Bioethics Human Biological Material: Recommendations for Collection, Use and Storage in Research
p.002003: (2005)
p.002003: Law Reform Commission Report on Vulnerable Adults and the Law (LRC 83 -2006) (available at www.lawreform.ie)
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Social / education
Searching for indicator education:
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p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
...
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
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p.000114:
p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: As a corollary to the rights given to parents as legal guardians of their children, there are also
p.000114: duties imposed on them to act in the best interests of their children. In the health and social care context this
p.000114: requires parents and legal guardians to engage with health and social care service providers to ensure that
p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
...
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p.000114:
p.000114: Part Three Research
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Research has the potential to promote scientific advances, improve health services and contribute
p.000114: to the wellbeing of individuals and society as a whole. It allows policymakers and service providers to
p.000114: prepare for and respond to the risks posed by e.g. disease or environmental hazards and to verify that drugs and
p.000114: medical devices etc. are safe and effective. It has the potential to feed into the formation of policy
p.000114: and is concerned with a range of human experiences, perspectives and needs e.g. health, education,
p.000114: housing, family and community services as well as the social institutions created to meet those needs. Research is a
p.000114: regular part of the work undertaken by many HSE staff. There are various types of research which cover a
p.000114: range of activities, from laboratory research, clinical trials, observational studies and
p.000114: epidemiological investigations to surveys and interviews. Research can also assist the HSE with organising and
p.000114: providing services.
p.000114: A number of international codes and standards as well as national and international legal instruments
p.000114: aimed at protecting research participants and ensuring high quality research have been developed in recent
p.000114: decades and these have been taken into account in formulating this policy24.
p.000114: Participation in research has the potential to offer participants direct benefits (e.g. improvements in health and
p.000114: well-being) and indirect benefits (e.g. greater access to professional care and support). The potential
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
...
p.000114: controlling access to data see Section 9).
p.000114:
p.000114:
p.000114: 6.2 Epidemiological research
p.000114:
p.000114:
p.000114: A REC may waive the requirement for consent if the expected benefit of the research is real and substantial. Such
p.000114: waivers may also be approved when the existence of a signed consent form would be an unjustified threat to
p.000114: the subject's confidentiality.
p.000114: Categories of epidemiological research for which consent might be waived include:
p.000114:
p.000114: • The use of anonymous material/data
p.000114:
p.000114: • Studies using health-related registries that are authorised for such use; and
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 82
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Cluster randomised trials (i.e. where groups are randomised as opposed to individuals).
p.000114: For example, villages, hospitals, families or classrooms may be randomised. Reasons for performing
p.000114: cluster randomised trials vary. Sometimes the intervention can only be administered to a group, for example
p.000114: an addition to the water supply (fluoride) or a public education campaign.
p.000114:
p.000114:
p.000114: 6.3 Covert research
p.000114:
p.000114:
p.000114: Covert research cannot, by definition, involve obtaining consent in advance because informing potential
p.000114: participants would render the research overt and may change its outcome e.g. observation of
p.000114: teenagers’ drinking habits. A distinction should be made between covert research and deception. Covert research
p.000114: refers to studies undertaken without the knowledge of the research subjects e.g. where a researcher observes
p.000114: the routine actions of others. Deception, on the other hand, refers to situations where the researcher deliberately
p.000114: misrepresents his/her intentions to the research participants.
p.000114: There is consensus that covert research should not be undertaken routinely, rather it should occur only where it can
p.000114: provide a unique form of evidence that cannot be gathered in any other way or where important issues of sociological
p.000114: significance are being addressed. While serious ethical and legal issues arise in relation to covert research,
p.000114: the use of covert methods may be justified in certain circumstances. For example, difficulties arise when
p.000114: research participants change their behaviour because they know they are being observed.
p.000114: Where consent has not been obtained prior to the research it should, where possible, be obtained at a later time. In
p.000114: cases where participants who are asked to give retrospective consent express concerns about their inclusion in a
p.000114: project, the researcher should give them the option of removing their data from the study.
...
Searching for indicator educational:
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p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
...
Social / employees
Searching for indicator employees:
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p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
...
Social / parents
Searching for indicator parent:
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p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
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p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Reader Information
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Corporate Responsibility:
p.000011: HSE National Quality Improvement Team, Chief Clinical Office
p.000011:
p.000011:
p.000011:
p.000011: Title:
p.000011:
p.000011: Document Reference Number: Version Number:
p.000011: Author:
p.000011: National Consent Policy HSE V.1.3
p.000011: V. 1.3
p.000011:
p.000011: National Consent Advisory Group
p.000011:
p.000011:
p.000011: Approval Date:
p.000011: April 2013
p.000011:
p.000011:
p.000011: Published Date:
p.000011: May 2013
p.000011:
p.000011:
p.000011: Superseded Documents: Changes to V.1
p.000011: Changes to V.1.1
p.000011:
p.000011:
p.000011: Changes to V.1.2
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Revision Date: Contact Details:
p.000011: National Consent Policy V1 (2013)
p.000011:
p.000011: Text added to Part 2 Children and Minors Page 49—2 Role of Parent(s) and Legal Guardian(s)
p.000011: Text changed on Part 2 Children and Minors Page 49—2.1 What is legal guardianship?
p.000011: Text added to Part 1, General Principles, Section 3.5 Consent and pregnancy.
p.000011: Text deleted to Part 1, General Principles, Section 7.7.1 Refusal of treatment in pregnancy.
p.000011: Text added to Part 1, General Principles, Section 7.10 Refusal of treatment in pregnancy.
p.000011: May 2016, June 2019 Marie Tighe
p.000011: Project Manager- Consent
p.000011: HSE National Office for Assisted Decision Making and Consent
p.000011: Email: marie.tighe1@hse.ie
p.000011:
p.000011: Web: www.hse.ie
p.000011:
p.000011:
p.000011: ISBN: 978-1-906218-63-8
p.000011:
p.000011:
p.000011:
p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011: I would like to acknowledge the hard work, guidance and patience of the members of the National Consent
p.000011: Advisory Group and our sub-groups whose expertise and experience was critical to the development of this
p.000011: Policy.
p.000011: I would also like to express my sincere thanks to Angela Hughes and Larraine Gilligan of the Quality
p.000011: and Patient Safety Division of the HSE for their hard work, diligence, and support in ensuring the
...
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
p.000042: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
p.000055:
p.000055:
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p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
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p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
...
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
p.000114:
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p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
p.000114: • the minor’s views are stable and a true reflection of his or her core values and beliefs,
p.000114: taking into account his or her physical and mental health and any other factors that affect his or her
p.000114: ability to exercise independent judgement;
p.000114: • the nature, purpose and usefulness of the treatment or social care intervention;
p.000114:
p.000114: • the risks and benefits involved in the treatment or social care intervention, and
p.000114:
p.000114: • any other specific welfare, protection or public health considerations, in respect of which relevant
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the Freedom of Information Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 Freedom of Information Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
...
p.000114: This policy proposes that in cases where an individual between the age of 16 and 18 refuses a treatment or service, in
p.000114: general such refusal should be respected in the same way as for adults. However, if the refusal relates to life
p.000114: sustaining treatment, or other decisions which may have profound, irreversible consequences for him or her, reasonable
p.000114: efforts must be made to discuss the young person’s refusal with all the relevant parties, including the involvement of
p.000114: the HSE Advocacy services and/or a third party mediator where appropriate, in an attempt to reach
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
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p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
p.000114: As noted in Section 2, parent(s)/legal guardian(s) are generally considered best placed to safeguard the
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
p.000114: for children and have expertise in the particular needs of their child. Parent(s)/legal guardian(s) are
p.000114: entitled to be treated with courtesy and respect and to be provided with adequate information and support in relation
p.000114: to the provision of health and social care services to their children (see further Part One Section 3).
p.000114: It is important for service providers to recognise the role of the parent(s)/legal guardian(s) in
p.000114: deciding together with health and social care professionals what is in the best interests of the child. Case
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
p.000114: parent(s)/legal guardian(s) about the decision they are making in relation to their child and carry out
p.000114: an assessment of the minor as outlined in Section 3 above. If appropriate, the maternal grandparents might
p.000114: also be asked to participate in this discussion with the consent of the minor parent/legal guardian. Failing
p.000114: resolution, it is recommended that legal advice is sought.
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
p.000114: In relation to children who are subject to interim and emergency care orders, an application can be made to the
p.000114: District Court pursuant to the Child Care Act 1991 in regard to medical treatment.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 58
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to children who are subject to a full care order, although it is good practice to seek the consent of the
p.000114: parent/legal guardian, the HSE is authorised pursuant to Section 18 of the 1991 Childcare Act to consent to any
p.000114: necessary medical or psychiatric treatment, assessment or examination. However, different procedures apply to
p.000114: admission and treatment under the Mental Health Act 2001 (see Section 9).
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
p.000114: control over the child as if they were the child’s parent/legal guardian provided that:
p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
p.000114: Page 59
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
p.000114:
p.000114:
p.000114: Page 60
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: The 2001 Act also contains certain provisions in relation to the treatment of a detained child. Section
p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
...
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
p.000114: law, a girl under the age of 17 who has sexual intercourse may not be convicted of an offence on
p.000114: that ground alone. This exemption from prosecution does not apply to boys of the same age.
p.000114: There is no specific provision in law regarding the age at which contraceptive advice and treatment and
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
p.000114: Page 61
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
...
p.000114: For the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own
p.000114: behalf27. For all other research, the person must be over the age of 18 years in order to provide consent.
p.000114: The following principles should be adhered to when conducting research involving children:
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 26 Researchers should refer to the Department of Children and Youth Affairs document Guidance for Developing Research
p.000114: Projects Involving Children which was published in April 2012
p.000114: 27 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI no 190 of 2004,
p.000114: section 4
p.000114:
p.000114: Page 72
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There is an international consensus that children should not be exposed to more than minimal risk in the absence of
p.000114: direct benefit to the participants themselves. The standard of minimal risk requires that the probability and
p.000114: magnitude of the possible harms posed by participating in research are no greater than those encountered by
p.000114: participants in their everyday life or during the performance of routine physical or psychological examinations or
p.000114: tests.
p.000114: Where the research entails only minimal risk, it is sufficient if the research offers the prospect of benefits either
p.000114: to the participants directly or to the group which is the focus of the research and to which the participants belong.
p.000114: Where the research poses more than minimal risk, it should aim to generate new knowledge of sufficient importance for
p.000114: addressing the participants’ conditions/needs. Such research should offer the prospect of direct benefits for
p.000114: the participants themselves and be commensurate with the level of foreseeable risk. The benefit-to-risk ratio presented
p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
p.000114: Page 73
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
p.000114: Therefore, it is essential that researchers should be aware of the possibility of parental therapeutic
p.000114: misconceptions when determining how to explain the potential benefits and risks of research participation during the
p.000114: consent process.
p.000114: In certain circumstances, it will not be possible for the researcher to guarantee confidentiality to the child due
p.000114: to mandatory reporting obligations. For instance, if a child reveals that they or others are at significant
p.000114: risk of harm, or the researcher observes or receives evidence of incidents likely to cause serious harm, the
p.000114: researcher must divulge this information to the appropriate authorities. This should occur only following
p.000114: discussion with the child. The child and his/her parent(s)/legal guardian(s) should be informed of this
p.000114: obligation during the consent/assent process and it should be highlighted in participant information leaflets. A
p.000114: strategy for information disclosure should be submitted to and approved by the REC in advance of the
p.000114: research being commenced.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 74
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
p.000114: In accordance with the functional approach to capacity (see Part One), there may be instances where a person might have
p.000114: limited capacity and may require assistance in deciding whether or not to participate in research. In such cases,
p.000114: researchers must ensure that efforts are made to assist people in reaching their decision and that they are provided
p.000114: with the appropriate tools to maximise their decision-making ability.
p.000114: The objectives as well as the potential risks and benefits of the research should be explained as fully as possible to
p.000114: the prospective participant given their level of understanding. The information should be provided using easily
...
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
p.000114:
p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
p.000114:
p.000114: Page 110
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
p.000114: be in the child’s best interests and a DNAR order should be put in place.
p.000114: Given the additional complexity and the emotionally-demanding nature of decisions relating to CPR for
p.000114: children this process should be underpinned by a number of fundamental guiding principles:
p.000114: • Parent(s)/legal guardian(s) and the healthcare team should work in partnership when deciding about
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
p.000114:
p.000114: Page 111
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: • Therefore, children should be informed and listened to and their ascertainable views and preferences should
p.000114: be taken into consideration
p.000114: • The final decision reached should be in the best interests of the child.
p.000114:
p.000114: In some instances, consensus may be reached on a child’s proposed treatment and care plan following a
p.000114: detailed discussion about his/her condition and prognosis, the likelihood of CPR being successful as well as the
p.000114: benefits and risks associated with CPR. However, disagreements with parent(s)/legal guardian(s) may be more
p.000114: likely to arise where a healthcare professional considers that the provision of CPR would be clinically
p.000114: inappropriate. In such cases continued communication and obtaining a second opinion from an
p.000114: independent senior healthcare professional may help to resolve the disagreement. Nonetheless, if the
p.000114: disagreement persists, healthcare professionals should seek ethical and legal advice and court involvement
p.000114: may ultimately be required to reach a solution.
p.000114:
p.000114:
p.000114:
p.000114: 8. Documenting and communicating CPR/DNAR decisions
p.000114:
p.000114:
p.000114: A decision whether or not to attempt CPR should be clearly and accurately documented in the individual’s healthcare
p.000114: record, along with how the decision was made, the date of the decision, the rationale for it, and who was involved in
p.000114: discussing the decision.
p.000114: It is recommended that service providers should develop specific mechanisms for the documentation
p.000114: and dissemination of decisions relating to resuscitation35.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 35 For example, the development of a standardised and colour-coded DNAR card, to be included in an individual’s
p.000114: records, to help highlight his/her DNAR status
p.000114:
p.000114: Page 112
p.000114:
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p.000114: validation against the controlled version
p.000114:
...
Searching for indicator parents:
(return to top)
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: National Consent Advisory Group Membership 124
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 10
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
...
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Part Two Children and Minors
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 49
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
...
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: As a corollary to the rights given to parents as legal guardians of their children, there are also
p.000114: duties imposed on them to act in the best interests of their children. In the health and social care context this
p.000114: requires parents and legal guardians to engage with health and social care service providers to ensure that
p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
...
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
...
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
...
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
p.000114: control over the child as if they were the child’s parent/legal guardian provided that:
p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
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p.000114:
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
...
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
p.002003:
p.002003: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.002003: Subjects (1964 – 2008)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 120
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Academic Commentary
p.002003:
p.002003: Ballard HO, Shook LA, Desai NS, Anand KJS. Neonatal research and the Validity of Informed Consent
p.002003: obtained in the Perinatal Period. Journal of Perniatology (2004), 24(7): p409-415
p.002003: Ballard HO, Shook LA, Locono J, Bernard P, Hayes D. Parents’ Understanding and Recall of Informed
p.002003: Consent Information for Neonatal Research. IRB: Ethics & Human Research (May-June 2011), p12-19
p.002003: Beach MC and Morrison RS (2002).The Effect of Do-Not-Resuscitate Orders on Physician Decision- Making.Journal of the
p.002003: American Geriatrics Society 50(12): 2057-2061
p.002003: Brazier and Cave Medicine, Patients and the Law (Penguin, 2007)
p.002003:
p.002003: British Medical Association, Resuscitation Council (UK) and Royal College of Nursing
p.002003: (2007).Decisions relating to cardiopulmonary resuscitation: A joint statement from the British Medical
p.002003: Association, the Resuscitation Council (UK) and the Royal College of Nursing. British Medical Association,
p.002003: London, 24p
p.002003: Butler MW, Saaidin N, Sheikh AA and Fennell JS (2006). Dissatisfaction with Do Not Attempt Resuscitation
p.002003: Orders: A nationwide study of Irish consultant physician practices. Irish Medical Journal 99(7): 208-210
p.002003: Burns JP, Edwards J, Johnson J, Cassem NH and Truog RD (2003). Do-not-resuscitate order after 25 years. Critical Care
p.002003: Medicine 31(5): 1543-1550
p.002003: Canadian Medical Association (1995).Joint Statement on Resuscitative Interventions (Update
p.002003: 1995).Canadian Medical Association Journal 153(11): 1652A-1652F
p.002003: Cherniak EP (2002). Increasing use of DNR orders in the elderly worldwide: whose choice is it?
p.002003: Journal of Medical Ethics 28(5): 303-307
p.002003:
p.002003: Clayton JM, Hancock KM, Butow PN, Tattersall MHN and Currow DC (2007).Clinical practice guidelines for
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000114: may be able to provide insight into the service user’s likely preferences - nobody else can consent on behalf of the
p.000114: service user in this situation.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 6 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 7 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: 8 See section 5.5 for provisions relating to the assessment of capacity
p.000114: Page 34
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
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p.000114: 5.6.3 Non-emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In non-emergency situations, a distinction can be made between those service users who, depending on the
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
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p.000114: consent of the service user and to make every effort to ensure that the treatment is acceptable to the service user.
p.000114:
p.000114: Nor does the Mental Health Act 2001 remove the ethical obligation to maximise service user capacity and
p.000114: to involve service users lacking capacity in the decision-making process to the greatest extent possible.
p.000114: All care given to the service user should be explained to him/her once their condition improves.
p.000114: Where the service user who has been admitted under the 2001 Act requires any other treatment or intervention not
p.000114: related to their mental health, the general principles of consent apply as discussed in this policy.
p.000114:
p.000114:
p.000114: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of Garda investigations into driving under
p.000114: the influence of alcohol and/or drugs
p.000114:
p.000114:
p.000114: The general principles regarding consent apply when testing for intoxicants. When such testing is clinically indicated,
p.000114: the urgency of the situation in which such testing commonly occurs means that explicit discussion of the pros and cons
p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
p.000114:
p.000114:
p.000114: 7.8 Advance refusal of treatment
p.000114:
p.000114:
p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
p.000114: including advance refusal of medical treatment. There is no Irish legislation confirming the enforceability of such
p.000114: advance refusals. However, such an advance plan should be respected on condition that:
p.000114: • The decision was an informed choice, according to the principles discussed in Sections 2-5
p.000114: • The decision specifically covers the situation that has arisen, and
p.000114:
...
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
p.000114: for children and have expertise in the particular needs of their child. Parent(s)/legal guardian(s) are
p.000114: entitled to be treated with courtesy and respect and to be provided with adequate information and support in relation
p.000114: to the provision of health and social care services to their children (see further Part One Section 3).
p.000114: It is important for service providers to recognise the role of the parent(s)/legal guardian(s) in
p.000114: deciding together with health and social care professionals what is in the best interests of the child. Case
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
...
p.000114: end-of-life care will be possible in which individuals should be helped to understand the severity of their condition.
p.000114: However, it should be emphasised that this does not necessarily require explicit discussion of CPR or an ‘offer’ of
p.000114: CPR. Implementing a DNAR order for those close to death does not equate to “doing nothing”; all care provided should
p.000114: follow a palliative approach and focus on easing that individual’s suffering and making him/her as comfortable as
p.000114: possible.
p.000114:
p.000114:
p.000114: 4.3 Cardiorespiratory arrest is considered possible or likely
p.000114:
p.000114:
p.000114: For certain individuals there may be an identifiable risk of cardiorespiratory arrest occurring as a result of their
p.000114: clinical condition. These include individuals with acute severe illness and those with severe or multiple coexisting
p.000114: medical conditions or diseases.
p.000114: Advance care planning, including consideration of issues such as CPR/DNAR is often appropriate for such individuals and
p.000114: should occur in the context of a general discussion about the individual’s prognosis and the likelihood that CPR would
p.000114: be successful, as well as his/her values, concerns, expectations and goals of care.
p.000114:
p.000114: 32 There is currently no specific legislation pertaining to advance healthcare directives in Ireland. However, the
p.000114: Irish courts have established that an individual with capacity has the right to refuse treatment to facilitate a
p.000114: natural death. The weight of legal opinion has been interpreted to mean that an advance healthcare directive made by an
p.000114: individual, when he/she had capacity, would be upheld. In addition, the Medical Council Guide to Professional Conduct
p.000114: and Ethics for Registered Practitioners (2009) also recognises advance healthcare directives
p.000114: Page 104
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Most CPR discussions and decisions will occur in this group. However, it must be emphasised that this is not a
p.000114: homogenous group, as the likelihood of success from CPR varies widely, and this necessarily influences how
p.000114: discussions are conducted.
p.000114:
p.000114:
p.000114:
p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
...
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: 6. Balancing the benefits and risks of providing CPR
p.000114:
p.000114:
p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
p.000114: acknowledging the uncertainty inherent in many medical predictions, healthcare professionals still have an
p.000114: obligation to provide an opinion, based on their expertise.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Principles to be applied in reaching a decision about CPR33
p.000114:
p.000114: • Decisions about CPR must be made on the basis of an individual assessment of each person’s case.
p.000114: • The likely clinical outcome of attempting CPR should be considered, including the likelihood of
p.000114: successfully re-starting the individual’s heart and breathing for a sustained period, and the level of recovery
p.000114: that can reasonably be expected after successful CPR.
p.000114: • Advance care planning, including making decisions about CPR, is an important part of good clinical care for
p.000114: those at risk of cardiorespiratory arrest.
p.000114: • Communication and the provision of information in a sensitive manner are central to discussions about CPR
...
p.000114: benefits and that a DNAR order should be put in place. However, there is often considerable variability in how
p.000114: strongly and the degree of certainty with which this judgement is held.
p.000114: In these situations, it is appropriate for the healthcare professional to explain the reasons behind this judgement,
p.000114: including any uncertainty, to recommend that a DNAR order should be written, and to seek the views of the individual in
p.000114: this regard.
p.000114:
p.000114: Page 108
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 6.4 When there is disagreement about the balance of benefits and risks of CPR
p.000114:
p.000114:
p.000114: While in many cases, the individual and healthcare professional will agree that a DNAR order is appropriate or
p.000114: inappropriate; this may not always be the case.
p.000114: Many disagreements result from miscommunication and misunderstandings, such as an unrealistic
p.000114: expectation by an individual of the likely success rate of CPR or an underestimation by the healthcare professional of
p.000114: the acceptability of the current or predicted future quality of life of the individual. In many such cases, continued
p.000114: discussion will lead to agreement, and an ultimate decision should be deferred pending further discussion. If
p.000114: disagreement persists, an offer of a second, independent opinion should be made. Where all previous
p.000114: efforts at resolution have proven unsuccessful it may be necessary for parties to consider obtaining legal advice.
p.000114: The same procedure should be carried out if those close to an individual who lacks decision-making
p.000114: capacity do not accept a DNAR decision.
p.000114:
p.000114:
p.000114: 6.5 Where an individual does not want to discuss CPR and DNAR orders
p.000114:
p.000114:
p.000114: Situations may arise where an individual does not want to discuss CPR/DNAR orders. In some cases such
p.000114: refusals may be linked to the timing of the discussion and the individual should be given the opportunity
p.000114: to defer the discussion and revisit the issues of CPR and DNAR orders at a later time. However, if an individual
p.000114: refuses to participate in the discussion, his/her wishes should be respected. If the individual would prefer that the
p.000114: healthcare professional discuss the decision with somebody else such as a relative, partner or friend, this should be
p.000114: respected. However, it should be emphasised that the role of those close to the individual is not to
p.000114: make the final decision relating to CPR, but rather to help the senior healthcare professional to make the most
p.000114: appropriate decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
...
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
p.000114:
p.000114: Page 111
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: • Therefore, children should be informed and listened to and their ascertainable views and preferences should
p.000114: be taken into consideration
p.000114: • The final decision reached should be in the best interests of the child.
p.000114:
p.000114: In some instances, consensus may be reached on a child’s proposed treatment and care plan following a
p.000114: detailed discussion about his/her condition and prognosis, the likelihood of CPR being successful as well as the
p.000114: benefits and risks associated with CPR. However, disagreements with parent(s)/legal guardian(s) may be more
p.000114: likely to arise where a healthcare professional considers that the provision of CPR would be clinically
p.000114: inappropriate. In such cases continued communication and obtaining a second opinion from an
p.000114: independent senior healthcare professional may help to resolve the disagreement. Nonetheless, if the
p.000114: disagreement persists, healthcare professionals should seek ethical and legal advice and court involvement
p.000114: may ultimately be required to reach a solution.
p.000114:
p.000114:
p.000114:
p.000114: 8. Documenting and communicating CPR/DNAR decisions
p.000114:
p.000114:
p.000114: A decision whether or not to attempt CPR should be clearly and accurately documented in the individual’s healthcare
p.000114: record, along with how the decision was made, the date of the decision, the rationale for it, and who was involved in
p.000114: discussing the decision.
p.000114: It is recommended that service providers should develop specific mechanisms for the documentation
p.000114: and dissemination of decisions relating to resuscitation35.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114: 35 For example, the development of a standardised and colour-coded DNAR card, to be included in an individual’s
p.000114: records, to help highlight his/her DNAR status
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 9. Reviewing DNAR orders
p.000114:
p.000114:
p.000114: The need to review a DNAR order will depend on the rationale for the decision and should be considered within the
...
Economic / Economic/Poverty
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR), including chest compressions, defibrillation (with electric shocks), the
p.000114: injection of drugs and ventilation of the lungs, is an important and potentially life- saving intervention for victims
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergency situation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
...
General/Other / Dependent
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p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
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p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
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p.000091: validation against the controlled version
p.000091:
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p.000091:
p.000091:
p.000091: Table of contents
p.000091:
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p.000091: Page
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p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
...
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
p.000114: Participants who regain capacity (or their legal representatives once located) should be given all the relevant
p.000114: information and their consent to continued participation should be obtained as soon as is reasonably possible. The
p.000114: option to withdraw and to seek the destruction of any biological material or data collected as part of the study should
p.000114: also be given.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 78
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5.2 People highly dependent on medical care
p.000114:
p.000114:
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
p.000114: the terminally ill) is valuable, their reliance on medical treatment may impact on their willingness to consent to
p.000114: research participation and this raises significant ethical issues. Therefore, such research should only be
p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
...
p.000114: personal preferences regarding CPR and DNAR orders and to ensure that decisions relating to CPR and DNAR orders are
p.000114: made consistently, transparently and in line with best practice. Where a decision is made to attempt CPR, it should be
p.000114: performed competently and any decision to restrict the extent and/or duration of the CPR attempt should be
p.000114: based on balancing the benefits and risks of continuing CPR. Unethical and inappropriate practices such as
p.000114: “slow-coding” and “sham resuscitations” where a full resuscitation is deliberately not attempted must not be performed.
p.000114: This policy document should be read in conjunction with other relevant guidance, including the Medical Council’s, Guide
p.000114: to Professional Conduct and Ethics for Registered Medical Practitioners (2009) and An Bord Altranais, The Code
p.000114: of Professional Conduct for each Nurse and Midwife (2009).
p.000114:
p.000114:
p.000114:
p.000114: 2. Definition and scope of resuscitation decisions
p.000114:
p.000114:
p.000114: 2.1 Do not attempt resuscitation or do not resuscitate
p.000114:
p.000114:
p.000114: Throughout this document the term “do not attempt resuscitation” (DNAR) orders will be used as opposed to “do not
p.000114: resuscitate” (DNR) orders. This change has been made in an effort to underscore the uncertainty surrounding
p.000114: the success of CPR: “do not resuscitate” may imply that resuscitation would likely be successful if it
p.000114: were undertaken, whereas “do not attempt resuscitation” emphasises that the success of any resuscitation
p.000114: intervention is less clear cut and situation dependent.
p.000114:
p.000114:
p.000114: 2.2 Scope of DNAR orders
p.000114:
p.000114:
p.000114: A decision not to attempt CPR applies only to CPR. It does not apply to any other aspect of treatment
p.000114: and all other treatments and care that are appropriate for the individual should continue. If a
p.000114: decision is made to restrict the nature or extent of CPR, this should be carefully documented and
p.000114: communicated effectively to all members of the healthcare team caring for the individual.
p.000114:
p.000114: Page 99
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
p.000114: • Beneficence - maximising the potential benefits of the research and minimising the risks;
p.000114: • Justice - the duty to neither neglect nor discriminate against individuals or groups who may benefit from
p.000114: research and to avoid placing an unfair burden of research participation on particular groups; and
p.000114:
p.000114:
p.000114: 24 These documents are referred to in the bibliography
p.000114:
p.000114: Page 66
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • Respect for persons – the notion that individuals should be treated as autonomous agents and that
p.000114: individuals with diminished autonomy should be protected.
p.000114: Respect for persons is most commonly manifested through the exercise of informed consent (hereafter
p.000114: referred to as consent), which requires that people’s beliefs and opinions be valued, and that they be allowed to
p.000114: choose for themselves whether or not to participate in research.
p.000114: All modern codes of ethics concerning research with human participants affirm the importance of consent. The goal of
p.000114: consent is to ensure that participants have sufficient information to be able to make decisions about research
p.000114: participation which are compatible with their individual interests and values.
p.000114: Special consideration must also be given to the timing of the consent process. Prospective research
p.000114: participants should be given enough time to fully consider their participation and to ask questions.
p.000114:
p.000114:
p.000114:
p.000114: 2. General principles of consent for research
p.000114:
p.000114:
p.000114: 2.1 Content of the information to be provided
p.000114:
p.000114:
p.000114: When preparing consent documentation, researchers must provide all of the information necessary for
p.000114: making an informed decision. Prospective research participants should be provided with the information in the following
...
General/Other / Ease of Access
Searching for indicator ease of access:
(return to top)
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative ease of access to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 11
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
p.000114:
p.000114:
p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
p.000114:
p.000114:
p.000114: Autonomy
p.000114: The capacity to make decisions and take actions that are in keeping with one’s values and beliefs.
p.000114:
p.000114:
p.000114: Bioethics
p.000114: A multidisciplinary activity dealing with the ethical implications of biological research and medicine.
p.000114:
p.000114:
p.000114: Biobank
p.000114: A centralised archive of human biological material from which materials are made available for research purposes.
p.000114:
p.000114:
p.000114: Capacity
p.000114: The ability to understand the nature and consequences of a decision in the context of available choices at the time the
p.000114: decision is to be made.
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR)
p.000114: Cardiopulmonary resuscitation (CPR) is an attempt to restore breathing (sometimes with support) and spontaneous
p.000114: circulation in an individual in cardiorespiratory arrest. CPR usually includes chest compressions,
p.000114: attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 12
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Cardiorespiratory arrest
...
p.000114:
p.000114:
p.000114: 1.1 Scope of this policy
p.000114:
p.000114:
p.000114: The need for consent, and the application of the general principles in this policy, extends to all interventions
p.000114: conducted by or on behalf of the HSE on service users in all locations. Thus, it includes social as
p.000114: well as health care interventions and applies to those receiving care and treatment in hospitals, in the
p.000114: community and in residential care settings. How the principles are applied, such as the amount of information
p.000114: provided and the degree of discussion needed to obtain valid consent, will vary with the particular
p.000114: situation. In some situations, permission, as matter of common courtesy and of respect for the service
p.000114: user, rather than consent may be required e.g. to enter a person’s home, and should be obtained in
p.000114: keeping with relevant HSE codes of conduct1. Knowledge of the importance of obtaining consent is expected
p.000114: of all staff employed or contracted by the HSE.
p.000114:
p.000114:
p.000114: 1.2 Ethical issues regarding consent
p.000114:
p.000114:
p.000114: The ethical rationale behind the importance of consent is the need to respect the service user’s right to
p.000114: self-determination (or autonomy) – their right to control their own life and to decide what happens to
p.000114: their own body.
p.000114:
p.000114:
p.000114:
p.000114: 1 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 20
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Those providing health and social care can often claim greater expertise in decisions regarding the ‘means’ to
p.000114: achieve the ‘end’ of better health, such as what medication will best treat blood pressure or whether admission to
p.000114: long-term care is advisable, although service users retain ultimate decision-making authority and must consent
p.000114: to the intervention.
p.000114: Service users are the experts in determining what ‘ends’ matter to them, including how they should live
p.000114: their everyday lives, decisions about risk-taking and preference for privacy or non- interference. With rare
p.000114: exceptions, the competent service user’s right to refuse an intervention applies even when their decision seems unwise
p.000114: to the health and social care professional.
p.000114: While respect for autonomy is very important, it is not the only ethical principle relevant to consent.
p.000114: Health and social care professionals also have a responsibility to try and maximise the health and well-being of, and
p.000114: to minimise harm to, service users and others. They also have an obligation to ensure the fair and appropriate
p.000114: use of resources. This means that service users (whether contemporaneously or in an advance healthcare
p.000114: directive) cannot demand whatever interventions they want, regardless of their effectiveness.
p.000114:
p.000114:
p.000114: 1.3 Health and social care decision-making
p.000114:
p.000114:
p.000114: The relationship between those who provide health and social care and the service user should be a partnership based
p.000114: on openness, trust and good communication. Almost every health and social care intervention involves decisions
p.000114: made by service users and those providing theircare.
p.000114: Good decision making requires a dialogue between parties that recognises and acknowledges the service user’s goals,
p.000114: values and preferences as well as the specialist knowledge, experience and clinical judgment of health and social care
p.000114: professionals.
p.000114:
p.000114:
p.000114: 1.4 Consent in Irish law
p.000114:
p.000114:
p.000114: It is a basic rule at common law that consent must be obtained for medical examination, treatment,
p.000114: service or investigation. This is well established in Irish case law and ethical standards. The requirement for consent
...
p.000114: validation against the controlled version
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Part Two Children and Minors
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
...
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
p.000114: • Beneficence - maximising the potential benefits of the research and minimising the risks;
p.000114: • Justice - the duty to neither neglect nor discriminate against individuals or groups who may benefit from
p.000114: research and to avoid placing an unfair burden of research participation on particular groups; and
p.000114:
p.000114:
p.000114: 24 These documents are referred to in the bibliography
p.000114:
p.000114: Page 66
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • Respect for persons – the notion that individuals should be treated as autonomous agents and that
p.000114: individuals with diminished autonomy should be protected.
p.000114: Respect for persons is most commonly manifested through the exercise of informed consent (hereafter
p.000114: referred to as consent), which requires that people’s beliefs and opinions be valued, and that they be allowed to
p.000114: choose for themselves whether or not to participate in research.
p.000114: All modern codes of ethics concerning research with human participants affirm the importance of consent. The goal of
p.000114: consent is to ensure that participants have sufficient information to be able to make decisions about research
p.000114: participation which are compatible with their individual interests and values.
p.000114: Special consideration must also be given to the timing of the consent process. Prospective research
p.000114: participants should be given enough time to fully consider their participation and to ask questions.
p.000114:
p.000114:
p.000114:
p.000114: 2. General principles of consent for research
p.000114:
p.000114:
p.000114: 2.1 Content of the information to be provided
p.000114:
p.000114:
p.000114: When preparing consent documentation, researchers must provide all of the information necessary for
p.000114: making an informed decision. Prospective research participants should be provided with the information in the following
...
p.000114: and all other treatments and care that are appropriate for the individual should continue. If a
p.000114: decision is made to restrict the nature or extent of CPR, this should be carefully documented and
p.000114: communicated effectively to all members of the healthcare team caring for the individual.
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
p.000114: In particular, individuals are the best judges of their own quality of life; healthcare professionals and families
p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
...
p.000114: healthcare team, as part of the overall discussion regarding the procedure. However, if the individual is willing to
p.000114: accept the additional risk then the healthcare professional should continue with the procedure.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
p.000114:
p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
p.000114:
p.000114: Page 110
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
...
p.002003: Canadian Medical Association (1995).Joint Statement on Resuscitative Interventions (Update
p.002003: 1995).Canadian Medical Association Journal 153(11): 1652A-1652F
p.002003: Cherniak EP (2002). Increasing use of DNR orders in the elderly worldwide: whose choice is it?
p.002003: Journal of Medical Ethics 28(5): 303-307
p.002003:
p.002003: Clayton JM, Hancock KM, Butow PN, Tattersall MHN and Currow DC (2007).Clinical practice guidelines for
p.002003: communicating prognosis and end-of-life issues with adults in the advanced stages of a life-limiting illness, and their
p.002003: caregivers. The Medical Journal of Australia 186(12): S77-S108
p.002003: Desch K, Li J, Kim S, Laventhal N, Metzger k, Siemieniak D, Ginsburg D. Analysis of Informed Consent
p.002003: Document Utilization in a Minimal-Risk Genetic Study. Annals of Internal Medicine (2011), 155(5): p316-322
p.002003:
p.002003:
p.002003:
p.002003: Page 121
p.002003:
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p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Diem SJ, Lantos JD and Tulsky JA (1996). Cardiopulmonary Resuscitation on Television: Miracles and Misinformation. The
p.002003: New England Journal of Medicine 334(24): 1578-1582
p.002003: Donnelly Healthcare Decision-Making and the Law: Autonomy, Capacity and the Limits of Liberalism (Cambridge University
p.002003: Press, 2010)
p.002003: Donnelly ‘The Right of Autonomy in Irish Law’ (2008) 14 Medico-Legal Journal of Ireland 34
p.002003:
p.002003: Ehlenbach WJ, Barnato AE, Curtis JR, Kreuter W, Koepsell TD, Deyo RA and Stapleton RD (2009). Epidemiologic Study of
p.002003: In-Hospital Cardiopulmonary Resuscitation in the Elderly. The New England Journal of Medicine 361(1): 22-31
p.002003: Ferguson RP, Phelan T, Haddad T, Hinduja A and Dubin NH (2008). Survival After In-Hospital Cardiopulmonary
p.002003: Resuscitation. Southern Medical Journal 101(10): 1007-1011
p.002003: Fritz Z and Fuld J (2010). Ethical issues surrounding do not attempt resuscitation orders: decisions, discussions and
p.002003: deleterious effects. Journal of Medical Ethics 36(10): 593-597.
p.002003: Herring Medical Law and Ethics (2nd Ed)(OUP, 2009)
p.002003:
p.002003: Hogan and Whyte JM Kelly: The Irish Constitution (4th Ed) (Lexis NexisButterworths, 2003) Jackson Medical Law: Texts,
p.002003: Cases and Materials (2nd Ed) (OUP, 2009)
p.002003: Lannon R and O’Keeffe ST (2010).Cardiopulmonary resuscitation in older people – a review.
p.002003: Reviews in Clinical Gerontology 20: 20–29
p.002003:
p.002003: Lippert FK, Raffay V, Georgiou M, Steen PA and Bossaert L (2010). European Resuscitation Council Guidelines for
p.002003: Resuscitation 2010, Section 10. The ethics of resuscitation and end-of-life decisions. Resuscitation
p.002003: 81(10): 1445–1451
p.002003: Loertscher L, Reed DA, Bannon MP and Mueller PS (2010). Cardiopulmonary Resuscitation and Do
p.002003: -Not-Resuscitate Orders: A Guide for Clinicians. The American Journal of Medicine 123(1): 4-9 Madden Medicine, Ethics
...
General/Other / Incapacitated
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p.000114: consent process that it will not be possible to withdraw their material and/ or data.
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 11. Reconsent
p.000114:
p.000114:
p.000114: The consent process should consist of a continued exchange of information for the duration of a study. When substantial
p.000114: changes occur in the conditions or the procedures of a study, researchers should once again seek the consent of the
p.000114: participants. It is imperative that research participants be informed when there is new information that might
p.000114: affect their willingness to continue participation. There are a number of reasons why reconsent may be required
p.000114: which include but are not limited to cases where:
p.000114: • the research protocol has been substantially altered;
p.000114:
p.000114: • new safety information has come to light;
p.000114:
p.000114: • alternative treatments have become available;
p.000114:
p.000114: • a child participant reaches legal maturity (i.e. 18 years or 16 years in the case of clinical trials);
p.000114: • a formerly incapacitated adult has regained capacity; or
p.000114:
p.000114: • a substantial period of time has elapsed since the original consent was obtained (e.g. longitudinal study).
p.000114: A strategy for reconsenting participants should be presented to the REC responsible for reviewing and approving the
p.000114: study.
p.000114:
p.000114:
p.000114:
p.000114: 12. Research where consent may not be required
p.000114:
p.000114:
p.000114: As noted above, certain types of research may not require the consent of the research participant by virtue of a legal
p.000114: basis (e.g. research in public health emergencies) or because a REC has waived the requirement for consent (e.g.
p.000114: population based research). It should be noted that in the latter case, the waiver applies only to de-identified
p.000114: material/data.
p.000114: Waiver of consent is to be regarded as an exception to the rule and studies seeking waiver of consent
p.000114: must receive REC approval. Before a waiver of consent may be granted the researcher must satisfy the REC
p.000114: that:
p.000114:
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p.000114:
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p.000024: 3.3 What information about risks and side effects of an intervention should be 25
p.000024: provided?
p.000024: 3.4 How and when information should be provided 26
p.000024: 3.4.1 Service users with limited English proficiency 27
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
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p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
p.000034: 5.6.2 Emergency situations involving service users who lack capacity 34
p.000034: 5.6.3 Non-emergency situations involving service users who lack capacity 35
p.000034: 5.7 Wards of court
p.000035: 35
p.000035: 6. Is it always necessary to seek consent from a service user? 36
p.000035: 6.1 Emergency situations
p.000036: 36
p.000036: 6.2 Where the service user declines information
p.000036: 36
p.000036: 7. Specific issues relating consent
p.000037: 37
p.000037: 7.1 Scope of consent
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
...
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.4 When to consider incapacity
p.000114:
p.000114:
p.000114: An important implication of the presumption of capacity is that this presumption should not be challenged unless an
p.000114: adequate “trigger” exists. All service users may experience temporary lack of capacity due to severe illness, loss of
p.000114: consciousness or other similar circumstances.
p.000114:
p.000114:
p.000114: The possibility of incapacity and the need to assess capacity formally should only be considered,
p.000114: if, having been given all appropriate help and support, a service user:
p.000114:
p.000114: • is unable to communicate a clear and consistent choice or
p.000114:
p.000114: • is obviously unable to understand and use the information and choices provided.
p.000114:
p.000114:
p.000114: 5.5 Assessing capacity to consent
p.000114:
p.000114:
p.000114: Capacity to consent should be assessed if there is sufficient reason, as indicated in Section 5.4, to question the
p.000114: presumption of capacity. This involves assessing whether:
p.000114: • The service user understands in broad terms and believes the reasons for and nature of the
p.000114: decision to be made
p.000114: • The service user has sufficient understanding of the principal benefits and risks of an intervention and
p.000114: relevant alternative options after these have been explained to them in a manner and in a language appropriate
p.000114: to their individual level of cognitive functioning
p.000114: • The service user understands the relevance of the decision, appreciates the advantages
p.000114: and disadvantages in relation to the choices open to them and is able to retain this knowledge long enough to make a
p.000114: voluntary choice.
p.000114: The fact that a person may not, in their current situation have sufficient understanding or appreciation
p.000114: regarding a decision should in the first instance signal a requirement for the provision of supports in
p.000114: order to ensure that the decision-making capacity of the individual is enhanced to the greatest degree
p.000114: possible, rather than an inevitable finding of incapacity to make that decision.
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.6 Making decisions if capacity is absent
p.000114:
p.000114:
p.000114: There is currently no legislative framework to govern how a decision about treatment and care should be made for those
p.000114: who lack capacity to make that decision themselves.
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
p.000114: capacity, the health and social care professional should determine what is in their best interests, which is decided by
p.000114: reference to their values and preferences if known.
p.000114:
p.000114:
p.000114: The health and social care professional should:
p.000114:
p.000114: • Consider whether the service user's lack of capacity is temporary or permanent. In those with
p.000114: fluctuating cognitive impairment, it may be possible to make use of lucid periods to obtain consent
p.000114: • Consider which options for treatment would provide overall clinical benefit for the service user
...
p.000114: service user’s future choices. While it is good practice to inform those close to the service user – and they
p.000114: may be able to provide insight into the service user’s likely preferences - nobody else can consent on behalf of the
p.000114: service user in this situation.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 6 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 7 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: 8 See section 5.5 for provisions relating to the assessment of capacity
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5.6.3 Non-emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In non-emergency situations, a distinction can be made between those service users who, depending on the
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
...
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
p.000114:
p.000114:
p.000114: 7.8 Advance refusal of treatment
p.000114:
p.000114:
p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
p.000114: including advance refusal of medical treatment. There is no Irish legislation confirming the enforceability of such
p.000114: advance refusals. However, such an advance plan should be respected on condition that:
p.000114: • The decision was an informed choice, according to the principles discussed in Sections 2-5
p.000114: • The decision specifically covers the situation that has arisen, and
p.000114:
p.000114: • There is no evidence that the service user has changed their mind since the advance plan was made.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 14 As specified in the Act
p.000114:
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p.000114:
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p.000114: validation against the controlled version
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p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114: If there is reasonable doubt about the existence of an advance treatment plan, the service user’s capacity at the
p.000114: time of making the treatment plan or whether it still applies in the present circumstances, treatment
p.000114: decisions should be made according to the principles discussed in Section 5.6.
p.000114:
p.000114: 7.9 Withdrawal of consent
p.000114:
p.000114:
p.000114: A service user with capacity is entitled to withdraw consent at any time, including during the
...
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
...
General/Other / Manipulable
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p.000114: which is expected to come into effect in 2016, will take the form of a Regulation which will ensure that, in the main,
p.000114: the rules governing clinical trials will be identical throughout Europe . Other aspects, such as the structure and
p.000114: function of RECs and eligibility for the role of legal representative will be decided at a national level
p.000114: 30 It is also important to note that the European Commission is in the process of reviewing EU legal frameworks
p.000114: relating to medical devices and on the protection of personal data
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000024: 3.4.3 Blind and visually impaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
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p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
p.000034: 5.6.2 Emergency situations involving service users who lack capacity 34
p.000034: 5.6.3 Non-emergency situations involving service users who lack capacity 35
p.000034: 5.7 Wards of court
p.000035: 35
p.000035: 6. Is it always necessary to seek consent from a service user? 36
p.000035: 6.1 Emergency situations
p.000036: 36
p.000036: 6.2 Where the service user declines information
p.000036: 36
p.000036: 7. Specific issues relating consent
p.000037: 37
p.000037: 7.1 Scope of consent
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
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p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
...
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
p.000075: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Page 8
p.000091:
p.000091:
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p.000091: validation against the controlled version
p.000091:
...
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: National Consent Advisory Group Membership 124
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 10
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 11
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
p.000114:
p.000114:
p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
p.000114:
p.000114:
p.000114: Autonomy
...
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
...
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114: 5.6.1 Role of the family
p.000114:
p.000114:
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service6 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so7.
p.000114: However, it may be helpful to include those who have a close, ongoing, personal relationship with the
p.000114: service user, in particular anyone chosen by the service user to be involved in treatment decisions, in the
p.000114: discussion and decision-making process pertaining to health and social care interventions.
p.000114: Their role in such situations is not to make the final decision, but rather to provide greater insight into his/her
p.000114: previously expressed views and preferences and to outline what they believe the individual would have
p.000114: wanted. In some cases, involvement of those close to the service user will facilitate the service user in reaching a
p.000114: decision in conjunction with health/social care providers.
p.000114:
p.000114:
p.000114: 5.6.2 Emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In emergency situations where a service user is deemed to lack capacity8 consent is not necessary.
p.000114: The health and social care professional may treat the service user provided the treatment is immediately
p.000114: necessary to save their life or to prevent a serious deterioration of their condition and that there is no valid
p.000114: advance refusal of treatment (discussed in 7.9). The treatment provided should be the least restrictive of the
p.000114: service user’s future choices. While it is good practice to inform those close to the service user – and they
p.000114: may be able to provide insight into the service user’s likely preferences - nobody else can consent on behalf of the
p.000114: service user in this situation.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 6 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 7 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: 8 See section 5.5 for provisions relating to the assessment of capacity
p.000114: Page 34
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5.6.3 Non-emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In non-emergency situations, a distinction can be made between those service users who, depending on the
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
...
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
p.000114:
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p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 6. Is it always necessary to seek service user consent?
p.000114:
p.000114:
p.000114: The general principles of consent apply to all decisions about care: from the treatment of minor and self-limiting
p.000114: conditions, to major interventions with significant risks or side effects. However, while the agreement of the
p.000114: service user should always be sought, there are a number of situations where the amount of information
p.000114: provided about an intervention may legitimately be abbreviated. These include:
p.000114: • Emergency situations
p.000114:
p.000114: • Where the service user declines information.
p.000114:
p.000114:
p.000114: 6.1 Emergency situations
p.000114:
p.000114:
p.000114: In an emergency life-threatening situation where the service user lacks capacity to consent or where the
p.000114: urgency of the relevant intervention imposes time limitations on the ability of the service user to
p.000114: appreciate what treatment is required, the necessary treatment may be administered in the absence of
p.000114: the expressed consent of the service user. The application of this exception is limited to situations where the
p.000114: treatment is immediately necessary to save the life or preserve the health of the service user.
p.000114:
p.000114:
p.000114: 6.2 Where the service user declines information
p.000114:
p.000114:
p.000114: Some service users do not want to know in detail about their condition or the treatment. While this should be respected
p.000114: if possible, it is important that some basic information be provided about major interventions in order that consent
p.000114: can be obtained and the service user has been advised of what is involved. If a service user refuses to receive
p.000114: detailed information about their condition, this should be documented9.
p.000114: The fact that a service user might be upset or refuse treatment or services as a result of receiving
p.000114: information as part of the consent process is not a valid reason for withholding information that they
p.000114: need or are entitled to know.
p.000114:
p.000114: 9 Further details on the documentation of consent are provided at 7.5
p.000114:
p.000114: Page 36
p.000114:
...
p.000114: advance what they would like the health and social care professional to do if the difficulty occurs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 10 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 37
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: It is important that service users understand the scope of any decisions to be made, especially if:
p.000114:
p.000114: • Treatment will be provided in stages, with the possibility that changes or adjustments might be needed
p.000114: • Different professionals will provide particular parts of an investigation or treatment, such as
p.000114: anaesthesia and surgery
p.000114: • A number of different investigations or treatments are involved.
p.000114:
p.000114: The service user should be asked if there are any particular procedures they object to in the context
p.000114: of their proposed treatment and this should be clearly documented on their record. If they agree only to parts of
p.000114: the proposed intervention/treatment, there should be a clear process through which they can be involved in
p.000114: making decisions at a later stage. Those who provide health and social care must not exceed the scope of the
p.000114: authority given by a service user, except in an emergency.
p.000114:
p.000114:
p.000114: 7.2 Who should seek consent from a service user?
p.000114:
p.000114:
p.000114: The person who is providing a particular health and social care service or intervention is ultimately
p.000114: responsible for ensuring that the service user is consenting to what is being done. The task of providing information
p.000114: and seeking consent may be delegated to another professional, as long as that professional is suitably trained and
p.000114: qualified.
p.000114: In particular, they must have sufficient knowledge of the proposed intervention and of the benefits and
p.000114: risks in order to be able to provide the information the service user requires. Inappropriate delegation
p.000114: (for example where the seeking of consent is assigned to a junior health and social care professional with
p.000114: inadequate knowledge of the procedure) may mean that the “consent” obtained is not valid.
p.000114: If different aspects of care are to be provided by different professional disciplines, each should usually obtain
p.000114: consent for their particular intervention.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 38
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
...
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
...
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
p.000114: In relation to children who are subject to interim and emergency care orders, an application can be made to the
p.000114: District Court pursuant to the Child Care Act 1991 in regard to medical treatment.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to children who are subject to a full care order, although it is good practice to seek the consent of the
p.000114: parent/legal guardian, the HSE is authorised pursuant to Section 18 of the 1991 Childcare Act to consent to any
p.000114: necessary medical or psychiatric treatment, assessment or examination. However, different procedures apply to
p.000114: admission and treatment under the Mental Health Act 2001 (see Section 9).
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
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p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
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p.000114: relating to medical devices and on the protection of personal data
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
p.000114: Participants who regain capacity (or their legal representatives once located) should be given all the relevant
p.000114: information and their consent to continued participation should be obtained as soon as is reasonably possible. The
p.000114: option to withdraw and to seek the destruction of any biological material or data collected as part of the study should
p.000114: also be given.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5.2 People highly dependent on medical care
p.000114:
p.000114:
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
...
p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
p.000114: In some instances where CPR has been started, additional information may subsequently become available which makes
p.000114: continued CPR inappropriate, for example clinical information which indicates that CPR is unlikely to
p.000114: be successful, or information regarding the individual’s preferences.
p.000114: As was discussed in Section 4.2, there will be some individuals for whom no formal DNAR decision has been made, but
p.000114: where attempting CPR is clearly inappropriate because death is imminent and unavoidable, for example, in the final
p.000114: stages of a terminal illness. In these circumstances, it is reasonable for healthcare professionals not to
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: 6. Balancing the benefits and risks of providing CPR
p.000114:
p.000114:
p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
p.000114: acknowledging the uncertainty inherent in many medical predictions, healthcare professionals still have an
p.000114: obligation to provide an opinion, based on their expertise.
p.000114:
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General/Other / Relationship to Authority
Searching for indicator authority:
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p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
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p.000114: keeping with relevant HSE codes of conduct1. Knowledge of the importance of obtaining consent is expected
p.000114: of all staff employed or contracted by the HSE.
p.000114:
p.000114:
p.000114: 1.2 Ethical issues regarding consent
p.000114:
p.000114:
p.000114: The ethical rationale behind the importance of consent is the need to respect the service user’s right to
p.000114: self-determination (or autonomy) – their right to control their own life and to decide what happens to
p.000114: their own body.
p.000114:
p.000114:
p.000114:
p.000114: 1 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 20
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Those providing health and social care can often claim greater expertise in decisions regarding the ‘means’ to
p.000114: achieve the ‘end’ of better health, such as what medication will best treat blood pressure or whether admission to
p.000114: long-term care is advisable, although service users retain ultimate decision-making authority and must consent
p.000114: to the intervention.
p.000114: Service users are the experts in determining what ‘ends’ matter to them, including how they should live
p.000114: their everyday lives, decisions about risk-taking and preference for privacy or non- interference. With rare
p.000114: exceptions, the competent service user’s right to refuse an intervention applies even when their decision seems unwise
p.000114: to the health and social care professional.
p.000114: While respect for autonomy is very important, it is not the only ethical principle relevant to consent.
p.000114: Health and social care professionals also have a responsibility to try and maximise the health and well-being of, and
p.000114: to minimise harm to, service users and others. They also have an obligation to ensure the fair and appropriate
p.000114: use of resources. This means that service users (whether contemporaneously or in an advance healthcare
p.000114: directive) cannot demand whatever interventions they want, regardless of their effectiveness.
p.000114:
p.000114:
p.000114: 1.3 Health and social care decision-making
p.000114:
p.000114:
p.000114: The relationship between those who provide health and social care and the service user should be a partnership based
p.000114: on openness, trust and good communication. Almost every health and social care intervention involves decisions
p.000114: made by service users and those providing theircare.
p.000114: Good decision making requires a dialogue between parties that recognises and acknowledges the service user’s goals,
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p.000114:
p.000114:
p.000114: It is a basic rule at common law that consent must be obtained for medical examination, treatment,
p.000114: service or investigation. This is well established in Irish case law and ethical standards. The requirement for consent
p.000114: is also recognised in international and European human rights law and under the Irish Constitution.
p.000114:
p.000114:
p.000114:
p.000114: Page 21
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
p.000114: as a service user under the age of 18 years, “other than a service user who is or who has been married”.
p.000114: This is discussed further in Part Two of this policy.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: • Consider the views of people who have a close, ongoing, personal relationship with the service user such
p.000114: as family or friends
p.000114: • Consider involving an advocate to support the service user who lacks capacity to participate in the
p.000114: decision making process around consent. This may be particularly helpful in difficult situations such
p.000114: as when service users with no family or friends have to make a complex decision; or when there is
p.000114: significant disagreement regarding the best course of action.
p.000114:
p.000114:
p.000114: Page 33
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114: 5.6.1 Role of the family
p.000114:
p.000114:
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service6 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so7.
p.000114: However, it may be helpful to include those who have a close, ongoing, personal relationship with the
p.000114: service user, in particular anyone chosen by the service user to be involved in treatment decisions, in the
p.000114: discussion and decision-making process pertaining to health and social care interventions.
p.000114: Their role in such situations is not to make the final decision, but rather to provide greater insight into his/her
p.000114: previously expressed views and preferences and to outline what they believe the individual would have
p.000114: wanted. In some cases, involvement of those close to the service user will facilitate the service user in reaching a
p.000114: decision in conjunction with health/social care providers.
p.000114:
p.000114:
p.000114: 5.6.2 Emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In emergency situations where a service user is deemed to lack capacity8 consent is not necessary.
p.000114: The health and social care professional may treat the service user provided the treatment is immediately
p.000114: necessary to save their life or to prevent a serious deterioration of their condition and that there is no valid
p.000114: advance refusal of treatment (discussed in 7.9). The treatment provided should be the least restrictive of the
p.000114: service user’s future choices. While it is good practice to inform those close to the service user – and they
...
p.000114: how to proceed.
p.000114: If there is a significant risk of a particular problem arising, the service user should be asked in
p.000114: advance what they would like the health and social care professional to do if the difficulty occurs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 10 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 37
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: It is important that service users understand the scope of any decisions to be made, especially if:
p.000114:
p.000114: • Treatment will be provided in stages, with the possibility that changes or adjustments might be needed
p.000114: • Different professionals will provide particular parts of an investigation or treatment, such as
p.000114: anaesthesia and surgery
p.000114: • A number of different investigations or treatments are involved.
p.000114:
p.000114: The service user should be asked if there are any particular procedures they object to in the context
p.000114: of their proposed treatment and this should be clearly documented on their record. If they agree only to parts of
p.000114: the proposed intervention/treatment, there should be a clear process through which they can be involved in
p.000114: making decisions at a later stage. Those who provide health and social care must not exceed the scope of the
p.000114: authority given by a service user, except in an emergency.
p.000114:
p.000114:
p.000114: 7.2 Who should seek consent from a service user?
p.000114:
p.000114:
p.000114: The person who is providing a particular health and social care service or intervention is ultimately
p.000114: responsible for ensuring that the service user is consenting to what is being done. The task of providing information
p.000114: and seeking consent may be delegated to another professional, as long as that professional is suitably trained and
p.000114: qualified.
p.000114: In particular, they must have sufficient knowledge of the proposed intervention and of the benefits and
p.000114: risks in order to be able to provide the information the service user requires. Inappropriate delegation
p.000114: (for example where the seeking of consent is assigned to a junior health and social care professional with
p.000114: inadequate knowledge of the procedure) may mean that the “consent” obtained is not valid.
p.000114: If different aspects of care are to be provided by different professional disciplines, each should usually obtain
p.000114: consent for their particular intervention.
p.000114:
p.000114:
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p.000114:
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p.000114:
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p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
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p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
...
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
...
p.000114: consent is to ensure that participants have sufficient information to be able to make decisions about research
p.000114: participation which are compatible with their individual interests and values.
p.000114: Special consideration must also be given to the timing of the consent process. Prospective research
p.000114: participants should be given enough time to fully consider their participation and to ask questions.
p.000114:
p.000114:
p.000114:
p.000114: 2. General principles of consent for research
p.000114:
p.000114:
p.000114: 2.1 Content of the information to be provided
p.000114:
p.000114:
p.000114: When preparing consent documentation, researchers must provide all of the information necessary for
p.000114: making an informed decision. Prospective research participants should be provided with the information in the following
p.000114: list, as appropriate. Not all of the listed information will be required for all research. However, in certain
p.000114: circumstances additional information may be required.
p.000114: The proposed information should be submitted to a research ethics committee (REC)25 for a consideration of
p.000114: whether it is adequate to achieve consent.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 25 The Department of Health intends to designate the Health, Information and Quality Authority (HIQA) as
p.000114: the supervisory body for recognising and monitoring REC’s. To this end, HIQA has established a Research
p.000114: Ethics Advisory Group with the aim of preparing national standards for RECs based on best international practice
p.000114: Page 67
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.1.1 Explanation of the research study
p.000114:
p.000114:
p.000114: • The purpose of the study should be explained to research participants. They should be informed
p.000114: of the types of material/data required, the methods used to collect it and how the material/data will be utilised
p.000114: during the course of the study.
p.000114: • Research participants should be told how long their material/data will be retained and how it will be
p.000114: disposed of. They should also be informed how long/often they will be expected to attend the trial centre. Researchers
p.000114: should give a description of any other aspects of the study, e.g. whether questionnaires or diary cards will be used.
p.000114: • Participants should be informed whether or not they will be given feedback e.g. study results or any
p.000114: incidental findings see Section 8) as the study progresses. In instances where the material/data will be anonymous it
p.000114: should be made clear to prospective participants that feedback will not be possible.
...
p.000114:
p.000114: The requirement for consent might be waived in public health emergencies, where a health threat and possible
p.000114: treatments/alleviations must be identified as quickly as possible. For instance, a waiver may be permissible,
p.000114: where a delay caused by the time needed to obtain consent from a person suffering from a new strain of
p.000114: pandemic influenza or other biological, chemical, radiological or nuclear agent, might not only
p.000114: jeopardise his/her health but also the health of others within the population.
p.000114:
p.000114:
p.000114: 6.5 Multi-jurisdictional research
p.000114:
p.000114:
p.000114: When multi-jurisdiction research is being undertaken, additional ethical considerations might arise. While
p.000114: researchers should be cognisant of the local research ethics requirements, they should comply with this
p.000114: policy and act in accordance with Irish legislation.
p.000114: When multi-jurisdictional research is to be conducted, local cultural values should be
p.000114: acknowledged in the design and conduct of the research. Irrespective of cultural traditions, consent must
p.000114: always be given by the prospective research participant. In certain cases it may be appropriate to seek the
p.000114: agreement of a person(s) invested with a certain authority within the community.
p.000114: Researchers must do their utmost to communicate information accurately and in a
p.000114: comprehensible and appropriate way. Where formal written consent from the participant is not possible, the following
p.000114: should be observed:
p.000114: • a community representative trained by the research team should be made available; and
p.000114: • the oral approval should be witnessed by the trained and independent community representative. S/he will
p.000114: verify that the purpose of the research has been explained to the participant and that that the consent was freely
p.000114: given.
p.000114: Researchers should be mindful that in some countries, participating in research may be the only way that individuals
p.000114: can access healthcare and they must ensure that this circumstance does not act as an undue inducement to research
p.000114: participation.
p.000114:
p.000114:
p.000114:
p.000114: Page 84
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6.6 Research involving archival material
p.000114:
p.000114:
p.000114: Researchers may want to use biological material or data that was previously accumulated for clinical
p.000114: purposes or that was collected by other researchers. This raises privacy issues, such as whether the
...
p.002003: Law Reform Commission Report on Advance Care Directives (LRC 94–2009) (available at
p.002003: www.lawreform.ie)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 119
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners (7th Ed) (2009)
p.002003: (available at www.medicalcouncil.ie)
p.002003: Medical Research Council (MRC).MRC Ethics Guide.Medical Research Involving Children (2004).
p.002003:
p.002003: Medical Research Council (MRC).MRC Ethics Guide. Medical Research Involving Adults who cannot Consent (2007)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
p.002003: National Disability Authority, Ethical Guidance for Research with People with Disabilities (October 2009)
p.002003: National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee.
p.002003: National Statement on Ethical Conduct in Human Research (2007)
p.002003: National Health and Medical Research Council (Australia) Biobank Information Paper (2010)
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
p.002003:
p.002003: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.002003: Subjects (1964 – 2008)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 120
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Academic Commentary
p.002003:
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undue influence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 75
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000114: Mental Health Act 2001 (Approved Centres) Regulations 2006(SI 551 of 2006)
p.000114:
p.000114: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
p.000114: medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC,
p.000114: Directive 2001/83/EC and Regulation (EC) No 726/2004.
p.000114: Road Traffic Act 2010
p.000114:
p.000114: UNESCO Universal Declaration on Bioethics and Human Rights 2005 UNESCO International Declaration on Human Genetic Data
p.002003: 2003
p.002003: UNESCO Universal Declaration on the Human Genome and Human Rights 1997 United Nations Convention on the Rights of
p.002003: Persons with Disabilities 2006 United Nations Convention on the Rights of the child 1989
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Reports/Guidance
p.002003:
p.002003: Association of Anaesthetists of Great Britain and Ireland (2009) Do Not Attempt Resuscitation (DNAR)
p.002003: Decisions in the Perioperative Period. Association of Anaesthetists of Great Britain and Ireland, London
p.002003: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and
p.002003: Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for
p.002003: Research Involving Humans (December 2010)
p.002003: Council on Ethical and Judicial Affairs, American Medical Association (1991) CEJA Report D – I-90. Guidelines for the
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 118
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
p.002003: Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector
p.002003: (2007)
p.002003:
p.002003: Department of Children and Youth Affairs, Guidance for Developing Ethical Research Projects Involving
p.002003: Children (2012)
p.002003: Dublin Hospitals Group Risk Management Forum (2010).Matters for consideration regarding Do Not Attempt to Resuscitate
p.002003: Orders for Adult Patients
p.002003: European Union Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric
p.002003: Population (2008)
p.002003: General Medical Council (2010) Treatment and care towards the end of life: good practice in decision
p.002003: making. General Medical Council, London
p.002003: Hospice Friendly Hospitals Programme and the National Council on Ageing and Older People (2008).End-of-Life
p.002003: Care for Older People in Acute and Long-Stay Care Settings in Ireland Joint Statement Dublin
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
p.002003: Pharmaceuticals for human Use. ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
p.002003: International Conference on Harmonisation of technical Requirements for Registration of
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.002003: Mental Health Commission Rules Governing the Use of Electro-Convulsive Therapy (2009) (available at www.mhcirl.ie)
p.002003: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.Belmot
p.002003: Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
p.002003: National Disability Authority, Ethical Guidance for Research with People with Disabilities (October 2009)
p.002003: National Health and Medical Research Council, Australian Research Council, Australian Vice- Chancellors’ Committee.
p.002003: National Statement on Ethical Conduct in Human Research (2007)
p.002003: National Health and Medical Research Council (Australia) Biobank Information Paper (2010)
p.002003:
p.002003: National Institute for Health and Clinical Excellence (NICE).Principles for Best Practice in Clinical Audit (2002)
p.002003: Nuremberg Code Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol.
p.002003: 2, pp. 181-182 (1947)
p.002003: Royal College of Nursing. Informed Consent and Social Care Research. RCB Guidance for Nurses
p.002003: 2nd ed. (2011)
p.002003:
p.002003: University Hospital Bristol NHS, How To: Apply Ethics to Clinical Audit (2009)
p.002003:
p.002003: World Medical Association Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving
p.002003: Subjects (1964 – 2008)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 120
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Academic Commentary
p.002003:
p.002003: Ballard HO, Shook LA, Desai NS, Anand KJS. Neonatal research and the Validity of Informed Consent
p.002003: obtained in the Perinatal Period. Journal of Perniatology (2004), 24(7): p409-415
p.002003: Ballard HO, Shook LA, Locono J, Bernard P, Hayes D. Parents’ Understanding and Recall of Informed
p.002003: Consent Information for Neonatal Research. IRB: Ethics & Human Research (May-June 2011), p12-19
p.002003: Beach MC and Morrison RS (2002).The Effect of Do-Not-Resuscitate Orders on Physician Decision- Making.Journal of the
p.002003: American Geriatrics Society 50(12): 2057-2061
p.002003: Brazier and Cave Medicine, Patients and the Law (Penguin, 2007)
p.002003:
p.002003: British Medical Association, Resuscitation Council (UK) and Royal College of Nursing
p.002003: (2007).Decisions relating to cardiopulmonary resuscitation: A joint statement from the British Medical
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000114: Re T (adult: refusal of treatment) [1992] 3 WLR 782
p.000114:
p.000114: Re Y (Mental Patient: Bone Marrow Donation) [1997] Fam 110 Schloendorff v Society of New York Hospital (1914) 211 N.Y.
p.000114: 125: S v HSE [2009] IEHC 106
p.000114: St George's Healthcare NHS Trust v S; R v Collins and others, ex parte S [1998] 3 WLR 936
p.000114:
p.000114: Storck v Germany [2005] ECHR 406
p.000114:
p.000114: Tysiac v Poland [2007] 45 EHRR 42
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 116
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Bibliography
p.000114:
p.000114:
p.000114: Legislation/Conventions/Treaties
p.000114:
p.000114: Bunreacht na hEireann/Constitution of Ireland 1937
p.000114:
p.000114: Charter of Fundamental Rights of the European Union (2000)
p.000114:
p.000114: Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical
p.000114: practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of
p.000114: the manufacturing or importation of such products.
p.000114: Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the
p.000114: Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo (1997)
p.000114: Council of Europe Additional Protocol to the Convention of Human Rights and Biomedicine Concerning
p.000114: Biomedical Research (2005)
p.000114: Data Protection Act (1988)
p.000114:
p.000114: Data Protection (Amendment) Act (2003)
p.000114:
p.000114: European Commission, Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the
p.000114: approximation of the laws, regulations and administrative provisions of the Member States relating to the
p.000114: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
p.000114: European Commission, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
p.000114: Community code relating to medicinal products for human use
p.000114: European Commission, Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
p.000114: protection of individuals with regard to the processing of personal data and on the free movement of such data
p.000114: European Commission, Proposal for a Regulation of the European Parliament and of the Council on clinical trials on
p.000114: medicinal products for human use, and repealing Directive 2001/20/EC. 17th July 2012
p.000114: European Convention on Human Rights and Fundamental Freedoms 1953 Health Act 1947
p.000114:
p.000114:
p.000114: Page 117
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(return to top)
p.000114:
p.000114:
p.000114: Page 117
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Bibliography
p.000114:
p.000114:
p.000114: Mental Health Act 2001
p.000114:
p.000114: Mental Health Act 2001 (Approved Centres) Regulations 2006(SI 551 of 2006)
p.000114:
p.000114: Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on
p.000114: medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC,
p.000114: Directive 2001/83/EC and Regulation (EC) No 726/2004.
p.000114: Road Traffic Act 2010
p.000114:
p.000114: UNESCO Universal Declaration on Bioethics and Human Rights 2005 UNESCO International Declaration on Human Genetic Data
p.002003: 2003
p.002003: UNESCO Universal Declaration on the Human Genome and Human Rights 1997 United Nations Convention on the Rights of
p.002003: Persons with Disabilities 2006 United Nations Convention on the Rights of the child 1989
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Reports/Guidance
p.002003:
p.002003: Association of Anaesthetists of Great Britain and Ireland (2009) Do Not Attempt Resuscitation (DNAR)
p.002003: Decisions in the Perioperative Period. Association of Anaesthetists of Great Britain and Ireland, London
p.002003: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and
p.002003: Social Sciences and Humanities Research Council of Canada Tri-Council Policy Statement: Ethical Conduct for
p.002003: Research Involving Humans (December 2010)
p.002003: Council on Ethical and Judicial Affairs, American Medical Association (1991) CEJA Report D – I-90. Guidelines for the
p.002003: Appropriate Use of Do-Not-Resuscitate Orders.Journal of the American Medical Association 265(14): 1868-1871
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical
p.002003: Research Involving Human Subjects (2002)
p.002003:
p.002003:
p.002003:
p.002003:
p.002003: Page 118
p.002003:
p.002003: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.002003: validation against the controlled version
p.002003:
p.002003: National Consent Policy HSE V.1.3
p.002003:
p.002003:
p.002003: Bibliography
p.002003:
p.002003:
p.002003: Council for International Organizations of Medical Sciences (CIOMS) International Guidelines for Epidemiological
p.002003: Studies (2008)
p.002003: Data Protection Commissioner, Data Protection Guidelines on Research in the Health Sector
p.002003: (2007)
p.002003:
p.002003: Department of Children and Youth Affairs, Guidance for Developing Ethical Research Projects Involving
p.002003: Children (2012)
...
Orphaned Trigger Words
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Revision Date: Contact Details:
p.000011: National Consent Policy V1 (2013)
p.000011:
p.000011: Text added to Part 2 Children and Minors Page 49—2 Role of Parent(s) and Legal Guardian(s)
p.000011: Text changed on Part 2 Children and Minors Page 49—2.1 What is legal guardianship?
p.000011: Text added to Part 1, General Principles, Section 3.5 Consent and pregnancy.
p.000011: Text deleted to Part 1, General Principles, Section 7.7.1 Refusal of treatment in pregnancy.
p.000011: Text added to Part 1, General Principles, Section 7.10 Refusal of treatment in pregnancy.
p.000011: May 2016, June 2019 Marie Tighe
p.000011: Project Manager- Consent
p.000011: HSE National Office for Assisted Decision Making and Consent
p.000011: Email: marie.tighe1@hse.ie
p.000011:
p.000011: Web: www.hse.ie
p.000011:
p.000011:
p.000011: ISBN: 978-1-906218-63-8
p.000011:
p.000011:
p.000011:
p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011:
p.000011: Acknowledgement
p.000011:
p.000011: I would like to acknowledge the hard work, guidance and patience of the members of the National Consent
p.000011: Advisory Group and our sub-groups whose expertise and experience was critical to the development of this
p.000011: Policy.
p.000011: I would also like to express my sincere thanks to Angela Hughes and Larraine Gilligan of the Quality
p.000011: and Patient Safety Division of the HSE for their hard work, diligence, and support in ensuring the
p.000011: completion of the policy and supporting documentation. I am also grateful to Dr Philip Crowley, John Kenny
p.000011: and Wini Ryan for their help and support during this project.
p.000011: Finally sincere thanks to all of the staff, service users and members of the public who made
p.000011: submissions during the consultation phase of this work and who were significant stakeholders in the development of this
p.000011: Policy.
p.000011: Dr Deirdre Madden
p.000011:
p.000011: Chair, National Consent Advisory Group.
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
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p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011:
p.000011: Page 3
p.000011:
p.000011: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000011: validation against the controlled version
p.000011:
p.000011: National Consent Policy HSE V.1.3
p.000011:
p.000011:
p.000011: Table of contents
p.000011:
p.000011:
p.000011: Page
p.000011: Glossary
p.000011: 11
p.000011: Part One – General Principles 19
p.000011: 1. Introduction
p.000020: 20
p.000020: 1.1 Scope of this policy
p.000020: 20
p.000020: 1.2 Ethical issues regarding consent
p.000020: 20
p.000020: 1.3 Health and social care decision-making
p.000021: 21
p.000021: 1.4 Consent in Irish law
p.000021: 21
p.000021: 1.5 Age of consent in Irish law
p.000022: 22
p.000022: 2. What is valid and genuine consent? 23
p.000022: 3. Providing information and discussing treatment options 23
p.000022: 3.1 Importance of individual circumstances
p.000024: 24
p.000024: 3.2 What information should be provided about interventions? 24
p.000024: 3.3 What information about risks and side effects of an intervention should be 25
p.000024: provided?
p.000024: 3.4 How and when information should be provided 26
p.000024: 3.4.1 Service users with limited English proficiency 27
p.000024: 3.4.2 Deaf and hard of hearing service users 28
p.000024: 3.4.3 Blind and visuallyXimpaired service users 28
p.000024: 3.5 Consent and Pregnancy
p.000028: 28
p.000028: 4. Ensuring consent is voluntary
p.000029: 29
p.000029: 5. Has the service user capacity to make the decision? 30
p.000029: 5.1 General principles
p.000030: 30
p.000030: Page 4
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p.000030: validation against the controlled version
p.000030:
p.000030: National Consent Policy HSE V.1.3
p.000030: Table of contents
p.000030: Page
p.000030: 5.2 Duty to maximise capacity
p.000030: 30
p.000030: 5.3 Presumption of capacity
p.000031: 31
p.000031: 5.4 When to consider incapacity
p.000032: 32
p.000032: 5.5 Assessing capacity to consent
p.000032: 32
p.000032: 5.6 Making decisions if capacity is absent
p.000033: 33
p.000033: 5.6.1 Role of the family
p.000034: 34
p.000034: 5.6.2 Emergency situations involving service users who lack capacity 34
p.000034: 5.6.3 Non-emergency situations involving service users who lack capacity 35
p.000034: 5.7 Wards of court
p.000035: 35
p.000035: 6. Is it always necessary to seek consent from a service user? 36
p.000035: 6.1 Emergency situations
p.000036: 36
p.000036: 6.2 Where the service user declines information
p.000036: 36
p.000036: 7. Specific issues relating consent
p.000037: 37
p.000037: 7.1 Scope of consent
p.000037: 37
p.000037: 7.2 Who should seek consent from a service user?
p.000038: 38
p.000038: 7.3 When should consent be sought?
p.000039: 39
p.000039: 7.4 Types of consent
p.000039: 39
p.000039: 7.5 How should consent be documented?
p.000040: 40
p.000040: 7.6 Confidentiality and data protection
p.000041: 41
p.000041: 7.7 When consent is refused
p.000042: 42
p.000042: 7.7.1 Refusal of isolation for infectious disease 42
p.000042: Page 5
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p.000042: validation against the controlled version
p.000042:
p.000042: National Consent Policy HSE V.1.3
p.000042: Table of contents
p.000042: Page
p.000042: 7.7.2 Refusal of treatment by a service user involuntarily admitted under the 43 Mental Health Act 2001
p.000042: 7.7.3 Refusal of the taking of blood and urine samples for the purposes of 43
p.000042: Garda investigations into driving under the influence of alcohol and /or drugs
p.000042: 7.8 Advanced refusal of treatment
p.000044: 44
p.000044: 7.9 Withdrawal of consent
p.000045: 45
p.000045: 7.10 Refusal of treatment in pregnancy
p.000045: 45
p.000045: Part Two – Children and Minors 47
p.000045: 1. Introduction
p.000048: 48
p.000048: 2. Role of parent(s) and legal guardian(s) 49
p.000048: 2.1 What is legal guardianship?
p.000049: 49
p.000049: 2.2 Who can give consent for a child?
p.000050: 50
p.000050: 3. Age of consent
p.000052: 52
p.000052: 3.1 Confidentiality and the minor
p.000055: 55
p.000055: 4. Refusal of health or social care services by children and minors 55
p.000055: 5. Refusal of treatment or social care intervention by a person between 56
p.000055: 16 and 18 years
p.000055: 6. Refusal of health and social care intervention by parent(s)/ legal 57
p.000055: guardian(s)
p.000055:
p.000055:
p.000055:
p.000055:
p.000055:
p.000055: Page 6
p.000055:
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p.000055: validation against the controlled version
p.000055:
p.000055: National Consent Policy HSE V.1.3
p.000055:
p.000055:
p.000055: Table of contents
p.000055:
p.000055:
p.000055: Page
p.000055: 7. The minor parent
p.000058: 58
p.000058: 8. Children in the care of the HSE
p.000058: 58
p.000058: 9. Mental health services
p.000060: 60
p.000060: 10. Sexual health services
p.000061: 61
p.000061: Part Three – Research
p.000065: 65
p.000065: 1. Introduction
p.000066: 66
p.000066: 2. General principles of consent for research 67
p.000066: 2.1 Content of the information to be provided
p.000067: 67
p.000067: 2.1.1 Explanation of the research study
p.000068: 68
p.000068: 2.1.2 Explanation of the risks and benefits
p.000068: 68
p.000068: 2.1.3 Confidentiality
p.000069: 69
p.000069: 2.1.4 Commercialisation
p.000069: 69
p.000069: 2.2 Who should seek consent?
p.000071: 71
p.000071: 2.3 How should consent be documented?
p.000071: 71
p.000071: 3. Children
p.000072: 72
p.000072: 3.1 Healthy children as participants
p.000075: 75
p.000075: 3.2 Children in care
p.000075: 75
p.000075: 3.3 Neonates
p.000075: 75
p.000075: 4. Adults lacking decision-making capacity and consent for research 76
p.000075: Page 7
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p.000075: validation against the controlled version
p.000075:
p.000075: National Consent Policy HSE V.1.3
p.000075: Table of contents
p.000075: Page
p.000075: 5. Vulnerable research participants
p.000078: 78
p.000078: 5.1 Research in emergency situations
p.000078: 78
p.000078: 5.2 People highly dependent on medical care
p.000079: 79
p.000079: 5.3 People in dependent or unequal relationships
p.000080: 80
p.000080: 6. Categories of research
p.000081: 81
p.000081: 6.1 Genetic research
p.000081: 81
p.000081: 6.2 Epidemiological research
p.000082: 82
p.000082: 6.3 Covert research
p.000083: 83
p.000083: 6.4 Research in public health emergencies
p.000084: 84
p.000084: 6.5 Multi-jurisdictional research
p.000084: 84
p.000084: 6.6 Research involving archival material
p.000085: 85
p.000085: 6.7 Research involving deceased people
p.000086: 86
p.000086: 7. Consent for future uses
p.000086: 86
p.000086: 8. Consent and incidental findings
p.000088: 88
p.000088: 9. Consent and controlling access to data 89
p.000088: 10. Withdrawal of consent
p.000090: 90
p.000090: 11. Reconsent
p.000091: 91
p.000091: 12. Research where consent may not be required 91
p.000091:
p.000091:
p.000091:
p.000091:
p.000091:
p.000091: Page 8
p.000091:
p.000091:
p.000091: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000091: validation against the controlled version
p.000091:
p.000091: National Consent Policy HSE V.1.3
p.000091:
p.000091:
p.000091: Table of contents
p.000091:
p.000091:
p.000091: Page
p.000091: 13. Remuneration of research participants 92
p.000091: 13.1 Reimbursement
p.000092: 92
p.000092: 13.2 Payment
p.000093: 93
p.000093: 14. Audit
p.000093: 93
p.000093: Part Four – Do Not Attempt Resuscitation (DNAR) 97
p.000093: 1. Introduction
p.000098: 98
p.000098: 2. Definition and scope of resuscitation decisions 99
p.000098: 2.1 Do not attempt resuscitation or do not resuscitate
p.000099: 99
p.000099: 2.2 Scope of DNAR orders
p.000099: 99
p.000099: 3. General principles
p.000100: 100
p.000100: 3.1 Need for individual decision making
p.000100: 100
p.000100: 3.2 Involving the individual in discussions regarding CPR
p.000101: 101
p.000101: 3.3 Involving family or friends in discussions regarding CPR 101
p.000101: 3.4 Decision-making capacity
p.000102: 102
p.000102: 3.5 Provision of information
p.000102: 102
p.000102: 3.6 Decision-making regarding CPR and DNAR orders 102
p.000102: 4. When should CPR and DNAR decisions be considered? 103
p.000102: 4.1 Cardiorespiratory arrest is considered unlikely
p.000103: 103
p.000103: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable 104
p.000103: 4.3 Cardiorespiratory arrest is considered possible or likely 104
p.000103: Page 9
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p.000103: validation against the controlled version
p.000103:
p.000103: National Consent Policy HSE V.1.3
p.000103: Table of contents
p.000103: Page
p.000103: 5. Presumption in favour of providing CPR 105
p.000103: 6. Balancing the benefits and risks of providing CPR 106
p.000103: 6.1 Respecting an individual’s refusal of CPR
p.000108: 108
p.000108: 6.2 When the balance between risk and benefit is uncertain 108
p.000108: 6.3 When the risks outweigh the benefits
p.000108: 108
p.000108: 6.4 When there is disagreement about the balance of benefits and risks of CPR 109
p.000108: 6.5 Where an individual does not want to discuss CPR and DNAR orders 109
p.000108: 6.6 DNAR orders and readily reversible cardiorespiratory arrests 110
p.000108: 7. DNAR decisions and children
p.000110: 110
p.000110: 8. Documenting and communicating CPR/DNAR decisions 112
p.000110: 9. Reviewing DNAR orders
p.000113: 113
p.000113:
p.000113:
p.000113:
p.000113: Bibliography
p.000114: 114
p.000114:
p.000114:
p.000114:
p.000114: National Consent Advisory Group Membership 124
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 10
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Adoption
p.000114: Adoption in Ireland provides for the permanent transfer of parental rights and duties from the birth parents to the
p.000114: adoptive parents. An adopted child is considered to be the child of the adopters as if born to them in lawful wedlock.
p.000114:
p.000114:
p.000114: Adult
p.000114: A person over the age of 18 years.
p.000114:
p.000114:
p.000114: Advance care planning
p.000114: A process of discussion between a service user and his/her care providers about future medical and social
p.000114: care preferences in the event that the service user is unable to speak for him/herself due to an emergency or serious
p.000114: illness.
p.000114:
p.000114:
p.000114: Advance healthcare directive
p.000114: A statement made by a service user with decision-making capacity relating to the type and extent of
p.000114: healthcare interventions he/she would or would not want to undergo in the event that the service user is unable to
p.000114: speak for him/herself due to an emergency or serious illness.
p.000114:
p.000114:
p.000114: Advocate
p.000114: An advocate refers to an individual tasked with empowering and promoting the interests of people by supporting them
p.000114: to assert their views and claim their entitlements and, where necessary, representing and negotiating on their
p.000114: behalf.
p.000114:
p.000114:
p.000114: Anonymous data
p.000114: Data collected without identifiers such as name, address or date of birth and that can never be linked to an
p.000114: individual.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 11
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Approved centre
p.000114: A hospital or inpatient service that is registered by the Mental Health Commission.
p.000114:
p.000114:
p.000114: Assent
p.000114: An expression of willingness or affirmative agreement to a health or social care intervention given by a young
p.000114: person who is not legally authorised or has insufficient understanding to be competent to give full consent.
p.000114: The assent procedure should reflect a reasonable effort to enable the child to understand, to the degree they are
p.000114: capable, what their agreement would involve.
p.000114:
p.000114:
p.000114: Autonomy
p.000114: The capacity to make decisions and take actions that are in keeping with one’s values and beliefs.
p.000114:
p.000114:
p.000114: Bioethics
p.000114: A multidisciplinary activity dealing with the ethical implications of biological research and medicine.
p.000114:
p.000114:
p.000114: Biobank
p.000114: A centralised archive of human biological material from which materials are made available for research purposes.
p.000114:
p.000114:
p.000114: Capacity
p.000114: The ability to understand the nature and consequences of a decision in the context of available choices at the time the
p.000114: decision is to be made.
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR)
p.000114: Cardiopulmonary resuscitation (CPR) is an attempt to restore breathing (sometimes with support) and spontaneous
p.000114: circulation in an individual in cardiorespiratory arrest. CPR usually includes chest compressions,
p.000114: attempted defibrillation with electric shocks, injection of drugs and ventilation of the lungs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 12
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Cardiorespiratory arrest
p.000114: Cardiac arrest is the cessation of cardiac contraction. Respiratory arrest is the cessation of effective
p.000114: oxygenation and ventilation. Cardiorespiratory arrest is a combination of cardiac and respiratory arrest.
p.000114:
p.000114:
p.000114: Child
p.000114: A person under the age of 18 years, unless that person has attained full age through marriage.
p.000114:
p.000114:
p.000114: Coercion/Duress
p.000114: Forcing someone to behave in a particular way by use of threats or intimidation or some other form of pressure or
p.000114: force.
p.000114:
p.000114:
p.000114: Consent
p.000114: Consent is the giving of permission or agreement for an intervention, receipt or use of a service or participation in
p.000114: research following a process of communication in which the service user has received sufficient
p.000114: information to enable him/her to understand the nature, potential risks and benefits of the proposed intervention or
p.000114: service.
p.000114:
p.000114:
p.000114: Data controller
p.000114: Data controller refers to a person who, either alone or with others, controls the contents and use of personal data.
p.000114:
p.000114:
p.000114: Data processor
p.000114: Data processor refers to a person who processes personal data on behalf of a data controller but does not include an
p.000114: employee of a data controller who processes such data in the course of his/ her employment.
p.000114:
p.000114:
p.000114: Data subject
p.000114: Data subject refers to an individual who is the subject of personal data.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 13
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: De-identified data
p.000114: Data are separated from personal identifiers, for example, through the use of a link e.g. a code.
p.000114: Access to the link is strictly controlled. As long as a link exists, data are considered indirectly
p.000114: identifiable as opposed to being anonymous.
p.000114:
p.000114:
p.000114: Do not attempt resuscitation (DNAR) order
p.000114: A do not attempt resuscitation (DNAR) order is a written order stating that resuscitation should not be attempted if an
p.000114: individual suffers a cardiac or respiratory arrest.
p.000114:
p.000114:
p.000114: Family
p.000114: May include the immediate biological family and/or other relatives, spouses, partners (including civil, same sex and de
p.000114: facto partners).
p.000114:
p.000114:
p.000114: Foster care
p.000114: Foster care is caring for someone else's child in one's own home – providing family life for a child who, for one
p.000114: reason or another, cannot live with his or her own parents, either on a short or a long term basis.
p.000114:
p.000114:
p.000114: Health and social care professional
p.000114: Health and social care professional is generally used as an umbrella term to cover all the various
p.000114: health and social care staff who have a designated responsibility and authority to obtain consent from
p.000114: service users prior to an intervention. These include doctors, dentists, psychologists, nurses, allied health
p.000114: professionals, social workers.
p.000114:
p.000114:
p.000114: Interpreter
p.000114: A person who facilitates communication between users of different languages by use of oral translation or sign-language
p.000114: methods, either simultaneously or consecutively.
p.000114:
p.000114:
p.000114: Intervention
p.000114: The provision of treatment or investigation, whether physical or psychological, or personal or social care for a
p.000114: service user or the involvement of a service user in teaching and research.
p.000114:
p.000114: Page 14
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Glossary
p.000114:
p.000114:
p.000114: Legal guardian
p.000114: A person with formal rights and responsibilities in respect of someone who lacks legal capacity.
p.000114:
p.000114:
p.000114: Legal representative
p.000114: In the context of a clinical trial, a legal representative is a person not connected with the conduct of the trial
p.000114: who by virtue of his/her family relationship with an adult lacking decision-making capacity, is suitable to
p.000114: act as the legal representative and is willing and able to do so or (if there is no such individual) a person who is
p.000114: not connected with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114:
p.000114:
p.000114: Major procedure
p.000114: A significant healthcare intervention, usually complex and high-risk.
p.000114:
p.000114:
p.000114: Minor
p.000114: A person who is less than 18 years of age, who is not or has not been married.
p.000114:
p.000114:
p.000114: Personal data
p.000114: Data relating to a living individual who is or can be identified either from the data or from the data in conjunction
p.000114: with other information that is in, or is likely to come into, the possession of the data controller.
p.000114:
p.000114:
p.000114: Reasonable person
...
p.000114: keeping with relevant HSE codes of conduct1. Knowledge of the importance of obtaining consent is expected
p.000114: of all staff employed or contracted by the HSE.
p.000114:
p.000114:
p.000114: 1.2 Ethical issues regarding consent
p.000114:
p.000114:
p.000114: The ethical rationale behind the importance of consent is the need to respect the service user’s right to
p.000114: self-determination (or autonomy) – their right to control their own life and to decide what happens to
p.000114: their own body.
p.000114:
p.000114:
p.000114:
p.000114: 1 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 20
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Those providing health and social care can often claim greater expertise in decisions regarding the ‘means’ to
p.000114: achieve the ‘end’ of better health, such as what medication will best treat blood pressure or whether admission to
p.000114: long-term care is advisable, although service users retain ultimate decision-making authority and must consent
p.000114: to the intervention.
p.000114: Service users are the experts in determining what ‘ends’ matter to them, including how they should live
p.000114: their everyday lives, decisions about risk-taking and preference for privacy or non- interference. With rare
p.000114: exceptions, the competent service user’s right to refuse an intervention applies even when their decision seems unwise
p.000114: to the health and social care professional.
p.000114: While respect for autonomy is very important, it is not the only ethical principle relevant to consent.
p.000114: Health and social care professionals also have a responsibility to try and maximise the health and well-being of, and
p.000114: to minimise harm to, service users and others. They also have an obligation to ensure the fair and appropriate
p.000114: use of resources. This means that service users (whether contemporaneously or in an advance healthcare
p.000114: directive) cannot demand whatever interventions they want, regardless of their effectiveness.
p.000114:
p.000114:
p.000114: 1.3 Health and social care decision-making
p.000114:
p.000114:
p.000114: The relationship between those who provide health and social care and the service user should be a partnership based
p.000114: on openness, trust and good communication. Almost every health and social care intervention involves decisions
p.000114: made by service users and those providing theircare.
p.000114: Good decision making requires a dialogue between parties that recognises and acknowledges the service user’s goals,
p.000114: values and preferences as well as the specialist knowledge, experience and clinical judgment of health and social care
p.000114: professionals.
p.000114:
p.000114:
p.000114: 1.4 Consent in Irish law
p.000114:
p.000114:
p.000114: It is a basic rule at common law that consent must be obtained for medical examination, treatment,
p.000114: service or investigation. This is well established in Irish case law and ethical standards. The requirement for consent
p.000114: is also recognised in international and European human rights law and under the Irish Constitution.
p.000114:
p.000114:
p.000114:
p.000114: Page 21
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: Therefore, other than in exceptional circumstances2, treating service users without their consent is a violation of
p.000114: their legal and constitutional rights and may result in civil or criminal proceedings being taken by the service user.
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service3 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so4.
p.000114: Health and social care professionals have a responsibility to keep themselves informed of professional
p.000114: standards relevant to obtaining consent in their practice. Likewise, the employer or service provider has a
p.000114: responsibility to staff to provide access to legal information which may have a bearing on the service
p.000114: provided.
p.000114:
p.000114:
p.000114: 1.5 Age of consent in Irish law
p.000114:
p.000114:
p.000114: The age of consent in Ireland is outlined in the following Acts:
p.000114:
p.000114: • The Non-Fatal Offences against the Persons Act, 1997 states that persons over the age of 16 years can give
p.000114: consent for surgical, medical and dental procedures.
p.000114: • The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a “child”
...
p.000114:
p.000114: • The nature of their condition.
p.000114:
p.000114:
p.000114: 3.2 What information should be provided about interventions?
p.000114:
p.000114:
p.000114: The amount of information to be provided about an intervention will depend on the urgency, complexity,
p.000114: nature and level of risk associated with the intervention.
p.000114: Choosing whether to undergo or to forego medical investigation and treatment or whether to agree or not to
p.000114: a major lifestyle change such as admission to residential care often requires the service user to balance the
p.000114: potential risks and benefits of both approaches. In these circumstances, service users need adequate
p.000114: information about:
p.000114: • Their diagnosis and prognosis including any uncertainties about the diagnosis or prognosis
p.000114: • Options for treating or managing the condition, including the option not to treat
p.000114: • The purpose of any proposed intervention and what it will involve
p.000114: • The potential benefits, risks and the likelihood of success of a proposed intervention, as well as that
p.000114: of any available alternative
p.000114: • Whether a proposed investigation or treatment is experimental or part of a research project
p.000114: • If relevant, that costs will have to be paid and how and where information about these costs may be
p.000114: obtained.
p.000114:
p.000114:
p.000114: Page 24
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: By contrast, the nature and effect of some interventions, such as removal of a dressing or provision of
p.000114: assisted personal care in the home, are often self-evident and relatively risk-free. In these circumstances, it is
p.000114: usually enough for staff to seek consent to proceed after a brief description of the intervention.
p.000114: Refusal of permission, especially if it may be harmful to the service user or a request for additional
p.000114: information should trigger additional discussion.
p.000114: Although service users may be provided with standardised informational material, they should be told if their
p.000114: particular circumstances might modify the risks or benefits as stated in such material.
p.000114: Service users should be asked if they have understood the information they have been given, and whether or not they
p.000114: would like more information before making a decision. Questions should be answered honestly and, as far as practical,
p.000114: as fully as the service users wishes.
p.000114:
p.000114:
p.000114: 3.3 What information about risks and side effects of an intervention should be provided?
p.000114:
p.000114:
p.000114: The amount of information about risk that staff should share with service users will depend on the individual service
p.000114: user and what they want or need to know. Although most service users will be aware that no physical procedure or
p.000114: medication is entirely risk free, they may not be as familiar with the potential risks of common
p.000114: procedures such as the administration of blood products or radiographic procedures. Factors such as service
p.000114: users’ occupations or lifestyles may influence those risks that they consider significant or particularly undesirable.
p.000114: A general rule is to provide information that a reasonable person in the service user’s situation would expect to be
p.000114: told. This is in line with ethical and professional standards as well as the legal standard applied by the Irish
p.000114: courts. Such information includes the likelihood of:
p.000114: • side effects or complications of an intervention;
p.000114:
p.000114: • failure of an intervention to achieve the desired aim; and
p.000114:
p.000114: • the risks associated with taking no action or with taking an alternative approach.
p.000114:
p.000114: A risk may be seen as material/significant if a reasonable person in the patient's position if warned of
p.000114: the risk would attach significance to it. Such risks must be disclosed to the patient.
p.000114: Page 25
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Thus, common, even if minor, side effects should be disclosed as should rare but serious adverse outcomes. The latter
p.000114: include death, permanent disability (such as paralysis or blindness), permanent disfigurement and chronic
p.000114: pain.
p.000114:
p.000114: Information about risk should be given in a balanced way. Service users may understand information about
p.000114: risk differently from those providing health and social care. This is particularly true when using descriptive terms
p.000114: such as ‘often’ or ‘uncommon’. Potential biases related to how risks are ‘framed’ are important: a 1 in a thousand risk
p.000114: of a complication also means that 999 out of a thousand service users will not experience that complication.
p.000114: In order to best support service users in assessing the risks and benefits of various interventions/ course of action
p.000114: consideration should be given to:
p.000114: • Designing and employing communications that use plain language
p.000114:
p.000114:
p.000114: • Avoid explaining risks in purely descriptive terms (such as low risk), try to supplement with numerical
p.000114: data
p.000114: • Use absolute numbers or percentages; avoid using relative risk or percentage improvements
p.000114: • Use visual aids e.g. pictographs wherever possible, to maximise understanding.
p.000114:
p.000114:
p.000114: 3.4 How and when information should be provided
p.000114:
p.000114:
p.000114: The manner in which the health and social care options are discussed with a service user is as important as the
p.000114: information itself. The following measures are often helpful:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information. Sensitive issues should be discussed in an appropriate location to ensure that the service
p.000114: user’s privacy is protected to the greatest degree possible in the circumstances.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 26
p.000114: • Providing adequate time and support, including, if necessary, repeating information
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: • Use of simple, clear and concise English and avoidance of medical terminology
p.000114:
p.000114: • Supplementing written or verbal information with visual depictions, e.g. pictures
p.000114:
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations.
p.000114:
p.000114:
p.000114: Service users should be given the time and support they need to maximise their ability to make decisions for
p.000114: themselves. It is particularly important to ensure this is the case for those with limited literacy
p.000114: skills and those who may have difficulty making decisions including those with communication difficulties,
p.000114: intellectual disability or cognitive impairment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of communication
p.000114: difficulties, intellectual disability or cognitive impairment.
p.000114: For those with communication difficulties, speaking to those close to the service user and to other
p.000114: health and social care staff about the best ways of communicating with the service user, taking account of
p.000114: confidentiality issues, may be helpful.
p.000114: Additional measures may be required in specific circumstances:
p.000114:
p.000114:
p.000114: 3.4.1 Service users with limited English language proficiency
p.000114:
p.000114:
p.000114: Except in emergency situations, an interpreter proficient in the service user’s language is required to facilitate the
p.000114: service user giving consent for interventions that may have a significant impact on his or her health and
p.000114: well-being. Where practicable, this is best achieved in most cases by using a professional interpreter.
p.000114: The use of family (in particular of minor children) and friends should be avoided if at all possible.
p.000114: Additional time will always be required for discussions involving an interpreter, and this should be planned for in
p.000114: advance5.
p.000114:
p.000114:
p.000114:
p.000114: 5 On Speaking Terms: Good Practice Guidelines for HSE Staff in the Provision of Interpreting Services (2009)
p.000114:
p.000114: Page 27
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 3.4.2 Deaf and hard of hearing service users
p.000114:
p.000114:
p.000114: Deaf and hard of hearing service users should be asked how they would like information to be provided. Some individuals
p.000114: with impaired hearing can lip read, some use hearing aids and others
p.000114:
p.000114: may require sign language interpreters. Information can also be made more accessible using text and email applications.
p.000114: If required, a sign language interpreter should be obtained. In relation to the use of children, family and friends as
p.000114: interpreters see section above.
p.000114:
p.000114:
p.000114: 3.4.3 Blind and visuallyXimpaired service users
p.000114:
p.000114:
p.000114: People with a visual impairment should be asked how they would like information to be provided. There are
p.000114: a range of formats that can be used to make written information accessible to people with visual impairments.
p.000114: These include large print, Braille, writing in thick black marker pen and use of audio information. Information can
p.000114: also be made more accessible using text and email applications.
p.000114:
p.000114:
p.000114: 3.5 Consent and Pregnancy
p.000114:
p.000114: Service users who are pregnant must have received sufficient information in a manner that is
p.000114: comprehensible to them about the nature, purpose, benefits and risks of an intervention or lack thereof on their health
p.000114: and life.
p.000114:
p.000114: Service users who are pregnant will need to receive sufficient information about the benefits and risks of an
p.000114: intervention or lack thereof on the viability and health of a foetus as defined below. They will also need sufficient
p.000114: information on the benefits and risks of an intervention or failure to intervene on the viability and health of the
p.000114: child that will be delivered.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 28
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: The Health (Regulation of Termination of Pregnancy) Act 2018 defines as follows: “foetus in relation to
p.000114: pregnancy, means an embryo or a foetus during the period of time commencing after implantation in the uterus of a woman
p.000114: and ending on the complete emergence of the foetus from the body of the woman”.
p.000114:
p.000114:
p.000114: 4. Ensuring consent is voluntary
p.000114:
p.000114:
p.000114: For consent to be valid the service user must not be acting under duress and their agreement should be given
p.000114: freely, in other words they must understand that they have a choice. Use of threats to induce consent
p.000114: such as withdrawal of any privileges is not acceptable.
p.000114: Duress refers to pressures or threats imposed by others. However, this is distinct from the pressures
p.000114: that illness itself can impose on service users, who may feel they have little choice regarding treatment
p.000114: as a result. Also, duress should be distinguished from providing the service user, when appropriate, with strong
p.000114: recommendations regarding a particular treatment or lifestyle issue or from pointing out the likely consequences
p.000114: of choices the service user may make on their health or treatment options.
p.000114: Service users may also be subject to pressure from family and friends to accept or reject a particular
p.000114: intervention, such as, for example, to enter a nursingXhome if they are perceived to be at risk of harm at home. Staff
p.000114: should take particular care in these circumstances to ensure as far as practical that the service user’s decision has
p.000114: not been made under undue pressure and may need to meet the service user alone so that ultimately he or she makes their
p.000114: own decision.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 29
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5. Has the service user the capacity to make the decision?
p.000114:
p.000114:
p.000114: 5.1 General principles
p.000114:
p.000114:
p.000114: Best practice favours a ‘functional’ or decision-specific approach to defining decision-making capacity: that
p.000114: capacity is to be judged in relation to a particular decision to be made, at the time it is to be made - in other words
p.000114: it should be issue specific and time specific – and depends upon the ability of an individual to comprehend,
p.000114: reason with and express a choice with regard to information about the specific decision. The “functional”
p.000114: approach recognises that there is a hierarchy of complexity in decisions and also that cognitive
p.000114: deficits are only relevant if they actually impact on decision making.
p.000114:
p.000114:
p.000114: 5.2 Duty to maximise capacity
p.000114:
p.000114:
p.000114: Best practice and international human rights standards favour “supported decision-making” where possible. This
p.000114: requires that efforts must be made to support individuals in making decisions for themselves where this is possible. A
p.000114: service user’s ability to make decisions may depend on the nature and severity of their condition, or the
p.000114: difficulty or complexity of the decision. Some service users will always be able to make simple decisions, but may
p.000114: have difficulty if the decision is complex or involves a number of options. Other service users may be able to make
p.000114: decisions at certain times but not at other times, because of fluctuations in their condition or because factors such
p.000114: as confusion, panic, shock, fatigue, pain or medication temporarily affect their ability to understand,
p.000114: retain or weigh up information, or communicate their wishes.
p.000114:
p.000114:
p.000114: It is important to give those who may have difficulty making decisions the time and support they need to maximise their
p.000114: ability to make decisions for themselves.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 30
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: Approaches that may be helpful in this regard include:
p.000114:
p.000114: • Discussing treatment options in a place and at a time when the service user is best able to understand and
p.000114: retain the information
p.000114: • Asking the service user if there is anything that would help them remember information, or
p.000114: make it easier to make a decision; such as bringing a relative, partner, friend, carer or advocate to
p.000114: consultations, or having written or audio information about their condition
p.000114: • Speak to those close to the service user and to other health and social care staff about the best ways
p.000114: of communicating with the service user, taking account of confidentiality issues.
p.000114:
p.000114:
p.000114: 5.3 Presumption of capacity
p.000114:
p.000114:
p.000114: Those who provide health and social care services must work on the presumption that every adult service
p.000114: user has the capacity to make decisions about their care, and to decide whether to agree to, or refuse, an examination,
p.000114: investigation or treatment.
p.000114: It must not be assumed that a service user lacks capacity to make a decision solely because of their age, disability,
p.000114: appearance, behaviour, medical condition (including intellectual disability, mental illness, dementia or
p.000114: scores on tests of cognitive function), their beliefs, their apparent inability to communicate, or the fact
p.000114: that they make a decision that seems unwise to the health and social care professional. Capacity should not be
p.000114: confused with a health and social care professional’s assessment of the reasonableness of the service user’s
p.000114: decision. The person who has capacity can make their own choices, however foolish, irrational or idiosyncratic others
p.000114: may consider those choices. Similarly, the fact that a service user has been found to lack capacity to make a
p.000114: decision on a particular occasion does not mean that they lack capacity to make any decisions at all, or
p.000114: that they will not be able to make similar or other decisions in the future.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 31
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.4 When to consider incapacity
p.000114:
p.000114:
p.000114: An important implication of the presumption of capacity is that this presumption should not be challenged unless an
p.000114: adequate “trigger” exists. All service users may experience temporary lack of capacity due to severe illness, loss of
p.000114: consciousness or other similar circumstances.
p.000114:
p.000114:
p.000114: The possibility of incapacity and the need to assess capacity formally should only be considered,
p.000114: if, having been given all appropriate help and support, a service user:
p.000114:
p.000114: • is unable to communicate a clear and consistent choice or
p.000114:
p.000114: • is obviously unable to understand and use the information and choices provided.
p.000114:
p.000114:
p.000114: 5.5 Assessing capacity to consent
p.000114:
p.000114:
p.000114: Capacity to consent should be assessed if there is sufficient reason, as indicated in Section 5.4, to question the
p.000114: presumption of capacity. This involves assessing whether:
p.000114: • The service user understands in broad terms and believes the reasons for and nature of the
p.000114: decision to be made
p.000114: • The service user has sufficient understanding of the principal benefits and risks of an intervention and
p.000114: relevant alternative options after these have been explained to them in a manner and in a language appropriate
p.000114: to their individual level of cognitive functioning
p.000114: • The service user understands the relevance of the decision, appreciates the advantages
p.000114: and disadvantages in relation to the choices open to them and is able to retain this knowledge long enough to make a
p.000114: voluntary choice.
p.000114: The fact that a person may not, in their current situation have sufficient understanding or appreciation
p.000114: regarding a decision should in the first instance signal a requirement for the provision of supports in
p.000114: order to ensure that the decision-making capacity of the individual is enhanced to the greatest degree
p.000114: possible, rather than an inevitable finding of incapacity to make that decision.
p.000114:
p.000114: Page 32
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 5.6 Making decisions if capacity is absent
p.000114:
p.000114:
p.000114: There is currently no legislative framework to govern how a decision about treatment and care should be made for those
p.000114: who lack capacity to make that decision themselves.
p.000114: However, Irish case law, national and international guidelines suggest that in making decisions for those who lack
p.000114: capacity, the health and social care professional should determine what is in their best interests, which is decided by
p.000114: reference to their values and preferences if known.
p.000114:
p.000114:
p.000114: The health and social care professional should:
p.000114:
p.000114: • Consider whether the service user's lack of capacity is temporary or permanent. In those with
p.000114: fluctuating cognitive impairment, it may be possible to make use of lucid periods to obtain consent
p.000114: • Consider which options for treatment would provide overall clinical benefit for the service user
p.000114: • Consider which option, including the option not to treat, would be least restrictive of the service user's
p.000114: future choices
p.000114: • Support and encourage service users to be involved, as far as they want to and are able, in decisions
p.000114: about their treatment and care
p.000114: • Seek any evidence of the service user's previously expressed preferences, such as an advance statement
p.000114: or decision, and of the service user’s previous wishes and beliefs
p.000114: • Consider the views of anyone the service user asks you to consult
p.000114:
p.000114: • Consider the views of people who have a close, ongoing, personal relationship with the service user such
p.000114: as family or friends
p.000114: • Consider involving an advocate to support the service user who lacks capacity to participate in the
p.000114: decision making process around consent. This may be particularly helpful in difficult situations such
p.000114: as when service users with no family or friends have to make a complex decision; or when there is
p.000114: significant disagreement regarding the best course of action.
p.000114:
p.000114:
p.000114: Page 33
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114: 5.6.1 Role of the family
p.000114:
p.000114:
p.000114: No other person such as a family member, friend or carer and no organisation can give or refuse consent
p.000114: to a health or social care service6 on behalf of an adult service user who lacks capacity to consent unless they have
p.000114: specific legal authority to do so7.
p.000114: However, it may be helpful to include those who have a close, ongoing, personal relationship with the
p.000114: service user, in particular anyone chosen by the service user to be involved in treatment decisions, in the
p.000114: discussion and decision-making process pertaining to health and social care interventions.
p.000114: Their role in such situations is not to make the final decision, but rather to provide greater insight into his/her
p.000114: previously expressed views and preferences and to outline what they believe the individual would have
p.000114: wanted. In some cases, involvement of those close to the service user will facilitate the service user in reaching a
p.000114: decision in conjunction with health/social care providers.
p.000114:
p.000114:
p.000114: 5.6.2 Emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In emergency situations where a service user is deemed to lack capacity8 consent is not necessary.
p.000114: The health and social care professional may treat the service user provided the treatment is immediately
p.000114: necessary to save their life or to prevent a serious deterioration of their condition and that there is no valid
p.000114: advance refusal of treatment (discussed in 7.9). The treatment provided should be the least restrictive of the
p.000114: service user’s future choices. While it is good practice to inform those close to the service user – and they
p.000114: may be able to provide insight into the service user’s likely preferences - nobody else can consent on behalf of the
p.000114: service user in this situation.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 6 See Part Three section 3 for provisions relating to medical research involving persons lacking decision-making
p.000114: capacity
p.000114: 7 Such as if the service user has been made a Ward of Court (see section 5.7) or is the subject of an enduring power of
p.000114: attorney which covers the decision in question
p.000114: 8 See section 5.5 for provisions relating to the assessment of capacity
p.000114: Page 34
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 5.6.3 Non-emergency situations involving service users who lack capacity
p.000114:
p.000114:
p.000114: In non-emergency situations, a distinction can be made between those service users who, depending on the
p.000114: nature of their incapacity, may or may not be able to express an opinion regarding the proposed
p.000114: intervention. Even in the presence of incapacity, the expressed view of the service user carries great weight:
p.000114: • Cannot express opinion: This includes service users who are in a coma or have severe dementia
p.000114: or have sufficient clouding of consciousness to impair effective communication. Decisions should be made in
p.000114: the best interests of the service user, bearing in mind the principles outlined above. It is good practice to
p.000114: inform those close to the service user of planned interventions and to seek their agreement if possible.
p.000114: However, it is important to remember that the primary duty of the health and social care professional is to the service
p.000114: user.
p.000114: • Can express opinion: Many service users who lack capacity to make a decision will nevertheless be able to
p.000114: express a preference to receive or forgo an intervention. Such preferences should in general be respected.
p.000114: Most health and social care decisions regarding those who lack capacity arise in the community, and, except in
p.000114: emergencies, it may often be impractical or undesirable to try to impose care, treatment or investigation
p.000114: on someone who refuses it. Legal advice should be sought in respect of refusal of any major intervention
p.000114: including surgery, prolonged detention or other restrictions on liberty.
p.000114:
p.000114:
p.000114: 5.7 Wards of Court
p.000114:
p.000114:
p.000114: If a ward needs a healthcare intervention for which written consent is required by the service provider,
p.000114: the approval of the President of the High Court should be obtained. In practice a request for consent,
p.000114: for example to carry out an elective surgical procedure or administer an anaesthetic is normally made by
p.000114: the clinician concerned to the Office of Wards of Court. However, emergencies will arise where it is not
p.000114: possible to obtain timely approval and in those circumstances the necessary treatment may be administered in the
p.000114: service user’s best interests (see further Section 6.1).
p.000114:
p.000114:
p.000114: Page 35
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114:
p.000114: 6. Is it always necessary to seek service user consent?
p.000114:
p.000114:
p.000114: The general principles of consent apply to all decisions about care: from the treatment of minor and self-limiting
p.000114: conditions, to major interventions with significant risks or side effects. However, while the agreement of the
p.000114: service user should always be sought, there are a number of situations where the amount of information
p.000114: provided about an intervention may legitimately be abbreviated. These include:
p.000114: • Emergency situations
p.000114:
p.000114: • Where the service user declines information.
p.000114:
p.000114:
p.000114: 6.1 Emergency situations
p.000114:
p.000114:
p.000114: In an emergency life-threatening situation where the service user lacks capacity to consent or where the
p.000114: urgency of the relevant intervention imposes time limitations on the ability of the service user to
p.000114: appreciate what treatment is required, the necessary treatment may be administered in the absence of
p.000114: the expressed consent of the service user. The application of this exception is limited to situations where the
p.000114: treatment is immediately necessary to save the life or preserve the health of the service user.
p.000114:
p.000114:
p.000114: 6.2 Where the service user declines information
p.000114:
p.000114:
p.000114: Some service users do not want to know in detail about their condition or the treatment. While this should be respected
p.000114: if possible, it is important that some basic information be provided about major interventions in order that consent
p.000114: can be obtained and the service user has been advised of what is involved. If a service user refuses to receive
p.000114: detailed information about their condition, this should be documented9.
p.000114: The fact that a service user might be upset or refuse treatment or services as a result of receiving
p.000114: information as part of the consent process is not a valid reason for withholding information that they
p.000114: need or are entitled to know.
p.000114:
p.000114: 9 Further details on the documentation of consent are provided at 7.5
p.000114:
p.000114: Page 36
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7. Specific Issues relating to consent
p.000114:
p.000114:
p.000114: 7.1 Scope of consent
p.000114:
p.000114:
p.000114: The need for consent, and the application of the general principles in this policy, extends to all interventions
p.000114: conducted by or on behalf of the HSE on service users in all locations. Thus, it includes social as
p.000114: well as health care interventions and applies to those receiving care and treatment in hospitals, in the
p.000114: community and in residential care settings. How the principles are applied, such as the amount of information
p.000114: provided and the degree of discussion needed to obtain valid consent, will vary with the particular
p.000114: situation. In some situations, permission, as matter of common courtesy and of respect for the service
p.000114: user, rather than consent may be required e.g. to enter a person’s home, and should be obtained in
p.000114: keeping with relevant HSE codes of conduct10.
p.000114: Provision of health and social care to a service user during a single episode often involves a number
p.000114: of interventions. This is particularly true during acute hospital admissions. A useful approach to consent
p.000114: in this context is to consider what a reasonable person in the service user’s situation would consider appropriate.
p.000114: Thus, for example, it might be judged that someone facing potentially hazardous surgery would more likely prefer to
p.000114: focus on the risks of the surgical procedure than on the much smaller risks associated with the ancillary
p.000114: antibiotic treatment. However, individual preferences remain important in these circumstances: if
p.000114: service users have a strong preference for detailed information and for involvement in all aspects of
p.000114: decision-making, this should be respected as far as possible.
p.000114: Those who provide health and social care services should discuss with service users the possibility of additional
p.000114: problems arising during an intervention or treatment when they may not be in a position to make a decision about
p.000114: how to proceed.
p.000114: If there is a significant risk of a particular problem arising, the service user should be asked in
p.000114: advance what they would like the health and social care professional to do if the difficulty occurs.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 10 HSE Doc 2.1: Code of Standards and Behaviour (V3) (2009)
p.000114:
p.000114: Page 37
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: It is important that service users understand the scope of any decisions to be made, especially if:
p.000114:
p.000114: • Treatment will be provided in stages, with the possibility that changes or adjustments might be needed
p.000114: • Different professionals will provide particular parts of an investigation or treatment, such as
p.000114: anaesthesia and surgery
p.000114: • A number of different investigations or treatments are involved.
p.000114:
p.000114: The service user should be asked if there are any particular procedures they object to in the context
p.000114: of their proposed treatment and this should be clearly documented on their record. If they agree only to parts of
p.000114: the proposed intervention/treatment, there should be a clear process through which they can be involved in
p.000114: making decisions at a later stage. Those who provide health and social care must not exceed the scope of the
p.000114: authority given by a service user, except in an emergency.
p.000114:
p.000114:
p.000114: 7.2 Who should seek consent from a service user?
p.000114:
p.000114:
p.000114: The person who is providing a particular health and social care service or intervention is ultimately
p.000114: responsible for ensuring that the service user is consenting to what is being done. The task of providing information
p.000114: and seeking consent may be delegated to another professional, as long as that professional is suitably trained and
p.000114: qualified.
p.000114: In particular, they must have sufficient knowledge of the proposed intervention and of the benefits and
p.000114: risks in order to be able to provide the information the service user requires. Inappropriate delegation
p.000114: (for example where the seeking of consent is assigned to a junior health and social care professional with
p.000114: inadequate knowledge of the procedure) may mean that the “consent” obtained is not valid.
p.000114: If different aspects of care are to be provided by different professional disciplines, each should usually obtain
p.000114: consent for their particular intervention.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 38
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.3 When should consent be sought?
p.000114:
p.000114:
p.000114: The provision of information and the seeking and giving of consent should involve a continuing process of keeping
p.000114: service users up to date with any changes in their condition and the interventions proposed. It
p.000114: should not be a once-off, sometimes ‘eleventh hour’ event, exemplified by getting a hurried signature
p.000114: on a consent form.
p.000114: While there are no legal provisions relating to the duration of consent, for major interventions it is good practice
p.000114: where possible to seek the service user’s consent to the proposed procedure well in advance, when there
p.000114: is time to respond to the service user’s questions and provide adequate information. Clinicians should then
p.000114: check, before the procedure starts, that the service user has no questions or concerns and still consents to proceed.
p.000114: If there is a significant time-lapse between the initial seeking and giving of consent and the actual date of an
p.000114: intervention, it is helpful to check if the service user can remember the treatment information given
p.000114: previously and if they have any questions in relation to that information. If the service user isn’t satisfied that he
p.000114: or she can remember the earlier information or if he or she has cognitive difficulties that might interfere with his or
p.000114: her recollection of the earlier discussion or there is a change in the service users condition or in the
p.000114: information about the proposed intervention which may result in a change in the nature, purpose or risks
p.000114: associated with the procedure, a fresh consent following provision of appropriate information should be sought.
p.000114: Asking a service user to provide consent just before the procedure is due to start, at a time when they may be feeling
...
p.000114: requirements of the legislation are complied with11. (The legislation distinguishes between “sensitive” and
p.000114: “non-sensitive” data. For non-sensitive data, information may be shared (“processed”) where it is necessary to prevent
p.000114: injury or other damage to the health of the data subject. For sensitive data, information may be shared where it is
p.000114: necessary for medical purposes and is undertaken by a medical professional).
p.000114: This also applies if a third party, such as a family member, makes a complaint regarding the care of a service user:
p.000114: it is essential in these circumstances to ensure that the service user has consented to their personal
p.000114: information being made available for any internal investigations/ reviews.
p.000114: Sharing of information on a strict ‘need to know’ basis between staff involved in a service user’s care is essential to
p.000114: the provision of safe and effective care. Similarly, an integral component of modern health and social care is the use
p.000114: of audit and quality assurance programmes to ensure that the care provided is of the highest quality when
p.000114: benchmarked against national and international standards. Consent from the service user is not
p.000114: usually sought in these circumstances except where identifiable data is being made available to a third party.
p.000114: However, it is good practice to make service users aware that such practices occur and that safeguards exist to ensure
p.000114: that their personal information is protected. For example, this could be done in hospitals by providing
p.000114: such information on admission.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 11 See Part Three section 9 for provisions relating to confidentiality and data protection in the context of research
p.000114:
p.000114: Page 41
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: 7.7 When consent is refused
p.000114:
p.000114:
p.000114: If an adult with capacity to make an informed decision makes a voluntary and appropriately informed
p.000114: decision to refuse treatment or service, this decision must be respected, even where the service user’s decision may
p.000114: result in his or her death. In such cases it is particularly important to accurately document the discussions with the
p.000114: service user, including the procedure that has been offered, the service user’s decision to decline and the
p.000114: fact that the implications of this decision have been fully outlined.
p.000114: Those who provide health and social care services should also consider and discuss with the service user
p.000114: whether an alternative treatment/measure is acceptable to the service user.
p.000114: For example in the case of a service user who is refusing a blood transfusion for religious reasons, the service user
p.000114: should be referred for a haematology consultation to ascertain whether any alternative treatment would be
p.000114: acceptable.
p.000114: In the context of social care, for example, where a frail older person is assessed to require home supports in order
...
p.000114:
p.000114:
p.000114: The general principles regarding consent apply when testing for intoxicants. When such testing is clinically indicated,
p.000114: the urgency of the situation in which such testing commonly occurs means that explicit discussion of the pros and cons
p.000114: of the particular test is not required.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 13 Section 38 of the Health Act (1947): ‘Where a chief medical officer is of opinion. that such person is a probable
p.000114: source of infection with an infectious disease and that his isolation is necessary as a safeguard against the spread of
p.000114: infection, and that such person cannot be effectively isolated in his home, such medical officer may order in writing
p.000114: the detention and isolation of such person in a specified hospital or other place until such medical officer gives a
p.000114: certificate that such person is no longer a probable source of infection
p.000114:
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p.000114:
p.000114:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part One—General Principles
p.000114:
p.000114:
p.000114: However, specific legal rules apply to the taking of blood and urine samples for the purposes of Garda investigations
p.000114: into driving under the influence of alcohol and/or drugs. Section 14 of the Road Traffic Act 2010 relates to situations
p.000114: where an “event”14 has occurred and, as a result, a person is injured and is admitted to or attends at a hospital. In
p.000114: such a situation, where a Garda is of the opinion that, at the time of the event, the person was driving or attempting
p.000114: to drive, the Garda may require the person to permit a doctor or nurse who has been specifically designated by the
p.000114: Garda Siochána to take a sample of blood or (at the person’s option) to provide a sample of urine.
p.000114: The Garda must first consult with the designated doctor or nurse in order to ensure that this
p.000114: requirement would not be prejudicial to the health of the person. Section 12 of the Act relates to testing at a Garda
p.000114: station by a designated doctor or nurse only. The Act does not provide for the forcible taking of a sample without the
p.000114: consent of the person. However, the person’s refusal to comply with the requirement to provide a sample is a criminal
p.000114: offence. Refusal is not an offence where the person is under the care of a doctor or nurse and the doctor
p.000114: or nurse refuses on medical grounds to permit the taking of the sample.
p.000114:
p.000114:
p.000114: 7.8 Advance refusal of treatment
p.000114:
p.000114:
p.000114: Sometimes service users may wish to plan for their medical treatment in the event of future incapacity,
...
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance. This policy advocates for a
p.000114: child-centred approach to be taken in relation to any decision in the area of health and social care services as they
p.000114: relate to children. Such an approach involves putting the interests and wellbeing of the child at the centre of all
p.000114: decisions and ensuring that the child’s own voice is heard and respected as far as possible.
p.000114: All service users have the right to participate in decision-making in relation to their care. In the provision of
p.000114: health and social care to children, it is important that respect for their autonomy is integrated into
p.000114: decision-making in the same way as for adults. This does not mean that the interests and views of
p.000114: parents or legal guardians will be displaced, as in most instances the child’s interests will be best
p.000114: represented by its parents or legal guardians, although their interests are not the same. However,
p.000114: respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right to make
p.000114: his/her own decisions.
p.000114: Involving children in decision-making may be different from obtaining consent in the adult context due to
p.000114: the age or capacity of the child to understand and participate in the decision and the role of the parents and/or legal
p.000114: guardians in decision-making. However, even where children are unable to give a valid consent for themselves,
p.000114: they should nonetheless be as involved as possible in decision-making as even young children may have
p.000114: opinions about their healthcare and have the right to have their views taken into consideration by
p.000114: giving their assent to the proposed treatment or service. This principle is in keeping with legal and
p.000114: international human rights standards and ethical guidance which provide that the child’s wishes should be taken into
p.000114: account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Children with disabilities have the right to express their views freely on all matters affecting them, on
p.000114: an equal basis with other children, with their views being given due weight according to their age and maturity.
p.000114: In order to realize this right, children with disabilities must be provided with disability and
p.000114: age-appropriate assistance (see further Part One Section 3.4).
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 2. Role of parent(s) and legal guardian(s)
p.000114:
p.000114:
p.000114: Parents and legal guardians are generally considered best placed to safeguard the health and wellbeing of
p.000114: their children. Parents, legal guardians and health and social care professionals have a responsibility to act in
p.000114: the best interests of children and to care for them in a manner that respects their dignity and wellbeing.
p.000114: Reference to ‘parent’ in this policy is intended to mean a parent as defined by Section 2 of the Guardianship of
p.000114: Infants Act 1964 as amended by the Status of Children Act 1987. These provisions mean that only a person who is a legal
p.000114: guardian may give consent in respect of his/ her child. legal guardianship is described below.
p.000114:
p.000114:
p.000114: 2.1 What is legal guardianship?
p.000114:
p.000114:
p.000114: Legal guardianship refers to the right of a parent to be involved in all major decisions affecting the welfare and
p.000114: upbringing of a child including decisions relating to education, health, religious, monetary and moral concerns. Under
p.000114: current Irish law, the following guardianship rules apply:
p.000114: • Where parents are married, the child’s mother and father are the legal guardians.
p.000114:
p.000114: • Where a child has been jointly adopted, the adoptive parents are the child’s legal guardians.
p.000114: • Following a separation or divorce, both parents remain the child’s legal guardian evenif the child is not living
p.000114: with them and they have not been awarded custody of the child.
p.000114: • Where the child’s parents are not married:
p.000114:
p.000114: ◇ the child’s mother is an automatic legal guardian
p.000114:
p.000114: ◇ the child’s father is an automatic legal guardian if he has lived with the child’s mother for 12 consecutive
p.000114: months including at least 3 months with the mother and child following the child’s birth. This provision is not
p.000114: retrospective, so guardianship will only be acquired automatically where the parents live together for at least 12
p.000114: months after 18 January 2016.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 49
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: ◇ the mother and father of the child may make a statutory declaration to theeffect that they agree to the
p.000114: appointment of the father as legal guardian.
p.000114: ◇ the father may apply to court to be appointed legal guardian.
p.000114:
p.000114: • Any adult may apply to court for legal guardianship:
p.000114:
p.000114: ◇ if he or she is married to or in a civil partnership with, or has been cohabiting forat least 3 years, with
p.000114: the child’s parent and has shared parental responsibility for the child’s day-to-day care for at least 2 years.
p.000114: ◇ if he or she has provided for the child’s day-to-day care for a continuous period of more than 12 months and
p.000114: the child has no parent or guardian who is able or willing to act as guardian.
p.000114: • A guardian may nominate another person to act as temporary guardian in the event of the guardian’s
p.000114: incapacity. This is subject to court approval.
p.000114: • A guardian may appoint a person to act as the child’s guardian in the event of the guardian’s death.
p.000114:
p.000114:
p.000114: 2.2 Who can give consent for a child?
p.000114:
p.000114:
p.000114: For children below the age of 16, a parent(s) or legal guardian(s) can consent to the treatment of the child (and for a
p.000114: child below the age of 18 being treated for a mental disorder covered by the Mental Health Act, 2001). The age of
p.000114: consent is discussed further at Section 3.
p.000114: Where a child accesses a health or social care service in the company of an adult, the adult should be asked to
p.000114: confirm that they are the child’s parent and/or legal guardian and this should be documented in the
p.000114: child’s healthcare record. In the event that they indicate that they are not the child’s parent and/or legal guardian,
p.000114: contact must be made with the child’s parent and/or legal guardian in order to seek appropriate consent.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 50
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Consent obtained from parents or legal guardians by telephone, or otherwise than in person, is acceptable in
p.000114: circumstances where the parent and/or legal guardian is unable to attend and is willing to provide consent by
p.000114: telephone. The same standards and principles of informed consent set out in Part One of this policy apply to
p.000114: consent obtained by these means and the consent should be clearly documented in the healthcare records.
p.000114: Currently, there is some discussion in health and social care practice as to whether one or both parents/legal
p.000114: guardians consent is required prior to commencement of medical treatment and/or social care intervention.
p.000114: On the one hand, it may be argued that the consent of both parents/legal guardians is required prior to treatment of
p.000114: the child on the basis of the rights of the parents/legal guardians in keeping with Article 41 of the Constitution
p.000114: which recognises the family as the natural primary and fundamental unit group of society and the Guardianship
p.000114: of Infants Act, 1964. However, seeking joint parental consent may cause delays in children receiving services
p.000114: and potential logistical difficulties in ensuring that all forms are co-signed e.g. parents/legal guardians working
p.000114: abroad. In addition the requirement for joint consent may be perceived by those parents/legal guardians not
p.000114: in dispute to be bureaucratic.
p.000114: Conversely, it may be argued that seeking the consent of only one parent/legal guardian is widely recognised in
p.000114: health and social care practice and is considered to be more practical for safe, timely and effective
p.000114: service provision. It is generally accepted in other jurisdictions from a legal perspective that, in protecting
p.000114: health professionals from an action in battery15, the consent of one parent or legal guardian (or in their
p.000114: absence, that of the court) is sufficient.
p.000114: The acceptance of consent of one parent/legal guardian assumes that the child’s welfare is paramount,
p.000114: which is in line with the Child Care Acts 1991 and 2001, and that the Health and Social Care
p.000114: professional is proposing a treatment or intervention in the child’s best interests. It also assumes that both of the
p.000114: parents/legal guardians are concerned with the child’s welfare.
p.000114: The provisions of the Irish Constitution 1937 acknowledge the important role and responsibility that all parents and
p.000114: legal guardians have to safeguard the welfare of their children in relation to decisions in many different contexts,
p.000114: including health, social development, education and so on.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 15 Battery is a form of trespass to the person resulting from proof of contact with the body without consent
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: As a corollary to the rights given to parents as legal guardians of their children, there are also
p.000114: duties imposed on them to act in the best interests of their children. In the health and social care context this
p.000114: requires parents and legal guardians to engage with health and social care service providers to ensure that
p.000114: the child receives the best possible care and services. Such involvement by parents and legal guardians should be
p.000114: encouraged and facilitated by service providers as much as possible.
p.000114: Where both parents/legal guardians have indicated a wish and willingness to participate fully in decision making for
p.000114: their child, this must be accommodated as far as possible by the service provider. This also imposes a
p.000114: responsibility on the parents/legal guardians to be contactable and available at relevant times when decisions may have
p.000114: to be made for the child.
p.000114: Even where both parents/legal guardians have not clearly indicated their wish to be involved in decision making, if
p.000114: the decision will have profound and irreversible consequences for the child, both parents/legal guardians
p.000114: should be consulted if possible. However if urgent care is required and the second parent/legal guardian cannot be
p.000114: contacted despite reasonable efforts to do so, the service provider has a paramount duty to act in the best interests
p.000114: of the child.
p.000114: Apart from the circumstances outlined above and in keeping with the prioritisation of the best interests
p.000114: of the child, the consent of one parent/legal guardian will provide sufficient authority in respect of any health or
p.000114: social care intervention in relation to a child.
p.000114: In emergency circumstances where neither parent/legal guardian is contactable, the general doctrine of
p.000114: necessity applies16 and the service provider is obliged to act in the best interests of the child.
p.000114:
p.000114:
p.000114: 3. Age of consent
p.000114:
p.000114:
p.000114: The Child Care Act 1991, the Children Act 2001 and the Mental Health Act 2001 define a child as a service user under
p.000114: the age of 18 years of age, other than a service user who is or has been married.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 16 See Part One section 6.1
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: Section 23 of the Non-Fatal Offences against the Person Act 1997 provides that a person over the age of 16 years can
p.000114: give consent to surgical, medical or dental treatment and it is not necessary to obtain consent for it from his
p.000114: or her parent(s) or legal guardian(s). The section covers any procedure undertaken for the purposes of
p.000114: diagnosis and any procedure, such as administration of anaesthetic, which is ancillary to treatment17.
p.000114: This means that consent to surgical, medical or dental treatment by a 16 and 17 year old has the same status under this
p.000114: Act as if he or she were an 18 year old. While currently there are no legal provisions in Ireland for minors under
p.000114: 16 years to give consent on their own behalf, it is nonetheless good practice to involve the minor in
p.000114: decisions relating to them and listen to their wishes and concerns in terms of their treatment and care.
p.000114: In many jurisdictions a minor is capable of giving informed consent when he or she achieves a sufficient understanding
p.000114: and intelligence to enable him/her to understand fully what is proposed. For example, in England the 1985 Gillick
p.000114: case18 established that a doctor had discretion to give contraceptive advice or treatment to a girl under the age of 16
p.000114: years without her parents’ or legal guardians’ knowledge or consent provided the girl had reached an age where she had
p.000114: a sufficient understanding to enable her to understand fully what was proposed.
p.000114: Hence, the concept of a ‘mature minor’ is dependent on the child’s level of maturity, with no lower age
p.000114: limit defined. In addition, the gravity and nature of the treatment are also taken into account when assessing a
p.000114: minor’s capacity to fully understand all aspects of the situation and to objectively weigh up treatment options. This
p.000114: concept of the mature minor has been accepted in other jurisdictions including Northern Ireland, Scotland, New
p.000114: Zealand, Australia and some provinces in Canada. However, the Gillick case and other similar cases elsewhere do not
p.000114: have any application in Ireland although they may be of persuasive authority in the event of a judicial
p.000114: determination on this issue.
p.000114: In Ireland, the courts place great emphasis on the rights of the family and the rights of parent(s)/ legal guardian(s)
p.000114: to decide what is in the best interests of their children. It is possible that the Irish courts may interpret the
p.000114: provisions of the Constitution in such as way as to require parental consent to be obtained before providing a health
p.000114: or social care service to any minor under the age of 16 years.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 17 For detailed information about the assessment of capacity please refer to Part 1: underpinning principles, section
p.000114: 5.5
p.000114: 18 Gillick v Western Norfolk and Wisbech Area Health Authority and another [1985] 3 AER 402
p.000114: Page 53
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: However, as against this, it should be noted that children and minors also have significant personal
p.000114: rights of their own under the Constitution, the European Convention of Human Rights, and the United Nations
p.000114: Convention on the Rights of the Child. These rights include rights to liberty, bodily integrity, the
p.000114: freedom to communicate with others and to follow their own conscience.
p.000114: This policy acknowledges that in health and social care practice it is usual to involve parent(s)/ legal guardian(s)
p.000114: and seek their consent when providing a service or treatment to a minor under
p.000114: 16. However, the minor may seek to make a decision on their own without parental
p.000114: involvement or consent. In such circumstances it is best practice to encourage and advise the minor to communicate
p.000114: with and involve their parent(s) or legal guardian(s). It is only in exceptional circumstances that,
p.000114: having regard to the need to take account of an objective assessment of both the rights and the best
p.000114: interests of the person under 16, health and social care interventions would be provided for those under 16 without the
p.000114: knowledge or consent of parent(s) or legal guardian(s).
p.000114: In those circumstances, an assessment must be made as to whether:
p.000114:
p.000114: • the minor has sufficient maturity to understand the information relevant to making the decision and to
p.000114: appreciate its potential consequences;
p.000114: • the minor’s views are stable and a true reflection of his or her core values and beliefs,
p.000114: taking into account his or her physical and mental health and any other factors that affect his or her
p.000114: ability to exercise independent judgement;
p.000114: • the nature, purpose and usefulness of the treatment or social care intervention;
p.000114:
p.000114: • the risks and benefits involved in the treatment or social care intervention, and
p.000114:
p.000114: • any other specific welfare, protection or public health considerations, in respect of which relevant
p.000114: guidance and protocols such as the 2011 Children First: National Guidelines for the Protection and
p.000114: Welfare of Children (or any equivalent replacement document) must be applied.
p.000114: This same assessment of maturity is relevant for all minors under 16 including those who have been diagnosed with
p.000114: intellectual disability.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 54
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 3.1 Confidentiality and the minor
p.000114:
p.000114:
p.000114: Prior to giving consent for a health or social care intervention, the minor should be informed by the health or social
p.000114: care provider that confidentiality cannot be assured as his/her parent(s)/legal guardian(s) may have rights to access
p.000114: the minor’s medical/other records under the FreedomXofXInformation Act 199719.
p.000114: In certain circumstances there may also be a legal obligation on the health or social care provider to report sexual
p.000114: activity due to the age of the minor (see further Section 10). The minor should be informed of the health and social
p.000114: care provider’s intention to report such activity to the HSE or the Garda Siochana.
p.000114:
p.000114:
p.000114:
p.000114: 4. Refusal of health or social care services by children and minors
p.000114:
p.000114:
p.000114: In the case of young children who are not assessed as falling within the mature minor category described in Section 3
p.000114: above, consent from the child’s parent(s)/ legal guardian(s) is required for every intervention. If the child
p.000114: refuses despite parental consent, the child should be given the opportunity to explain the reasons for their
p.000114: refusal and reasonable attempts should be made to give the child sufficient time, explanation and reassurance to try to
p.000114: address the child’s fears or concerns about the intervention.
p.000114: Where a mature minor refuses a health or social care service the service provider should, as a first step, encourage
p.000114: the minor to involve their parent(s)/legal guardian(s) in the decision. If the minor does not want to involve their
p.000114: parent(s)/legal guardian(s) and the service is deemed to be in best interests of the minor, then the parent(s)/legal
p.000114: guardian(s) must be informed despite the minor’s refusal.
p.000114: Consultation should take place involving the minor and the parent(s)/legal guardian(s), with the assistance of the HSE
p.000114: Advocacy service and/or a third party mediator where appropriate, in order to try to reach a consensus if possible. If
p.000114: this is unsuccessful legal advice should be sought as to whether an application to court is required to resolve
p.000114: the matter, particularly if a physical intervention is envisaged.
p.000114:
p.000114: 19 FreedomXofXInformation Act, 1997 (Section 28(6)) Regulations 2009
p.000114:
p.000114: Page 55
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 5. Refusal of treatment or social care intervention by a person between 16 and 18 years
p.000114:
p.000114:
p.000114: The legal position relating to refusal of treatment or social care by a person between the age of 16 and 18 years is
p.000114: unclear. It may be argued that consent and refusal are opposite sides of the same coin and should be regarded in the
p.000114: same way.
p.000114: This would mean that a young person between the age of 16 and 18 years who is recognised as having the legal capacity
p.000114: to consent must also have the capacity to refuse. However, courts in other jurisdictions have held that
p.000114: there is a clear practical distinction to be made between consent to and refusal of medical treatment in
p.000114: that consent involves acceptance of what is an experienced medical view whereas refusal rejects that
p.000114: experience from a position of comparatively limited knowledge. Consequently, it is argued that the implications
p.000114: of refusal may be more serious and, in extreme cases, may even result in death.
p.000114: Section 23 of the Non-Fatal Offences Against the Person Act 1997, while it allows the young person aged
p.000114: 16-18 to give consent to medical treatment, does not include an express entitlement to refuse such treatment.
p.000114: This policy proposes that in cases where an individual between the age of 16 and 18 refuses a treatment or service, in
p.000114: general such refusal should be respected in the same way as for adults. However, if the refusal relates to life
p.000114: sustaining treatment, or other decisions which may have profound, irreversible consequences for him or her, reasonable
p.000114: efforts must be made to discuss the young person’s refusal with all the relevant parties, including the involvement of
p.000114: the HSE Advocacy services and/or a third party mediator where appropriate, in an attempt to reach
p.000114: consensus. Failing agreement, an application should be made to the High Court to adjudicate on the refusal.
p.000114: In such a case, the High Court could intervene to order treatment that is necessary to save life and where this is in
p.000114: the best interests of the young person. In the event of such an application, it would be best practice that the young
p.000114: person would be separately represented.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: 6. Refusal of health and social care intervention by parent(s)/legal guardian(s)
p.000114:
p.000114:
p.000114: As noted in Section 2, parent(s)/legal guardian(s) are generally considered best placed to safeguard the
p.000114: health and wellbeing of their children. Service providers should recognise the caring relationship
p.000114: between parent and child in which parent(s)/legal guardian(s) act as advocates and care providers
p.000114: for children and have expertise in the particular needs of their child. Parent(s)/legal guardian(s) are
p.000114: entitled to be treated with courtesy and respect and to be provided with adequate information and support in relation
p.000114: to the provision of health and social care services to their children (see further Part One Section 3).
p.000114: It is important for service providers to recognise the role of the parent(s)/legal guardian(s) in
p.000114: deciding together with health and social care professionals what is in the best interests of the child. Case
p.000114: conferences involving the parent(s)/legal guardian(s) and all relevant care providers are often a useful way of
p.000114: ensuring that parent(s)/legal guardian(s) and professionals work in partnership in decision-making for the
p.000114: child.
p.000114: Where a second opinion is sought by parent(s)/legal guardian(s) in order to assist their decision- making, this should
p.000114: be facilitated as far as possible by the service-provider.
p.000114: In exceptional circumstances where there is disagreement between parent(s)/legal guardian(s) and the health
p.000114: and social care professionals, or where parent(s)/legal guardian(s) refuse medical treatment on behalf of a child, the
p.000114: service provider may consider applying to the court to have such refusal overruled in the best interests of the child.
p.000114: This is provided for by Article 42(5) of the Constitution which states that where a child’s parents have failed in
p.000114: their duty to the child the State may intervene to safeguard the welfare of the child. The parent(s)/legal guardian(s)
p.000114: have the right to seek legal representation and to be heard in relation to any such application.
p.000114: In circumstances where parent(s)/legal guardian(s) disagree between themselves about the provision of a health
p.000114: or social care service to their child, they should be advised that they have a responsibility to discuss the matter and
p.000114: reach an agreement between themselves as quickly as possible, with the assistance of the HSE advocacy services and a
p.000114: third party mediator if required. If agreement is not possible then the service should generally not be provided to the
p.000114: child unless it is deemed by the health and social care professional to be necessary to safeguard the child’s best
p.000114: interests. In such circumstances legal advice should be sought as to whether an application to court is required.
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 7. The minor parent
p.000114:
p.000114:
p.000114: Parent(s)/legal guardian(s) are presumed to be the best decision-makers for their children and to act in their best
p.000114: interests. This presumption holds even if the parent/legal guardian is under 16 years.
p.000114: As with all decisions made by parent(s)/legal guardian(s), if the decision is not considered to be in the best
p.000114: interests of the child then the health and social care professional should engage in dialogue with the
p.000114: parent(s)/legal guardian(s) about the decision they are making in relation to their child and carry out
p.000114: an assessment of the minor as outlined in Section 3 above. If appropriate, the maternal grandparents might
p.000114: also be asked to participate in this discussion with the consent of the minor parent/legal guardian. Failing
p.000114: resolution, it is recommended that legal advice is sought.
p.000114:
p.000114:
p.000114:
p.000114: 8. Children in the care of the HSE
p.000114:
p.000114:
p.000114: It is the responsibility of the HSE to ensure that there is an appropriate care order in place for a child in respect
p.000114: of whom consent is required to be given for the provision of health or social care services. In respect of children
p.000114: who are in voluntary care, consent is required from the child’s parent/legal guardian unless a court order
p.000114: has been made dispensing with that person’s consent. If there is no parent/legal guardian, or that person is
p.000114: unavailable, the HSE must make an application to the District Court under Section 47 of the Child Care
p.000114: Act 1991 authorising the relevant social worker to give consent. This also applies to children who are in foster
p.000114: care for less than five years or in respect of whom an application has not been made under Section 43A of the 1991 Act
p.000114: described below.
p.000114: In relation to children who are subject to interim and emergency care orders, an application can be made to the
p.000114: District Court pursuant to the Child Care Act 1991 in regard to medical treatment.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to children who are subject to a full care order, although it is good practice to seek the consent of the
p.000114: parent/legal guardian, the HSE is authorised pursuant to Section 18 of the 1991 Childcare Act to consent to any
p.000114: necessary medical or psychiatric treatment, assessment or examination. However, different procedures apply to
p.000114: admission and treatment under the Mental Health Act 2001 (see Section 9).
p.000114: For children who are in foster care for five years or more, in accordance with Section 43A of the Child Care Act
p.000114: 199120 a foster carer or relative may make an application, and be granted an Order, giving them like
p.000114: control over the child as if they were the child’s parent/legal guardian provided that:
p.000114: • The child has been formally placed in their care for five years or more
p.000114:
p.000114: • The granting of the Order is in the child’s best interest
p.000114:
p.000114: • The HSE consents to the making of such an Order
p.000114:
p.000114: • Parental/legal guardian consent is obtained for children in voluntary care or on temporary Orders
p.000114: • Parent(s)/legal guardian(s) are given notice of the application in the case ofchildren who are subject of
p.000114: full Care Orders
p.000114: • The wishes of the child have been given due consideration, as appropriate.
p.000114:
p.000114: The effect of such an Order will be to grant such foster parents/carers the right to do all that is reasonable to
p.000114: safeguard and promote the child’s welfare, health and development. This includes the giving of consent to any
p.000114: necessary medical or psychiatric assessment, examination or treatment; and to the issuing of a passport. This
p.000114: Order should be produced by the foster parent to the service provider on request.
p.000114: In the case of any child in an emergency life-threatening situation, the welfare of the child is the paramount
p.000114: consideration and the doctrine of necessity will apply whereby a medical practitioner may dispense with the requirement
p.000114: for consent.
p.000114: As with all children and minors, children in care have the right to express their views freely on all matters
p.000114: affecting them with their views being given due weight according to their age and maturity.
p.000114:
p.000114:
p.000114: 20 As inserted by section 4 of the Child Care (Amendment) Act 2007
p.000114:
p.000114: Page 59
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114: 9. Mental health services
p.000114:
p.000114:
p.000114: The provision of mental health services to children follows the same general principles as for other
p.000114: health and social care services. This means that for children below the age of 16 years, consent from
p.000114: the child’s parent/legal guardian is required. For minors between 16 and 18 years who access mental health
p.000114: treatment on an outpatient basis through Child and Mental Health Services, general practitioners or other
p.000114: counselling services, the provisions in Section 3 of this policy apply.
p.000114: The Mental Health Act 2001 sets out some additional provisions in respect of admission and treatment of
p.000114: a child in an approved centre i.e. an inpatient mental health service. The Mental Health Act 2001 defines a
p.000114: child as a person under 18 years of age unless they are or have been married.
p.000114: Most children are admitted to an approved centre on a ‘voluntary basis’. A child is considered a voluntary patient
p.000114: where their parent(s)/legal guardian(s) consent(s) to the admission. Parental/ legal guardian consent is also
p.000114: required to treat the child. Regardless of age, an underlying principle of the 2001 Act (Section 4) is that
p.000114: when it is proposed to give treatment to a person, the person should be consulted and their views listened to and taken
p.000114: into consideration before any treatment is given to them.
p.000114: It is particularly important that information is provided in a form and language that the child or young person can
p.000114: understand.
p.000114: Occasionally, a child may need to be detained in an approved centre. This can occur where it appears
p.000114: to the HSE that the child is suffering from a mental disorder and the child requires treatment which he
p.000114: or she is unlikely to receive without formal admission. Such situations may arise, for example, where the
p.000114: parent(s)/legal guardian(s) of a child do not wish to have their child admitted, contrary to the advice of the treating
p.000114: consultant psychiatrist. In such instances, the HSE must make an application to the District Court for a Section 25
p.000114: order authorising the admission and detention for treatment of the child in a specified approved centre.
p.000114: Where a young person is the subject of a Statutory Care Order, it is also necessary to seek a Section
p.000114: 25 order for assessment, admission and treatment in an approved centre. It is considered best practice in such
p.000114: situations for the child or young person to have separate legal representation.
p.000114:
p.000114:
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: The 2001 Act also contains certain provisions in relation to the treatment of a detained child. Section
p.000114: 61 requires the approval of the consultant psychiatrist responsible for the care and treatment of the
p.000114: child and the authorisation of a second consultant psychiatrist before medication which has been
p.000114: prescribed to a child for a continuous period of three months can be continued. Electroconvulsive therapy or
p.000114: psychosurgery cannot be given to a detained child without the approval of the District Court.
p.000114: There is an uncertain relationship between the 2001 Act and the Non-Fatal Offences against the Person Act 1997. This
p.000114: has created confusion over the capacity of 16 and 17 year olds who have been admitted under the 2001 Act to make mental
p.000114: healthcare decisions and it remains unclear whether 16 and 17 year olds in this situation can consent to
p.000114: treatment without parental/legal guardian consent. Where the young person who has been admitted under the 2001 Act
p.000114: requires any other treatment or intervention not related to their mental health, the general principles of consent
p.000114: apply as discussed in this policy.
p.000114:
p.000114:
p.000114:
p.000114: 10. Sexual health services
p.000114:
p.000114:
p.000114: Under Irish law it is a criminal offence to engage or attempt to engage in a sexual act with a child under 17 years of
p.000114: age21. It is not a defence to show that the child consented to the sexual act. The consent of the Director of Public
p.000114: Prosecutions is required for any prosecution of a child under the age of 17 years for this offence. Under the
p.000114: law, a girl under the age of 17 who has sexual intercourse may not be convicted of an offence on
p.000114: that ground alone. This exemption from prosecution does not apply to boys of the same age.
p.000114: There is no specific provision in law regarding the age at which contraceptive advice and treatment and
p.000114: sexual health services can be provided to a young person and therefore the provision of such advice,
p.000114: treatment or service should follow the same general principles as for any other health and social care service22.
p.000114: In keeping with Section 23 of the Non-Fatal Offences against the Person Act 1997, a young person aged over 16 years can
p.000114: give their own consent to contraceptive/ sexual health advice or interventions (see Section 3). However, in light of
p.000114: the fact that the activity may constitute a criminal offence for a person under the age of 17, efforts should be made
p.000114: to involve the parent(s)/legal guardian(s) in this consultation and decision making.
p.000114:
p.000114: 21 Section 3 of the Criminal Law (Sex Offences) Act 2006 as amended by Section 5 of the Criminal Law (Sexual Offences)
p.000114: (Amendment) Act 2007
p.000114: 22 Section 3 of the Criminal Law (Sex Offences) as above
p.000114:
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p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Two—Children and Minors
p.000114:
p.000114:
p.000114: In relation to the Criminal Law (Sexual Offences) Act 2006 and child protection guidelines, it is critical that the
p.000114: heath or social care professional rules out any possibility or suspicion that any aspect of sexual intercourse was
p.000114: abusive, exploitative, or non-consensual. Health professionals need to be mindful of the risks involved in providing
p.000114: medical treatment to this age group. They should therefore:
p.000114: • document the result of an assessment (to see if there is suspicion or evidence of abuse) and actions taken;
p.000114: and
p.000114: • document efforts to encourage the minor to involve his/herparent(s)/legal guardian(s).
p.000114: In addition, the health and social care professional must be aware of any legal requirements to report sexual activity
p.000114: of a minor under 17 years to either the Gardai or to the HSE under the Children First Guidelines (2011)23.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
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p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 23 or any other relevant legislation or national guidelines
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p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part Three Research
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Research has the potential to promote scientific advances, improve health services and contribute
p.000114: to the wellbeing of individuals and society as a whole. It allows policymakers and service providers to
p.000114: prepare for and respond to the risks posed by e.g. disease or environmental hazards and to verify that drugs and
p.000114: medical devices etc. are safe and effective. It has the potential to feed into the formation of policy
p.000114: and is concerned with a range of human experiences, perspectives and needs e.g. health, education,
p.000114: housing, family and community services as well as the social institutions created to meet those needs. Research is a
p.000114: regular part of the work undertaken by many HSE staff. There are various types of research which cover a
p.000114: range of activities, from laboratory research, clinical trials, observational studies and
p.000114: epidemiological investigations to surveys and interviews. Research can also assist the HSE with organising and
p.000114: providing services.
p.000114: A number of international codes and standards as well as national and international legal instruments
p.000114: aimed at protecting research participants and ensuring high quality research have been developed in recent
p.000114: decades and these have been taken into account in formulating this policy24.
p.000114: Participation in research has the potential to offer participants direct benefits (e.g. improvements in health and
p.000114: well-being) and indirect benefits (e.g. greater access to professional care and support). The potential
p.000114: benefits of research can never be guaranteed. Therefore, it is important to ensure that any possible benefits of
p.000114: research are not overstated in order to avoid unrealistic expectations by prospective participants. Research, by its
p.000114: nature, also holds out the prospect of risk and it is essential that the risks of research be reasonable in light of
p.000114: any expectedbenefits.
p.000114: A number of principles govern the ethical conduct of research, which aim to protect the wellbeing and
p.000114: rights of research participants. They include:
p.000114: • Beneficence - maximising the potential benefits of the research and minimising the risks;
p.000114: • Justice - the duty to neither neglect nor discriminate against individuals or groups who may benefit from
p.000114: research and to avoid placing an unfair burden of research participation on particular groups; and
p.000114:
p.000114:
p.000114: 24 These documents are referred to in the bibliography
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • Respect for persons – the notion that individuals should be treated as autonomous agents and that
p.000114: individuals with diminished autonomy should be protected.
p.000114: Respect for persons is most commonly manifested through the exercise of informed consent (hereafter
p.000114: referred to as consent), which requires that people’s beliefs and opinions be valued, and that they be allowed to
p.000114: choose for themselves whether or not to participate in research.
p.000114: All modern codes of ethics concerning research with human participants affirm the importance of consent. The goal of
p.000114: consent is to ensure that participants have sufficient information to be able to make decisions about research
p.000114: participation which are compatible with their individual interests and values.
p.000114: Special consideration must also be given to the timing of the consent process. Prospective research
p.000114: participants should be given enough time to fully consider their participation and to ask questions.
p.000114:
p.000114:
p.000114:
p.000114: 2. General principles of consent for research
p.000114:
p.000114:
p.000114: 2.1 Content of the information to be provided
p.000114:
p.000114:
p.000114: When preparing consent documentation, researchers must provide all of the information necessary for
p.000114: making an informed decision. Prospective research participants should be provided with the information in the following
p.000114: list, as appropriate. Not all of the listed information will be required for all research. However, in certain
p.000114: circumstances additional information may be required.
p.000114: The proposed information should be submitted to a research ethics committee (REC)25 for a consideration of
p.000114: whether it is adequate to achieve consent.
p.000114:
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p.000114: 25 The Department of Health intends to designate the Health, Information and Quality Authority (HIQA) as
p.000114: the supervisory body for recognising and monitoring REC’s. To this end, HIQA has established a Research
p.000114: Ethics Advisory Group with the aim of preparing national standards for RECs based on best international practice
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.1.1 Explanation of the research study
p.000114:
p.000114:
p.000114: • The purpose of the study should be explained to research participants. They should be informed
p.000114: of the types of material/data required, the methods used to collect it and how the material/data will be utilised
p.000114: during the course of the study.
p.000114: • Research participants should be told how long their material/data will be retained and how it will be
p.000114: disposed of. They should also be informed how long/often they will be expected to attend the trial centre. Researchers
p.000114: should give a description of any other aspects of the study, e.g. whether questionnaires or diary cards will be used.
p.000114: • Participants should be informed whether or not they will be given feedback e.g. study results or any
p.000114: incidental findings see Section 8) as the study progresses. In instances where the material/data will be anonymous it
p.000114: should be made clear to prospective participants that feedback will not be possible.
p.000114: • It is important that consent be sought from research participants should there be secondary uses planned
p.000114: for the material/data e.g. future research studies.
p.000114:
p.000114:
p.000114: 2.1.2 Explanation of the risks and benefits
p.000114:
p.000114:
p.000114: • Prospective research participants should be given an account of the foreseeable risks and benefits
p.000114: associated with participating in the research study. They should be assured that they can withdraw from the research
p.000114: study at any time and that their decision will not have any negative repercussions.
p.000114: (For more information see Section 10 on Withdrawal of Consent). The contact details of researchers should be
p.000114: provided to the research participant should s/he require clarification on any issue relating to the
p.000114: research.
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p.000114: National Consent Policy HSE V.1.3
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p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.1.3 Confidentiality
p.000114:
p.000114:
p.000114: • Participants should be informed what information will be collected and for what purposes.
p.000114: • Participants should also be told in what form the data will be stored (e.g. de- identified)
p.000114: and what measures the researchers will put in place to ensure confidentiality for the full
p.000114: life-cycle of the study.
p.000114: • Research participants should be told which persons will have access to their data including
p.000114: third parties outside the jurisdiction.
p.000114: • Participants should be advised in relation to the fate of their data at the end of the study.
p.000114: • Participants should be advised of the risks of re-identification in the event of data security breaches.
p.000114:
p.000114:
p.000114: 2.1.4 Commercialisation
p.000114:
p.000114:
p.000114: • Researchers should clearly explain to research participants whether or not they will receive payment
p.000114: (either financial or non-financial) for participating in the research project or have their expenses covered.
p.000114: • Research participants should be made aware that they will not be entitled to a share of any
p.000114: profits that may arise from use of their material/data or products derived from it.
p.000114: • Researchers should disclose any conflict of interest they may have e.g. a financial interest in the
p.000114: study.
p.000114: (See Figure 1 for a list of sample information which might be included in a consent form)
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Figure 1.
p.000114:
p.000114: • A statement that the study involves research participants and an explanation of the purposes of the research.
p.000114: • The expected duration of the participant's involvement.
p.000114:
p.000114: • A description of the procedures to be followed/drug to be tested, and an identification of any procedures
p.000114: which are experimental.
p.000114: • A statement that participation is voluntary including a statement offering the participant the opportunity to
p.000114: ask questions and to withdraw at any time from the research without consequences. In the case of withdrawal,
p.000114: information regarding what will happen to material/data should be provided.
p.000114: • Information about who is organising and funding the research.
p.000114:
p.000114: • A description of any reasonably foreseeable risk, discomfort or disadvantages.
p.000114:
p.000114: • A description of any benefits to the participant or to others which may reasonably be expected from the
p.000114: research, avoiding inappropriate expectations.
p.000114: • A disclosure of appropriate alternative procedures for treatment/diagnosis, if any, that might be advantageous
p.000114: to the participant.
p.000114: • A statement describing the procedures adopted for ensuring data protection/ confidentiality/privacy including
p.000114: duration of storage of personal data.
p.000114: • A description of how incidental findings are to be handled.
p.000114:
p.000114: • A description of any planned genetic tests, including whether results will be disseminated to research
p.000114: participants.
p.000114: • An explanation as to whether there are any treatments or compensation if injury occurs (where relevant) and,
p.000114: if so, what they consist of, or where further information may be obtained. Insurance coverage should be
p.000114: mentioned.
p.000114: • Contact details to access information about the research and research participants' rights.
p.000114:
p.000114: • An explanation of what will happen with the material/data at the end of the research and if the material/data
p.000114: are retained or sent/sold to a third party for further research.
p.000114: • Information about what will happen to the results of the research.
p.000114:
p.000114: • A statement regarding the potential commercialisation of the research (where applicable).
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 2.2 Who should seek consent?
p.000114:
p.000114:
p.000114: The person obtaining consent should have sufficient knowledge about the research and be capable of
p.000114: answering questions from prospective participants.
p.000114: Depending on the circumstances, prospective research participants may be approached directly (e.g. by advertisement) or
p.000114: indirectly (e.g. by the individual’s GP). Where researchers are not also the service provider, best practice and
p.000114: data protection considerations require that the service provider should act as a gatekeeper and make the initial
p.000114: contact with the prospective participant and provide him/her with the contact details of the research team.
p.000114: There may be situations where the researcher is also directly involved in providing care or support to
p.000114: the individual. Where this is the case, it is essential that any conflict of interest that might arise as a result of
p.000114: the original relationship be acknowledged and that any possibility that the individual might feel obliged to
p.000114: participate be averted. This might be achieved by having the consent either obtained or witnessed by a person who is
p.000114: independent of the research.
p.000114:
p.000114:
p.000114: 2.3 How should consent be documented?
p.000114:
p.000114:
p.000114: For the majority of cases, prospective research participants should provide written consent. However, in
p.000114: cases where decision-making capacity is lacking, the research team should seek consent from the person’s
p.000114: legal representative (for a more in–depth discussion see Section 4 on Adults lacking decision-making capacity and
p.000114: consent for research).
p.000114: There may be certain circumstances where it is not possible for a prospective participant to provide
p.000114: written consent due to e.g. literacy levels or physical inability. In such cases a witness who is
p.000114: independent of the research should be present during the entire consent process and should sign the consent
p.000114: form. By signing the consent form, the witness acknowledges that the information provided to the individual was
p.000114: explained and that the consent was freely given. A video/audio tape recording of the consent interview might also
p.000114: be made with the permission of the research participant, however, researchers using this method must be
p.000114: mindful of their obligations to protect the confidentiality of the participant.
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3. Children
p.000114:
p.000114:
p.000114: Children should not be denied the possible benefits of research participation but instead should be afforded the
p.000114: opportunity to participate in research on matters that might affect them. Neither should children be exploited or
p.000114: inappropriately enrolled in research because they lack the capacity to consent to participation26.
p.000114: For the purposes of participation in clinical trials, anyone over the age of 16 years can consent on his/her own
p.000114: behalf27. For all other research, the person must be over the age of 18 years in order to provide consent.
p.000114: The following principles should be adhered to when conducting research involving children:
p.000114:
p.000114: • The research should only include children where the relevant knowledge cannot be obtained by conducting
p.000114: research involving adults
p.000114: • The purpose of the research is to generate knowledge about the health or social care needs of children
p.000114: • The research does not pose more than minimal risk unless there is a prospect of direct benefit for the
p.000114: participants
p.000114: • The research has been designed to minimise pain, discomfort, fear and any other foreseeable risk to the
p.000114: child or his/her stage of development
p.000114: • Consent to the child’s participation must be obtained from a parent/legal guardian
p.000114:
p.000114: • Whenever s/he has sufficient competence to provide it, the child’s assent must be sought in a
p.000114: child-appropriate manner; and
p.000114: • A child’s refusal to participate or continue in research should be respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 26 Researchers should refer to the Department of Children and Youth Affairs document Guidance for Developing Research
p.000114: Projects Involving Children which was published in April 2012
p.000114: 27 European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI no 190 of 2004,
p.000114: section 4
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There is an international consensus that children should not be exposed to more than minimal risk in the absence of
p.000114: direct benefit to the participants themselves. The standard of minimal risk requires that the probability and
p.000114: magnitude of the possible harms posed by participating in research are no greater than those encountered by
p.000114: participants in their everyday life or during the performance of routine physical or psychological examinations or
p.000114: tests.
p.000114: Where the research entails only minimal risk, it is sufficient if the research offers the prospect of benefits either
p.000114: to the participants directly or to the group which is the focus of the research and to which the participants belong.
p.000114: Where the research poses more than minimal risk, it should aim to generate new knowledge of sufficient importance for
p.000114: addressing the participants’ conditions/needs. Such research should offer the prospect of direct benefits for
p.000114: the participants themselves and be commensurate with the level of foreseeable risk. The benefit-to-risk ratio presented
p.000114: by the research should be at least as favourable to participants as that presented by available alternative approaches.
p.000114: It is sufficient for one parent/legal guardian to provide consent for a child’s participation in research
p.000114: unless the REC has found that the risks involved in participation require the consent of both parent(s)/legal
p.000114: guardian(s). A parent or legal guardian who provides consent on a child’s behalf should be given the
p.000114: opportunity, to a reasonable extent, to observe the research as it proceeds.
p.000114: Researchers must respect the developing capacity of children to be involved in decisions about their participation in
p.000114: research and, where appropriate, the child’s assent to participation must be sought. It is important to note that
p.000114: a child’s capacity and/or vulnerability may fluctuate depending on age, maturity and the type and complexity of
p.000114: the research being proposed.
p.000114: Older children, who are more capable of giving assent (i.e. children over the age of 7 years)28, should be
p.000114: selected before younger children, unless there are valid scientific, age-related reasons for involving younger children
p.000114: first.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 28 The Department of Children and Youth Affairs’ document Guidance for Developing Research Projects
p.000114: Involving Children makes reference to the US National Commission for the Protection of Human Subjects of Biomedical and
p.000114: Behavioural Research’s report Research Involving Children (1977), which recommends seeking assent from
p.000114: children seven years or older
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: In order to assist children to make decisions, they should be informed as fully as possible, given their age and
p.000114: competence, about the nature of the study and the methods to be employed from the outset. Information for children five
p.000114: years and under should be predominantly pictorial. For older children, information sheets should be provided that
p.000114: explain briefly and in simple terms the background and aim of the study, so they can consider assent.
p.000114: It should also contain an explanation that their parent(s)/legal guardian(s) will be asked for consent.
p.000114: The information should be written in clear and simple language and should be read to them. It should be explained to
p.000114: children that they may choose to withdraw from the study if they are uncomfortable with continuing.
p.000114: The objection of a child to participate in research should be considered and adhered to unless the intervention being
p.000114: tested were to offer an important direct benefit to the child.
p.000114: Parent(s)/legal guardian(s) who enroll their child in a study might believe that the research is designed
p.000114: to provide a direct therapeutic benefit to the child, as opposed to contributing to medical knowledge
p.000114: for the benefit of individuals in the future. This is commonly referred to as therapeutic misconception.
p.000114: Therefore, it is essential that researchers should be aware of the possibility of parental therapeutic
p.000114: misconceptions when determining how to explain the potential benefits and risks of research participation during the
p.000114: consent process.
p.000114: In certain circumstances, it will not be possible for the researcher to guarantee confidentiality to the child due
p.000114: to mandatory reporting obligations. For instance, if a child reveals that they or others are at significant
p.000114: risk of harm, or the researcher observes or receives evidence of incidents likely to cause serious harm, the
p.000114: researcher must divulge this information to the appropriate authorities. This should occur only following
p.000114: discussion with the child. The child and his/her parent(s)/legal guardian(s) should be informed of this
p.000114: obligation during the consent/assent process and it should be highlighted in participant information leaflets. A
p.000114: strategy for information disclosure should be submitted to and approved by the REC in advance of the
p.000114: research being commenced.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 3.1 Healthy children as participants
p.000114:
p.000114:
p.000114: In certain types of research it may be necessary to involve healthy child participants to act as a control group. In
p.000114: such instances, healthy volunteers should be treated in the same manner as other child participants. The
p.000114: risks posed to healthy child participants should be no more than minimal in the absence of any direct benefit
p.000114: for this cohort.
p.000114:
p.000114:
p.000114: 3.2 Children in care
p.000114:
p.000114:
p.000114: Research involving children in care is permitted once the criteria listed above are adhered to. In order to conduct
p.000114: research involving a child in care, researchers should first get consent from the responsible legal guardians e.g.
p.000114: a parent and/or the child’s health/social care providers or someone with a duty of care to the child. This
p.000114: consent must be supplemented with the child’s assent.
p.000114: Given the vulnerability of children in care, researchers should consider appointing an advocate, agreed by the child.
p.000114: The task of the advocate would be to ensure that the child is not exploited, coerced or subjected to undueXinfluence or
p.000114: harm during the course of the research and that the child has freely given his/her assent to participation.
p.000114:
p.000114:
p.000114: 3.3 Neonates
p.000114:
p.000114:
p.000114: Research involving full-term or pre-term neonates is, in principle, similar to research involving children
p.000114: as the decision-making power rests with their parent(s)/legal guardian(s) and, in general, the same rules apply.
p.000114: However, this type of research raises additional issues relating to consent, as the parent(s)/legal guardian(s) may
p.000114: be distressed following a difficult or premature birth. Nevertheless, because of the important benefits that
p.000114: might accrue from such research, if consent can be obtained from a parent/legal guardian of the child then, providing
p.000114: conditions in relation to levels of risk (as set out in the criteria above) are met and the research can be justified
p.000114: to a REC, the research can proceed.
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 4. Adults lacking decision-making capacity and consent for research
p.000114:
p.000114:
p.000114: In accordance with the functional approach to capacity (see Part One), there may be instances where a person might have
p.000114: limited capacity and may require assistance in deciding whether or not to participate in research. In such cases,
p.000114: researchers must ensure that efforts are made to assist people in reaching their decision and that they are provided
p.000114: with the appropriate tools to maximise their decision-making ability.
p.000114: The objectives as well as the potential risks and benefits of the research should be explained as fully as possible to
p.000114: the prospective participant given their level of understanding. The information should be provided using easily
p.000114: comprehensible language and the prospective participant should be informed of the right to withdraw from the
p.000114: study at any time without there being any negative repercussions.
p.000114: There may be some instances where the capacity to consent to research participation is lacking. Adults who lack
p.000114: decision-making capacity must neither be unfairly excluded from the potential benefits of research participation,
p.000114: nor may their lack of capacity to consent be used to inappropriately include them in research. However,
p.000114: special measures should be taken to protect their rights and interests.
p.000114: The following principles should be adhered to when conducting research involving adults lacking decision-making
p.000114: capacity:
p.000114: • The research should only be undertaken if the required knowledge cannot be obtained by
p.000114: conducting research involving adults with decision-making capacity
p.000114: • The research is expected to provide a direct benefit to the participants or to provide
p.000114: knowledge about the cause or treatment of the impairing or similar condition. Where there is no prospect
p.000114: of direct benefit for participants, the risks involved should be no more than minimal (For more
p.000114: information on minimal risk see Section 3 on Children)
p.000114: • Consent for participation must be sought from the person’s legal representative
p.000114:
p.000114: • A REC must approve the participation of adults lacking decision-making capacity in research taking all of
p.000114: the above factors into consideration
p.000114: • The explicit wish of a participant to refuse participation in or to be withdrawn from the study should be
p.000114: respected.
p.000114:
p.000114: Page 76
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where a prospective research participant lacks decision-making capacity but has some ability to understand the
p.000114: significance of the research, the researcher should ascertain the wishes of that individual with respect to
p.000114: his/her participation.
p.000114: Under the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations
p.000114: 200429,30, consent for research participation on behalf of an adult lacking decision- making capacity must
p.000114: be obtained from the person’s legal representative. A legal representative has been defined as a person not connected
p.000114: with the conduct of the trial who by virtue of his/her family relationship with that adult, is suitable to act as the
p.000114: legal representative and is willing and able to do so or (if there is no such individual) a person who is not connected
p.000114: with the conduct of the trial, who is a solicitor nominated by the relevant health care provider.
p.000114: Outside of clinical trials, there is currently no legal framework for a person who lacks decision-
p.000114: making capacity to participate in research. In the absence of any such legal regulations, it is
p.000114: recommended that as a matter of best practice the same principles should apply to both clinical trials and other
p.000114: forms of research. This means that consent for participation in any form of research on behalf of an
p.000114: adult lacking decision-making capacity must be obtained from the person’s legal representative, as defined
p.000114: above.
p.000114: Refusal to participate in a research project by an individual lacking decision-making capacity should be
p.000114: respected.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: 29 In July 2012 the European Commission published a proposal to repeal the Clinical Trials Directive 2001/20/EC and for
p.000114: new legislation relating to the conduct of clinical trials on Medicinal Products for Human Use. The new legislation,
p.000114: which is expected to come into effect in 2016, will take the form of a Regulation which will ensure that, in the main,
p.000114: the rules governing clinical trials will be identical throughout Europe . Other aspects, such as the structure and
p.000114: function of RECs and eligibility for the role of legal representative will be decided at a national level
p.000114: 30 It is also important to note that the European Commission is in the process of reviewing EU legal frameworks
p.000114: relating to medical devices and on the protection of personal data
p.000114:
p.000114: Page 77
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5. Vulnerable research participants
p.000114:
p.000114:
p.000114: It is important to recognise that research involving human participants requires special
p.000114: justification in the case of potentially vulnerable people. Certain groups may continually be sought as
p.000114: research subjects, owing to their ready availability in settings where research is conducted, or the
p.000114: conditions they suffer from. Such groups should be protected against the danger of being involved in research
p.000114: solely for administrative convenience, or because they are easy to manipulate as a result of their illness or
p.000114: socioeconomic condition. Vulnerability is sensitive to context and individuals may be vulnerable in one situation
p.000114: but not in another.
p.000114:
p.000114:
p.000114: 5.1 Research in emergency situations
p.000114:
p.000114:
p.000114: Research in emergency situations involves individuals who have a life-threatening medical condition that
p.000114: necessitates urgent intervention (for which available treatments are unproven or unsatisfactory), and who, because of
p.000114: their condition (e.g. traumatic brain injury) cannot provide consent. In emergency situations, when it is not possible
p.000114: to obtain the consent of the prospective participant, then the consent of the participant's legal
p.000114: representative should be sought. (See Section 4 on Adults lacking decision-making capacity and consent for
p.000114: research.) If there is no legal representative present then the individual can only be enrolled in research
p.000114: if the following criteria are met:
p.000114: • the research addresses the emergency needs of the individual involved;
p.000114:
p.000114: • the experimental interventions have a realistic probability of benefit equal to or greater than standard
p.000114: interventions; and
p.000114: • the risks associated with the research are reasonable in view of the critical nature of the condition and
p.000114: the risks associated with standard interventions.
p.000114: Participants who regain capacity (or their legal representatives once located) should be given all the relevant
p.000114: information and their consent to continued participation should be obtained as soon as is reasonably possible. The
p.000114: option to withdraw and to seek the destruction of any biological material or data collected as part of the study should
p.000114: also be given.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 78
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 5.2 People highly dependent on medical care
p.000114:
p.000114:
p.000114: While research involving people who are highly dependent on medical care (e.g. people in intensive care or
p.000114: the terminally ill) is valuable, their reliance on medical treatment may impact on their willingness to consent to
p.000114: research participation and this raises significant ethical issues. Therefore, such research should only be
p.000114: undertaken when:
p.000114: • it is likely that the research will lead to an increased understanding of, or an improvement
p.000114: in, the care of that population; and
p.000114: • any risk or burden of the proposed research to a particular participant is justified by the potential
p.000114: benefits that might accrue to him/her.
p.000114: There should be an explicit recorded explanation that not participating in or withdrawing from the research will not
p.000114: adversely affect either the quality of care received or the relationship with the medical team.
p.000114: When undertaking studies involving people highly dependent on medical care, researchers must be mindful of the
p.000114: potential for unrealistic expectations of benefits and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated. Where the research involves terminally ill people, their needs and wishes to
p.000114: spend time as they choose, particularly with family members, must be respected.
p.000114: For research involving people who are highly dependent on medical care:
p.000114:
p.000114: • steps should be taken to minimise the risk that stress or emotional factors may have on
p.000114: the person’s understanding of the research or his/her decision to participate; and
p.000114: • researchers must ensure that the dependency of prospective participants on the medical personnel
p.000114: providing treatment does not compromise the voluntariness of their consent.
p.000114: People who are highly dependent on medical care may have impaired capability for verbal or written
p.000114: communication. Provision should be made for them to receive information and to express their wishes, in
p.000114: other ways.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 79
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: Where the researcher is also the service provider, it should be considered whether a person who is independent of
p.000114: the research should make the initial approach and/or seek consent from potential participants.
p.000114: In cases where people who are highly dependent on medical care lack the decision-making capacity required
p.000114: for consent the criteria listed in Section 4 should be adhered to.
p.000114:
p.000114:
p.000114: 5.3 People in dependent or unequal relationships
p.000114:
p.000114:
p.000114: Dependent or unequal relationships might include those between: health and social care professionals and
p.000114: residents in care; teachers and students; penal institutions and prisoners; employers and employees; or
p.000114: governments and refugees.
p.000114: Being in a dependent or unequal relationship may influence a person’s decision to participate in research. While this
p.000114: influence does not necessarily invalidate the decision, it necessitates close inspection of the process through
p.000114: which consent is negotiated. In the consent process, researchers should, wherever possible,
p.000114: invite prospective participants to discuss their participation with someone who is able to support
p.000114: them in making their decision. Where prospective participants are especially vulnerable or powerless,
p.000114: consideration should be given to the appointment of a participant advocate (see Section on Children in Care 3.2). It
p.000114: may also be appropriate that consent is obtained by a person who is independent of the research. People in dependent or
p.000114: unequal relationships might be vulnerable to being over-researched because of the relative easeXofXaccess to them as
p.000114: research populations.
p.000114: Researchers should take account of this vulnerability in deciding whether to seek out members of these populations as
p.000114: research participants.
p.000114: A person who wishes to decline an invitation to participate in research or withdraw from a study should not suffer any
p.000114: negative consequences such as discrimination, reduction in care, dismissal from employment, exam penalties or any
p.000114: other disadvantage. Researchers must protect the confidentiality of participants, especially in settings
p.000114: such as shared workplaces, educational institutions, hospitals or prisons.
p.000114: Researchers should be mindful that in some relationships of dependency, participants may have an unrealistic
p.000114: expectation of the benefits of research and must ensure that the prospect of benefit from research
p.000114: participation is not exaggerated.
p.000114:
p.000114:
p.000114: Page 80
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6. Categories of research
p.000114:
p.000114:
p.000114: 6.1 Genetic research
p.000114:
p.000114:
p.000114: The Disability Act 2005 (part 4) states that consent for the processing of any genetic data to be derived from testing
p.000114: must be obtained.
p.000114: The act also stipulates that a person shall not process genetic data unless all reasonable steps have been
p.000114: taken to provide the data subject with all of the appropriate information concerning:
p.000114: • the purpose and possible outcomes of the proposed processing; and
p.000114:
p.000114: • any potential implications for the health of the data subject which may become known as a result of the
p.000114: processing.
p.000114: As a result of the highly sensitive nature of genetic data, it is important that researchers formulate a
p.000114: strategy regarding third party disclosure, in particular to family members. The results of genetic research might
p.000114: create a need for alternative life decisions, including those concerning reproductive choices or those with the
p.000114: potential to improve health e.g. dietary modification or career choices.
p.000114: When participants or their relatives are to be informed about genetic data that may be important for their health or
p.000114: lifestyle choices, the disclosure strategy should provide access to genetic and clinical advice/counselling, or
p.000114: clearly recommend to participants that they seek these services. Advice about the results of genetic
p.000114: research needs to include a clear explanation of the difference between research and clinical testing,
p.000114: and to clarify any need for the clinical confirmation of research results by an accredited laboratory.
p.000114: Where people are asked to consent to the collection of their genetic material or data for research, they
p.000114: should be advised:
p.000114: • That, by its nature, genetic material is in principle identifiable, even if personal identifiers are not
p.000114: collected or are removed
p.000114: • That they are free to decline participation without giving reasons
p.000114:
p.000114: • About arrangements to ensure the privacy and confidentiality of their genetic data with regard to both
p.000114: family members and others
p.000114:
p.000114:
p.000114: Page 81
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Whether the research may reveal information of potential importance to their future health, or the future
p.000114: health of their blood relatives
p.000114: • That a genetic test may reveal unexpected relationships, such as non-paternity (i.e. a different biological
p.000114: father); and
p.000114: • That, if it is proposed to approach blood relatives, consent to do so will first be sought from the
p.000114: participant.
p.000114: Identifiers of genetic material or related data:
p.000114:
p.000114: • Should not be removed without the consent of participants, if removal would make it difficult to
p.000114: communicate personal results; and
p.000114: • Should be removed if participants request it, provided they have been informed that the material or data
p.000114: would remain potentially identifiable
p.000114: • Researchers should not transfer genetic material or related data to any researcher not engaged in the
p.000114: research project unless:
p.000114: ◇ where the material or data is identifiable, participants have been informed about the transfer and have
p.000114: explicitly consented to it; or
p.000114: ◇ a REC has judged that the conditions for transfer have been met (for more information on consent and
p.000114: controlling access to data see Section 9).
p.000114:
p.000114:
p.000114: 6.2 Epidemiological research
p.000114:
p.000114:
p.000114: A REC may waive the requirement for consent if the expected benefit of the research is real and substantial. Such
p.000114: waivers may also be approved when the existence of a signed consent form would be an unjustified threat to
p.000114: the subject's confidentiality.
p.000114: Categories of epidemiological research for which consent might be waived include:
p.000114:
p.000114: • The use of anonymous material/data
p.000114:
p.000114: • Studies using health-related registries that are authorised for such use; and
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 82
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Cluster randomised trials (i.e. where groups are randomised as opposed to individuals).
p.000114: For example, villages, hospitals, families or classrooms may be randomised. Reasons for performing
p.000114: cluster randomised trials vary. Sometimes the intervention can only be administered to a group, for example
p.000114: an addition to the water supply (fluoride) or a public education campaign.
p.000114:
p.000114:
p.000114: 6.3 Covert research
p.000114:
p.000114:
p.000114: Covert research cannot, by definition, involve obtaining consent in advance because informing potential
p.000114: participants would render the research overt and may change its outcome e.g. observation of
p.000114: teenagers’ drinking habits. A distinction should be made between covert research and deception. Covert research
p.000114: refers to studies undertaken without the knowledge of the research subjects e.g. where a researcher observes
p.000114: the routine actions of others. Deception, on the other hand, refers to situations where the researcher deliberately
p.000114: misrepresents his/her intentions to the research participants.
p.000114: There is consensus that covert research should not be undertaken routinely, rather it should occur only where it can
p.000114: provide a unique form of evidence that cannot be gathered in any other way or where important issues of sociological
p.000114: significance are being addressed. While serious ethical and legal issues arise in relation to covert research,
p.000114: the use of covert methods may be justified in certain circumstances. For example, difficulties arise when
p.000114: research participants change their behaviour because they know they are being observed.
p.000114: Where consent has not been obtained prior to the research it should, where possible, be obtained at a later time. In
p.000114: cases where participants who are asked to give retrospective consent express concerns about their inclusion in a
p.000114: project, the researcher should give them the option of removing their data from the study.
p.000114: For research where identifiable data (e.g. images, video recordings) is being collected, then the consent
p.000114: of prospective research participants must be sought.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 83
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 6.4 Research in public health emergencies
p.000114:
p.000114:
p.000114: The requirement for consent might be waived in public health emergencies, where a health threat and possible
p.000114: treatments/alleviations must be identified as quickly as possible. For instance, a waiver may be permissible,
p.000114: where a delay caused by the time needed to obtain consent from a person suffering from a new strain of
p.000114: pandemic influenza or other biological, chemical, radiological or nuclear agent, might not only
p.000114: jeopardise his/her health but also the health of others within the population.
p.000114:
p.000114:
p.000114: 6.5 Multi-jurisdictional research
p.000114:
p.000114:
p.000114: When multi-jurisdiction research is being undertaken, additional ethical considerations might arise. While
p.000114: researchers should be cognisant of the local research ethics requirements, they should comply with this
p.000114: policy and act in accordance with Irish legislation.
p.000114: When multi-jurisdictional research is to be conducted, local cultural values should be
p.000114: acknowledged in the design and conduct of the research. Irrespective of cultural traditions, consent must
p.000114: always be given by the prospective research participant. In certain cases it may be appropriate to seek the
p.000114: agreement of a person(s) invested with a certain authority within the community.
p.000114: Researchers must do their utmost to communicate information accurately and in a
p.000114: comprehensible and appropriate way. Where formal written consent from the participant is not possible, the following
p.000114: should be observed:
p.000114: • a community representative trained by the research team should be made available; and
p.000114: • the oral approval should be witnessed by the trained and independent community representative. S/he will
p.000114: verify that the purpose of the research has been explained to the participant and that that the consent was freely
p.000114: given.
p.000114: Researchers should be mindful that in some countries, participating in research may be the only way that individuals
p.000114: can access healthcare and they must ensure that this circumstance does not act as an undue inducement to research
p.000114: participation.
p.000114:
p.000114:
p.000114:
p.000114: Page 84
p.000114:
...
p.000114: information see Section 9 Consent and controlling access to data).
p.000114:
p.000114:
...
p.000114: Biobank custodians have an obligation to respect an individual’s expressed preferences. Where an individual does not
p.000114: want biological materials used for future research, custodians should remove these biological materials and/or
p.000114: data from any collections used or made available for research.
p.000114: Research participants whose biological material is (or is intended to be) stored in a biobank must be informed of
p.000114: their right to withdraw their material and/or data without any negative repercussions. It is
p.000114: recommended that researchers offer prospective research participants a set of graded options for withdrawal, such
p.000114: as, no further contact from researchers or complete withdrawal.
p.000114: • No further contact: participants would no longer be contacted by the researchers or data controllers but
p.000114: their previously provided biological material/data would still be available for use in the current research and/or
p.000114: future research.
p.000114:
p.000114: Page 87
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114: • Limited further use: participants’ biological material would be destroyed but the previously
p.000114: collected data derived from that material would be available for further use in the current research and/or future
p.000114: research. Participants might also be given the option to identify the types of research they would or would
p.000114: not want their material/data to be used for.
p.000114: • No further use: all biological material/data previously collected could no longer be used by researchers
p.000114: but would instead be destroyed.
p.000114: Whatever option is selected by an individual should be adhered to. It is important to note that the subsequent use
p.000114: of biological material or data collected for a specified purpose may not proceed without first receiving REC
p.000114: approval.
p.000114: In the case of longitudinal studies, children who are recruited as research participants should be asked for consent
p.000114: to their continued participation in research on reaching the age of maturity (i.e. 18 years). (For more
p.000114: information on Reconsent see Section 11 ).
p.000114:
p.000114:
p.000114:
p.000114: 8. Consent and incidental findings
p.000114:
p.000114:
p.000114: The term “incidental findings” refers to the unanticipated discoveries made in the course of research but
p.000114: that are outside the scope of the research. Medically relevant incidental findings are findings that have been
p.000114: interpreted as having significant implications for the participant, whether health-related, psychological or social.
p.000114: As part of the consent process, prospective research participants should be provided with the option of
p.000114: whether or not they wish to have medically relevant incidental findings disclosed to them. Should
p.000114: prospective participants indicate a desire not to be given medically relevant information, then this decision
p.000114: should be documented and respected.
p.000114: When medically relevant incidental findings are likely, researchers should develop a plan indicating how
p.000114: they will disclose such findings to participants and submit this plan for REC review.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114: Page 88
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: The plan should identify the circumstances under which research results would warrant disclosure,
p.000114: a strategy for managing such disclosure, and include arrangements for appropriate medical advice or referral
p.000114: when disclosure is made. Disclosure of research results should be done in a sensitive manner with the consent of
p.000114: the participant. Incidental findings and/or research results (especially in the case of genetic research)
p.000114: should be confirmed by an accredited laboratory.
p.000114: In cases where incidental findings are regarded to be of vital and immediate clinical significance (e.g. tumours,
p.000114: blood clots, aneurysms), the researcher involved has a duty of care to that individual. Prospective
p.000114: research participants must be advised that such a duty of care exists during the consent process.
p.000114: Researchers should be especially aware of their obligations to protect the confidentiality of research
p.000114: participants when releasing data to third parties. For instance, in the case of genetic research, family
p.000114: members may need to be informed of potential genetic risks. Similarly, data may be of interest to other researchers or
p.000114: biobanks.
p.000114: Provided that consent is in place, transfer of identifiable data to such third parties is permissible and provided a
p.000114: comparable level of security and protection of privacy can be ensured. (For more information on Consent and controlling
p.000114: access to data see Section 9).
p.000114: The Disability Act 2005 (Part 4) provides that insurers cannot request, take into account or process the
p.000114: results of genetic tests (for a more in-depth discussion of genetic research see Section 6.1).
p.000114: Certain types of information may be made available to public health officials for important purposes, for
p.000114: example, the reporting of infectious diseases, without the explicit consent of the individual.
p.000114:
p.000114:
p.000114:
p.000114: 9. Consent and controlling access to data
...
p.000114: participants. It is imperative that research participants be informed when there is new information that might
p.000114: affect their willingness to continue participation. There are a number of reasons why reconsent may be required
p.000114: which include but are not limited to cases where:
p.000114: • the research protocol has been substantially altered;
p.000114:
p.000114: • new safety information has come to light;
p.000114:
p.000114: • alternative treatments have become available;
p.000114:
p.000114: • a child participant reaches legal maturity (i.e. 18 years or 16 years in the case of clinical trials);
p.000114: • a formerly incapacitated adult has regained capacity; or
p.000114:
p.000114: • a substantial period of time has elapsed since the original consent was obtained (e.g. longitudinal study).
p.000114: A strategy for reconsenting participants should be presented to the REC responsible for reviewing and approving the
p.000114: study.
p.000114:
p.000114:
p.000114:
p.000114: 12. Research where consent may not be required
p.000114:
p.000114:
p.000114: As noted above, certain types of research may not require the consent of the research participant by virtue of a legal
p.000114: basis (e.g. research in public health emergencies) or because a REC has waived the requirement for consent (e.g.
p.000114: population based research). It should be noted that in the latter case, the waiver applies only to de-identified
p.000114: material/data.
p.000114: Waiver of consent is to be regarded as an exception to the rule and studies seeking waiver of consent
p.000114: must receive REC approval. Before a waiver of consent may be granted the researcher must satisfy the REC
p.000114: that:
p.000114:
p.000114: Page 91
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: • the overall benefit to research is real and substantial
p.000114:
p.000114: • the benefits from the research justify any risks of harm associated with not seeking consent;
p.000114: • it is impracticable to obtain consent (for example, due to the quantity, age or accessibility of records);
p.000114: • there is no known or likely reason for thinking that participants would not have consented if they had been
p.000114: asked;
p.000114: • there is sufficient protection of their privacy; and
p.000114:
p.000114: • there is an adequate plan to protect the confidentiality of data.
p.000114:
p.000114: It is important to note that the word “impracticable” refers to excessive difficulty or onerousness that jeopardises
p.000114: the conduct of the research as opposed to inconvenience.
p.000114:
p.000114:
p.000114:
p.000114: 13. Remuneration of research participants
p.000114:
p.000114:
p.000114: 13.1 Reimbursement
p.000114:
p.000114:
p.000114: Research participants may be reimbursed for lost earnings, travel costs and other expenses incurred.
p.000114: Another acceptable form of reimbursement might be the provision of free medical services. Compensation for
p.000114: the time and inconvenience involved in research participation (e.g. payment at minimum wage levels) might also
p.000114: be permissible as research participants should not be expected to bear the costs that relate to taking part in a
p.000114: study. However, it is important to note that compensation is understood to mean a recompense for losses sustained
p.000114: e.g. time away from work.
p.000114: Any reimbursements or compensation that might be offered to prospective participants should first be approved
p.000114: by a REC in order to ensure that they are reasonable and do not reflect any undue inducement by
p.000114: encouraging people to act against their better judgment or take unnecessary risks.
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: 13.2 Payment
p.000114:
p.000114:
p.000114: There may be instances where research participants will be paid for any inconvenience and time given to the study.
p.000114: Payment may be financial (not limited to reimbursement, compensation or nominal levels) or non-financial e.g.
p.000114: entry into prize draws, gift vouchers, book tokens. Payment that is disproportionate to the time involved or is likely
p.000114: to encourage participants to take risks, is ethically unacceptable. The timing of payments must be such that they do
p.000114: not constitute undue inducement.
p.000114: Where researchers wish to offer payment to prospective research participants, they must justify to a REC their
p.000114: reasons as well as the amount/reward being offered. Payments or rewards that undermine a person’s ability
p.000114: to exercise free choice would be deemed to invalidate his/her consent.
p.000114:
p.000114:
p.000114:
p.000114: 14. Audit
p.000114:
p.000114:
p.000114: In general, audit does not require informed consent. If audit is to be conducted by those involved in the care of the
p.000114: individual or their support staff (e.g. clinical audit staff) then explicit consent is not required provided that the
p.000114: individual:
p.000114: • has accessXtoXinformation outlining the possibility that their personal data may be disclosed for local
p.000114: clinical audit; and
p.000114: • has been given an opportunity to opt out.
p.000114:
p.000114: Where clinical audit is to be conducted by an external third party, then the data must be de-
p.000114: identified (therefore no consent would be required). In cases where identifiable data is necessary for clinical audit
p.000114: purposes, the data may only be disclosed to third parties with the explicit consent of the individuals
p.000114: concerned.
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Three—Research
p.000114:
p.000114:
p.000114: There are a number of key differences between audit and research:
p.000114:
p.000114: Research Audit
p.000114:
p.000114:
p.000114: Purpose
p.000114: To provide new knowledge e.g. to set or change clinical standards.
p.000114: To measure practice against evidence- based standards.
p.000114:
p.000114:
p.000114:
p.000114: Methodology
p.000114: Addresses clearly defined questions/hypotheses using systematic and rigorous processes. Designed so that it can be
p.000114: replicated and results can be generalised to other groups.
p.000114: Addresses clearly defined audit questions using a robust methodology, usually asking whether a specific standard has
p.000114: been met. Results are specific and local.
p.000114:
p.000114:
p.000114: Data Analysis
p.000114: Requires data analysis (i.e. quantitative/ qualitative) to make inferences.
p.000114: Simple statistics (e.g. means, frequencies) to compare audit cycles.
p.000114:
p.000114: Ethical Approval
p.000114: Required.
p.000114: May not be required.
p.000114:
p.000114:
p.000114: New Treatments
p.000114: May involve a completely new treatment or practice.
p.000114: Will never involve a completely new treatment or practice.
p.000114:
p.000114:
p.000114: Randomisation
p.000114: May involve allocating individuals randomly to different treatment groups.
p.000114: Will never involve allocating individuals randomly to different treatment groups.
p.000114:
p.000114: Sample Size
p.000114: Statistically powered calculation.
p.000114: Sufficient number of cases to influence practice based on findings.
p.000114:
p.000114:
p.000114: Outcome
p.000114: Improved knowledge.
p.000114: Strategies in place to improve clinical practice.
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114:
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p.000114:
p.000114:
p.000114: Part Four
p.000114: Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 1. Introduction
p.000114:
p.000114:
p.000114: Cardiopulmonary resuscitation (CPR), including chest compressions, defibrillation (with electric shocks), the
p.000114: injection of drugs and ventilation of the lungs, is an important and potentially life- saving intervention for victims
p.000114: of cardiorespiratory arrest. Positive developments in recent years that have resulted in improved outcomes include CPR
p.000114: training for the public and the widespread availability of automated external defibrillators.
p.000114: CPR, when instituted rapidly, is a valuable intervention for reducing the burden of sudden cardiac death. For this
p.000114: reason, when an individual’s expressed wishes regarding CPR are unknown and/or in an emergencyXsituation there is a
p.000114: presumption in favour of providing CPR. The likelihood of success with CPR depends on factors such as the
p.000114: underlying health status of the individual, the cause of the cardiac arrest, and how quickly CPR is started.
p.000114: However, it is important for both service providers and the public to be aware that the overall survival rate
p.000114: after CPR is relatively low: following cardiorespiratory arrest in a hospital the chances of surviving to hospital
p.000114: discharge are about 13-20%; following out of hospital cardiorespiratory arrest, the survival rate is lower.
p.000114: The success rate is particularly poor in those with severe acute non-cardiac illness or those with multiple chronic
p.000114: illnesses. There is a risk that the individual may be left with long-term brain damage and disability,
p.000114: especially if there is delay between cardiorespiratory arrest and the initiation of the CPR. Finally, CPR can
p.000114: be a relatively traumatic procedure and in extreme cases adverse effects may include bone fractures and organ rupture.
p.000114: These considerations have prompted extensive national and international debate regarding the appropriate use of this
p.000114: procedure. Existing local and regional guidelines in Ireland relating to CPR and do not attempt resuscitation (DNAR)
p.000114: orders show a lack of consistency in how resuscitation decisions are made and documented and a lack of clarity about
p.000114: the roles and responsibilities of different parties (i.e. the individual, those close to the individual if he/she is
p.000114: unable to participate and healthcare professionals) within the decision-making process. Hence, it is
p.000114: considered that there is a need for national guidelines in this area.
p.000114: It is acknowledged that no single policy or guidelines can address all the complex individual clinical
p.000114: situations that will arise in healthcare. This policy document discusses issues pertaining to CPR and DNAR orders
p.000114: within the broader context of consent. It is not intended as guidance for technical and practical considerations
p.000114: relating to resuscitation procedures; therefore, such issues are not dealt with in this policy.
p.000114:
p.000114:
p.000114:
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p.000114: validation against the controlled version
p.000114:
p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: The aim of the national policy is to provide a decision-making framework that will facilitate the advance discussion of
p.000114: personal preferences regarding CPR and DNAR orders and to ensure that decisions relating to CPR and DNAR orders are
p.000114: made consistently, transparently and in line with best practice. Where a decision is made to attempt CPR, it should be
p.000114: performed competently and any decision to restrict the extent and/or duration of the CPR attempt should be
p.000114: based on balancing the benefits and risks of continuing CPR. Unethical and inappropriate practices such as
p.000114: “slow-coding” and “sham resuscitations” where a full resuscitation is deliberately not attempted must not be performed.
p.000114: This policy document should be read in conjunction with other relevant guidance, including the Medical Council’s, Guide
p.000114: to Professional Conduct and Ethics for Registered Medical Practitioners (2009) and An Bord Altranais, The Code
p.000114: of Professional Conduct for each Nurse and Midwife (2009).
p.000114:
p.000114:
p.000114:
p.000114: 2. Definition and scope of resuscitation decisions
p.000114:
p.000114:
p.000114: 2.1 Do not attempt resuscitation or do not resuscitate
p.000114:
p.000114:
p.000114: Throughout this document the term “do not attempt resuscitation” (DNAR) orders will be used as opposed to “do not
p.000114: resuscitate” (DNR) orders. This change has been made in an effort to underscore the uncertainty surrounding
p.000114: the success of CPR: “do not resuscitate” may imply that resuscitation would likely be successful if it
p.000114: were undertaken, whereas “do not attempt resuscitation” emphasises that the success of any resuscitation
p.000114: intervention is less clear cut and situation dependent.
p.000114:
p.000114:
p.000114: 2.2 Scope of DNAR orders
p.000114:
p.000114:
p.000114: A decision not to attempt CPR applies only to CPR. It does not apply to any other aspect of treatment
p.000114: and all other treatments and care that are appropriate for the individual should continue. If a
p.000114: decision is made to restrict the nature or extent of CPR, this should be carefully documented and
p.000114: communicated effectively to all members of the healthcare team caring for the individual.
p.000114:
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114: However, while a decision may be made to attempt CPR in the event of cardiorespiratory arrest it may not be clinically
p.000114: appropriate to provide certain other intensive treatments and procedures. For example, prolonged support for
p.000114: multi-organ failure (e.g. artificial ventilation and renal dialysis) in an intensive care unit (ICU) may be
p.000114: clinically inappropriate if the individual is unlikely to survive this, even though his/her heart has been re-started.
p.000114: Decisions relating to CPR must be made separately for each individual based on an assessment of his/her case. An
p.000114: individual should not be obliged to put a DNAR order in place to gain admission to a long-stay care setting, such
p.000114: as a nursing home. Such an obligation could be seen as discriminatory and a breach of that individual’s
p.000114: autonomy.
p.000114: This policy is applicable to all those who provide services on behalf of the HSE, which includes the ambulance service,
p.000114: acute and community hospitals, long-stay care settings as well as individuals being cared for in their own homes.
p.000114:
p.000114:
p.000114:
p.000114: 3. General principles
p.000114:
p.000114:
p.000114: 3.1 Need for individual decision making
p.000114:
p.000114:
p.000114: Decisions about CPR must always be made on the basis of an individual assessment of each case and not, for example,
p.000114: on the basis of age, disability, the subjective views of healthcare professionals regarding the individual’s
p.000114: quality of life or whether he/she lives in the community or in long-term care. The individual’s own views and values
p.000114: are centrally important.
p.000114: In particular, individuals are the best judges of their own quality of life; healthcare professionals and families
p.000114: may underestimate the quality of life of, for example, those with disabilities. However, quality of life is
p.000114: not the main criterion on which resuscitation decisions should be based and it is also necessary to consider the
p.000114: likelihood of CPR being successful as well as balancing the benefits and risks involved.
p.000114:
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 3.2 Involving the individual in discussions regarding CPR
p.000114:
p.000114:
p.000114: Decisions pertaining to CPR and DNAR orders should be made in the context of the likelihood of success and the
p.000114: potential risks as well as the individual’s overall goals and preferences for his/her treatment and care.
p.000114: Determination of the former requires discussion with the individual him/ herself.
p.000114: Decisions relating to CPR and DNAR orders are complex and potentially emotive therefore, it is important for such
p.000114: issues to be dealt with in an open, honest and sensitive manner.
p.000114: On-going communication between individuals, those close to them (where appropriate) and healthcare
p.000114: professionals is essential in achieving this goal (see also Section 6.5).
p.000114:
p.000114:
p.000114: 3.3 Involving family or friends in discussions regarding CPR
p.000114:
p.000114:
p.000114: If the individual wishes to have the support or involvement of others, such as family or friends, in decision making,
p.000114: this should be respected. If a person has decision-making capacity then his/her family or friends should only be
p.000114: involved in discussions regarding his/her treatment and care with that individual’s consent. If the individual is
p.000114: unable to participate in discussions due to his/her physical or cognitive condition, those with a close,
...
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Situations may arise where a decision regarding CPR has to be made quickly and the most senior healthcare professional
p.000114: is unavailable. In such circumstances, decision-making responsibility can be delegated to other less senior
p.000114: healthcare professionals, who should notify and discuss with their senior colleague as soon as possible.
p.000114:
p.000114:
p.000114:
p.000114: 4. When should CPR and DNAR decisions be considered?
p.000114:
p.000114:
p.000114: Advance care planning, including making decisions about CPR, is an important part of good clinical care
p.000114: for those at risk of cardiorespiratory arrest and is preferable to making decisions only after a crisis has arisen.
p.000114: Hence, the likelihood of cardiorespiratory arrest occurring should be taken into account when determining
p.000114: how, when and if to consider the need for CPR/DNAR discussions or decisions for an individual. Three
p.000114: broad groups can be identified based on the likelihood of cardiorespiratory arrest within the foreseeable
p.000114: future:
p.000114: • Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114: • Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114: • Cardiorespiratory arrest is considered possible or likely.
p.000114:
p.000114:
p.000114: 4.1 Cardiorespiratory arrest is considered unlikely
p.000114:
p.000114:
p.000114: For most people, within the general population, the likelihood of cardiorespiratory arrest within a given period is
p.000114: very small. In general, these would be healthy individuals for whom cardiorespiratory arrest
p.000114: would represent an unanticipated emergencyXsituation. Moreover, given the low likelihood of arrest, it is unlikely that
p.000114: the issues of CPR and DNAR orders would have been raised previously with such individuals since healthcare
p.000114: professionals are not required to discuss every possible eventuality with every individual. Instead, the
p.000114: general presumption in favour of CPR should operate in the unlikely event of an arrest. However, if an individual
p.000114: indicates that he/ she wishes to discuss CPR, then this should be respected.
p.000114:
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p.000114: However, a small cohort of individuals within the general population may have prepared an advance
p.000114: healthcare directive refusing CPR under specific circumstances. The wishes of such individuals should be
p.000114: respected if the directive is considered valid and applicable to the situation that has arisen32.
p.000114:
p.000114: 4.2 Cardiorespiratory arrest, as a terminal event, is considered inevitable
p.000114:
p.000114:
p.000114: Some individuals may be so unwell that death is considered to be imminent and unavoidable. For such
p.000114: individuals, cardiorespiratory arrest may represent the terminal event in their illness and the provision of CPR
p.000114: would not be clinically indicated (i.e. would not restart the heart and maintain breathing for a
p.000114: sustained period). Attempting CPR in such circumstances may cause harm to the individual, increase his/her
p.000114: suffering and/or result in a traumatic and undignified death. In many cases, a sensitive but open discussion of
p.000114: end-of-life care will be possible in which individuals should be helped to understand the severity of their condition.
p.000114: However, it should be emphasised that this does not necessarily require explicit discussion of CPR or an ‘offer’ of
p.000114: CPR. Implementing a DNAR order for those close to death does not equate to “doing nothing”; all care provided should
p.000114: follow a palliative approach and focus on easing that individual’s suffering and making him/her as comfortable as
p.000114: possible.
p.000114:
p.000114:
p.000114: 4.3 Cardiorespiratory arrest is considered possible or likely
p.000114:
p.000114:
p.000114: For certain individuals there may be an identifiable risk of cardiorespiratory arrest occurring as a result of their
p.000114: clinical condition. These include individuals with acute severe illness and those with severe or multiple coexisting
p.000114: medical conditions or diseases.
p.000114: Advance care planning, including consideration of issues such as CPR/DNAR is often appropriate for such individuals and
p.000114: should occur in the context of a general discussion about the individual’s prognosis and the likelihood that CPR would
p.000114: be successful, as well as his/her values, concerns, expectations and goals of care.
p.000114:
p.000114: 32 There is currently no specific legislation pertaining to advance healthcare directives in Ireland. However, the
p.000114: Irish courts have established that an individual with capacity has the right to refuse treatment to facilitate a
p.000114: natural death. The weight of legal opinion has been interpreted to mean that an advance healthcare directive made by an
p.000114: individual, when he/she had capacity, would be upheld. In addition, the Medical Council Guide to Professional Conduct
p.000114: and Ethics for Registered Practitioners (2009) also recognises advance healthcare directives
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114:
p.000114: Most CPR discussions and decisions will occur in this group. However, it must be emphasised that this is not a
p.000114: homogenous group, as the likelihood of success from CPR varies widely, and this necessarily influences how
p.000114: discussions are conducted.
p.000114:
p.000114:
p.000114:
p.000114: 5. Presumption in favour of providing CPR
p.000114:
p.000114:
p.000114: As a general rule, if no advance decision not to perform CPR has been made, and the wishes of the individual are
p.000114: unknown and cannot be ascertained, there is a presumption in favour of providing CPR, and healthcare
p.000114: professionals should make all appropriate efforts to resuscitate him/her. In these circumstances, the extent
p.000114: and/or duration of the CPR attempt should be based on the clinical circumstances of the arrest, the progress
p.000114: of the resuscitation attempt and balancing the risks and benefits of continuing CPR.
p.000114: In some instances where CPR has been started, additional information may subsequently become available which makes
p.000114: continued CPR inappropriate, for example clinical information which indicates that CPR is unlikely to
p.000114: be successful, or information regarding the individual’s preferences.
p.000114: As was discussed in Section 4.2, there will be some individuals for whom no formal DNAR decision has been made, but
p.000114: where attempting CPR is clearly inappropriate because death is imminent and unavoidable, for example, in the final
p.000114: stages of a terminal illness. In these circumstances, it is reasonable for healthcare professionals not to
p.000114: commence CPR.
p.000114: Some healthcare facilities may not provide all aspects of CPR such as defibrillation. In the event of a
p.000114: cardiorespiratory arrest occurring in such a facility, basic CPR and a call to the emergency services
p.000114: should occur in the absence of a prior decision not to perform CPR. The extent of the CPR interventions available in
p.000114: such facilities should be notified to prospective residents or users of the facility, and if there is dissatisfaction
p.000114: with how cardiorespiratory arrests will be responded to then an alternative arrangement should be made if possible.
p.000114:
p.000114:
p.000114:
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p.000114: National Consent Policy HSE V.1.3
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: 6. Balancing the benefits and risks of providing CPR
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p.000114: The decision to use any treatment, including CPR, should be based on the balance of risks and benefits to
p.000114: the person receiving the treatment and on that individual’s own preferences and values. When discussing CPR
p.000114: with individuals, it is important to ensure that they understand the relevant benefits and risks. While
p.000114: acknowledging the uncertainty inherent in many medical predictions, healthcare professionals still have an
p.000114: obligation to provide an opinion, based on their expertise.
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p.000114: validation against the controlled version
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p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: Principles to be applied in reaching a decision about CPR33
p.000114:
p.000114: • Decisions about CPR must be made on the basis of an individual assessment of each person’s case.
p.000114: • The likely clinical outcome of attempting CPR should be considered, including the likelihood of
p.000114: successfully re-starting the individual’s heart and breathing for a sustained period, and the level of recovery
p.000114: that can reasonably be expected after successful CPR.
p.000114: • Advance care planning, including making decisions about CPR, is an important part of good clinical care for
p.000114: those at risk of cardiorespiratory arrest.
p.000114: • Communication and the provision of information in a sensitive manner are central to discussions about CPR
p.000114: and should be undertaken by the most senior healthcare professional available.
p.000114: • It is not necessary to initiate a discussion about CPR with an individual if there is no reason to believe
p.000114: that he/she is likely to suffer a cardiorespiratory arrest.
p.000114: • Where no explicit decision has been made in advance there should be an initial presumption in
p.000114: favour of CPR.
...
p.000114:
p.000114:
p.000114: 6.4 When there is disagreement about the balance of benefits and risks of CPR
p.000114:
p.000114:
p.000114: While in many cases, the individual and healthcare professional will agree that a DNAR order is appropriate or
p.000114: inappropriate; this may not always be the case.
p.000114: Many disagreements result from miscommunication and misunderstandings, such as an unrealistic
p.000114: expectation by an individual of the likely success rate of CPR or an underestimation by the healthcare professional of
p.000114: the acceptability of the current or predicted future quality of life of the individual. In many such cases, continued
p.000114: discussion will lead to agreement, and an ultimate decision should be deferred pending further discussion. If
p.000114: disagreement persists, an offer of a second, independent opinion should be made. Where all previous
p.000114: efforts at resolution have proven unsuccessful it may be necessary for parties to consider obtaining legal advice.
p.000114: The same procedure should be carried out if those close to an individual who lacks decision-making
p.000114: capacity do not accept a DNAR decision.
p.000114:
p.000114:
p.000114: 6.5 Where an individual does not want to discuss CPR and DNAR orders
p.000114:
p.000114:
p.000114: Situations may arise where an individual does not want to discuss CPR/DNAR orders. In some cases such
p.000114: refusals may be linked to the timing of the discussion and the individual should be given the opportunity
p.000114: to defer the discussion and revisit the issues of CPR and DNAR orders at a later time. However, if an individual
p.000114: refuses to participate in the discussion, his/her wishes should be respected. If the individual would prefer that the
p.000114: healthcare professional discuss the decision with somebody else such as a relative, partner or friend, this should be
p.000114: respected. However, it should be emphasised that the role of those close to the individual is not to
p.000114: make the final decision relating to CPR, but rather to help the senior healthcare professional to make the most
p.000114: appropriate decision.
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p.000114: National Consent Policy HSE V.1.3
p.000114:
p.000114:
p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
p.000114:
p.000114:
p.000114: 6.6 DNAR orders and readily reversible cardiorespiratory arrests
p.000114:
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p.000114: In certain situations, an individual with a DNAR order may suffer a cardiorespiratory arrest from a
p.000114: readily reversible cause unconnected to his/her underlying illness. In such cases CPR would be appropriate,
p.000114: while the reversible cause of arrest is treated. For example, choking restricts an individual’s intake of
p.000114: oxygen, which could potentially lead to a cardiorespiratory arrest if not treated promptly. The initial response should
p.000114: concentrate on removing the cause of the tracheal blockage, but in the event of a subsequent cardiorespiratory arrest,
p.000114: CPR should be provided.
p.000114: Where an individual with a DNAR order in place is to undergo a medical or surgical procedure, it may be appropriate
p.000114: to review the DNAR order given the potential for cardiorespiratory arrest to occur under anaesthesia. In such
p.000114: situations, should a cardiorespiratory arrest occur, there should be a presumption in favour of
p.000114: providing CPR. Therefore, in advance of procedures involving anaesthesia it may be advisable to temporarily
p.000114: suspend an individual’s DNAR order. The process of reviewing the DNAR order should involve discussion with
p.000114: the individual as part of the consent process in advance of the procedure. If the DNAR order is to be suspended this
p.000114: decision should be clearly documented as well as the time at which the DNAR order is to be
p.000114: re-instated. If an individual wishes his/her DNAR order to remain valid during the procedure, despite the
p.000114: increased likelihood of cardiorespiratory arrest, this might significantly increase the overall level of risk
p.000114: associated with the procedure. This issue of elevated risk should be highlighted to the individual, by his/her
p.000114: healthcare team, as part of the overall discussion regarding the procedure. However, if the individual is willing to
p.000114: accept the additional risk then the healthcare professional should continue with the procedure.
p.000114:
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p.000114: 7. DNAR decisions and children
p.000114:
p.000114:
p.000114: In any matter relating to children, the child’s best interests are of paramount importance34. This policy
p.000114: advocates for a child-centred approach to be taken in relation to any decision in the area of health and
p.000114: social care services as they relate to children.
p.000114:
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p.000114: 34 For a more detailed discussion regarding the issue of who can give consent on behalf of a child, see Part Two of
p.000114: this policy
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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p.000114: It is important that respect for the child’s autonomy is integrated into all decision-making in the same way as for
p.000114: adults.
p.000114: This does not mean that the interests and views of parent(s)/legal guardian(s) will be displaced, as in most instances
p.000114: the child’s interests will be best represented by its parent(s)/legal guardian(s), although their interests are not the
p.000114: same. However, respect for the autonomy of the child entails the facilitation, wherever possible, of the child’s right
p.000114: to make his/her own decisions.
p.000114: As discussed in Part Two of this policy, involving children in decision-making may be different from
p.000114: obtaining consent in the adult context due to the age or capacity of the child to understand and participate in the
p.000114: decision and the role of the parents/ legal guardians in decision-making. However, even where children
p.000114: are unable to give a valid consent for themselves, they should nonetheless be as involved as possible
p.000114: in decision-making as even young children may have opinions about their healthcare and have the right to have
p.000114: their views taken into consideration by giving their assent to the proposed treatment or service. This principle is in
p.000114: keeping with legal and international human rights standards and ethical guidance which provide that the child’s wishes
p.000114: should be taken into account and, as the child grows towards maturity, given more weight accordingly.
p.000114: Acting in children’s best interests generally involves sustaining their lives and restoring their health to
p.000114: an acceptable standard, which may include attempting CPR.
p.000114: In general, if a child suffers a cardiorespiratory arrest before a definite decision about
p.000114: resuscitation has been made there should be an initial presumption in favour of attempting CPR. However, situations
p.000114: may arise where attempting CPR is unlikely to be successful or the risks associated with CPR would
p.000114: significantly outweigh the benefits of providing it. In such circumstances attempting CPR may no longer
p.000114: be in the child’s best interests and a DNAR order should be put in place.
p.000114: Given the additional complexity and the emotionally-demanding nature of decisions relating to CPR for
p.000114: children this process should be underpinned by a number of fundamental guiding principles:
p.000114: • Parent(s)/legal guardian(s) and the healthcare team should work in partnership when deciding about
p.000114: CPR, with decisions being made on the basis of consensus
p.000114: • Where appropriate, given the child’s level of knowledge, understanding and experience,
p.000114: he/she should also be involved and participate in the decision-making partnership
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p.000114: • Therefore, children should be informed and listened to and their ascertainable views and preferences should
p.000114: be taken into consideration
p.000114: • The final decision reached should be in the best interests of the child.
p.000114:
p.000114: In some instances, consensus may be reached on a child’s proposed treatment and care plan following a
p.000114: detailed discussion about his/her condition and prognosis, the likelihood of CPR being successful as well as the
p.000114: benefits and risks associated with CPR. However, disagreements with parent(s)/legal guardian(s) may be more
p.000114: likely to arise where a healthcare professional considers that the provision of CPR would be clinically
p.000114: inappropriate. In such cases continued communication and obtaining a second opinion from an
p.000114: independent senior healthcare professional may help to resolve the disagreement. Nonetheless, if the
p.000114: disagreement persists, healthcare professionals should seek ethical and legal advice and court involvement
p.000114: may ultimately be required to reach a solution.
p.000114:
p.000114:
p.000114:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| age | Age |
| arrest | person under arrest |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| blind | visual impairment |
| blindness | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| coerced | Presence of Coercion |
| cognitive | Cognitive Impairment |
| coma | Comatose |
| criminal | criminal |
| dependency | Drug Dependence |
| dependent | Dependent |
| detained | person in detention center |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| displaced | displaced |
| drug | Drug Usage |
| ease of access | Ease of Access |
| education | education |
| educational | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| employees | employees |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| freedomXofXinformation | Access to information |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| ill | ill |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapacitated | Incapacitated |
| incapacity | Incapacitated |
| influence | Drug Usage |
| injured | injured |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| literacy | Literacy |
| manipulate | Manipulable |
| married | Marital Status |
| military | Soldier |
| minor | Youth/Minors |
| neonates | Fetus/Neonate |
| nursing home | In Nursing Home |
| officer | Police Officer |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| parent | parents |
| parents | parents |
| party | political affiliation |
| poor | Economic/Poverty |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| religious | Religion |
| single | Marital Status |
| terminal | Terminally Ill |
| terminally | Terminally Ill |
| threat | Threat of Stigma |
| tri-council | tri-council policy statement |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| visually impaired | visual impairment |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| access to information | ['freedomXofXinformation'] |
| blind | ['blindness', 'visuallyXimpaired'] |
| blindness | ['blind', 'visuallyXimpaired'] |
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired', 'impairment'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| emergencies | ['emergencyXsituation'] |
| emergency situation | ['emergencies'] |
| foetus | ['neonates'] |
| freedomXofXinformation | ['accessXtoXinformation'] |
| impaired | ['cognitive', 'impairment'] |
| impairment | ['cognitive', 'impaired'] |
| incapacitated | ['incapacity'] |
| incapacity | ['incapacitated'] |
| influence | ['drug'] |
| married | ['single'] |
| minor | ['youth'] |
| neonates | ['foetus'] |
| parent | ['parents'] |
| parents | ['parent'] |
| single | ['married'] |
| terminal | ['terminally'] |
| terminally | ['terminal'] |
| visually impaired | ['blind', 'blindness'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
| youth | ['minor'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input