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

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsprisoners1
Politicalcriminalcriminal8
Politicaldisplaceddisplaced2
Politicalperson in detention centerdetained3
Politicalperson under arrestarrest44
Politicalpolitical affiliationparty9
Politicalvulnerablevulnerable8
Politicalvulnerablevulnerability4
HealthCognitive Impairmentcognitive8
HealthCognitive Impairmentimpaired2
HealthCognitive Impairmentimpairment4
HealthComatosecoma1
HealthDrug Dependencedependency2
HealthDrug Usagedrug1
HealthDrug Usageinfluence7
HealthHealthy Peoplevolunteers1
HealthMentally Disableddisability13
HealthMotherhood/Familyfamily26
HealthPhysically Disabledillness12
HealthPregnantpregnant2
HealthTerminally Illterminally2
HealthTerminally Illterminal5
Healthillill2
Healthinjuredinjured1
Healthpatients in emergency situationsemergencies6
Healthpatients in emergency situationsemergency situation2
Healthvisual impairmentblind2
Healthvisual impairmentblindness1
Healthvisual impairmentvisually impaired2
SocialAccess to Social Goodsaccess16
SocialAccess to informationaccess to information1
SocialAccess to informationfreedomXofXinformation2
SocialAgeage50
SocialChildchild165
SocialChildchildren112
SocialElderlyelderly2
SocialFetus/Neonatefoetus4
SocialFetus/Neonateneonates3
SocialIn Nursing Homenursing home1
SocialIncarceratedliberty2
SocialLinguistic Proficiencylanguage11
SocialLiteracyliteracy2
SocialMarital Statusmarried7
SocialMarital Statussingle2
SocialPolice Officerofficer7
SocialPresence of Coercioncoerced1
SocialProperty Ownershiphome8
SocialReligionreligious2
SocialSoldiermilitary1
SocialThreat of Stigmathreat2
SocialTrade Union Membershipunion2
SocialVictim of Abuseabuse1
SocialYouth/Minorsminor34
SocialYouth/Minorsyouth3
Socialeducationeducation4
Socialeducationeducational1
Socialembryoembryo1
Socialemployeesemployees1
Socialparentsparent76
Socialparentsparents33
Socialphilosophical differences/differences of opinionopinion10
EconomicEconomic/Povertypoor1
General/OtherDependentdependent14
General/OtherDiminished Autonomydiminished1
General/OtherEase of Accessease of access1
General/OtherImpaired Autonomyautonomy11
General/OtherIncapacitatedincapacitated1
General/OtherIncapacitatedincapacity8
General/OtherManipulablemanipulate1
General/OtherPublic Emergencyemergency23
General/OtherRelationship to Authorityauthority11
General/OtherUndue Influenceundue influence1
General/Othercioms guidelinescioms2
General/Otherdeclaration of helsinkihelsinki1
General/Otheroviedooviedo1
General/Othertri-council policy statementtri-council1

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.
p.000114:
p.000114:
p.000114:
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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.
...

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.
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:
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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:
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p.000114: 1.5 Age of consent in Irish law
p.000114:
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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.
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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 One—General Principles
p.000114:
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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.
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.
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p.000114: 14 As specified in the Act
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p.000114: Page 44
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: 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.
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
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: • 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:
p.000114: 23 or any other relevant legislation or national guidelines
p.000114:
p.000114: Page 62
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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:
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Political / displaced

Searching for indicator displaced:

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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
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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:
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
...

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:
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: 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
...

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
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.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:
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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:
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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:
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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
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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: 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
p.000114:
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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.
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:
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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)
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
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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:
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:
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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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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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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: • 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:
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:
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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 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.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:
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: 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:
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:
...

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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:
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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:
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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
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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:
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.
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
...

Political / vulnerable

Searching for indicator vulnerable:

(return to top)
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:

(return to top)
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:

(return to top)
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:
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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:
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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: 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:

(return to top)
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:

(return to top)
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:

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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:
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p.000055:
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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:
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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: 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:
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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:
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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:
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Health / Healthy People

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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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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.
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Health / Mentally Disabled

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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.
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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: 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.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:
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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:
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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:
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:
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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:
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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:
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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: 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:
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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:
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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,
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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
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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:
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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:
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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:
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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: 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:
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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:
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p.000114: 7.6 Confidentiality and data protection
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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.
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p.000114: 11 See Part Three section 9 for provisions relating to confidentiality and data protection in the context of research
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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.
p.000114:
p.000114:
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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:
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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: 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: 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: National Consent Policy HSE V.1.3
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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
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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: 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:
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).
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p.000114: Part Four—Do Not Attempt Resuscitation (DNAR)
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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:
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: 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: 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
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:
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: 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:
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:
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
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:
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:
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:
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:
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
...

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:
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:
...

Searching for indicator terminal:

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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
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.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:
p.000114: Page 103
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
p.000114:
p.000114:
p.000114:
p.000114: Page 105
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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
...

Health / ill

Searching for indicator ill:

(return to top)
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
...

Health / injured

Searching for indicator injured:

(return to top)
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: 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
...

Health / patients in emergency situations

Searching for indicator emergencies:

(return to top)
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:
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.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: 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:
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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 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:
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;
...

Searching for indicator emergency situation:

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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:
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 96
p.000114:
p.000114: This is a controlled 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:
p.000114:
p.000114:
p.000114:
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:
p.000114: Page 103
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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

Searching for indicator blind:

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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
...

Searching for indicator blindness:

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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:
...

Searching for indicator visually impaired:

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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:
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:
...

Social / Access to Social Goods

Searching for indicator access:

(return to top)
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
...

Social / Access to information

Searching for indicator access to information:

(return to top)
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:

(return to top)
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:

(return to top)
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:
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:
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:
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: 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
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:
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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: 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:
p.000114: Page 48
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
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: 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: 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: 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:
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:
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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:
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
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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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
p.000114: 23 or any other relevant legislation or national guidelines
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:
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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:
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: 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:
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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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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: 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.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: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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 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:
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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: 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:
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: 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:
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
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Social / Child

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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
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.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:
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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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
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:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
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:
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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:
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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: 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:
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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:
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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: 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:
p.000114: Page 51
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore 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:
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
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
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:
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:
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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:
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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: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
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:
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: 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:
p.000114: Page 90
p.000114:
p.000114: This is a controlled document. Any printed version should be considered “uncontrolled”, and is therefore subject to
p.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:
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)
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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
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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
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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:
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
...

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:
p.000113:
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:
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:
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.
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p.000114: Section 1.4 of this Policy.
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p.000114:
p.000114: National Consent Policy HSE V.1.3
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
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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: 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.
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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.
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: 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:
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: 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: 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:
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: 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: 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:
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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 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
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:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
p.000114:
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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.
p.000114:
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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: 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: 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.
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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:
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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:
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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.
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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:
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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:
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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: • 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:
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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: 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:
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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: • 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.
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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:
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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)
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:
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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:

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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:

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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 acc