79C3C34C52B45572883A05D425EB0F82
Ethical Guidelines for ObservationalStudies: Observational Research, Audits and Related Activities (2012))
https://www.moh.govt.nz/notebook/nbbooks.nsf/0/F21C6588D45EBA67CC257A600009C6C7/$file/ethical-guidelines-for-observational-studies-2012.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
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p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
...
Political / Illegal Activity
Searching for indicator illegal:
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p.000022:
p.000022: 7.3 See also the HIPC, Rule 10 and Privacy Act 1993, Principle 10.
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p.000022: 20 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 8 Confidentiality of data
p.000022:
p.000022: General considerations
p.000022:
p.000022: 8.1 Observational studies may involve collecting and storing personal information relating to individuals and
p.000022: groups, and such data, if disclosed to third parties, may cause harm or distress.
p.000022:
p.000022: 8.2 Investigators should arrange to protect the confidentiality of such data by, for example, omitting
p.000022: information that might lead to the identification of individual participants, or limiting access to the data, or by
p.000022: other means.
p.000022:
p.000022: 8.3 Investigators are required to ensure the adequate physical and electronic security of data.
p.000022:
p.000022: 8.4 For studies involving the collection of information about illegal activities – for example, the use of
p.000022: illegal substances – potential participants should be made aware of whether investigators can or cannot ensure
p.000022: confidentiality.
p.000022:
p.000022: 8.5 Identified or potentially identifiable personal data should not be used when the study could be done
p.000022: without personal identification (for example, by key coding or unlinking the data).
p.000022:
p.000022: 8.6 When personal identifiers remain on records used for a study, investigators should be able to justify this
p.000022: and ensure confidentiality will be protected.
p.000022:
p.000022: 8.7 In the unusual event that group confidentiality cannot be maintained or is violated, investigators should
p.000022: take all reasonable steps to maintain or restore a group’s good name and status.
p.000022:
p.000022: 8.8 Audits or related activities should be conducted by people who are under a professional or an employment
p.000022: obligation to maintain patient confidentiality. Such activity may be initiated from outside the organisation or by the
p.000022: organisation itself, and may be conducted by the organisation (an internal audit or related activity) or by a party
p.000022: external to it (an external audit or related activity).
p.000022:
p.000022: 8.9 Note that ‘privacy’ is the status of information about aspects of a person’s life over which he or she
p.000022: claims control and may wish to exclude others from knowing. Privacy is a relative status, and claims to it must be
p.000022: negotiated against countering claims, such as the rights of others or collective societal goods. ‘Confidentiality’ is
p.000022: the respectful handling of information disclosed within relationships of trust, especially as regards further
p.000022: disclosure (Lowrance 2002).
p.000022:
...
Political / Indigenous
Searching for indicator indigenous:
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p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
p.000022: concerned, including appropriate whānau, hapū or iwi. He Korowai Oranga states: ‘Comprehensive, high-quality Māori
p.000022: health research and information is necessary to inform the Government and to assist whānau, hapū and iwi to determine
p.000022: and provide for their own health priorities’ (Minister of Health and Associate Minister of Health 2002, p 23).
p.000022:
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p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
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p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
p.000022:
p.000022: Beneficence and non-maleficence
p.000022:
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Political / political affiliation
Searching for indicator party:
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p.000003: Foreword to the 2006 edition iv
p.000003: 1 Introduction 1
p.000003: 2 Guidelines scope and definitions 3
p.000003: Types of observational research
p.000003: 3
p.000003: Types of audit or related activity
p.000004: 4
p.000004: 3 Ethics of observational studies 6
p.000004: Worth of observational studies
p.000006: 6
p.000006: Ethical requirements of observational studies
p.000006: 6
p.000006: 4 Underlying ethical considerations 8
p.000006: Respect for people
p.000008: 8
p.000008: Māori and ethical considerations
p.000008: 8
p.000008: Justice
p.000009: 9
p.000009: Beneficence and non-maleficence
p.000009: 9
p.000009: Integrity
p.000010: 10
p.000010: Diversity
p.000010: 10
p.000010: Conflict of interest
p.000010: 10
p.000010: 5 Design of study and protocol 11
p.000010: Study question
p.000011: 11
p.000011: Study design
p.000011: 11
p.000011: Scientifically sound
p.000011: 11
p.000011: Skills and resources
p.000012: 12
p.000012: Protocol
p.000012: 12
p.000012: 6 Collecting health information 13
p.000012: Identifiability of health information
p.000013: 13
p.000013: Collection of health information directly from individuals
p.000014: 14
p.000014: Collection of health information from a third party
p.000018: 18
p.000018: 7 Use of information 20
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p.000018:
p.000018: Ethical Guidelines for Observational Studies: Observational research, audits and related activities v
p.000018:
p.000018: 8 Confidentiality of data 21
p.000018: General considerations
p.000021: 21
p.000021: Record linkage
p.000022: 22
p.000022: 9 When to reveal information obtained by observational studies 23
p.000022: 10 Communicating study results 24
p.000022: 11 Features of observational studies that pose more than minimal risk 25
p.000022: 12 Additional points 27
p.000022: Bibliography 28
p.000022: Appendix: Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the
p.000022: scientific validity of
p.000022: research 30
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p.000022: vi Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 1 Introduction
p.000022:
...
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
p.000022: b) the injustice that would arise from their exclusion from the benefits of observational studies in these groups.
p.000022: (See also the Code of Rights, Right 7(3): ‘Where a consumer has diminished competence, that consumer retains the right
p.000022: to make informed choices and give informed consent, to the extent appropriate to his or her level of competence’.)
p.000022:
p.000022: 6.20 Subject to applicable legal requirements, individuals who are not legally competent may be asked to become
p.000022: participants in observational research only when the study question can only be addressed:
p.000022: a) with the participation of those individuals from identified group(s); and
p.000022: b) when free and informed consent is sought from their legal representative(s), such as a welfare guardian or a
p.000022: representative with enduring power of attorney.
p.000022: (See also the Code of Rights, Right 7(4).)
p.000022:
p.000022: 6.21 When free and informed consent has been obtained from an authorised third party, and in those circumstances
p.000022: where the legally incompetent individual understands the nature and consequences of the study, the investigator must
p.000022: seek to ascertain the individual’s wishes concerning his or her participation. The potential participant’s dissent will
p.000022: preclude his or her participation.
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p.000022: Inducements
p.000022:
p.000022: 6.22 Investigators may seek to create legitimate motivation for participation in studies, but may not exert
p.000022: pressure by offering inappropriate inducements.
p.000022:
p.000022: 6.23 Risks involved in participation should be acceptable to participants even in the absence of inducement.
p.000022:
p.000022: 6.24 It is acceptable for investigators to repay the incurred expenses of participants (for example, travel
p.000022: costs).
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p.000022: 16 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.25 A koha may be offered in line with the cultural norms of the study participants, but should not be of such a
p.000022: value that it could reasonably be interpreted as an inappropriate inducement or as a payment for participation. For
p.000022: this reason, it is often not appropriate to discuss koha before getting an agreement to participate. (Traditionally,
p.000022: koha is an acknowledgement of the knowledge and/or hospitality extended by tāngata whenua to manuhiri. It is presented
p.000022: as part of the pōwhiri onto a marae or other venue of the tāngata whenua. However, the definition of koha should not be
p.000022: restricted by reference to its traditional roots; contemporary meanings include the giving of koha in a different
p.000022: manner during research.)
p.000022:
p.000022:
p.000022: Documentation
p.000022:
p.000022: 6.26 Evidence of free and informed consent by a participant or authorised third party should ordinarily be
p.000022: obtained in writing.
p.000022:
p.000022: 6.27 When written consent is culturally unacceptable or good reasons exist for not recording consent in writing
p.000022: (such as in the case of anonymous data collection or telephone interviews), the procedures used to seek free and
p.000022: informed consent should be documented.
p.000022:
p.000022: 6.28 Questionnaires are often innocuous, and may even be offered by mail. Completion of the questionnaire can be
p.000022: taken as consent, provided the letter of invitation expressly leaves the participant free of obligation.
p.000022:
p.000022: 6.29 Some studies may involve interviews or questionnaires that are intrusive and may cause distress. In this
p.000022: case, it is appropriate to seek participants’ prior consent by forewarning them of the potentially distressing nature
p.000022: of participation.
p.000022:
p.000022:
p.000022: Collective consent
p.000022:
p.000022: 6.30 For communities in which collective decision-making is customary, communal leaders can express the
p.000022: collective will. However, the agreement or refusal of individuals to participate in a study has to be respected: a
p.000022: leader may express agreement or refusal on behalf of a community, but an individual’s agreement or refusal of personal
p.000022: participation is binding. When an individual wishes to participate in a study that community leaders have objected to,
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p.000022: study are expected. In addition, a system of accountability of the investigators to the whānau, hapū or iwi concerned
p.000022: should be instituted after full discussion with and agreement by the participants and investigators. A group’s right to
p.000022: decline to have a study proceed within their whānau, hapū or iwi if the study is unacceptable to them is paramount.
p.000022:
p.000022: 6.34 Not all Māori have contact with whānau, hapū or iwi, and the usual requirements for fully informed consent
p.000022: to participate in a study proposal will be expected in such cases.
p.000022:
p.000022: 6.35 When it is not possible to request informed consent from every individual to be studied (for example, in a
p.000022: community study of the effects of water fluoridation), the agreement of a representative of a community or group may be
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
p.000022:
p.000022: 6.39 Investigators should be aware that access to health information is subject to the HIPC, and that access to
p.000022: personal information is subject to the Privacy Act 1993. Access to personal information may also be subject to the
p.000022: Official Information Act 1982.
p.000022:
p.000022: 6.40 A named investigator to whom records are disclosed should give a written undertaking to ensure the
p.000022: confidentiality of the records.
p.000022:
p.000022:
p.000022:
p.000022: 18 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.41 In the case of records involving Māori health information, where a kaitiaki group has been established to
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
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p.000022: information that might lead to the identification of individual participants, or limiting access to the data, or by
p.000022: other means.
p.000022:
p.000022: 8.3 Investigators are required to ensure the adequate physical and electronic security of data.
p.000022:
p.000022: 8.4 For studies involving the collection of information about illegal activities – for example, the use of
p.000022: illegal substances – potential participants should be made aware of whether investigators can or cannot ensure
p.000022: confidentiality.
p.000022:
p.000022: 8.5 Identified or potentially identifiable personal data should not be used when the study could be done
p.000022: without personal identification (for example, by key coding or unlinking the data).
p.000022:
p.000022: 8.6 When personal identifiers remain on records used for a study, investigators should be able to justify this
p.000022: and ensure confidentiality will be protected.
p.000022:
p.000022: 8.7 In the unusual event that group confidentiality cannot be maintained or is violated, investigators should
p.000022: take all reasonable steps to maintain or restore a group’s good name and status.
p.000022:
p.000022: 8.8 Audits or related activities should be conducted by people who are under a professional or an employment
p.000022: obligation to maintain patient confidentiality. Such activity may be initiated from outside the organisation or by the
p.000022: organisation itself, and may be conducted by the organisation (an internal audit or related activity) or by a party
p.000022: external to it (an external audit or related activity).
p.000022:
p.000022: 8.9 Note that ‘privacy’ is the status of information about aspects of a person’s life over which he or she
p.000022: claims control and may wish to exclude others from knowing. Privacy is a relative status, and claims to it must be
p.000022: negotiated against countering claims, such as the rights of others or collective societal goods. ‘Confidentiality’ is
p.000022: the respectful handling of information disclosed within relationships of trust, especially as regards further
p.000022: disclosure (Lowrance 2002).
p.000022:
p.000022: 8.10 See also HIPC, Rules 5 and 11 and Privacy Act 1993, Principles 5 and 11.
p.000022:
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 21
p.000022:
p.000022: Record linkage
p.000022:
p.000022: 8.11 An investigator must justify to an ethics committee any observational study that involves linkage between
p.000022: records without consent, where participants are identified or are potentially identifiable, on the basis of the
p.000022: following principles:
p.000022: a) the identity of participants is not disclosed except for the purposes of the record linkage and is not retained
p.000022: once record linkage has been completed; and
p.000022: b) identifying information is used with sufficient security; and
p.000022: c) the research has potential to benefit the public.
p.000022:
p.000022: 8.12 In the case of audits and related activities, the use of record linkages without specific or additional
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Searching for indicator political:
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p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 17
p.000022:
p.000022: 6.32 An individual’s right to decline to participate in the study, expressed in hui, should also be noted. The
p.000022: statement of group consent obtained in hui should allow for study participants to withdraw at any time from the study
p.000022: if they so wish.
p.000022:
p.000022: 6.33 When a study is initiated from outside the whānau, hapū or iwi, or when the investigators do not have a
p.000022: representative from that group within their number, the usual procedures for informed consent to participate in the
p.000022: study are expected. In addition, a system of accountability of the investigators to the whānau, hapū or iwi concerned
p.000022: should be instituted after full discussion with and agreement by the participants and investigators. A group’s right to
p.000022: decline to have a study proceed within their whānau, hapū or iwi if the study is unacceptable to them is paramount.
p.000022:
p.000022: 6.34 Not all Māori have contact with whānau, hapū or iwi, and the usual requirements for fully informed consent
p.000022: to participate in a study proposal will be expected in such cases.
p.000022:
p.000022: 6.35 When it is not possible to request informed consent from every individual to be studied (for example, in a
p.000022: community study of the effects of water fluoridation), the agreement of a representative of a community or group may be
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
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Political / vulnerable
Searching for indicator vulnerable:
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 7
p.000022:
p.000022: 4 Underlying ethical considerations
p.000022:
p.000022: 4.1 The following considerations are important to the ethics of observational studies. The application and
p.000022: weighting of these considerations will vary depending on the nature and particular circumstances of the observational
p.000022: study in question.
p.000022:
p.000022:
p.000022: Respect for people
p.000022:
p.000022: 4.2 Respect for people, and for their rights, incorporates at least two fundamental principles:
p.000022: a) autonomy, which requires that people who are capable of deliberation about their personal goals should be
p.000022: treated with respect for their capacity for self- determination
p.000022: b) protection of people with impaired or diminished autonomy, which requires that people who are dependent or
p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
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p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
p.000022: concerned, including appropriate whānau, hapū or iwi. He Korowai Oranga states: ‘Comprehensive, high-quality Māori
p.000022: health research and information is necessary to inform the Government and to assist whānau, hapū and iwi to determine
p.000022: and provide for their own health priorities’ (Minister of Health and Associate Minister of Health 2002, p 23).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
p.000022:
p.000022: Beneficence and non-maleficence
p.000022:
p.000022: 4.9 The risks of a study should be reasonable in the light of the expected benefits.
p.000022:
p.000022: 4.10 Investigators should consider the features of a proposed study in the light of ethical considerations, and
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
p.000022:
...
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Human Tissue Act 2008,
p.000022: section 20(f) or the Code of Rights, Right 7(10)(c)) applies
p.000022: • where stored samples are used by health professionals undertaking one or more of the following activities to
p.000022: assure or improve the quality of services:
p.000022: a) a professionally recognised quality assurance programme (for example, pathologists re-reading specimens to check
p.000022: the accuracy of their own or a peer’s work)
p.000022: b) an external audit of services
p.000022: c) an external evaluation of services.
p.000022:
p.000022: The justification for this is that the use is related to the primary purpose of the sample collection. See the Code of
p.000022: Rights, Right 7(10).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 25
p.000022:
p.000022: 11.5 Secondary use of identifiable health information without consent
p.000022: Investigator use of identifiable health information that was primarily collected for clinical care for a secondary
p.000022: purpose without consent constitutes a more than minimal risk activity.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
p.000022: a more than minimal risk activity, and does not trigger any requirement for ethics committee review. Any investigator
...
Searching for indicator vulnerability:
(return to top)
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
p.000022: refusal to participate in, or decision to withdraw from, the study will not result in discrimination, a reduced level
p.000022: of care or any other disadvantage.
p.000022:
p.000022:
p.000022: People with diminished competence to give consent
p.000022:
p.000022: 6.19 Ethical consideration of studies involving individuals or groups who have diminished competence to give free
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
p.000022: b) the injustice that would arise from their exclusion from the benefits of observational studies in these groups.
p.000022: (See also the Code of Rights, Right 7(3): ‘Where a consumer has diminished competence, that consumer retains the right
p.000022: to make informed choices and give informed consent, to the extent appropriate to his or her level of competence’.)
p.000022:
p.000022: 6.20 Subject to applicable legal requirements, individuals who are not legally competent may be asked to become
p.000022: participants in observational research only when the study question can only be addressed:
p.000022: a) with the participation of those individuals from identified group(s); and
p.000022: b) when free and informed consent is sought from their legal representative(s), such as a welfare guardian or a
p.000022: representative with enduring power of attorney.
p.000022: (See also the Code of Rights, Right 7(4).)
p.000022:
p.000022: 6.21 When free and informed consent has been obtained from an authorised third party, and in those circumstances
p.000022: where the legally incompetent individual understands the nature and consequences of the study, the investigator must
p.000022: seek to ascertain the individual’s wishes concerning his or her participation. The potential participant’s dissent will
p.000022: preclude his or her participation.
p.000022:
p.000022:
p.000022: Inducements
p.000022:
...
p.000022: assure or improve the quality of services:
p.000022: a) a professionally recognised quality assurance programme (for example, pathologists re-reading specimens to check
p.000022: the accuracy of their own or a peer’s work)
p.000022: b) an external audit of services
p.000022: c) an external evaluation of services.
p.000022:
p.000022: The justification for this is that the use is related to the primary purpose of the sample collection. See the Code of
p.000022: Rights, Right 7(10).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 25
p.000022:
p.000022: 11.5 Secondary use of identifiable health information without consent
p.000022: Investigator use of identifiable health information that was primarily collected for clinical care for a secondary
p.000022: purpose without consent constitutes a more than minimal risk activity.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
...
Health / Cognitive Impairment
Searching for indicator impaired:
(return to top)
p.000022: the activity and gives the investigator immunity from civil liability. See also Protected Quality Assurance Activities
p.000022: under the Health Practitioners Competence Assurance Act 2003 (Ministry of Health 2004).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 7
p.000022:
p.000022: 4 Underlying ethical considerations
p.000022:
p.000022: 4.1 The following considerations are important to the ethics of observational studies. The application and
p.000022: weighting of these considerations will vary depending on the nature and particular circumstances of the observational
p.000022: study in question.
p.000022:
p.000022:
p.000022: Respect for people
p.000022:
p.000022: 4.2 Respect for people, and for their rights, incorporates at least two fundamental principles:
p.000022: a) autonomy, which requires that people who are capable of deliberation about their personal goals should be
p.000022: treated with respect for their capacity for self- determination
p.000022: b) protection of people with impaired or diminished autonomy, which requires that people who are dependent or
p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
p.000022:
p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000022: be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any
p.000022: enactment, or the common law, or any other provision of this code provides otherwise’).
p.000022:
p.000022: 6.11 Informed consent has two basic components.
p.000022: a) The decision is informed by adequate understanding of any information that is relevant to that decision.
p.000022: b) The decision is voluntary, and is therefore free from undue influence such as manipulation or coercion.
p.000022: (See also the Code of Rights, Right 2: ‘Every consumer has the right to be free from discrimination, coercion,
p.000022: harassment, and sexual, financial or other exploitation’.)
p.000022:
p.000022: 6.12 Information about the purpose of the study should be as specific as possible without compromising the
p.000022: validity of the study.
p.000022:
p.000022: 6.13 In some situations, providing very specific information about the study in advance of seeking consent would
p.000022: prejudice the purposes of the collection by compromising the scientific validity of the study. For example, if a mother
p.000022: is to be interviewed to establish whether she has been exposed to a particular medicine that might have caused a
p.000022: congenital abnormality in her baby, it would be wrong, when asking her to consent to the study, to give her the name of
p.000022: the drug in question. If the name of the drug were disclosed, this may have at least one scientifically unacceptable
p.000022: consequence, in that the information collected may be biased. This is because if the mother in question had a baby with
p.000022: a birth defect, she would have had both a reason and a longer period of time, in advance of the actual interview, to
p.000022: remember that she had been exposed to the drug.
p.000022:
p.000022: 6.14 In contrast, a mother of a healthy baby would have less reason to remember past exposure, and would not
p.000022: reflect on possible past exposure during the period between the consent procedure and the actual interview. This effect
p.000022: could lead to a spurious association between birth defects and drug exposure in the mothers interviewed; thus, if such
p.000022: an association were found, the finding could be scientifically invalid. In studies such as this, biased reporting can
p.000022: be minimised, and scientific validity assured, only by not disclosing in advance the complete details of the hypothesis
p.000022: under test (HRC 2002a, p 38).
p.000022:
p.000022: 6.15 When specific information cannot be provided at the outset, the investigator should offer to provide results
p.000022: to participants. (See also the Code of Rights, Right 6(3)(d): ‘Every consumer has the right to honest and accurate
p.000022: answers to questions relating to services, including questions about … the results of research’.)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
...
p.000022:
p.000022:
p.000022: Consent
p.000022:
p.000022: 6.42 The consent of participants should generally be obtained for using identified or potentially identifiable
p.000022: data for research.
p.000022:
p.000022:
p.000022: Collection of health information without consent
p.000022:
p.000022: 6.43 Access to identified or potentially identifiable data for research without the consent of the people the
p.000022: data identifies or makes potentially identifiable may be justifiable when:
p.000022: a) the procedures required to obtain consent are likely to cause unnecessary anxiety for those whose consent would
p.000022: be sought; or the requirement for consent would prejudice the scientific value of the study; or it is impossible in
p.000022: practice to obtain consent due to the quantity or age of the records; and
p.000022: b) there would be no disadvantage to the participants or their relatives or to any collectivities involved; and
p.000022: c) the public interest in the study outweighs the public interest in privacy.
p.000022:
p.000022: 6.44 An example of when the procedures required to obtain consent were likely to cause unnecessary anxiety is a
p.000022: study of the use of an asthma drug as a possible cause of sudden deaths from asthma. This study compared the medical
p.000022: records of individuals who had died from asthma with the records of asthmatics who had been admitted to hospital but
p.000022: had not died. It would have been wrong to have sought the consent of the group who had not died, because informing
p.000022: these people of an untested hypothesis might have frightened and distressed them without good cause (HRC 2002a, p 37).
p.000022:
p.000022: 6.45 An investigator who proposes not to seek informed consent for use of identified or potentially identifiable
p.000022: data for research must explain to an ethics committee the reasons for not seeking consent, and how the study would be
p.000022: ethical in the absence of consent.
p.000022:
p.000022: 6.46 The investigator must show how safeguards will be maintained to protect confidentiality, and that the study
p.000022: has the goal of protecting or advancing health.
p.000022:
p.000022: 6.47 In the case of audits and related activities it may be ethical to use health information without additional
p.000022: or specific consent, as these activities are sometimes an essential part of high-quality health care delivery, so the
p.000022: activity may be one of the reasons why the data were collected.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 19
p.000022:
...
Searching for indicator substance:
(return to top)
p.000022: verifiable scientific merit. Peer review of scientific validity may include consideration of cultural relevance and
p.000022: appropriateness.
p.000022: • Peer review delivers an objective opinion: Those acting in the capacity of reviewers are charged with delivering a
p.000022: balanced and considered analysis of the research. Generally, the success of the peer review process is determined by
p.000022: the extent to which these evaluations can be considered free of bias, equitable and fair. Objectivity can be
p.000022: compromised if peer reviewers have conflicts of interest, and so appropriate peer reviewers typically will not be
p.000022: materially connected to the researcher(s) in a way that might undermine objectivity, and be free from either positive
p.000022: or negative inducements.
p.000022: • A consensus opinion on scientific validity is formed: An HDEC will need to receive assurance that the peer review
p.000022: process has delivered support for the scientific validity of the proposed research. When a peer review process has
p.000022: engaged a range of experts, there needs to be a process that leads to a consensus opinion about the quality of the
p.000022: research.
p.000022: • Intellectual capital in the research proposal is respected: A peer reviewer is in a privileged position through
p.000022: having access to the unexploited ideas and intellectual capital of the researcher. A peer review process should require
p.000022: that reviewers do not disclose the substance of any research proposal, unless there is explicit permission to do so.
p.000022:
p.000022:
p.000022: Limitations of peer review
p.000022: Peer reviewers typically are not privy to the operational details of a proposed research study. Research proposals
p.000022: usually will outline a methodology, but not explain its implementation in detail. For example, a proposal might state
p.000022: how many patients will be recruited, but will not necessarily explain how patients will be approached, how they might
p.000022: be compensated for participation, nor what information any participant information sheet might contain. Similarly, the
p.000022: detailed clinical trial protocols are not typically included in a peer review. (Detailed examination of a trial
p.000022: protocol is often undertaken by the independent data and safety monitoring committee associated with the trial.) Ethics
p.000022: committees should be aware that studies can be of satisfactory scientific quality as judged by peer review, but still
p.000022: pose ethical concerns because of how the research is to be operationalised. Necessarily, consideration of the safety of
p.000022: participants and researchers, and the balance of risk and benefit, by ethics committees is likely to involve scrutiny
p.000022: of study design and execution.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.000022: about … the identity and qualifications of the provider’.)
p.000022:
p.000022: 6.3 See also the HIPC, Rule 3 and Privacy Act 1993, Principle 3.
p.000022:
p.000022:
p.000022: Identifiability of health information
p.000022:
p.000022: 6.4 A key issue concerning health information is whether the individual concerned is ‘identifiable’ from the
p.000022: information. The data used for observational studies can be identified, potentially identifiable, partially
p.000022: de-identified, de-identified or anonymous. These terms are defined below.
p.000022: • Identified data: Identified data allow a specific individual to be identified. Identifiers may include the
p.000022: individual’s name, date of birth or address. In particularly small sets of data even information such as a postcode may
p.000022: be an identifier.
p.000022: • Potentially identifiable (key-coded, re-identifiable) data: Key coding is the technique of separating personally
p.000022: identified data from substantive data, maintaining a potential link by assigning an arbitrary code number to each
p.000022: data-identifier pair before splitting them. Held securely and separately, the key allows the re-associating of the
p.000022: substantive data with the identifiers, under specified conditions, if that is ever necessary (Lowrance 2002). Data may
p.000022: be single-coded, or double-coded if extra security is required. Data can also be potentially identifiable if it is
p.000022: possible to infer an individual’s identity from them.
p.000022: • Partially de-identified (AIDS-type code) data: Data coded with abbreviated identifiers (for example, initials,
p.000022: date of birth, sex) are used for reporting AIDS, HIV and some other conditions. This allows re-identification by the
p.000022: clinician reporting, but is anonymous to the recipient, although duplicates can be linked.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 13
p.000022:
p.000022: • De-identified (not re-identifiable, anonymised, anonymous, unlinked) data: The process of de-identification can be
p.000022: irreversible if the identifiers have been removed permanently. These data are referred to as ‘de-identified’ data. It
p.000022: should be recognised that the term ‘de-identified’ is used frequently in other documents to refer to sets of data from
p.000022: which only names have been removed; in fact such data may remain ‘potentially identifiable’.
p.000022: • Anonymous data: Anonymous data have been collected without personal identifiers, and no personal identifier can be
p.000022: inferred from them.
p.000022:
p.000022:
p.000022: Collection of health information directly from individuals
p.000022:
p.000022: Approach
p.000022:
p.000022: 6.5 The investigator should choose a method of approaching participants that meets ethical and scientific
p.000022: standards.
p.000022:
p.000022: 6.6 Ethics committee approval is required if health records (including disease registries) are used to identify
p.000022: and then approach individuals for research; the approach may be made directly or by the participant’s doctor or
p.000022: relevant health practitioner. If the approach is not to be made through the participant’s health practitioner, the
p.000022: reasons for this should be presented to the ethics committee. In such cases, either prior agreement from the
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Ethical Guidelines for Observational Studies
p.000003: Observational research, audits and related activities:
p.000003: Revised edition
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p.000003:
p.000003: July 2012
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p.000003: Citation: National Ethics Advisory Committee. 2012. Ethical Guidelines for Observational Studies: Observational
p.000003: research, audits and related activities. Revised edition.
p.000003: Wellington: Ministry of Health.
p.000003:
p.000003: First published in December 2006, revised 2012, by the Ministry of Health PO Box 5013, Wellington 6145, New Zealand
p.000003:
p.000003: ISBN: 978-0-478-39363-7 (print)
p.000003: ISBN: 978-0-478-39364-4 (online)
p.000003: HP 5526
p.000003:
p.000003: This document is available at www.neac.health.govt.nz
p.000003:
p.000003: Foreword to the 2012 edition
p.000003: These Guidelines were first released in 2006; the current document is a revision. The Health Committee’s inquiry into
p.000003: improving New Zealand’s environment to support innovation through clinical trials (June 2011) resulted in significant
p.000003: changes to the ethics review process, as reflected in the revised Standard Operating Procedures (SOPs) for Health and
p.000003: Disability Ethics Committees.
p.000003:
p.000003: This 2012 revision aims to provide consistency with the SOPs. These Guidelines have been updated to remove process
p.000003: guidance, and ensure that policy previously included in the Operational Standard for Ethics Committees is now addressed
p.000003: by these Guidelines. The revision did not fundamentally change the existing ethical standards and principles set out in
p.000003: these Guidelines.
p.000003:
p.000003: As previously, the Guidelines are directed primarily to investigators, who have the main ethical responsibility for
p.000003: good study conduct. But the Guidelines also continue to be directed to others with a role in health and disability
p.000003: research ethics – particularly the ethics committees that review studies against established ethical standards. The key
p.000003: objectives of developing national ethical guidelines are to:
p.000003: • safeguard the rights and interests of participants in research and innovative practice
p.000003: • promote high-quality ethical research for the social, cultural and economic wellbeing of society
p.000003: • reflect the principles of the Treaty of Waitangi and protect Māori cultural interests, promote the wellbeing of
p.000003: Māori and ensure mechanisms for Māori participation in both research and ethical review
p.000003: • foster awareness of ethical principles and practices among health care providers, researchers and the wider
p.000003: community
p.000003: • give due consideration to local and national community views and perspectives on ethical review.
p.000003:
p.000003: The 2012 revision was subject to a brief targeted consultation and the Committee is grateful to all who have
p.000003: contributed.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Victoria Hinson
p.000003: Chair, National Ethics Advisory Committee Kāhui Matatika o te Motu
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p.000003: Ethical Guidelines for Observational Studies: Observational research, audits and related activities iii
p.000003:
p.000003: Foreword to the 2006 edition
p.000003: Observational studies benefit all of us. For example, they show us whether our services are safe and effective, they
p.000003: tell us whether chemicals in the environment are harmful, they enable us to deal with clusters of disease and outbreaks
p.000003: of infection by determining their source, and they monitor the state of our country’s health in key areas. In short,
p.000003: observational studies give us vital evidence about our health and how best to protect and improve it. They do this by
p.000003: using personal information for public good. To do it well they must meet high ethical standards.
p.000003: Observational studies are relatively low-risk. There are two main reasons for this. In these studies, the investigators
p.000003: observe and analyse information about health or disability but do not alter the care or services that people receive,
p.000003: and secondly, there is generally a reduced potential for conflict between the investigator role and the clinician role.
p.000003: Observational studies differ from intervention studies, in which investigators intentionally alter people’s care or
p.000003: services to study the safety and benefit of doing so.
p.000003: The following Ethical Guidelines for Observational Studies (the Guidelines) are intended to facilitate high-quality
p.000003: studies, protect the interests of participants and underpin public assurance of good study conduct. The Guidelines have
p.000003: several internationally significant features. One of these is their wide scope, covering observational research and
p.000003: audits and other activities that are related to observational research. These other activities are: programme
p.000003: evaluation, evaluation studies, quality assurance activities, outcome analysis, benchmarking, public health
p.000003: investigations, public health surveillance, pharmacovigilance and resource utilisation review.
p.000003: Second, the Guidelines are directed primarily to investigators, who have ethical responsibility for good study conduct.
p.000003: They are also directed to ethics committees that review studies against established ethical standards, and to other
p.000003: interested communities and individuals. Third the Guidelines are structured around the process of study conduct, from
p.000003: formulation of the study question through to dissemination of its findings. Fourth, the Guidelines set out the
p.000003: circumstances when observational studies require ethics committee review.
p.000003: The Guidelines base their requirements for ethical review on the principle that intensity of ethical scrutiny should be
p.000003: proportional to the level of risk of the activity. For procedural information about when a study requires health and
p.000003: disability ethics committee review, and whether it should constitute full review or expedited review, please visit
p.000003: www.ethics.health.govt.nz.
p.000003: The National Ethics Advisory Committee generated the first edition of the Guidelines through a thorough and inclusive
p.000003: process over three years. This included a questionnaire to health and disability ethics committee members and
p.000003: researchers, public consultation on two discussion documents, interviews and group meetings with key informants and
p.000003: public agencies, a cross- sectoral workshop and an independent peer review report. The Guidelines reflect the many
p.000003: improvements suggested by a wide range of stakeholders through these processes. The Committee is grateful to all those
p.000003: who have contributed.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Andrew Moore
p.000003: Chair (2001–2010), National Ethics Advisory Committee Kāhui Matatika o te Motu
p.000003:
p.000003:
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p.000003: iv Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000003:
p.000003: Contents
p.000003: Foreword to the 2012 edition iii
p.000003: Foreword to the 2006 edition iv
p.000003: 1 Introduction 1
p.000003: 2 Guidelines scope and definitions 3
p.000003: Types of observational research
p.000003: 3
p.000003: Types of audit or related activity
p.000004: 4
p.000004: 3 Ethics of observational studies 6
p.000004: Worth of observational studies
p.000006: 6
p.000006: Ethical requirements of observational studies
p.000006: 6
p.000006: 4 Underlying ethical considerations 8
p.000006: Respect for people
...
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p.000018: 8 Confidentiality of data 21
p.000018: General considerations
p.000021: 21
p.000021: Record linkage
p.000022: 22
p.000022: 9 When to reveal information obtained by observational studies 23
p.000022: 10 Communicating study results 24
p.000022: 11 Features of observational studies that pose more than minimal risk 25
p.000022: 12 Additional points 27
p.000022: Bibliography 28
p.000022: Appendix: Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the
p.000022: scientific validity of
p.000022: research 30
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p.000022: vi Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 1 Introduction
p.000022:
p.000022: 1.1 These Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities
p.000022: (the Guidelines) are issued in accordance with the statutory function of the National Advisory Committee on Health and
p.000022: Disability Support Services Ethics (the National Ethics Advisory Committee – Kāhui Matatika o te Motu, or NEAC), under
p.000022: the New Zealand Public Health and Disability Act 2000, section 16, to ‘determine nationally consistent ethical
p.000022: standards across the health sector’. The Guidelines are also developed in accordance with the Minister of Health’s
p.000022: request that NEAC:
p.000022: develop guidelines on conducting observational studies in an ethical manner and establish the parameters for the
p.000022: ethical review of observational studies (including guidance regarding weighing up the harms and benefits of this type
p.000022: of health research) (Minister of Health, 2001, 2004).
p.000022:
p.000022: 1.2 The Guidelines constitute ‘ethical standards’, for the purposes of the Code of Health and Disability
p.000022: Services Consumers’ Rights 1996 (the Code of Rights), Right 4(2).
p.000022:
p.000022: 1.3 An observational study is not a ‘clinical trial’, for the purposes of the Accident Compensation Act 2001,
p.000022: section 32.
p.000022:
p.000022: 1.4 An observational study is not ‘human reproductive research’, for the purposes of the Human Assisted
p.000022: Reproductive Technology Act 2004 (the HART Act). The Guidelines nevertheless constitute ‘applicable ethical standards’
p.000022: for the purposes of the HART Act, section 27(4).
p.000022:
p.000022: 1.5 An observational study is not ‘medical or scientific experimentation’ or ‘medical treatment’ for the
p.000022: purposes of the New Zealand Bill of Rights Act 1990, sections 10 and 11.
p.000022:
p.000022: 1.6 These Guidelines are based on statements from New Zealand and international guidelines (see the
p.000022: Bibliography). They accord with key international guidelines, including the World Medical Association Declaration of
p.000022: Helsinki: Ethical principles for medical research involving human subjects (WMA 2008) and the Council for International
p.000022: Organizations of Medical Sciences’ International Guidelines for Ethical Review of Epidemiological Studies (CIOMS 1991).
p.000022: Researchers should be familiar with relevant sources of international and domestic ethical guidance materials as
p.000022: indicated in the Bibliography. In the domestic context, researchers should particularly be aware of guidelines relating
p.000022: to research involving Māori, such as the Health Research Council’s Guidelines for Researchers on Health Research
p.000022: involving Māori (HRC 2010), and NEAC’s resource document Māori Research Ethics: An overview (in press).
p.000022:
p.000022: 1.7 These Guidelines are written primarily for investigators conducting observational studies. They are
p.000022: structured around the process an investigator undertakes when designing and conducting a study, from the consideration
p.000022: of the underlying ethical considerations to the communication of study results.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 1
p.000022:
p.000022: 1.8 Detailed matters concerning health and disability ethics committee (HDEC) review of observational studies
p.000022: are addressed in the standard operating procedures (SOPs) for HDECs established under the New Zealand Public Health and
p.000022: Disability Act 2000, section 11. The SOPs were created in 2012 in response to the Government response to the Select
p.000022: Committee inquiry into improving New Zealand’s environment to support innovation through clinical trials. They provide
p.000022: procedural guidance to HDECs and researchers, and set out the scope of HDEC review and information about how HDECs
p.000022: process applications. These Guidelines set the ethical standards that must be met or exceeded in all health and
p.000022: disability research, whether or not it requires HDEC review. The SOPs apply to observational studies, but these
p.000022: Guidelines have precedence over the SOPs on any point of conflict relating to the ethical standards and principles that
p.000022: must be met or exceeded in all health and disability research.
p.000022:
p.000022: 1.9 These Guidelines also include references to wider legislative provisions. It is the investigator’s
p.000022: responsibility to comply with all relevant legal requirements, including those set out in the Privacy Act 1993, the
p.000022: Code of Rights and the Health Information Privacy Code 1994 (the HIPC). (A useful guide to the HIPC is Health Research
p.000022: and Privacy: Guidance Notes for Health Researchers and Ethics Committees (HRC 2002b).)
p.000022:
p.000022: 1.10 The HIPC is issued under the Privacy Act 1993, section 46, is legally binding and has the status of a
p.000022: regulation. The HIPC specifies 12 information privacy rules in relation to health agencies and health information, so
p.000022: is applicable to observational studies. The HIPC is available on the Privacy Commissioner’s website
p.000022: (www.privacy.org.nz).
p.000022:
p.000022: 1.11 The Code of Rights is a regulation issued under the Health and Disability Commissioner Act 1994, section 74.
p.000022: The Code of Rights sets out 10 rights applicable to all health and disability services consumers, including those
p.000022: involved in research. Investigators conducting observational research, audits and other related activities should be
p.000022: familiar with their responsibilities under the Code of Rights, and should consider their study in light of the rights
p.000022: of (proposed) participants. The Code of Rights is available on the Health and Disability Commissioner’s website
p.000022: (www.hdc.org.nz). Specific rights from the Code of Rights are noted at relevant points in these Guidelines. (Note also
p.000022: that some provisions give legal effect to ethical standards. For example, the Code of Rights, Right 4(2) states: ‘Every
p.000022: consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant
p.000022: standards’.)
p.000022:
p.000022: 1.12 If you wish to comment on your experience with using these Guidelines, please contact NEAC at the address
p.000022: below. The Committee intends to review the Guidelines by the end of 2015, and would be grateful for your comments to
p.000022: inform that process.
p.000022: Email: neac@moh.govt.nz (with ‘Observational Studies’ in the subject line)
p.000022: Postal address: Observational Studies, National Ethics Advisory Committee Secretariat, PO Box 5013, Wellington 6145.
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p.000022: 2 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 2 Guidelines scope and definitions
p.000022:
p.000022: 2.1 This document is intended primarily to guide investigators conducting observational studies, including
p.000022: audits and related activities. The term ‘observational studies’, as used in these Guidelines, refers to epidemiological
p.000022: and clinical observational research and to audits and related activities. Audits and other activities are included
p.000022: because they share ethically relevant characteristics with observational research. These Guidelines apply primarily to
p.000022: observational studies in New Zealand settings.
p.000022:
p.000022: 2.2 In health research, observational studies are distinguished from intervention or experimental studies as no
p.000022: intervention other than recording, classifying, counting and analysing of data takes place. (In intervention or
p.000022: experimental studies investigators deliberately alter some feature of people’s health or disability circumstances to
p.000022: study the effect of doing so. Examples of intervention research include randomised controlled trials.) In observational
p.000022: studies the investigator has no control over study variables and merely observes outcomes. These studies are distinct
p.000022: from observational studies in social science research, which may include the observation of participants during an
p.000022: intervention. Most observational research is epidemiological or health services research, but some observational
p.000022: studies, including most case series and case studies, are conducted by clinicians in personal care settings.
p.000022:
p.000022:
p.000022: Types of observational research
p.000022:
p.000022: 2.3 The primary purpose or justification for observational research is to add to generalisable knowledge about
p.000022: a health or disability issue. The six main types of observational research are summarised below.
p.000022: • Case control studies examine the relationship between an attribute and a disease by comparing those with and
p.000022: without the disease with respect to the presence of the attribute or level of exposure to it.
p.000022: • Cohort studies examine the relationship between exposure to a factor or factors and the probability of the
p.000022: occurrence of a disease (or other outcome) by observing large numbers of people over a period of time and comparing
p.000022: incidence rates of the disease (or outcome) in relation to exposure levels. A cohort study may be a clinical cohort
p.000022: study (for example, where a group of patients with a given disease is followed to examine the prognosis).
p.000022: • Cross-sectional studies examine the relationship between diseases (or other health-related characteristics) and
p.000022: other variables of interest in a defined population at one particular point in time, by collecting health and other
p.000022: information concerning members of the population. These include questionnaires or surveys done for research purposes.
p.000022: • Case reports are reports of cases from health or disability services or research settings.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 3
p.000022:
p.000022: • Case series describe a set of cases of a disease (or similar problem). For example, a clinician may assemble a
p.000022: case series on a topic of interest, such as an unexpected adverse effect experienced by patients taking a particular
p.000022: medication.
p.000022: • Descriptive studies examine the existing distribution of variables in populations, for example, analyses of cancer
p.000022: registry data or emergency department data by person, place or time.
p.000022:
p.000022:
p.000022: Types of audit or related activity
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p.000022: 2.4 The primary purpose or justification for an audit or related activity is to improve delivery of the
p.000022: particular health or disability support service being studied or to control a threat to public health. (The results of
p.000022: audits and related activities should be disseminated at least to those able to take necessary action. Wider
p.000022: dissemination, including through publication in scientific journals, may sometimes be appropriate.) The 10 main types
p.000022: of audit and related activities are summarised below.
p.000022: • Audits involve the systematic evaluation of aspects of health or disability support service delivery by
p.000022: considering measurable indicators of performance and/or quality.
p.000022: • Programme evaluation is a type of audit where a whole programme is evaluated, rather than specific interventions.
p.000022: • Evaluation studies aim to determine the relevance, effectiveness and impact of activities in the light of their
p.000022: objectives. Several types of evaluation are distinguished, including evaluation of the structure, process and outcome
p.000022: of an activity.
p.000022: • Quality assurance activities aim to improve health and disability support services by assessing the adequacy of
p.000022: existing practice against a standard.
p.000022: • Outcome analyses involve the assessment of health and disability support service quality by reviewing health care
p.000022: information to evaluate outcomes without comparing them against a standard. For example, clinicians may retrospectively
p.000022: examine health care notes and perform descriptive analyses to determine the outcome of medical treatment or course of a
p.000022: particular illness.
p.000022: • Benchmarking aims to improve practice through the comparison of two or more health and disability support
p.000022: services.
p.000022: • Public health investigations explore possible risks to public health, are often of an immediate or urgent nature,
p.000022: and are often required by legislation. Examples are investigations into outbreaks or clusters of disease, analyses of
p.000022: vaccine safety and effectiveness, and contact tracing of communicable conditions.
p.000022: • Public health surveillance involves the monitoring of risks to health by methods that include the systematic
p.000022: collection, analysis and dissemination of information about disease rates.
p.000022: • Pharmacovigilance (post-marketing surveillance) involves monitoring the adverse effects of pharmaceuticals after
p.000022: their introduction into the general population, by such methods as the spontaneous reporting of adverse events and the
p.000022: monitoring of all adverse events for a restricted group of medicines (prescription event monitoring).
p.000022:
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p.000022: 4 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: • Resource utilisation reviews evaluate the use of resources in a particular health or disability service activity,
p.000022: for example, by reviewing health records to determine health care inputs such as chest X-rays for patients with a
p.000022: particular diagnosis.
p.000022:
p.000022: 2.5 A small number of observational studies include certain activities, such as specimen collection, storage
p.000022: and use and genetic testing, which are not addressed in these Guidelines. Investigators should refer to relevant
p.000022: international and national guidance regarding such activities. (For example, information on the collection and use of
p.000022: human materials can be found in Guidelines on Ethics in Health Research (HRC 2002a.) Note that all clinical research
p.000022: involving the manipulation of human genetic material must be approved by the Health Research Council’s Gene Technology
p.000022: Advisory Committee (HRC 2002a). See the Medicines Act 1981, section 30; the Crown Entities Act 2004, section 73(1)(c)
p.000022: and Schedule 1; and HRC 2002a, p 28.
p.000022:
p.000022: 2.6 These Guidelines do not apply to observational research that uses only publicly available documents or
p.000022: data.
p.000022:
p.000022: 2.7 While these Guidelines may be useful for investigators conducting other forms of non- intervention study,
p.000022: such as qualitative and social science research, note that those studies use distinct methods that may raise separate
p.000022: ethical issues.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 5
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p.000022: 3 Ethics of observational studies
p.000022:
p.000022: 3.1 This section concerns the worth of observational studies and responsibilities for the ethics of the
p.000022: studies.
p.000022:
p.000022:
p.000022: Worth of observational studies
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p.000022: 3.2 The public is entitled to health and disability support services that are safe and effective. The public
p.000022: also has an interest in a safe environment. Observational studies play important roles in support of these public
p.000022: interests. For example, observational research might examine the relationship between exposures (such as chemicals in
p.000022: the environment or the use of medicines) and subsequent disease. For health services users, observational research can
p.000022: further the understanding and management of their disorder. Similarly, it is essential that any deficiency in health or
p.000022: disability support services is identified and acted upon, and audits and related activities can play key roles in this.
p.000022: Service providers should inform the public that observational studies are essential for the high-quality delivery of
p.000022: health or disability services, and that their information may be used for such activities. They should also give
p.000022: consumers details of the measures taken to protect participants from harm.
p.000022:
p.000022:
p.000022: Ethical requirements of observational studies
p.000022:
p.000022: 3.3 Investigators conducting, or involved in conducting, observational studies are responsible for ensuring
p.000022: these studies meet ethical standards. This is the case whether or not ethics committee review is also required. When
p.000022: there is more than one investigator, the principal investigator has the overall responsibility for the ethics of the
p.000022: activity.
p.000022:
p.000022: 3.4 The greater the risk of harm from an observational study, the greater the care that is required in
p.000022: assessing and addressing the ethical issues raised.
p.000022:
p.000022: 3.5 Section 11 of these Guidelines outlines the features of observational studies that may present more than
p.000022: minimal risk to participants and that require review by an ethics committee. The Ministry of Health’s SOPs provide
p.000022: specific guidance about when HDEC review is required. If an investigator is unsure whether ethics committee review of
p.000022: any particular study is required, he or she should seek advice from an ethics committee.
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p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
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p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
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p.000022: Beneficence and non-maleficence
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p.000022: 4.9 The risks of a study should be reasonable in the light of the expected benefits.
p.000022:
p.000022: 4.10 Investigators should consider the features of a proposed study in the light of ethical considerations, and
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
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p.000022: 4.12 Above the threshold of minimal risk, a study warrants greater provision for the protection of participants.
p.000022: A study is within the range of minimal risk if potential participants can reasonably be expected to regard the
p.000022: probability and magnitude of possible harms from participation in the study as no greater than those encountered in
p.000022: those aspects of everyday life that relate to the study (for example, a clinical consultation with a health care
p.000022: provider).
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 9
p.000022:
p.000022: 4.13 The potential harms associated with observational studies are generally less than with experimental studies,
p.000022: as no intrusive intervention takes place and participants are less likely to be in a dependent relationship with the
p.000022: investigator. Depending on the method used (whether previously collected information is used or new information is
p.000022: collected) potential harms in observational studies could include breaches of confidentiality.
p.000022:
p.000022: 4.14 Audits and related activities are typically minimal-risk activities. Compared with research, they typically
p.000022: have more predictable benefits and reduced risks. They provide benefits for people receiving health care or disability
p.000022: services, by being specifically directed at improving the delivery of that care or those services, or provide benefits
p.000022: to the public by addressing risks to public health. For this reason, in some settings it is unethical for health care
p.000022: or disability services, or a public health risk, not to be studied by an audit or related activity. (See also the Code
p.000022: of Rights, Right 4(4): ‘Every consumer has the right to have services provided in a manner that minimises the potential
p.000022: harm to, and optimises the quality of life of, that consumer’.)
p.000022:
p.000022: 4.15 In general, when there is some engagement with affected communities during the conduct of the study, there
p.000022: is more likely to be long-term benefit to study participants and to the community.
p.000022:
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p.000022: Integrity
p.000022:
p.000022: 4.16 An investigator’s commitment to the advancement of knowledge implies a duty to conduct honest and thoughtful
p.000022: inquiry and rigorous analysis, and to be accountable for her or his activities.
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p.000022: Diversity
p.000022:
p.000022: 4.17 As they conduct observational studies, investigators should understand, respect and make due allowance for
p.000022: diversity among participants and their communities. (See also the Code of Rights, Right 1(3): ‘Every consumer has the
p.000022: right to be provided with services that take into account the needs, values, and beliefs of different cultural,
p.000022: religious, social, and ethnic groups, including the needs, values, and beliefs of Māori’.)
p.000022:
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p.000022: Conflict of interest
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p.000022: 4.18 Investigators should identify to co-investigators, sponsors, employers, participants and, where applicable,
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p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
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p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
p.000022: a more than minimal risk activity, and does not trigger any requirement for ethics committee review. Any investigator
p.000022: who intends to publish results of any observational study should ensure the activity has been conducted in accordance
p.000022: with these Guidelines, and should inform the editor concerned whether or not ethics committee review is required. This
p.000022: is consistent with the guidance provided in the International Committee of Medical Journal Editors’ Uniform
p.000022: Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical publication (2004,
p.000022: section 11.F).
p.000022:
p.000022: 12.2 When reporting experiments on human subjects, authors should indicate whether the procedures followed were
p.000022: in accordance with the ethical standards of the responsible committee on human experimentation (institutional and
p.000022: national) and with the Helsinki Declaration of 1975, as revised in 2000.
p.000022:
p.000022: 12.3 Investigators should ensure that they comply with internal organisational requirements in respect of
p.000022: observational research, all audits and related activities that they conduct in or through it. The appropriate approach
p.000022: will vary from organisation to organisation; as such, organisations might also specify their own processes regarding
p.000022: notification or approval.
p.000022:
p.000022: 12.4 Chapter 10 of the Ministry of Health SOPs provides guidance about requirements for locality authorisation.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 27
p.000022:
p.000022: Bibliography
p.000022: Note: This bibliography is restricted to national and international guidance statements. A full bibliography of works
p.000022: consulted in the preparation of these Guidelines is available on the NEAC website (www.neac.health.govt.nz).
p.000022:
p.000022: American College of Epidemiology. 2000. American College of Epidemiology Ethics Guidelines. Annals of Epidemiology
p.000022: 10(8): 487–97.
p.000022: Code of Health and Disability Services Consumers’ Rights. 1996.
p.000022: CIOMS. 1991. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: CIOMS. 2006. Special Ethical Considerations for Epidemiological Research (draft). Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: EMEA, CPMP. 2002. Position Paper on Terminology in Pharmacogenetics. London: European Agency for the Evaluation of
p.000022: Medicinal Products, Committee for Proprietary Medicinal Products.
p.000022: HRC. 2002a. Guidelines on Ethics in Health Research. Wellington: Health Research Council.
p.000022: HRC. 2002b. Health Research and Privacy: Guidance Notes for Health Researchers and Ethics Committees. Wellington:
p.000022: Health Research Council.
p.000022: HRC. 2010. Guidelines for Researchers on Health Research involving Māori. Wellington: Health Research Council.
p.000022: ICMJE. 2004. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical
p.000022: publication. Philadelphia: International Committee of Medical Journal Editors.
p.000022: Lowrance W. 2002. Learning from Experience: Privacy and the secondary use of data in health research. London: The
p.000022: Nuffield Trust.
p.000022: Medical Council of New Zealand. 2002a. Confidentiality and Public Safety. Wellington: Medical Council of New Zealand.
p.000022: Medical Council of New Zealand. 2002b. Information and Consent. Wellington: Medical Council of New Zealand.
p.000022: Medical Council of New Zealand. 2004. Good Medical Practice. Wellington: Medical Council of New Zealand.
p.000022: Minister of Health. 2000. The New Zealand Health Strategy. Wellington: Ministry of Health.
p.000022: Minister of Health. 2001. National Ethics Advisory Committee: Terms of Reference. Wellington: Ministry of Health.
p.000022: Minister of Health. 2004. Terms of Reference for Health and Disability Ethics Committees. Wellington: Ministry of
p.000022: Health.
p.000022: Minister of Health and Associate Minister of Health. 2002. He Korowai Oranga: Māori Health Strategy. Wellington:
p.000022: Ministry of Health.
p.000022: Ministry of Health. 2002. Operational Standard for Ethics Committees. Wellington: Ministry of Health.
p.000022: Ministry of Health. 2004. Protected Quality Assurance Activities under the Health Practitioners Competence Assurance
p.000022: Act 2003. Wellington: Ministry of Health.
p.000022: National Health and Medical Research Council. 1999. National Statement on Ethical Conduct in Research Involving Humans.
p.000022: Canberra: National Health and Medical Research Council.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 28 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: National Health and Medical Research Council. 2002. When Does Quality Assurance in Health Care Require Independent
p.000022: Ethical Review? Consultation draft. Canberra: National Health and Medical Research Council.
p.000022: NEAC. 2003a. Ethical Review of Observational Research, Audit and Related Activities. Discussion document. Wellington:
p.000022: National Ethics Advisory Committee.
p.000022: NEAC. In press. Māori Research Ethics: An overview. Wellington: National Ethics Advisory Committee.
p.000022: NEAC. 2003b. Review of the Current Processes for Ethical Review of Health and Disability Research in New Zealand:
p.000022: Report to the Minister of Health. Wellington: National Ethics Advisory Committee.
p.000022: New Zealand Medical Association. 2002. Code of Ethics. Wellington: New Zealand Medical Association.
p.000022: Nuffield Council on Bioethics. 2003. Pharmacogenetics: Ethical Issues. A guide to the report. London: Nuffield Council
p.000022: on Bioethics.
p.000022: Royal College of Physicians. 1996. Guidelines on the Practice of Ethics Committees in Medical Research Involving Human
p.000022: Subjects. 3rd edition. London: Royal College of Physicians.
p.000022: Tri-council. 1998. Tri-council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Medical
p.000022: Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities
p.000022: Research Council of Canada.
p.000022: WHO. 2011. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.
p.000022: Geneva: World Health Organization.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 29
p.000022:
p.000022: Appendix: Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the
p.000022: scientific validity of research
p.000022:
p.000022: Background
p.000022: This document seeks to outline the principles of peer review that might be undertaken to assure New Zealand’s Health
p.000022: and Disability Ethics Committees (HDECs) of the scientific validity of a research proposal. Scientific validity of a
p.000022: research project is one component of the research being ethically sound. Research with insufficient scientific
p.000022: validity will waste scarce resources, will misuse the trust and commitment of participants, and may needlessly expose
p.000022: them to risk for no appropriate return.
p.000022:
p.000022: The term ‘scientific validity’ is used in the 2012 Standard operating procedures (SOPs) for HDECs, without definition.
p.000022: These Guidelines and the Guidelines for Intervention Studies (2012) refer to studies being ‘scientifically sound’,
p.000022: which encompasses the expectation that a proposal’s objectives can reasonably be expected to be achieved. Standards and
p.000022: Operational Guidance for Ethics Review of Health-Related Research with Human Participants (WHO 2011) refers to ‘valid
p.000022: scientific methods’ as part of Standard 7: Ethical basis for decision-making in research ethics committees. Important
p.000022: factors in this standard include how the study will be conducted, the qualifications of the researcher(s), the adequacy
p.000022: of provisions made for monitoring and auditing, and the adequacy of the study site (eg, availability of qualified staff
p.000022: and appropriate infrastructures).
p.000022:
p.000022: The Government, in its response to the Health Committee’s 2011 Inquiry into improving New Zealand’s environment to
p.000022: support innovation through clinical trials (Health Committee, June 2011), decided that researchers and research
p.000022: sponsors will be ‘responsible for ensuring that their research has been peer-reviewed for scientific quality’ (response
p.000022: to recommendation 14). The SOPs state that HDECs will check that appropriate peer review (of scientific validity) has
p.000022: been carried out, but will not conduct it themselves. HDECs may not require specific, defined changes to research
p.000022: protocols on the grounds of lack of scientific validity as a condition of HDEC approval.
p.000022:
p.000022: This guidance does not explain how review of a research proposal can be obtained, but lays out the features of a
p.000022: fit-for-purpose peer review process. It is anticipated that these guidelines will be of use both to those seeking
p.000022: ethical approval for their health and disability research, and to those undertaking ethical review of research
p.000022: proposals, to verify that the scientific validity of proposed research has been assured through an appropriate peer
p.000022: review process.
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p.000022: 30 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Peer review
p.000022: The role of New Zealand’s HDECs is to check that proposed health and disability research meets established ethical
p.000022: standards that aim to protect participants (see the SOPs). The SOPs require that researchers and sponsors ensure that
p.000022: the scientific validity of proposed research has been peer-reviewed before an application is made to an HDEC. In this
p.000022: context, peer review is the process by which an applicant can assure an HDEC that a proposal has an appropriate degree
p.000022: of scientific merit, feasibility and likelihood of impact.
p.000022:
p.000022:
p.000022: Areas of focus during peer review
p.000022: Peer review can be tailored to deliver opinions on a variety of matters relating to a health and disability research
p.000022: proposal. In order to determine scientific validity, the following factors should specifically be determined:
p.000022: • The relative merit of the research: A key consideration is whether the proposed work is important, worthwhile and
p.000022: justifiable. The research should address a health issue that is important for health and/or society. The aims, research
p.000022: questions and hypotheses will build on and address gaps in existing knowledge.
p.000022: • The design and methods: The quality of study design and methods should be reviewed to assess its robustness. This
p.000022: might include study methodology, a description of sample recruitment and characteristics (including number, gender and
p.000022: ethnicity where relevant) and proposed methods of data analysis. Indication of timelines for the research should be
p.000022: included.
p.000022: • The feasibility of the research: This includes whether the overall strategy, methodology and analyses are well
p.000022: reasoned and appropriate to achieve the specific aims of the project. It should determine whether the research has the
p.000022: likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research
p.000022: field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research
p.000022: will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to
p.000022: undertake the research.
p.000022:
p.000022:
p.000022: Core features of the peer review process
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Health / Physically Disabled
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p.000022: audits and related activities should be disseminated at least to those able to take necessary action. Wider
p.000022: dissemination, including through publication in scientific journals, may sometimes be appropriate.) The 10 main types
p.000022: of audit and related activities are summarised below.
p.000022: • Audits involve the systematic evaluation of aspects of health or disability support service delivery by
p.000022: considering measurable indicators of performance and/or quality.
p.000022: • Programme evaluation is a type of audit where a whole programme is evaluated, rather than specific interventions.
p.000022: • Evaluation studies aim to determine the relevance, effectiveness and impact of activities in the light of their
p.000022: objectives. Several types of evaluation are distinguished, including evaluation of the structure, process and outcome
p.000022: of an activity.
p.000022: • Quality assurance activities aim to improve health and disability support services by assessing the adequacy of
p.000022: existing practice against a standard.
p.000022: • Outcome analyses involve the assessment of health and disability support service quality by reviewing health care
p.000022: information to evaluate outcomes without comparing them against a standard. For example, clinicians may retrospectively
p.000022: examine health care notes and perform descriptive analyses to determine the outcome of medical treatment or course of a
p.000022: particular illness.
p.000022: • Benchmarking aims to improve practice through the comparison of two or more health and disability support
p.000022: services.
p.000022: • Public health investigations explore possible risks to public health, are often of an immediate or urgent nature,
p.000022: and are often required by legislation. Examples are investigations into outbreaks or clusters of disease, analyses of
p.000022: vaccine safety and effectiveness, and contact tracing of communicable conditions.
p.000022: • Public health surveillance involves the monitoring of risks to health by methods that include the systematic
p.000022: collection, analysis and dissemination of information about disease rates.
p.000022: • Pharmacovigilance (post-marketing surveillance) involves monitoring the adverse effects of pharmaceuticals after
p.000022: their introduction into the general population, by such methods as the spontaneous reporting of adverse events and the
p.000022: monitoring of all adverse events for a restricted group of medicines (prescription event monitoring).
p.000022:
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p.000022: 4 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: • Resource utilisation reviews evaluate the use of resources in a particular health or disability service activity,
p.000022: for example, by reviewing health records to determine health care inputs such as chest X-rays for patients with a
p.000022: particular diagnosis.
p.000022:
p.000022: 2.5 A small number of observational studies include certain activities, such as specimen collection, storage
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p.000022: purpose without consent constitutes a more than minimal risk activity.
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p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
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p.000022: here: the amount of detail in the written protocol and the extent of protocol review processes should be related to the
p.000022: level of risk the study presents to participants.
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p.000022: 5.12 When relevant, the protocol should include a statistical plan indicating the rationale for the number of
p.000022: participants involved.
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p.000022: 12 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6 Collecting health information
p.000022:
p.000022: 6.1 In relation to the collection of health information, investigators should provide to observational study
p.000022: participants any information that a reasonable person in their circumstances would expect to receive. This is so
p.000022: whether or not consent to participate in the study is required. The information required (if any) will depend on the
p.000022: design of the observational study in question. The Code of Rights, Right 6(1)(d) states:
p.000022: Every consumer has the right to information that a reasonable consumer, in that consumer’s circumstances, would expect
p.000022: to receive, including … notification of any proposed participation in teaching or research, including whether the
p.000022: research requires and has received ethical approval.
p.000022: (See also paragraph 3.2.)
p.000022:
p.000022: 6.2 Investigators should provide to study participants any information about who will have access to study data
p.000022: that a reasonable person in their circumstances would expect to receive. (See also the Code of Rights, Right 6(3)(a):
p.000022: ‘Every consumer has the right to honest and accurate answers to questions relating to services, including questions
p.000022: about … the identity and qualifications of the provider’.)
p.000022:
p.000022: 6.3 See also the HIPC, Rule 3 and Privacy Act 1993, Principle 3.
p.000022:
p.000022:
p.000022: Identifiability of health information
p.000022:
p.000022: 6.4 A key issue concerning health information is whether the individual concerned is ‘identifiable’ from the
p.000022: information. The data used for observational studies can be identified, potentially identifiable, partially
p.000022: de-identified, de-identified or anonymous. These terms are defined below.
p.000022: • Identified data: Identified data allow a specific individual to be identified. Identifiers may include the
p.000022: individual’s name, date of birth or address. In particularly small sets of data even information such as a postcode may
p.000022: be an identifier.
p.000022: • Potentially identifiable (key-coded, re-identifiable) data: Key coding is the technique of separating personally
p.000022: identified data from substantive data, maintaining a potential link by assigning an arbitrary code number to each
p.000022: data-identifier pair before splitting them. Held securely and separately, the key allows the re-associating of the
p.000022: substantive data with the identifiers, under specified conditions, if that is ever necessary (Lowrance 2002). Data may
p.000022: be single-coded, or double-coded if extra security is required. Data can also be potentially identifiable if it is
p.000022: possible to infer an individual’s identity from them.
...
p.000022: consequence, in that the information collected may be biased. This is because if the mother in question had a baby with
p.000022: a birth defect, she would have had both a reason and a longer period of time, in advance of the actual interview, to
p.000022: remember that she had been exposed to the drug.
p.000022:
p.000022: 6.14 In contrast, a mother of a healthy baby would have less reason to remember past exposure, and would not
p.000022: reflect on possible past exposure during the period between the consent procedure and the actual interview. This effect
p.000022: could lead to a spurious association between birth defects and drug exposure in the mothers interviewed; thus, if such
p.000022: an association were found, the finding could be scientifically invalid. In studies such as this, biased reporting can
p.000022: be minimised, and scientific validity assured, only by not disclosing in advance the complete details of the hypothesis
p.000022: under test (HRC 2002a, p 38).
p.000022:
p.000022: 6.15 When specific information cannot be provided at the outset, the investigator should offer to provide results
p.000022: to participants. (See also the Code of Rights, Right 6(3)(d): ‘Every consumer has the right to honest and accurate
p.000022: answers to questions relating to services, including questions about … the results of research’.)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
p.000022: refusal to participate in, or decision to withdraw from, the study will not result in discrimination, a reduced level
p.000022: of care or any other disadvantage.
p.000022:
p.000022:
p.000022: People with diminished competence to give consent
p.000022:
p.000022: 6.19 Ethical consideration of studies involving individuals or groups who have diminished competence to give free
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
...
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
p.000022:
p.000022: 6.39 Investigators should be aware that access to health information is subject to the HIPC, and that access to
p.000022: personal information is subject to the Privacy Act 1993. Access to personal information may also be subject to the
p.000022: Official Information Act 1982.
p.000022:
p.000022: 6.40 A named investigator to whom records are disclosed should give a written undertaking to ensure the
p.000022: confidentiality of the records.
p.000022:
p.000022:
p.000022:
p.000022: 18 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.41 In the case of records involving Māori health information, where a kaitiaki group has been established to
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
p.000022: purpose of kaitiaki groups is to give Māori control and protection of data concerning Māori and to ensure the data are
p.000022: used for the benefit of Māori health, and that the aggregated data is not used in a way that negatively affects Māori.
p.000022: See, for example, the Health (Cervical Screening (Kaitiaki)) Regulations 1995.
p.000022:
p.000022:
p.000022: Consent
p.000022:
p.000022: 6.42 The consent of participants should generally be obtained for using identified or potentially identifiable
p.000022: data for research.
p.000022:
p.000022:
p.000022: Collection of health information without consent
p.000022:
p.000022: 6.43 Access to identified or potentially identifiable data for research without the consent of the people the
p.000022: data identifies or makes potentially identifiable may be justifiable when:
p.000022: a) the procedures required to obtain consent are likely to cause unnecessary anxiety for those whose consent would
p.000022: be sought; or the requirement for consent would prejudice the scientific value of the study; or it is impossible in
p.000022: practice to obtain consent due to the quantity or age of the records; and
p.000022: b) there would be no disadvantage to the participants or their relatives or to any collectivities involved; and
p.000022: c) the public interest in the study outweighs the public interest in privacy.
p.000022:
p.000022: 6.44 An example of when the procedures required to obtain consent were likely to cause unnecessary anxiety is a
p.000022: study of the use of an asthma drug as a possible cause of sudden deaths from asthma. This study compared the medical
p.000022: records of individuals who had died from asthma with the records of asthmatics who had been admitted to hospital but
p.000022: had not died. It would have been wrong to have sought the consent of the group who had not died, because informing
p.000022: these people of an untested hypothesis might have frightened and distressed them without good cause (HRC 2002a, p 37).
p.000022:
...
p.000022:
p.000022: 7.2 If study data are to be used for any purpose or by any people other than as specified in the approved
p.000022: protocol, investigators should ascertain whether they need to submit a proposed revision of the study protocol or a new
p.000022: protocol to an ethics committee (see the SOPs for HDECs).
p.000022:
p.000022: 7.3 See also the HIPC, Rule 10 and Privacy Act 1993, Principle 10.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 20 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 8 Confidentiality of data
p.000022:
p.000022: General considerations
p.000022:
p.000022: 8.1 Observational studies may involve collecting and storing personal information relating to individuals and
p.000022: groups, and such data, if disclosed to third parties, may cause harm or distress.
p.000022:
p.000022: 8.2 Investigators should arrange to protect the confidentiality of such data by, for example, omitting
p.000022: information that might lead to the identification of individual participants, or limiting access to the data, or by
p.000022: other means.
p.000022:
p.000022: 8.3 Investigators are required to ensure the adequate physical and electronic security of data.
p.000022:
p.000022: 8.4 For studies involving the collection of information about illegal activities – for example, the use of
p.000022: illegal substances – potential participants should be made aware of whether investigators can or cannot ensure
p.000022: confidentiality.
p.000022:
p.000022: 8.5 Identified or potentially identifiable personal data should not be used when the study could be done
p.000022: without personal identification (for example, by key coding or unlinking the data).
p.000022:
p.000022: 8.6 When personal identifiers remain on records used for a study, investigators should be able to justify this
p.000022: and ensure confidentiality will be protected.
p.000022:
p.000022: 8.7 In the unusual event that group confidentiality cannot be maintained or is violated, investigators should
p.000022: take all reasonable steps to maintain or restore a group’s good name and status.
p.000022:
p.000022: 8.8 Audits or related activities should be conducted by people who are under a professional or an employment
p.000022: obligation to maintain patient confidentiality. Such activity may be initiated from outside the organisation or by the
p.000022: organisation itself, and may be conducted by the organisation (an internal audit or related activity) or by a party
p.000022: external to it (an external audit or related activity).
p.000022:
p.000022: 8.9 Note that ‘privacy’ is the status of information about aspects of a person’s life over which he or she
...
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
p.000022: a more than minimal risk activity, and does not trigger any requirement for ethics committee review. Any investigator
p.000022: who intends to publish results of any observational study should ensure the activity has been conducted in accordance
p.000022: with these Guidelines, and should inform the editor concerned whether or not ethics committee review is required. This
p.000022: is consistent with the guidance provided in the International Committee of Medical Journal Editors’ Uniform
p.000022: Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical publication (2004,
p.000022: section 11.F).
p.000022:
p.000022: 12.2 When reporting experiments on human subjects, authors should indicate whether the procedures followed were
p.000022: in accordance with the ethical standards of the responsible committee on human experimentation (institutional and
p.000022: national) and with the Helsinki Declaration of 1975, as revised in 2000.
p.000022:
p.000022: 12.3 Investigators should ensure that they comply with internal organisational requirements in respect of
p.000022: observational research, all audits and related activities that they conduct in or through it. The appropriate approach
...
p.000022: topic and/or context for the research, have the appropriate expertise relative to the breadth and scope of research
p.000022: under review and, as a result, will be well placed to make a statement as to whether the research in question has
p.000022: verifiable scientific merit. Peer review of scientific validity may include consideration of cultural relevance and
p.000022: appropriateness.
p.000022: • Peer review delivers an objective opinion: Those acting in the capacity of reviewers are charged with delivering a
p.000022: balanced and considered analysis of the research. Generally, the success of the peer review process is determined by
p.000022: the extent to which these evaluations can be considered free of bias, equitable and fair. Objectivity can be
p.000022: compromised if peer reviewers have conflicts of interest, and so appropriate peer reviewers typically will not be
p.000022: materially connected to the researcher(s) in a way that might undermine objectivity, and be free from either positive
p.000022: or negative inducements.
p.000022: • A consensus opinion on scientific validity is formed: An HDEC will need to receive assurance that the peer review
p.000022: process has delivered support for the scientific validity of the proposed research. When a peer review process has
p.000022: engaged a range of experts, there needs to be a process that leads to a consensus opinion about the quality of the
p.000022: research.
p.000022: • Intellectual capital in the research proposal is respected: A peer reviewer is in a privileged position through
p.000022: having access to the unexploited ideas and intellectual capital of the researcher. A peer review process should require
p.000022: that reviewers do not disclose the substance of any research proposal, unless there is explicit permission to do so.
p.000022:
p.000022:
p.000022: Limitations of peer review
p.000022: Peer reviewers typically are not privy to the operational details of a proposed research study. Research proposals
p.000022: usually will outline a methodology, but not explain its implementation in detail. For example, a proposal might state
p.000022: how many patients will be recruited, but will not necessarily explain how patients will be approached, how they might
p.000022: be compensated for participation, nor what information any participant information sheet might contain. Similarly, the
p.000022: detailed clinical trial protocols are not typically included in a peer review. (Detailed examination of a trial
p.000022: protocol is often undertaken by the independent data and safety monitoring committee associated with the trial.) Ethics
p.000022: committees should be aware that studies can be of satisfactory scientific quality as judged by peer review, but still
p.000022: pose ethical concerns because of how the research is to be operationalised. Necessarily, consideration of the safety of
p.000022: participants and researchers, and the balance of risk and benefit, by ethics committees is likely to involve scrutiny
p.000022: of study design and execution.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
...
Social / Age
Searching for indicator age:
(return to top)
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
p.000022:
p.000022: Beneficence and non-maleficence
p.000022:
p.000022: 4.9 The risks of a study should be reasonable in the light of the expected benefits.
p.000022:
p.000022: 4.10 Investigators should consider the features of a proposed study in the light of ethical considerations, and
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
p.000022:
p.000022: 4.12 Above the threshold of minimal risk, a study warrants greater provision for the protection of participants.
p.000022: A study is within the range of minimal risk if potential participants can reasonably be expected to regard the
p.000022: probability and magnitude of possible harms from participation in the study as no greater than those encountered in
...
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
p.000022: purpose of kaitiaki groups is to give Māori control and protection of data concerning Māori and to ensure the data are
p.000022: used for the benefit of Māori health, and that the aggregated data is not used in a way that negatively affects Māori.
p.000022: See, for example, the Health (Cervical Screening (Kaitiaki)) Regulations 1995.
p.000022:
p.000022:
p.000022: Consent
p.000022:
p.000022: 6.42 The consent of participants should generally be obtained for using identified or potentially identifiable
p.000022: data for research.
p.000022:
p.000022:
p.000022: Collection of health information without consent
p.000022:
p.000022: 6.43 Access to identified or potentially identifiable data for research without the consent of the people the
p.000022: data identifies or makes potentially identifiable may be justifiable when:
p.000022: a) the procedures required to obtain consent are likely to cause unnecessary anxiety for those whose consent would
p.000022: be sought; or the requirement for consent would prejudice the scientific value of the study; or it is impossible in
p.000022: practice to obtain consent due to the quantity or age of the records; and
p.000022: b) there would be no disadvantage to the participants or their relatives or to any collectivities involved; and
p.000022: c) the public interest in the study outweighs the public interest in privacy.
p.000022:
p.000022: 6.44 An example of when the procedures required to obtain consent were likely to cause unnecessary anxiety is a
p.000022: study of the use of an asthma drug as a possible cause of sudden deaths from asthma. This study compared the medical
p.000022: records of individuals who had died from asthma with the records of asthmatics who had been admitted to hospital but
p.000022: had not died. It would have been wrong to have sought the consent of the group who had not died, because informing
p.000022: these people of an untested hypothesis might have frightened and distressed them without good cause (HRC 2002a, p 37).
p.000022:
p.000022: 6.45 An investigator who proposes not to seek informed consent for use of identified or potentially identifiable
p.000022: data for research must explain to an ethics committee the reasons for not seeking consent, and how the study would be
p.000022: ethical in the absence of consent.
p.000022:
p.000022: 6.46 The investigator must show how safeguards will be maintained to protect confidentiality, and that the study
p.000022: has the goal of protecting or advancing health.
p.000022:
...
Social / Child
Searching for indicator children:
(return to top)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
p.000022: refusal to participate in, or decision to withdraw from, the study will not result in discrimination, a reduced level
p.000022: of care or any other disadvantage.
p.000022:
p.000022:
p.000022: People with diminished competence to give consent
p.000022:
p.000022: 6.19 Ethical consideration of studies involving individuals or groups who have diminished competence to give free
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
p.000022: b) the injustice that would arise from their exclusion from the benefits of observational studies in these groups.
p.000022: (See also the Code of Rights, Right 7(3): ‘Where a consumer has diminished competence, that consumer retains the right
p.000022: to make informed choices and give informed consent, to the extent appropriate to his or her level of competence’.)
p.000022:
p.000022: 6.20 Subject to applicable legal requirements, individuals who are not legally competent may be asked to become
p.000022: participants in observational research only when the study question can only be addressed:
p.000022: a) with the participation of those individuals from identified group(s); and
p.000022: b) when free and informed consent is sought from their legal representative(s), such as a welfare guardian or a
p.000022: representative with enduring power of attorney.
p.000022: (See also the Code of Rights, Right 7(4).)
p.000022:
p.000022: 6.21 When free and informed consent has been obtained from an authorised third party, and in those circumstances
p.000022: where the legally incompetent individual understands the nature and consequences of the study, the investigator must
p.000022: seek to ascertain the individual’s wishes concerning his or her participation. The potential participant’s dissent will
...
p.000022: Investigator use of identifiable health information that was primarily collected for clinical care for a secondary
p.000022: purpose without consent constitutes a more than minimal risk activity.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000022: services, by being specifically directed at improving the delivery of that care or those services, or provide benefits
p.000022: to the public by addressing risks to public health. For this reason, in some settings it is unethical for health care
p.000022: or disability services, or a public health risk, not to be studied by an audit or related activity. (See also the Code
p.000022: of Rights, Right 4(4): ‘Every consumer has the right to have services provided in a manner that minimises the potential
p.000022: harm to, and optimises the quality of life of, that consumer’.)
p.000022:
p.000022: 4.15 In general, when there is some engagement with affected communities during the conduct of the study, there
p.000022: is more likely to be long-term benefit to study participants and to the community.
p.000022:
p.000022:
p.000022: Integrity
p.000022:
p.000022: 4.16 An investigator’s commitment to the advancement of knowledge implies a duty to conduct honest and thoughtful
p.000022: inquiry and rigorous analysis, and to be accountable for her or his activities.
p.000022:
p.000022:
p.000022: Diversity
p.000022:
p.000022: 4.17 As they conduct observational studies, investigators should understand, respect and make due allowance for
p.000022: diversity among participants and their communities. (See also the Code of Rights, Right 1(3): ‘Every consumer has the
p.000022: right to be provided with services that take into account the needs, values, and beliefs of different cultural,
p.000022: religious, social, and ethnic groups, including the needs, values, and beliefs of Māori’.)
p.000022:
p.000022:
p.000022: Conflict of interest
p.000022:
p.000022: 4.18 Investigators should identify to co-investigators, sponsors, employers, participants and, where applicable,
p.000022: ethics committees any perceived, potential or actual conflict of interest he or she might have in relation to any
p.000022: others who are involved with the study. Such conflicts of interest can compromise the design or conduct of a study or
p.000022: the reliability of its results, thereby exposing study participants or others to needless risk or inconvenience.
p.000022:
p.000022: 4.19 As appropriate to the circumstances, any conflict of interest should be minimised.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 10 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 5 Design of study and protocol
p.000022:
p.000022: Study question
p.000022:
p.000022: 5.1 Investigators should meet their obligations to communities by undertaking research that addresses important
p.000022: health problems.
p.000022:
p.000022: 5.2 In identifying and prioritising health problems to be studied, investigators should take into account the
p.000022: perceived importance of the problem to the people living in a community after information about the problem has been
p.000022: provided to them. However, if investigators perceive that a health problem exists but that the community is ignoring it
p.000022: or denying its existence, it may be appropriate to proceed with the study while simultaneously working with the
p.000022: community to gain its confidence and support.
p.000022:
...
Searching for indicator ethnicity:
(return to top)
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
p.000022:
p.000022: Beneficence and non-maleficence
p.000022:
p.000022: 4.9 The risks of a study should be reasonable in the light of the expected benefits.
p.000022:
p.000022: 4.10 Investigators should consider the features of a proposed study in the light of ethical considerations, and
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
p.000022:
p.000022: 4.12 Above the threshold of minimal risk, a study warrants greater provision for the protection of participants.
p.000022: A study is within the range of minimal risk if potential participants can reasonably be expected to regard the
p.000022: probability and magnitude of possible harms from participation in the study as no greater than those encountered in
...
p.000022: 30 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Peer review
p.000022: The role of New Zealand’s HDECs is to check that proposed health and disability research meets established ethical
p.000022: standards that aim to protect participants (see the SOPs). The SOPs require that researchers and sponsors ensure that
p.000022: the scientific validity of proposed research has been peer-reviewed before an application is made to an HDEC. In this
p.000022: context, peer review is the process by which an applicant can assure an HDEC that a proposal has an appropriate degree
p.000022: of scientific merit, feasibility and likelihood of impact.
p.000022:
p.000022:
p.000022: Areas of focus during peer review
p.000022: Peer review can be tailored to deliver opinions on a variety of matters relating to a health and disability research
p.000022: proposal. In order to determine scientific validity, the following factors should specifically be determined:
p.000022: • The relative merit of the research: A key consideration is whether the proposed work is important, worthwhile and
p.000022: justifiable. The research should address a health issue that is important for health and/or society. The aims, research
p.000022: questions and hypotheses will build on and address gaps in existing knowledge.
p.000022: • The design and methods: The quality of study design and methods should be reviewed to assess its robustness. This
p.000022: might include study methodology, a description of sample recruitment and characteristics (including number, gender and
p.000022: ethnicity where relevant) and proposed methods of data analysis. Indication of timelines for the research should be
p.000022: included.
p.000022: • The feasibility of the research: This includes whether the overall strategy, methodology and analyses are well
p.000022: reasoned and appropriate to achieve the specific aims of the project. It should determine whether the research has the
p.000022: likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research
p.000022: field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research
p.000022: will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to
p.000022: undertake the research.
p.000022:
p.000022:
p.000022: Core features of the peer review process
p.000022: A peer review process should be commensurate with the type of proposal, the potential risk to participants and where
p.000022: the research will be undertaken. The type of peer review process that is used must be fit-for-purpose and justifiable.
p.000022: For example, the mechanism for delivering peer review of a graduate student project carried out largely within a
p.000022: tertiary institution will differ from that of a multi-centre clinical trial. Opinions from one or more peers may be
p.000022: sought; again, the extent of peer review should be fit-for-purpose. Despite potential differences, an appropriate
p.000022: process for ensuring scientific validity will have the following features:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000022: of an activity.
p.000022: • Quality assurance activities aim to improve health and disability support services by assessing the adequacy of
p.000022: existing practice against a standard.
p.000022: • Outcome analyses involve the assessment of health and disability support service quality by reviewing health care
p.000022: information to evaluate outcomes without comparing them against a standard. For example, clinicians may retrospectively
p.000022: examine health care notes and perform descriptive analyses to determine the outcome of medical treatment or course of a
p.000022: particular illness.
p.000022: • Benchmarking aims to improve practice through the comparison of two or more health and disability support
p.000022: services.
p.000022: • Public health investigations explore possible risks to public health, are often of an immediate or urgent nature,
p.000022: and are often required by legislation. Examples are investigations into outbreaks or clusters of disease, analyses of
p.000022: vaccine safety and effectiveness, and contact tracing of communicable conditions.
p.000022: • Public health surveillance involves the monitoring of risks to health by methods that include the systematic
p.000022: collection, analysis and dissemination of information about disease rates.
p.000022: • Pharmacovigilance (post-marketing surveillance) involves monitoring the adverse effects of pharmaceuticals after
p.000022: their introduction into the general population, by such methods as the spontaneous reporting of adverse events and the
p.000022: monitoring of all adverse events for a restricted group of medicines (prescription event monitoring).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 4 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: • Resource utilisation reviews evaluate the use of resources in a particular health or disability service activity,
p.000022: for example, by reviewing health records to determine health care inputs such as chest X-rays for patients with a
p.000022: particular diagnosis.
p.000022:
p.000022: 2.5 A small number of observational studies include certain activities, such as specimen collection, storage
p.000022: and use and genetic testing, which are not addressed in these Guidelines. Investigators should refer to relevant
p.000022: international and national guidance regarding such activities. (For example, information on the collection and use of
p.000022: human materials can be found in Guidelines on Ethics in Health Research (HRC 2002a.) Note that all clinical research
p.000022: involving the manipulation of human genetic material must be approved by the Health Research Council’s Gene Technology
p.000022: Advisory Committee (HRC 2002a). See the Medicines Act 1981, section 30; the Crown Entities Act 2004, section 73(1)(c)
p.000022: and Schedule 1; and HRC 2002a, p 28.
p.000022:
p.000022: 2.6 These Guidelines do not apply to observational research that uses only publicly available documents or
p.000022: data.
p.000022:
p.000022: 2.7 While these Guidelines may be useful for investigators conducting other forms of non- intervention study,
p.000022: such as qualitative and social science research, note that those studies use distinct methods that may raise separate
p.000022: ethical issues.
p.000022:
p.000022:
p.000022:
p.000022:
...
p.000022: where the legally incompetent individual understands the nature and consequences of the study, the investigator must
p.000022: seek to ascertain the individual’s wishes concerning his or her participation. The potential participant’s dissent will
p.000022: preclude his or her participation.
p.000022:
p.000022:
p.000022: Inducements
p.000022:
p.000022: 6.22 Investigators may seek to create legitimate motivation for participation in studies, but may not exert
p.000022: pressure by offering inappropriate inducements.
p.000022:
p.000022: 6.23 Risks involved in participation should be acceptable to participants even in the absence of inducement.
p.000022:
p.000022: 6.24 It is acceptable for investigators to repay the incurred expenses of participants (for example, travel
p.000022: costs).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 16 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.25 A koha may be offered in line with the cultural norms of the study participants, but should not be of such a
p.000022: value that it could reasonably be interpreted as an inappropriate inducement or as a payment for participation. For
p.000022: this reason, it is often not appropriate to discuss koha before getting an agreement to participate. (Traditionally,
p.000022: koha is an acknowledgement of the knowledge and/or hospitality extended by tāngata whenua to manuhiri. It is presented
p.000022: as part of the pōwhiri onto a marae or other venue of the tāngata whenua. However, the definition of koha should not be
p.000022: restricted by reference to its traditional roots; contemporary meanings include the giving of koha in a different
p.000022: manner during research.)
p.000022:
p.000022:
p.000022: Documentation
p.000022:
p.000022: 6.26 Evidence of free and informed consent by a participant or authorised third party should ordinarily be
p.000022: obtained in writing.
p.000022:
p.000022: 6.27 When written consent is culturally unacceptable or good reasons exist for not recording consent in writing
p.000022: (such as in the case of anonymous data collection or telephone interviews), the procedures used to seek free and
p.000022: informed consent should be documented.
p.000022:
p.000022: 6.28 Questionnaires are often innocuous, and may even be offered by mail. Completion of the questionnaire can be
p.000022: taken as consent, provided the letter of invitation expressly leaves the participant free of obligation.
p.000022:
p.000022: 6.29 Some studies may involve interviews or questionnaires that are intrusive and may cause distress. In this
p.000022: case, it is appropriate to seek participants’ prior consent by forewarning them of the potentially distressing nature
p.000022: of participation.
p.000022:
p.000022:
p.000022: Collective consent
p.000022:
p.000022: 6.30 For communities in which collective decision-making is customary, communal leaders can express the
...
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
p.000022:
p.000022: 6.39 Investigators should be aware that access to health information is subject to the HIPC, and that access to
p.000022: personal information is subject to the Privacy Act 1993. Access to personal information may also be subject to the
p.000022: Official Information Act 1982.
p.000022:
p.000022: 6.40 A named investigator to whom records are disclosed should give a written undertaking to ensure the
p.000022: confidentiality of the records.
p.000022:
p.000022:
p.000022:
p.000022: 18 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.41 In the case of records involving Māori health information, where a kaitiaki group has been established to
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
p.000022: purpose of kaitiaki groups is to give Māori control and protection of data concerning Māori and to ensure the data are
p.000022: used for the benefit of Māori health, and that the aggregated data is not used in a way that negatively affects Māori.
p.000022: See, for example, the Health (Cervical Screening (Kaitiaki)) Regulations 1995.
p.000022:
p.000022:
p.000022: Consent
p.000022:
p.000022: 6.42 The consent of participants should generally be obtained for using identified or potentially identifiable
p.000022: data for research.
p.000022:
p.000022:
...
p.000022: assure or improve the quality of services:
p.000022: a) a professionally recognised quality assurance programme (for example, pathologists re-reading specimens to check
p.000022: the accuracy of their own or a peer’s work)
p.000022: b) an external audit of services
p.000022: c) an external evaluation of services.
p.000022:
p.000022: The justification for this is that the use is related to the primary purpose of the sample collection. See the Code of
p.000022: Rights, Right 7(10).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 25
p.000022:
p.000022: 11.5 Secondary use of identifiable health information without consent
p.000022: Investigator use of identifiable health information that was primarily collected for clinical care for a secondary
p.000022: purpose without consent constitutes a more than minimal risk activity.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
...
p.000022: is consistent with the guidance provided in the International Committee of Medical Journal Editors’ Uniform
p.000022: Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical publication (2004,
p.000022: section 11.F).
p.000022:
p.000022: 12.2 When reporting experiments on human subjects, authors should indicate whether the procedures followed were
p.000022: in accordance with the ethical standards of the responsible committee on human experimentation (institutional and
p.000022: national) and with the Helsinki Declaration of 1975, as revised in 2000.
p.000022:
p.000022: 12.3 Investigators should ensure that they comply with internal organisational requirements in respect of
p.000022: observational research, all audits and related activities that they conduct in or through it. The appropriate approach
p.000022: will vary from organisation to organisation; as such, organisations might also specify their own processes regarding
p.000022: notification or approval.
p.000022:
p.000022: 12.4 Chapter 10 of the Ministry of Health SOPs provides guidance about requirements for locality authorisation.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 27
p.000022:
p.000022: Bibliography
p.000022: Note: This bibliography is restricted to national and international guidance statements. A full bibliography of works
p.000022: consulted in the preparation of these Guidelines is available on the NEAC website (www.neac.health.govt.nz).
p.000022:
p.000022: American College of Epidemiology. 2000. American College of Epidemiology Ethics Guidelines. Annals of Epidemiology
p.000022: 10(8): 487–97.
p.000022: Code of Health and Disability Services Consumers’ Rights. 1996.
p.000022: CIOMS. 1991. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: CIOMS. 2006. Special Ethical Considerations for Epidemiological Research (draft). Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: EMEA, CPMP. 2002. Position Paper on Terminology in Pharmacogenetics. London: European Agency for the Evaluation of
p.000022: Medicinal Products, Committee for Proprietary Medicinal Products.
p.000022: HRC. 2002a. Guidelines on Ethics in Health Research. Wellington: Health Research Council.
p.000022: HRC. 2002b. Health Research and Privacy: Guidance Notes for Health Researchers and Ethics Committees. Wellington:
p.000022: Health Research Council.
p.000022: HRC. 2010. Guidelines for Researchers on Health Research involving Māori. Wellington: Health Research Council.
p.000022: ICMJE. 2004. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical
p.000022: publication. Philadelphia: International Committee of Medical Journal Editors.
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
p.000022:
p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
p.000022: concerned, including appropriate whānau, hapū or iwi. He Korowai Oranga states: ‘Comprehensive, high-quality Māori
p.000022: health research and information is necessary to inform the Government and to assist whānau, hapū and iwi to determine
p.000022: and provide for their own health priorities’ (Minister of Health and Associate Minister of Health 2002, p 23).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 8 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
...
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 11.6 Vulnerable participants
p.000022:
p.000022: A study poses more than minimal risk where one or more participants are potentially vulnerable. Vulnerability is a
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000022: (See also paragraph 3.2.)
p.000022:
p.000022: 6.2 Investigators should provide to study participants any information about who will have access to study data
p.000022: that a reasonable person in their circumstances would expect to receive. (See also the Code of Rights, Right 6(3)(a):
p.000022: ‘Every consumer has the right to honest and accurate answers to questions relating to services, including questions
p.000022: about … the identity and qualifications of the provider’.)
p.000022:
p.000022: 6.3 See also the HIPC, Rule 3 and Privacy Act 1993, Principle 3.
p.000022:
p.000022:
p.000022: Identifiability of health information
p.000022:
p.000022: 6.4 A key issue concerning health information is whether the individual concerned is ‘identifiable’ from the
p.000022: information. The data used for observational studies can be identified, potentially identifiable, partially
p.000022: de-identified, de-identified or anonymous. These terms are defined below.
p.000022: • Identified data: Identified data allow a specific individual to be identified. Identifiers may include the
p.000022: individual’s name, date of birth or address. In particularly small sets of data even information such as a postcode may
p.000022: be an identifier.
p.000022: • Potentially identifiable (key-coded, re-identifiable) data: Key coding is the technique of separating personally
p.000022: identified data from substantive data, maintaining a potential link by assigning an arbitrary code number to each
p.000022: data-identifier pair before splitting them. Held securely and separately, the key allows the re-associating of the
p.000022: substantive data with the identifiers, under specified conditions, if that is ever necessary (Lowrance 2002). Data may
p.000022: be single-coded, or double-coded if extra security is required. Data can also be potentially identifiable if it is
p.000022: possible to infer an individual’s identity from them.
p.000022: • Partially de-identified (AIDS-type code) data: Data coded with abbreviated identifiers (for example, initials,
p.000022: date of birth, sex) are used for reporting AIDS, HIV and some other conditions. This allows re-identification by the
p.000022: clinician reporting, but is anonymous to the recipient, although duplicates can be linked.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 13
p.000022:
p.000022: • De-identified (not re-identifiable, anonymised, anonymous, unlinked) data: The process of de-identification can be
p.000022: irreversible if the identifiers have been removed permanently. These data are referred to as ‘de-identified’ data. It
p.000022: should be recognised that the term ‘de-identified’ is used frequently in other documents to refer to sets of data from
p.000022: which only names have been removed; in fact such data may remain ‘potentially identifiable’.
p.000022: • Anonymous data: Anonymous data have been collected without personal identifiers, and no personal identifier can be
p.000022: inferred from them.
p.000022:
p.000022:
p.000022: Collection of health information directly from individuals
p.000022:
p.000022: Approach
p.000022:
p.000022: 6.5 The investigator should choose a method of approaching participants that meets ethical and scientific
p.000022: standards.
p.000022:
p.000022: 6.6 Ethics committee approval is required if health records (including disease registries) are used to identify
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.000022:
p.000022: 6.12 Information about the purpose of the study should be as specific as possible without compromising the
p.000022: validity of the study.
p.000022:
p.000022: 6.13 In some situations, providing very specific information about the study in advance of seeking consent would
p.000022: prejudice the purposes of the collection by compromising the scientific validity of the study. For example, if a mother
p.000022: is to be interviewed to establish whether she has been exposed to a particular medicine that might have caused a
p.000022: congenital abnormality in her baby, it would be wrong, when asking her to consent to the study, to give her the name of
p.000022: the drug in question. If the name of the drug were disclosed, this may have at least one scientifically unacceptable
p.000022: consequence, in that the information collected may be biased. This is because if the mother in question had a baby with
p.000022: a birth defect, she would have had both a reason and a longer period of time, in advance of the actual interview, to
p.000022: remember that she had been exposed to the drug.
p.000022:
p.000022: 6.14 In contrast, a mother of a healthy baby would have less reason to remember past exposure, and would not
p.000022: reflect on possible past exposure during the period between the consent procedure and the actual interview. This effect
p.000022: could lead to a spurious association between birth defects and drug exposure in the mothers interviewed; thus, if such
p.000022: an association were found, the finding could be scientifically invalid. In studies such as this, biased reporting can
p.000022: be minimised, and scientific validity assured, only by not disclosing in advance the complete details of the hypothesis
p.000022: under test (HRC 2002a, p 38).
p.000022:
p.000022: 6.15 When specific information cannot be provided at the outset, the investigator should offer to provide results
p.000022: to participants. (See also the Code of Rights, Right 6(3)(d): ‘Every consumer has the right to honest and accurate
p.000022: answers to questions relating to services, including questions about … the results of research’.)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000022: and then approach individuals for research; the approach may be made directly or by the participant’s doctor or
p.000022: relevant health practitioner. If the approach is not to be made through the participant’s health practitioner, the
p.000022: reasons for this should be presented to the ethics committee. In such cases, either prior agreement from the
p.000022: participant’s health practitioner should be sought to invite the individual to take part, or the participant’s health
p.000022: practitioner should be informed that the individual will be invited to take part. In the latter circumstance, the
p.000022: individual should be informed of the name of the person who agreed to their being approached.
p.000022:
p.000022: 6.7 The reason for seeking the consent of the person’s medical adviser for an individual to be invited to take
p.000022: part in research is not to usurp the individual’s right to make the final decision about whether to take part, but to
p.000022: minimise the possibility of harm or distress to them. The medical adviser should be aware of the person’s situation and
p.000022: be able to forbid a direct approach in the unusual situation that the person could be unduly distressed. Where there is
p.000022: uncertainty, the medical adviser should check with the individual concerned that an approach is acceptable (HRC 2002a,
p.000022: p 42).
p.000022:
p.000022: 6.8 When approaches to participants identified through health records involve visiting or telephoning them at
p.000022: their home, it is generally desirable that some advance notice be given (for example, through a letter).
p.000022:
p.000022:
p.000022: Interviews
p.000022:
p.000022: 6.9 Interviewers should be properly trained and culturally sensitive, and should carry identification.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 14 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Free and informed consent
p.000022:
p.000022: 6.10 Investigators should obtain the prior informed consent of study participants (with certain exceptions: see
p.000022: paragraphs 6.19–6.21, 6.27, 6.35–6.37 and especially 6.43–6.47; see also the Code of Rights, Right 7(1): ‘Services may
p.000022: be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any
p.000022: enactment, or the common law, or any other provision of this code provides otherwise’).
p.000022:
p.000022: 6.11 Informed consent has two basic components.
p.000022: a) The decision is informed by adequate understanding of any information that is relevant to that decision.
p.000022: b) The decision is voluntary, and is therefore free from undue influence such as manipulation or coercion.
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000022:
p.000022: 4.5 There should be due recognition of Māori as the tāngata whenua and indigenous people of Aotearoa New
p.000022: Zealand.
p.000022:
p.000022: 4.6 Researchers should have regard to guidelines relating to research involving Māori such as the Guidelines
p.000022: for Researchers on Health Research involving Māori (HRC 2010) and NEAC’s resource document Māori Research Ethics: An
p.000022: overview (in press).
p.000022:
p.000022:
p.000022: Justice
p.000022:
p.000022: 4.7 Justice requires that, within a population, there is a fair distribution of the benefits and burdens of
p.000022: participation in a study, and for any participant, a balance of burdens and benefits.
p.000022:
p.000022: 4.8 Accordingly, an investigator must:
p.000022: a) avoid imposing on particular groups an unfair burden of participation in research, audits or related
p.000022: activities; for example, vulnerable members of communities should not bear disproportionate burdens of studies from
p.000022: which other members of the community are intended to benefit
p.000022: b) design studies so the inclusion and exclusion conditions for participants are fair
p.000022: c) not discriminate in the selection and recruitment of participants by including or excluding them on the grounds
p.000022: of ethnicity, age, sex, disability or religious or spiritual beliefs, except when such exclusion or inclusion is
p.000022: essential to the purpose of the study.
p.000022:
p.000022:
p.000022: Beneficence and non-maleficence
p.000022:
p.000022: 4.9 The risks of a study should be reasonable in the light of the expected benefits.
p.000022:
p.000022: 4.10 Investigators should consider the features of a proposed study in the light of ethical considerations, and
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
p.000022:
p.000022: 4.12 Above the threshold of minimal risk, a study warrants greater provision for the protection of participants.
p.000022: A study is within the range of minimal risk if potential participants can reasonably be expected to regard the
p.000022: probability and magnitude of possible harms from participation in the study as no greater than those encountered in
p.000022: those aspects of everyday life that relate to the study (for example, a clinical consultation with a health care
p.000022: provider).
p.000022:
p.000022:
p.000022:
p.000022:
...
p.000022: services, by being specifically directed at improving the delivery of that care or those services, or provide benefits
p.000022: to the public by addressing risks to public health. For this reason, in some settings it is unethical for health care
p.000022: or disability services, or a public health risk, not to be studied by an audit or related activity. (See also the Code
p.000022: of Rights, Right 4(4): ‘Every consumer has the right to have services provided in a manner that minimises the potential
p.000022: harm to, and optimises the quality of life of, that consumer’.)
p.000022:
p.000022: 4.15 In general, when there is some engagement with affected communities during the conduct of the study, there
p.000022: is more likely to be long-term benefit to study participants and to the community.
p.000022:
p.000022:
p.000022: Integrity
p.000022:
p.000022: 4.16 An investigator’s commitment to the advancement of knowledge implies a duty to conduct honest and thoughtful
p.000022: inquiry and rigorous analysis, and to be accountable for her or his activities.
p.000022:
p.000022:
p.000022: Diversity
p.000022:
p.000022: 4.17 As they conduct observational studies, investigators should understand, respect and make due allowance for
p.000022: diversity among participants and their communities. (See also the Code of Rights, Right 1(3): ‘Every consumer has the
p.000022: right to be provided with services that take into account the needs, values, and beliefs of different cultural,
p.000022: religious, social, and ethnic groups, including the needs, values, and beliefs of Māori’.)
p.000022:
p.000022:
p.000022: Conflict of interest
p.000022:
p.000022: 4.18 Investigators should identify to co-investigators, sponsors, employers, participants and, where applicable,
p.000022: ethics committees any perceived, potential or actual conflict of interest he or she might have in relation to any
p.000022: others who are involved with the study. Such conflicts of interest can compromise the design or conduct of a study or
p.000022: the reliability of its results, thereby exposing study participants or others to needless risk or inconvenience.
p.000022:
p.000022: 4.19 As appropriate to the circumstances, any conflict of interest should be minimised.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 10 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 5 Design of study and protocol
p.000022:
p.000022: Study question
p.000022:
p.000022: 5.1 Investigators should meet their obligations to communities by undertaking research that addresses important
p.000022: health problems.
p.000022:
p.000022: 5.2 In identifying and prioritising health problems to be studied, investigators should take into account the
p.000022: perceived importance of the problem to the people living in a community after information about the problem has been
p.000022: provided to them. However, if investigators perceive that a health problem exists but that the community is ignoring it
p.000022: or denying its existence, it may be appropriate to proceed with the study while simultaneously working with the
p.000022: community to gain its confidence and support.
...
Social / Student
Searching for indicator student:
(return to top)
p.000022: questions and hypotheses will build on and address gaps in existing knowledge.
p.000022: • The design and methods: The quality of study design and methods should be reviewed to assess its robustness. This
p.000022: might include study methodology, a description of sample recruitment and characteristics (including number, gender and
p.000022: ethnicity where relevant) and proposed methods of data analysis. Indication of timelines for the research should be
p.000022: included.
p.000022: • The feasibility of the research: This includes whether the overall strategy, methodology and analyses are well
p.000022: reasoned and appropriate to achieve the specific aims of the project. It should determine whether the research has the
p.000022: likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research
p.000022: field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research
p.000022: will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to
p.000022: undertake the research.
p.000022:
p.000022:
p.000022: Core features of the peer review process
p.000022: A peer review process should be commensurate with the type of proposal, the potential risk to participants and where
p.000022: the research will be undertaken. The type of peer review process that is used must be fit-for-purpose and justifiable.
p.000022: For example, the mechanism for delivering peer review of a graduate student project carried out largely within a
p.000022: tertiary institution will differ from that of a multi-centre clinical trial. Opinions from one or more peers may be
p.000022: sought; again, the extent of peer review should be fit-for-purpose. Despite potential differences, an appropriate
p.000022: process for ensuring scientific validity will have the following features:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 31
p.000022:
p.000022: • Peer review delivers an informed opinion: An effective peer review process provides perspectives from subject
p.000022: matter experts. It may be suitable for informed perspectives to be sought from individuals in the same organisation as
p.000022: the researcher, as long as the requirements of freedom from bias, equity and fairness can be met. An appropriate peer
p.000022: is one who can deliver an informed opinion on some or all of a proposal. Reviewers will be knowledgeable about the
p.000022: topic and/or context for the research, have the appropriate expertise relative to the breadth and scope of research
p.000022: under review and, as a result, will be well placed to make a statement as to whether the research in question has
p.000022: verifiable scientific merit. Peer review of scientific validity may include consideration of cultural relevance and
p.000022: appropriateness.
p.000022: • Peer review delivers an objective opinion: Those acting in the capacity of reviewers are charged with delivering a
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000022: incidence rates of the disease (or outcome) in relation to exposure levels. A cohort study may be a clinical cohort
p.000022: study (for example, where a group of patients with a given disease is followed to examine the prognosis).
p.000022: • Cross-sectional studies examine the relationship between diseases (or other health-related characteristics) and
p.000022: other variables of interest in a defined population at one particular point in time, by collecting health and other
p.000022: information concerning members of the population. These include questionnaires or surveys done for research purposes.
p.000022: • Case reports are reports of cases from health or disability services or research settings.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 3
p.000022:
p.000022: • Case series describe a set of cases of a disease (or similar problem). For example, a clinician may assemble a
p.000022: case series on a topic of interest, such as an unexpected adverse effect experienced by patients taking a particular
p.000022: medication.
p.000022: • Descriptive studies examine the existing distribution of variables in populations, for example, analyses of cancer
p.000022: registry data or emergency department data by person, place or time.
p.000022:
p.000022:
p.000022: Types of audit or related activity
p.000022:
p.000022: 2.4 The primary purpose or justification for an audit or related activity is to improve delivery of the
p.000022: particular health or disability support service being studied or to control a threat to public health. (The results of
p.000022: audits and related activities should be disseminated at least to those able to take necessary action. Wider
p.000022: dissemination, including through publication in scientific journals, may sometimes be appropriate.) The 10 main types
p.000022: of audit and related activities are summarised below.
p.000022: • Audits involve the systematic evaluation of aspects of health or disability support service delivery by
p.000022: considering measurable indicators of performance and/or quality.
p.000022: • Programme evaluation is a type of audit where a whole programme is evaluated, rather than specific interventions.
p.000022: • Evaluation studies aim to determine the relevance, effectiveness and impact of activities in the light of their
p.000022: objectives. Several types of evaluation are distinguished, including evaluation of the structure, process and outcome
p.000022: of an activity.
p.000022: • Quality assurance activities aim to improve health and disability support services by assessing the adequacy of
p.000022: existing practice against a standard.
p.000022: • Outcome analyses involve the assessment of health and disability support service quality by reviewing health care
p.000022: information to evaluate outcomes without comparing them against a standard. For example, clinicians may retrospectively
p.000022: examine health care notes and perform descriptive analyses to determine the outcome of medical treatment or course of a
p.000022: particular illness.
p.000022: • Benchmarking aims to improve practice through the comparison of two or more health and disability support
...
Social / employees
Searching for indicator employees:
(return to top)
p.000022: broad category. It includes people who have restricted capability to make independent decisions about their
p.000022: participation in the study (ie, who might traditionally be regarded as lacking the capacity to consent to participate).
p.000022: It also encompasses people who may lack the ability to consent freely or may be particularly susceptible to harm either
p.000022: because of their health status, physical or mental capacity or employment status, or as a result of imprisonment.
p.000022: Non-exhaustive examples of potentially vulnerable people include:
p.000022: • children and young people
p.000022: • people with mental illness
p.000022: • people with serious intellectual disability
p.000022: • people with English as a second language and/or a different cultural background to the investigators (for studies
p.000022: whose details are primarily, or only, stated in English)
p.000022: • people whose freedom to make independent choices is restricted (eg, prisoners, employees or students of a
p.000022: researcher or sponsoring company).
p.000022: It is important to remember that even if a group is identified as being likely to be vulnerable, the label may not
p.000022: apply to all individuals in such groups, and even where it does apply, it may do so only intermittently.
p.000022: Exception
p.000022:
p.000022:
p.000022: Exceptions to this rule include:
p.000022: • where the individual has consented to this use or disclosure
p.000022: • where the information is not identifiable
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Code of Rights, Right
p.000022: 7(10)(c)) applies
p.000022: • where secondary use of data is for the purpose of quality assurance or outcome analysis
p.000022: • where resource review is undertaken by those employed or contracted by the health or disability support service
p.000022: provider holding the information.
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
...
Social / gender
Searching for indicator gender:
(return to top)
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 30 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Peer review
p.000022: The role of New Zealand’s HDECs is to check that proposed health and disability research meets established ethical
p.000022: standards that aim to protect participants (see the SOPs). The SOPs require that researchers and sponsors ensure that
p.000022: the scientific validity of proposed research has been peer-reviewed before an application is made to an HDEC. In this
p.000022: context, peer review is the process by which an applicant can assure an HDEC that a proposal has an appropriate degree
p.000022: of scientific merit, feasibility and likelihood of impact.
p.000022:
p.000022:
p.000022: Areas of focus during peer review
p.000022: Peer review can be tailored to deliver opinions on a variety of matters relating to a health and disability research
p.000022: proposal. In order to determine scientific validity, the following factors should specifically be determined:
p.000022: • The relative merit of the research: A key consideration is whether the proposed work is important, worthwhile and
p.000022: justifiable. The research should address a health issue that is important for health and/or society. The aims, research
p.000022: questions and hypotheses will build on and address gaps in existing knowledge.
p.000022: • The design and methods: The quality of study design and methods should be reviewed to assess its robustness. This
p.000022: might include study methodology, a description of sample recruitment and characteristics (including number, gender and
p.000022: ethnicity where relevant) and proposed methods of data analysis. Indication of timelines for the research should be
p.000022: included.
p.000022: • The feasibility of the research: This includes whether the overall strategy, methodology and analyses are well
p.000022: reasoned and appropriate to achieve the specific aims of the project. It should determine whether the research has the
p.000022: likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research
p.000022: field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research
p.000022: will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to
p.000022: undertake the research.
p.000022:
p.000022:
p.000022: Core features of the peer review process
p.000022: A peer review process should be commensurate with the type of proposal, the potential risk to participants and where
p.000022: the research will be undertaken. The type of peer review process that is used must be fit-for-purpose and justifiable.
p.000022: For example, the mechanism for delivering peer review of a graduate student project carried out largely within a
p.000022: tertiary institution will differ from that of a multi-centre clinical trial. Opinions from one or more peers may be
p.000022: sought; again, the extent of peer review should be fit-for-purpose. Despite potential differences, an appropriate
p.000022: process for ensuring scientific validity will have the following features:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000022: b) identifying information is used with sufficient security; and
p.000022: c) the research has potential to benefit the public.
p.000022:
p.000022: 8.12 In the case of audits and related activities, the use of record linkages without specific or additional
p.000022: consent is ethically justifiable when these activities are part of high-quality health care delivery.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 22 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 9 When to reveal information obtained by observational studies
p.000022:
p.000022: 9.1 If it is reasonably foreseeable that health problems previously unknown to an individual will be identified
p.000022: during the study process, then arrangements for referral, with the individual’s consent, should be made. When findings
p.000022: suggest serious disease, study participants who have not given permission for the transfer of the information to their
p.000022: medical advisor should be urged to seek further advice. Care should be taken not to interfere with health
p.000022: professional–patient relationships. Investigators should usually refrain from giving an opinion about how a particular
p.000022: finding should be dealt with by a participant’s doctor.
p.000022:
p.000022: 9.2 Individuals’ privacy and confidentiality of information need to be ensured unless there is an overriding
p.000022: ethical concern (for example, health or safety) justifying the release of such information or if such release is
p.000022: required by law.
p.000022:
p.000022: 9.3 If privacy or confidentiality must be breached, the investigator should first make a reasonable attempt to
p.000022: inform participants of such required infringements.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 23
p.000022:
p.000022: 10 Communicating study results
p.000022:
p.000022: 10.1 The potential benefits of observational studies are that participants and the community will be informed of
p.000022: general results that pertain to their health and that studies may provide objective results that policy makers can use
p.000022: to formulate sound public health policy.
p.000022:
p.000022: 10.2 Study protocols should include provision for communicating results in a timely, understandable and
p.000022: responsible manner, so that benefit to the community is maximised and fairly distributed. The optimal time at which to
p.000022: disseminate the results of observational studies can be difficult to determine. Both premature release and
...
p.000022: reasoned and appropriate to achieve the specific aims of the project. It should determine whether the research has the
p.000022: likelihood, on balance, of improving scientific knowledge, concepts, technical capacity or methods in the research
p.000022: field, or of contributing to better treatments, services, health outcomes or preventive interventions. The research
p.000022: will be achievable within the specified timeframe and the research team has the appropriate experience and expertise to
p.000022: undertake the research.
p.000022:
p.000022:
p.000022: Core features of the peer review process
p.000022: A peer review process should be commensurate with the type of proposal, the potential risk to participants and where
p.000022: the research will be undertaken. The type of peer review process that is used must be fit-for-purpose and justifiable.
p.000022: For example, the mechanism for delivering peer review of a graduate student project carried out largely within a
p.000022: tertiary institution will differ from that of a multi-centre clinical trial. Opinions from one or more peers may be
p.000022: sought; again, the extent of peer review should be fit-for-purpose. Despite potential differences, an appropriate
p.000022: process for ensuring scientific validity will have the following features:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 31
p.000022:
p.000022: • Peer review delivers an informed opinion: An effective peer review process provides perspectives from subject
p.000022: matter experts. It may be suitable for informed perspectives to be sought from individuals in the same organisation as
p.000022: the researcher, as long as the requirements of freedom from bias, equity and fairness can be met. An appropriate peer
p.000022: is one who can deliver an informed opinion on some or all of a proposal. Reviewers will be knowledgeable about the
p.000022: topic and/or context for the research, have the appropriate expertise relative to the breadth and scope of research
p.000022: under review and, as a result, will be well placed to make a statement as to whether the research in question has
p.000022: verifiable scientific merit. Peer review of scientific validity may include consideration of cultural relevance and
p.000022: appropriateness.
p.000022: • Peer review delivers an objective opinion: Those acting in the capacity of reviewers are charged with delivering a
p.000022: balanced and considered analysis of the research. Generally, the success of the peer review process is determined by
p.000022: the extent to which these evaluations can be considered free of bias, equitable and fair. Objectivity can be
p.000022: compromised if peer reviewers have conflicts of interest, and so appropriate peer reviewers typically will not be
p.000022: materially connected to the researcher(s) in a way that might undermine objectivity, and be free from either positive
p.000022: or negative inducements.
p.000022: • A consensus opinion on scientific validity is formed: An HDEC will need to receive assurance that the peer review
p.000022: process has delivered support for the scientific validity of the proposed research. When a peer review process has
p.000022: engaged a range of experts, there needs to be a process that leads to a consensus opinion about the quality of the
p.000022: research.
p.000022: • Intellectual capital in the research proposal is respected: A peer reviewer is in a privileged position through
p.000022: having access to the unexploited ideas and intellectual capital of the researcher. A peer review process should require
p.000022: that reviewers do not disclose the substance of any research proposal, unless there is explicit permission to do so.
p.000022:
p.000022:
p.000022: Limitations of peer review
p.000022: Peer reviewers typically are not privy to the operational details of a proposed research study. Research proposals
p.000022: usually will outline a methodology, but not explain its implementation in detail. For example, a proposal might state
p.000022: how many patients will be recruited, but will not necessarily explain how patients will be approached, how they might
p.000022: be compensated for participation, nor what information any participant information sheet might contain. Similarly, the
p.000022: detailed clinical trial protocols are not typically included in a peer review. (Detailed examination of a trial
p.000022: protocol is often undertaken by the independent data and safety monitoring committee associated with the trial.) Ethics
p.000022: committees should be aware that studies can be of satisfactory scientific quality as judged by peer review, but still
p.000022: pose ethical concerns because of how the research is to be operationalised. Necessarily, consideration of the safety of
p.000022: participants and researchers, and the balance of risk and benefit, by ethics committees is likely to involve scrutiny
...
Searching for indicator philosophy:
(return to top)
p.000022:
p.000022: 6.32 An individual’s right to decline to participate in the study, expressed in hui, should also be noted. The
p.000022: statement of group consent obtained in hui should allow for study participants to withdraw at any time from the study
p.000022: if they so wish.
p.000022:
p.000022: 6.33 When a study is initiated from outside the whānau, hapū or iwi, or when the investigators do not have a
p.000022: representative from that group within their number, the usual procedures for informed consent to participate in the
p.000022: study are expected. In addition, a system of accountability of the investigators to the whānau, hapū or iwi concerned
p.000022: should be instituted after full discussion with and agreement by the participants and investigators. A group’s right to
p.000022: decline to have a study proceed within their whānau, hapū or iwi if the study is unacceptable to them is paramount.
p.000022:
p.000022: 6.34 Not all Māori have contact with whānau, hapū or iwi, and the usual requirements for fully informed consent
p.000022: to participate in a study proposal will be expected in such cases.
p.000022:
p.000022: 6.35 When it is not possible to request informed consent from every individual to be studied (for example, in a
p.000022: community study of the effects of water fluoridation), the agreement of a representative of a community or group may be
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 7
p.000022:
p.000022: 4 Underlying ethical considerations
p.000022:
p.000022: 4.1 The following considerations are important to the ethics of observational studies. The application and
p.000022: weighting of these considerations will vary depending on the nature and particular circumstances of the observational
p.000022: study in question.
p.000022:
p.000022:
p.000022: Respect for people
p.000022:
p.000022: 4.2 Respect for people, and for their rights, incorporates at least two fundamental principles:
p.000022: a) autonomy, which requires that people who are capable of deliberation about their personal goals should be
p.000022: treated with respect for their capacity for self- determination
p.000022: b) protection of people with impaired or diminished autonomy, which requires that people who are dependent or
p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
p.000022:
p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
p.000022: concerned, including appropriate whānau, hapū or iwi. He Korowai Oranga states: ‘Comprehensive, high-quality Māori
...
p.000022: satisfactorily resolve ethical issues raised by the study. Not all ethical considerations weigh equally. A study may be
p.000022: assessed as ethically justifiable even if an usual ethical expectation, such as confidentiality of data, has not been
p.000022: comprehensively met, provided the potential benefits clearly outweigh the risks and the investigators can minimise the
p.000022: risks.
p.000022:
p.000022: 4.11 A proportionate approach should be taken: the greater the risk of harm from the study, the greater should be
p.000022: the care in addressing the ethical issues raised.
p.000022:
p.000022: 4.12 Above the threshold of minimal risk, a study warrants greater provision for the protection of participants.
p.000022: A study is within the range of minimal risk if potential participants can reasonably be expected to regard the
p.000022: probability and magnitude of possible harms from participation in the study as no greater than those encountered in
p.000022: those aspects of everyday life that relate to the study (for example, a clinical consultation with a health care
p.000022: provider).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 9
p.000022:
p.000022: 4.13 The potential harms associated with observational studies are generally less than with experimental studies,
p.000022: as no intrusive intervention takes place and participants are less likely to be in a dependent relationship with the
p.000022: investigator. Depending on the method used (whether previously collected information is used or new information is
p.000022: collected) potential harms in observational studies could include breaches of confidentiality.
p.000022:
p.000022: 4.14 Audits and related activities are typically minimal-risk activities. Compared with research, they typically
p.000022: have more predictable benefits and reduced risks. They provide benefits for people receiving health care or disability
p.000022: services, by being specifically directed at improving the delivery of that care or those services, or provide benefits
p.000022: to the public by addressing risks to public health. For this reason, in some settings it is unethical for health care
p.000022: or disability services, or a public health risk, not to be studied by an audit or related activity. (See also the Code
p.000022: of Rights, Right 4(4): ‘Every consumer has the right to have services provided in a manner that minimises the potential
p.000022: harm to, and optimises the quality of life of, that consumer’.)
p.000022:
p.000022: 4.15 In general, when there is some engagement with affected communities during the conduct of the study, there
p.000022: is more likely to be long-term benefit to study participants and to the community.
p.000022:
p.000022:
p.000022: Integrity
p.000022:
p.000022: 4.16 An investigator’s commitment to the advancement of knowledge implies a duty to conduct honest and thoughtful
p.000022: inquiry and rigorous analysis, and to be accountable for her or his activities.
p.000022:
p.000022:
p.000022: Diversity
...
p.000022: an association were found, the finding could be scientifically invalid. In studies such as this, biased reporting can
p.000022: be minimised, and scientific validity assured, only by not disclosing in advance the complete details of the hypothesis
p.000022: under test (HRC 2002a, p 38).
p.000022:
p.000022: 6.15 When specific information cannot be provided at the outset, the investigator should offer to provide results
p.000022: to participants. (See also the Code of Rights, Right 6(3)(d): ‘Every consumer has the right to honest and accurate
p.000022: answers to questions relating to services, including questions about … the results of research’.)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
p.000022: refusal to participate in, or decision to withdraw from, the study will not result in discrimination, a reduced level
p.000022: of care or any other disadvantage.
p.000022:
p.000022:
p.000022: People with diminished competence to give consent
p.000022:
p.000022: 6.19 Ethical consideration of studies involving individuals or groups who have diminished competence to give free
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
p.000022: b) the injustice that would arise from their exclusion from the benefits of observational studies in these groups.
p.000022: (See also the Code of Rights, Right 7(3): ‘Where a consumer has diminished competence, that consumer retains the right
p.000022: to make informed choices and give informed consent, to the extent appropriate to his or her level of competence’.)
p.000022:
p.000022: 6.20 Subject to applicable legal requirements, individuals who are not legally competent may be asked to become
p.000022: participants in observational research only when the study question can only be addressed:
p.000022: a) with the participation of those individuals from identified group(s); and
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.000022: under the Health Practitioners Competence Assurance Act 2003 (Ministry of Health 2004).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 7
p.000022:
p.000022: 4 Underlying ethical considerations
p.000022:
p.000022: 4.1 The following considerations are important to the ethics of observational studies. The application and
p.000022: weighting of these considerations will vary depending on the nature and particular circumstances of the observational
p.000022: study in question.
p.000022:
p.000022:
p.000022: Respect for people
p.000022:
p.000022: 4.2 Respect for people, and for their rights, incorporates at least two fundamental principles:
p.000022: a) autonomy, which requires that people who are capable of deliberation about their personal goals should be
p.000022: treated with respect for their capacity for self- determination
p.000022: b) protection of people with impaired or diminished autonomy, which requires that people who are dependent or
p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
p.000022:
p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
...
p.000022: under test (HRC 2002a, p 38).
p.000022:
p.000022: 6.15 When specific information cannot be provided at the outset, the investigator should offer to provide results
p.000022: to participants. (See also the Code of Rights, Right 6(3)(d): ‘Every consumer has the right to honest and accurate
p.000022: answers to questions relating to services, including questions about … the results of research’.)
p.000022:
p.000022: 6.16 When investigators collect information directly from individuals, or seek their consent to access records,
p.000022: they should inform them that supplying information is voluntary.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 15
p.000022:
p.000022: 6.17 The right of any person to decline to take part in a study or to withdraw from the study at any time must
p.000022: always be explained and respected. This includes the right to decline to answer all or any questions in a
p.000022: questionnaire. (See also the Code of Rights, Right 7(7): ‘Every consumer has the right to refuse services and to
p.000022: withdraw consent to services’.)
p.000022:
p.000022: 6.18 When a study involves people in dependent or unequal relationships, the investigator must ensure that their
p.000022: refusal to participate in, or decision to withdraw from, the study will not result in discrimination, a reduced level
p.000022: of care or any other disadvantage.
p.000022:
p.000022:
p.000022: People with diminished competence to give consent
p.000022:
p.000022: 6.19 Ethical consideration of studies involving individuals or groups who have diminished competence to give free
p.000022: and informed consent on their own behalf (for example, children) must seek to balance:
p.000022: a) the vulnerability that arises from the participants’ diminished competence; with
p.000022: b) the injustice that would arise from their exclusion from the benefits of observational studies in these groups.
p.000022: (See also the Code of Rights, Right 7(3): ‘Where a consumer has diminished competence, that consumer retains the right
p.000022: to make informed choices and give informed consent, to the extent appropriate to his or her level of competence’.)
p.000022:
p.000022: 6.20 Subject to applicable legal requirements, individuals who are not legally competent may be asked to become
p.000022: participants in observational research only when the study question can only be addressed:
p.000022: a) with the participation of those individuals from identified group(s); and
p.000022: b) when free and informed consent is sought from their legal representative(s), such as a welfare guardian or a
p.000022: representative with enduring power of attorney.
p.000022: (See also the Code of Rights, Right 7(4).)
p.000022:
p.000022: 6.21 When free and informed consent has been obtained from an authorised third party, and in those circumstances
p.000022: where the legally incompetent individual understands the nature and consequences of the study, the investigator must
p.000022: seek to ascertain the individual’s wishes concerning his or her participation. The potential participant’s dissent will
p.000022: preclude his or her participation.
p.000022:
p.000022:
p.000022: Inducements
p.000022:
p.000022: 6.22 Investigators may seek to create legitimate motivation for participation in studies, but may not exert
p.000022: pressure by offering inappropriate inducements.
p.000022:
p.000022: 6.23 Risks involved in participation should be acceptable to participants even in the absence of inducement.
p.000022:
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000022:
p.000022: 3.7 People conducting quality assurance activities should be familiar with the Health Practitioners Competence
p.000022: Assurance Act 2003 (HPCA), especially sections 54–63. When the Minister of Health has declared an activity to be a
p.000022: ‘protected quality assurance activity’, the HPCA protects the confidentiality of information obtained in the course of
p.000022: the activity and gives the investigator immunity from civil liability. See also Protected Quality Assurance Activities
p.000022: under the Health Practitioners Competence Assurance Act 2003 (Ministry of Health 2004).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 7
p.000022:
p.000022: 4 Underlying ethical considerations
p.000022:
p.000022: 4.1 The following considerations are important to the ethics of observational studies. The application and
p.000022: weighting of these considerations will vary depending on the nature and particular circumstances of the observational
p.000022: study in question.
p.000022:
p.000022:
p.000022: Respect for people
p.000022:
p.000022: 4.2 Respect for people, and for their rights, incorporates at least two fundamental principles:
p.000022: a) autonomy, which requires that people who are capable of deliberation about their personal goals should be
p.000022: treated with respect for their capacity for self- determination
p.000022: b) protection of people with impaired or diminished autonomy, which requires that people who are dependent or
p.000022: vulnerable be afforded security against harm.
p.000022: (See also the Code of Rights, Right 1(1): ‘Every consumer has the right to be treated with respect’.)
p.000022:
p.000022:
p.000022: Māori and ethical considerations
p.000022:
p.000022: 4.3 He Korowai Oranga: Māori Health Strategy specifies that ‘The Government is committed to fulfilling the
p.000022: special relationship between iwi and the Crown under the Treaty of Waitangi’ (Minister of Health and Associate Minister
p.000022: of Health 2002, p 2). This commitment should be respected by all investigators and, when applicable, should be
p.000022: reflected in the design and conduct of observational studies. Relevant principles that apply include:
p.000022: • partnership: working together with iwi, hapū, whānau and Māori communities to ensure Māori individual and
p.000022: collective rights are respected and protected in order to achieve health gain
p.000022: • participation: involving Māori in the design, governance, management,
p.000022: implementation and analysis of research, particularly research involving Māori
p.000022: • protection: actively protecting Māori individual and collective rights, and Māori data,
p.000022: cultural concepts, norms, practices and language in the research process.
p.000022:
p.000022: 4.4 Issues relating to Māori cultural and ethical values should be addressed in discussion with Māori
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000022:
p.000022: 6.35 When it is not possible to request informed consent from every individual to be studied (for example, in a
p.000022: community study of the effects of water fluoridation), the agreement of a representative of a community or group may be
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
p.000022:
p.000022: 6.39 Investigators should be aware that access to health information is subject to the HIPC, and that access to
p.000022: personal information is subject to the Privacy Act 1993. Access to personal information may also be subject to the
p.000022: Official Information Act 1982.
p.000022:
p.000022: 6.40 A named investigator to whom records are disclosed should give a written undertaking to ensure the
p.000022: confidentiality of the records.
p.000022:
p.000022:
p.000022:
p.000022: 18 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.41 In the case of records involving Māori health information, where a kaitiaki group has been established to
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
p.000022: purpose of kaitiaki groups is to give Māori control and protection of data concerning Māori and to ensure the data are
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000022: without the disease with respect to the presence of the attribute or level of exposure to it.
p.000022: • Cohort studies examine the relationship between exposure to a factor or factors and the probability of the
p.000022: occurrence of a disease (or other outcome) by observing large numbers of people over a period of time and comparing
p.000022: incidence rates of the disease (or outcome) in relation to exposure levels. A cohort study may be a clinical cohort
p.000022: study (for example, where a group of patients with a given disease is followed to examine the prognosis).
p.000022: • Cross-sectional studies examine the relationship between diseases (or other health-related characteristics) and
p.000022: other variables of interest in a defined population at one particular point in time, by collecting health and other
p.000022: information concerning members of the population. These include questionnaires or surveys done for research purposes.
p.000022: • Case reports are reports of cases from health or disability services or research settings.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 3
p.000022:
p.000022: • Case series describe a set of cases of a disease (or similar problem). For example, a clinician may assemble a
p.000022: case series on a topic of interest, such as an unexpected adverse effect experienced by patients taking a particular
p.000022: medication.
p.000022: • Descriptive studies examine the existing distribution of variables in populations, for example, analyses of cancer
p.000022: registry data or emergency department data by person, place or time.
p.000022:
p.000022:
p.000022: Types of audit or related activity
p.000022:
p.000022: 2.4 The primary purpose or justification for an audit or related activity is to improve delivery of the
p.000022: particular health or disability support service being studied or to control a threat to public health. (The results of
p.000022: audits and related activities should be disseminated at least to those able to take necessary action. Wider
p.000022: dissemination, including through publication in scientific journals, may sometimes be appropriate.) The 10 main types
p.000022: of audit and related activities are summarised below.
p.000022: • Audits involve the systematic evaluation of aspects of health or disability support service delivery by
p.000022: considering measurable indicators of performance and/or quality.
p.000022: • Programme evaluation is a type of audit where a whole programme is evaluated, rather than specific interventions.
p.000022: • Evaluation studies aim to determine the relevance, effectiveness and impact of activities in the light of their
p.000022: objectives. Several types of evaluation are distinguished, including evaluation of the structure, process and outcome
p.000022: of an activity.
p.000022: • Quality assurance activities aim to improve health and disability support services by assessing the adequacy of
p.000022: existing practice against a standard.
p.000022: • Outcome analyses involve the assessment of health and disability support service quality by reviewing health care
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000022:
p.000022: 6.28 Questionnaires are often innocuous, and may even be offered by mail. Completion of the questionnaire can be
p.000022: taken as consent, provided the letter of invitation expressly leaves the participant free of obligation.
p.000022:
p.000022: 6.29 Some studies may involve interviews or questionnaires that are intrusive and may cause distress. In this
p.000022: case, it is appropriate to seek participants’ prior consent by forewarning them of the potentially distressing nature
p.000022: of participation.
p.000022:
p.000022:
p.000022: Collective consent
p.000022:
p.000022: 6.30 For communities in which collective decision-making is customary, communal leaders can express the
p.000022: collective will. However, the agreement or refusal of individuals to participate in a study has to be respected: a
p.000022: leader may express agreement or refusal on behalf of a community, but an individual’s agreement or refusal of personal
p.000022: participation is binding. When an individual wishes to participate in a study that community leaders have objected to,
p.000022: individuals should be given information to this effect and the reasons why community leaders have declined to take
p.000022: part. Having considered this information, the individual then has the right to decide whether to participate.
p.000022: Paragraphs 6.31–6.35 should be interpreted in the light of this paragraph.
p.000022:
p.000022: 6.31 Investigators who initiate a study within a whānau, hapū or iwi, when the investigators and participants are
p.000022: members of that same group, may prefer to provide, via a kaumatua or other person of authority in the group, a
p.000022: statement in the study proposal that group consent for participation was obtained from the representatives or
p.000022: participants in hui.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 17
p.000022:
p.000022: 6.32 An individual’s right to decline to participate in the study, expressed in hui, should also be noted. The
p.000022: statement of group consent obtained in hui should allow for study participants to withdraw at any time from the study
p.000022: if they so wish.
p.000022:
p.000022: 6.33 When a study is initiated from outside the whānau, hapū or iwi, or when the investigators do not have a
p.000022: representative from that group within their number, the usual procedures for informed consent to participate in the
p.000022: study are expected. In addition, a system of accountability of the investigators to the whānau, hapū or iwi concerned
p.000022: should be instituted after full discussion with and agreement by the participants and investigators. A group’s right to
p.000022: decline to have a study proceed within their whānau, hapū or iwi if the study is unacceptable to them is paramount.
p.000022:
p.000022: 6.34 Not all Māori have contact with whānau, hapū or iwi, and the usual requirements for fully informed consent
p.000022: to participate in a study proposal will be expected in such cases.
p.000022:
p.000022: 6.35 When it is not possible to request informed consent from every individual to be studied (for example, in a
p.000022: community study of the effects of water fluoridation), the agreement of a representative of a community or group may be
p.000022: sought, but the representative should be chosen according to the nature, traditions and political philosophy of the
p.000022: community or group. Approval given by a community representative should be consistent with general ethical principles.
p.000022: When investigators work with communities, they will consider communal rights and protection as they would individual
p.000022: rights and protection.
p.000022:
p.000022:
p.000022: Collection of health information from a third party
p.000022:
p.000022: Authorisation
p.000022:
p.000022: 6.36 When an investigator proposes to collect information from a third party, this should be with the authority
p.000022: of the individual concerned, except in specific circumstances.
p.000022:
p.000022: 6.37 If the investigator proposes to collect personal information from a relative or other third party without
p.000022: the authority of the individual concerned, because that individual is deceased, untraceable or incapacitated, or for
p.000022: some other good reason, this approach should be justified to an ethics committee on ethical and scientific grounds.
p.000022:
p.000022:
p.000022: Collection of health information from records
p.000022:
p.000022: 6.38 Access to medical or other records for the purposes of observational studies should be restricted to
p.000022: appropriately qualified investigators and study associates responsible to them.
p.000022:
p.000022: 6.39 Investigators should be aware that access to health information is subject to the HIPC, and that access to
p.000022: personal information is subject to the Privacy Act 1993. Access to personal information may also be subject to the
p.000022: Official Information Act 1982.
p.000022:
p.000022: 6.40 A named investigator to whom records are disclosed should give a written undertaking to ensure the
p.000022: confidentiality of the records.
p.000022:
p.000022:
p.000022:
p.000022: 18 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.41 In the case of records involving Māori health information, where a kaitiaki group has been established to
p.000022: act as guardian of information concerning Māori in the area of study, the kaitiaki group should be consulted. The
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000022: p 42).
p.000022:
p.000022: 6.8 When approaches to participants identified through health records involve visiting or telephoning them at
p.000022: their home, it is generally desirable that some advance notice be given (for example, through a letter).
p.000022:
p.000022:
p.000022: Interviews
p.000022:
p.000022: 6.9 Interviewers should be properly trained and culturally sensitive, and should carry identification.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 14 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Free and informed consent
p.000022:
p.000022: 6.10 Investigators should obtain the prior informed consent of study participants (with certain exceptions: see
p.000022: paragraphs 6.19–6.21, 6.27, 6.35–6.37 and especially 6.43–6.47; see also the Code of Rights, Right 7(1): ‘Services may
p.000022: be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any
p.000022: enactment, or the common law, or any other provision of this code provides otherwise’).
p.000022:
p.000022: 6.11 Informed consent has two basic components.
p.000022: a) The decision is informed by adequate understanding of any information that is relevant to that decision.
p.000022: b) The decision is voluntary, and is therefore free from undue influence such as manipulation or coercion.
p.000022: (See also the Code of Rights, Right 2: ‘Every consumer has the right to be free from discrimination, coercion,
p.000022: harassment, and sexual, financial or other exploitation’.)
p.000022:
p.000022: 6.12 Information about the purpose of the study should be as specific as possible without compromising the
p.000022: validity of the study.
p.000022:
p.000022: 6.13 In some situations, providing very specific information about the study in advance of seeking consent would
p.000022: prejudice the purposes of the collection by compromising the scientific validity of the study. For example, if a mother
p.000022: is to be interviewed to establish whether she has been exposed to a particular medicine that might have caused a
p.000022: congenital abnormality in her baby, it would be wrong, when asking her to consent to the study, to give her the name of
p.000022: the drug in question. If the name of the drug were disclosed, this may have at least one scientifically unacceptable
p.000022: consequence, in that the information collected may be biased. This is because if the mother in question had a baby with
p.000022: a birth defect, she would have had both a reason and a longer period of time, in advance of the actual interview, to
p.000022: remember that she had been exposed to the drug.
p.000022:
p.000022: 6.14 In contrast, a mother of a healthy baby would have less reason to remember past exposure, and would not
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000022: request that NEAC:
p.000022: develop guidelines on conducting observational studies in an ethical manner and establish the parameters for the
p.000022: ethical review of observational studies (including guidance regarding weighing up the harms and benefits of this type
p.000022: of health research) (Minister of Health, 2001, 2004).
p.000022:
p.000022: 1.2 The Guidelines constitute ‘ethical standards’, for the purposes of the Code of Health and Disability
p.000022: Services Consumers’ Rights 1996 (the Code of Rights), Right 4(2).
p.000022:
p.000022: 1.3 An observational study is not a ‘clinical trial’, for the purposes of the Accident Compensation Act 2001,
p.000022: section 32.
p.000022:
p.000022: 1.4 An observational study is not ‘human reproductive research’, for the purposes of the Human Assisted
p.000022: Reproductive Technology Act 2004 (the HART Act). The Guidelines nevertheless constitute ‘applicable ethical standards’
p.000022: for the purposes of the HART Act, section 27(4).
p.000022:
p.000022: 1.5 An observational study is not ‘medical or scientific experimentation’ or ‘medical treatment’ for the
p.000022: purposes of the New Zealand Bill of Rights Act 1990, sections 10 and 11.
p.000022:
p.000022: 1.6 These Guidelines are based on statements from New Zealand and international guidelines (see the
p.000022: Bibliography). They accord with key international guidelines, including the World Medical Association Declaration of
p.000022: Helsinki: Ethical principles for medical research involving human subjects (WMA 2008) and the Council for International
p.000022: Organizations of Medical Sciences’ International Guidelines for Ethical Review of Epidemiological Studies (CIOMS 1991).
p.000022: Researchers should be familiar with relevant sources of international and domestic ethical guidance materials as
p.000022: indicated in the Bibliography. In the domestic context, researchers should particularly be aware of guidelines relating
p.000022: to research involving Māori, such as the Health Research Council’s Guidelines for Researchers on Health Research
p.000022: involving Māori (HRC 2010), and NEAC’s resource document Māori Research Ethics: An overview (in press).
p.000022:
p.000022: 1.7 These Guidelines are written primarily for investigators conducting observational studies. They are
p.000022: structured around the process an investigator undertakes when designing and conducting a study, from the consideration
p.000022: of the underlying ethical considerations to the communication of study results.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 1
p.000022:
p.000022: 1.8 Detailed matters concerning health and disability ethics committee (HDEC) review of observational studies
p.000022: are addressed in the standard operating procedures (SOPs) for HDECs established under the New Zealand Public Health and
p.000022: Disability Act 2000, section 11. The SOPs were created in 2012 in response to the Government response to the Select
p.000022: Committee inquiry into improving New Zealand’s environment to support innovation through clinical trials. They provide
p.000022: procedural guidance to HDECs and researchers, and set out the scope of HDEC review and information about how HDECs
...
p.000022:
p.000022: 12.3 Investigators should ensure that they comply with internal organisational requirements in respect of
p.000022: observational research, all audits and related activities that they conduct in or through it. The appropriate approach
p.000022: will vary from organisation to organisation; as such, organisations might also specify their own processes regarding
p.000022: notification or approval.
p.000022:
p.000022: 12.4 Chapter 10 of the Ministry of Health SOPs provides guidance about requirements for locality authorisation.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 27
p.000022:
p.000022: Bibliography
p.000022: Note: This bibliography is restricted to national and international guidance statements. A full bibliography of works
p.000022: consulted in the preparation of these Guidelines is available on the NEAC website (www.neac.health.govt.nz).
p.000022:
p.000022: American College of Epidemiology. 2000. American College of Epidemiology Ethics Guidelines. Annals of Epidemiology
p.000022: 10(8): 487–97.
p.000022: Code of Health and Disability Services Consumers’ Rights. 1996.
p.000022: CIOMS. 1991. International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: CIOMS. 2006. Special Ethical Considerations for Epidemiological Research (draft). Geneva: Council for International
p.000022: Organizations of Medical Sciences.
p.000022: EMEA, CPMP. 2002. Position Paper on Terminology in Pharmacogenetics. London: European Agency for the Evaluation of
p.000022: Medicinal Products, Committee for Proprietary Medicinal Products.
p.000022: HRC. 2002a. Guidelines on Ethics in Health Research. Wellington: Health Research Council.
p.000022: HRC. 2002b. Health Research and Privacy: Guidance Notes for Health Researchers and Ethics Committees. Wellington:
p.000022: Health Research Council.
p.000022: HRC. 2010. Guidelines for Researchers on Health Research involving Māori. Wellington: Health Research Council.
p.000022: ICMJE. 2004. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical
p.000022: publication. Philadelphia: International Committee of Medical Journal Editors.
p.000022: Lowrance W. 2002. Learning from Experience: Privacy and the secondary use of data in health research. London: The
p.000022: Nuffield Trust.
p.000022: Medical Council of New Zealand. 2002a. Confidentiality and Public Safety. Wellington: Medical Council of New Zealand.
p.000022: Medical Council of New Zealand. 2002b. Information and Consent. Wellington: Medical Council of New Zealand.
p.000022: Medical Council of New Zealand. 2004. Good Medical Practice. Wellington: Medical Council of New Zealand.
p.000022: Minister of Health. 2000. The New Zealand Health Strategy. Wellington: Ministry of Health.
p.000022: Minister of Health. 2001. National Ethics Advisory Committee: Terms of Reference. Wellington: Ministry of Health.
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.000022: relevant health practitioner. If the approach is not to be made through the participant’s health practitioner, the
p.000022: reasons for this should be presented to the ethics committee. In such cases, either prior agreement from the
p.000022: participant’s health practitioner should be sought to invite the individual to take part, or the participant’s health
p.000022: practitioner should be informed that the individual will be invited to take part. In the latter circumstance, the
p.000022: individual should be informed of the name of the person who agreed to their being approached.
p.000022:
p.000022: 6.7 The reason for seeking the consent of the person’s medical adviser for an individual to be invited to take
p.000022: part in research is not to usurp the individual’s right to make the final decision about whether to take part, but to
p.000022: minimise the possibility of harm or distress to them. The medical adviser should be aware of the person’s situation and
p.000022: be able to forbid a direct approach in the unusual situation that the person could be unduly distressed. Where there is
p.000022: uncertainty, the medical adviser should check with the individual concerned that an approach is acceptable (HRC 2002a,
p.000022: p 42).
p.000022:
p.000022: 6.8 When approaches to participants identified through health records involve visiting or telephoning them at
p.000022: their home, it is generally desirable that some advance notice be given (for example, through a letter).
p.000022:
p.000022:
p.000022: Interviews
p.000022:
p.000022: 6.9 Interviewers should be properly trained and culturally sensitive, and should carry identification.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 14 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: Free and informed consent
p.000022:
p.000022: 6.10 Investigators should obtain the prior informed consent of study participants (with certain exceptions: see
p.000022: paragraphs 6.19–6.21, 6.27, 6.35–6.37 and especially 6.43–6.47; see also the Code of Rights, Right 7(1): ‘Services may
p.000022: be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any
p.000022: enactment, or the common law, or any other provision of this code provides otherwise’).
p.000022:
p.000022: 6.11 Informed consent has two basic components.
p.000022: a) The decision is informed by adequate understanding of any information that is relevant to that decision.
p.000022: b) The decision is voluntary, and is therefore free from undue influence such as manipulation or coercion.
p.000022: (See also the Code of Rights, Right 2: ‘Every consumer has the right to be free from discrimination, coercion,
p.000022: harassment, and sexual, financial or other exploitation’.)
p.000022:
p.000022: 6.12 Information about the purpose of the study should be as specific as possible without compromising the
p.000022: validity of the study.
p.000022:
...
p.000022: pressure by offering inappropriate inducements.
p.000022:
p.000022: 6.23 Risks involved in participation should be acceptable to participants even in the absence of inducement.
p.000022:
p.000022: 6.24 It is acceptable for investigators to repay the incurred expenses of participants (for example, travel
p.000022: costs).
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 16 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 6.25 A koha may be offered in line with the cultural norms of the study participants, but should not be of such a
p.000022: value that it could reasonably be interpreted as an inappropriate inducement or as a payment for participation. For
p.000022: this reason, it is often not appropriate to discuss koha before getting an agreement to participate. (Traditionally,
p.000022: koha is an acknowledgement of the knowledge and/or hospitality extended by tāngata whenua to manuhiri. It is presented
p.000022: as part of the pōwhiri onto a marae or other venue of the tāngata whenua. However, the definition of koha should not be
p.000022: restricted by reference to its traditional roots; contemporary meanings include the giving of koha in a different
p.000022: manner during research.)
p.000022:
p.000022:
p.000022: Documentation
p.000022:
p.000022: 6.26 Evidence of free and informed consent by a participant or authorised third party should ordinarily be
p.000022: obtained in writing.
p.000022:
p.000022: 6.27 When written consent is culturally unacceptable or good reasons exist for not recording consent in writing
p.000022: (such as in the case of anonymous data collection or telephone interviews), the procedures used to seek free and
p.000022: informed consent should be documented.
p.000022:
p.000022: 6.28 Questionnaires are often innocuous, and may even be offered by mail. Completion of the questionnaire can be
p.000022: taken as consent, provided the letter of invitation expressly leaves the participant free of obligation.
p.000022:
p.000022: 6.29 Some studies may involve interviews or questionnaires that are intrusive and may cause distress. In this
p.000022: case, it is appropriate to seek participants’ prior consent by forewarning them of the potentially distressing nature
p.000022: of participation.
p.000022:
p.000022:
p.000022: Collective consent
p.000022:
p.000022: 6.30 For communities in which collective decision-making is customary, communal leaders can express the
p.000022: collective will. However, the agreement or refusal of individuals to participate in a study has to be respected: a
p.000022: leader may express agreement or refusal on behalf of a community, but an individual’s agreement or refusal of personal
p.000022: participation is binding. When an individual wishes to participate in a study that community leaders have objected to,
p.000022: individuals should be given information to this effect and the reasons why community leaders have declined to take
p.000022: part. Having considered this information, the individual then has the right to decide whether to participate.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000022: the New Zealand Public Health and Disability Act 2000, section 16, to ‘determine nationally consistent ethical
p.000022: standards across the health sector’. The Guidelines are also developed in accordance with the Minister of Health’s
p.000022: request that NEAC:
p.000022: develop guidelines on conducting observational studies in an ethical manner and establish the parameters for the
p.000022: ethical review of observational studies (including guidance regarding weighing up the harms and benefits of this type
p.000022: of health research) (Minister of Health, 2001, 2004).
p.000022:
p.000022: 1.2 The Guidelines constitute ‘ethical standards’, for the purposes of the Code of Health and Disability
p.000022: Services Consumers’ Rights 1996 (the Code of Rights), Right 4(2).
p.000022:
p.000022: 1.3 An observational study is not a ‘clinical trial’, for the purposes of the Accident Compensation Act 2001,
p.000022: section 32.
p.000022:
p.000022: 1.4 An observational study is not ‘human reproductive research’, for the purposes of the Human Assisted
p.000022: Reproductive Technology Act 2004 (the HART Act). The Guidelines nevertheless constitute ‘applicable ethical standards’
p.000022: for the purposes of the HART Act, section 27(4).
p.000022:
p.000022: 1.5 An observational study is not ‘medical or scientific experimentation’ or ‘medical treatment’ for the
p.000022: purposes of the New Zealand Bill of Rights Act 1990, sections 10 and 11.
p.000022:
p.000022: 1.6 These Guidelines are based on statements from New Zealand and international guidelines (see the
p.000022: Bibliography). They accord with key international guidelines, including the World Medical Association Declaration of
p.000022: Helsinki: Ethical principles for medical research involving human subjects (WMA 2008) and the Council for International
p.000022: Organizations of Medical Sciences’ International Guidelines for Ethical Review of Epidemiological Studies (CIOMS 1991).
p.000022: Researchers should be familiar with relevant sources of international and domestic ethical guidance materials as
p.000022: indicated in the Bibliography. In the domestic context, researchers should particularly be aware of guidelines relating
p.000022: to research involving Māori, such as the Health Research Council’s Guidelines for Researchers on Health Research
p.000022: involving Māori (HRC 2010), and NEAC’s resource document Māori Research Ethics: An overview (in press).
p.000022:
p.000022: 1.7 These Guidelines are written primarily for investigators conducting observational studies. They are
p.000022: structured around the process an investigator undertakes when designing and conducting a study, from the consideration
p.000022: of the underlying ethical considerations to the communication of study results.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 1
p.000022:
p.000022: 1.8 Detailed matters concerning health and disability ethics committee (HDEC) review of observational studies
p.000022: are addressed in the standard operating procedures (SOPs) for HDECs established under the New Zealand Public Health and
...
p.000022: The justification for this is that the use is related to the primary purpose of the data collection, and in such
p.000022: settings only individuals bound by a professional or an employment obligation to preserve confidentiality should have
p.000022: access to identified or potentially identifiable information.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: 26 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 12 Additional points
p.000022:
p.000022: 12.1 Publication or an intention to publish does not mean an activity is classified as research, does not make it
p.000022: a more than minimal risk activity, and does not trigger any requirement for ethics committee review. Any investigator
p.000022: who intends to publish results of any observational study should ensure the activity has been conducted in accordance
p.000022: with these Guidelines, and should inform the editor concerned whether or not ethics committee review is required. This
p.000022: is consistent with the guidance provided in the International Committee of Medical Journal Editors’ Uniform
p.000022: Requirements for Manuscripts Submitted to Biomedical Journals: Writing and editing for biomedical publication (2004,
p.000022: section 11.F).
p.000022:
p.000022: 12.2 When reporting experiments on human subjects, authors should indicate whether the procedures followed were
p.000022: in accordance with the ethical standards of the responsible committee on human experimentation (institutional and
p.000022: national) and with the Helsinki Declaration of 1975, as revised in 2000.
p.000022:
p.000022: 12.3 Investigators should ensure that they comply with internal organisational requirements in respect of
p.000022: observational research, all audits and related activities that they conduct in or through it. The appropriate approach
p.000022: will vary from organisation to organisation; as such, organisations might also specify their own processes regarding
p.000022: notification or approval.
p.000022:
p.000022: 12.4 Chapter 10 of the Ministry of Health SOPs provides guidance about requirements for locality authorisation.
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022:
p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 27
p.000022:
p.000022: Bibliography
p.000022: Note: This bibliography is restricted to national and international guidance statements. A full bibliography of works
p.000022: consulted in the preparation of these Guidelines is available on the NEAC website (www.neac.health.govt.nz).
p.000022:
p.000022: American College of Epidemiology. 2000. American College of Epidemiology Ethics Guidelines. Annals of Epidemiology
p.000022: 10(8): 487–97.
p.000022: Code of Health and Disability Services Consumers’ Rights. 1996.
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General/Other / tri-council policy statement
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p.000022: Canberra: National Health and Medical Research Council.
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p.000022: 28 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
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p.000022: National Health and Medical Research Council. 2002. When Does Quality Assurance in Health Care Require Independent
p.000022: Ethical Review? Consultation draft. Canberra: National Health and Medical Research Council.
p.000022: NEAC. 2003a. Ethical Review of Observational Research, Audit and Related Activities. Discussion document. Wellington:
p.000022: National Ethics Advisory Committee.
p.000022: NEAC. In press. Māori Research Ethics: An overview. Wellington: National Ethics Advisory Committee.
p.000022: NEAC. 2003b. Review of the Current Processes for Ethical Review of Health and Disability Research in New Zealand:
p.000022: Report to the Minister of Health. Wellington: National Ethics Advisory Committee.
p.000022: New Zealand Medical Association. 2002. Code of Ethics. Wellington: New Zealand Medical Association.
p.000022: Nuffield Council on Bioethics. 2003. Pharmacogenetics: Ethical Issues. A guide to the report. London: Nuffield Council
p.000022: on Bioethics.
p.000022: Royal College of Physicians. 1996. Guidelines on the Practice of Ethics Committees in Medical Research Involving Human
p.000022: Subjects. 3rd edition. London: Royal College of Physicians.
p.000022: Tri-council. 1998. Tri-council Policy Statement: Ethical Conduct for Research Involving Humans. Ottawa: Medical
p.000022: Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities
p.000022: Research Council of Canada.
p.000022: WHO. 2011. Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.
p.000022: Geneva: World Health Organization.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 29
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p.000022: Appendix: Joint Health Research Council and NEAC guidance on features of robust peer review for assessing the
p.000022: scientific validity of research
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p.000022: Background
p.000022: This document seeks to outline the principles of peer review that might be undertaken to assure New Zealand’s Health
p.000022: and Disability Ethics Committees (HDECs) of the scientific validity of a research proposal. Scientific validity of a
p.000022: research project is one component of the research being ethically sound. Research with insufficient scientific
p.000022: validity will waste scarce resources, will misuse the trust and commitment of participants, and may needlessly expose
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Orphaned Trigger Words
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p.000022: 3.3 Investigators conducting, or involved in conducting, observational studies are responsible for ensuring
p.000022: these studies meet ethical standards. This is the case whether or not ethics committee review is also required. When
p.000022: there is more than one investigator, the principal investigator has the overall responsibility for the ethics of the
p.000022: activity.
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p.000022: 3.4 The greater the risk of harm from an observational study, the greater the care that is required in
p.000022: assessing and addressing the ethical issues raised.
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p.000022: 3.5 Section 11 of these Guidelines outlines the features of observational studies that may present more than
p.000022: minimal risk to participants and that require review by an ethics committee. The Ministry of Health’s SOPs provide
p.000022: specific guidance about when HDEC review is required. If an investigator is unsure whether ethics committee review of
p.000022: any particular study is required, he or she should seek advice from an ethics committee.
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p.000022: 6 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
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p.000022: 3.6 Public health investigations, as defined above, do not require ethics committee review. This is because
p.000022: they are required for the protection of public health as a central part of public health practice, they are often of an
p.000022: immediate or urgent nature, and they are often required by legislation (the Health Act 1956, the Health (Infectious and
p.000022: Notifiable Diseases) Regulations 1966, the Tuberculosis Act 1948 or the Venereal Diseases Regulations 1982). Examples
p.000022: of such activities include investigations, undertaken by authorised people, into clusters of disease suspected to be
p.000022: caused by environmental agents, and contact tracing (in which efforts are made to locate and treat people who have had
p.000022: close or intimate contact with a person with a known case of a communicable disease). People conducting public health
p.000022: investigations are nevertheless free to seek advice from an ethics committee about any special issues that arise.
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p.000022: 3.7 People conducting quality assurance activities should be familiar with the Health Practitioners Competence
p.000022: Assurance Act 2003 (HPCA), especially sections 54–63. When the Minister of Health has declared an activity to be a
p.000022: ‘protected quality assurance activity’, the HPCA protects the confidentiality of information obtained in the course of
p.000022: the activity and gives the investigator immunity from civil liability. See also Protected Quality Assurance Activities
p.000022: under the Health Practitioners Competence Assurance Act 2003 (Ministry of Health 2004).
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p.000022: ethics committees any perceived, potential or actual conflict of interest he or she might have in relation to any
p.000022: others who are involved with the study. Such conflicts of interest can compromise the design or conduct of a study or
p.000022: the reliability of its results, thereby exposing study participants or others to needless risk or inconvenience.
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p.000022: 4.19 As appropriate to the circumstances, any conflict of interest should be minimised.
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p.000022: 10 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
p.000022:
p.000022: 5 Design of study and protocol
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p.000022: Study question
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p.000022: 5.1 Investigators should meet their obligations to communities by undertaking research that addresses important
p.000022: health problems.
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p.000022: 5.2 In identifying and prioritising health problems to be studied, investigators should take into account the
p.000022: perceived importance of the problem to the people living in a community after information about the problem has been
p.000022: provided to them. However, if investigators perceive that a health problem exists but that the community is ignoring it
p.000022: or denying its existence, it may be appropriate to proceed with the study while simultaneously working with the
p.000022: community to gain its confidence and support.
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p.000022: 5.3 Investigators should ensure any audit and related activities they undertake have the potential to improve
p.000022: health outcomes.
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p.000022: 5.4 The ethical principle of justice may be interpreted as requiring efforts to reduce inequalities.
p.000022: Decision-making about the study question could include consideration of the study’s potential to reduce health
p.000022: inequalities.
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p.000022: Study design
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p.000022: 5.5 The study design must minimise risk of harm.
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p.000022: 5.6 To the extent possible and whenever appropriate, investigators should involve community representatives in
p.000022: the planning and conduct of the study.
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p.000022: Scientifically sound
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p.000022: 5.7 Scientific inadequacies in a study proposal have ethical implications. The scientific quality of a proposal
p.000022: should be such that the proposal’s objectives can reasonably be expected to be achieved. For example, a questionnaire
p.000022: unlikely to achieve an adequate response rate will be scientifically inadequate. It is important that studies that
p.000022: include Māori participants and aim to generate conclusions relevant to Māori engage sufficient numbers of Māori
p.000022: participants to produce useful data and avoid imposing an unethical burden on Māori. Projects without scientific merit
p.000022: waste resources and needlessly use participants’ donated time.
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p.000022: Ethical Guidelines for Observational Studies: Observational research, audits and related activities 11
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p.000022: 5.8 Every study proposal must be based on a thorough review of relevant current literature. Scientific validity
p.000022: is an important component of good ethical practice in research. Investigators are advised to submit their proposals to
p.000022: independent peer review to help optimise scientific validity. HDECs also require evidence of adequate peer review.
p.000022: Additional information about the features of a robust peer review process for assessing the scientific validity of
p.000022: research is included in the Appendix.
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p.000022: Skills and resources
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p.000022: 5.9 Studies must be conducted or supervised only by investigators with the necessary skills and resources to
p.000022: conduct the study and deal with any contingencies that may affect participants. Necessary skills may include competence
p.000022: in understanding different cultural understandings of knowledge and of how such understandings might impact on the
p.000022: analysis and results of a study.
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p.000022: 5.10 People conducting audits or related activities must operate under professional standards or employment
p.000022: requirements that oblige them to maintain the confidentiality of patient data.
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p.000022: Protocol
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p.000022: 5.11 All observational studies should be conducted according to written protocols that state the aims of the
p.000022: study, the data needed and how the data will be collected, used and protected. A principle of proportionality applies
p.000022: here: the amount of detail in the written protocol and the extent of protocol review processes should be related to the
p.000022: level of risk the study presents to participants.
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p.000022: 5.12 When relevant, the protocol should include a statistical plan indicating the rationale for the number of
p.000022: participants involved.
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p.000022: 12 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
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p.000022: 6 Collecting health information
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p.000022: 6.1 In relation to the collection of health information, investigators should provide to observational study
p.000022: participants any information that a reasonable person in their circumstances would expect to receive. This is so
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p.000022: general results that pertain to their health and that studies may provide objective results that policy makers can use
p.000022: to formulate sound public health policy.
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p.000022: 10.2 Study protocols should include provision for communicating results in a timely, understandable and
p.000022: responsible manner, so that benefit to the community is maximised and fairly distributed. The optimal time at which to
p.000022: disseminate the results of observational studies can be difficult to determine. Both premature release and
p.000022: unnecessarily delayed release of study results can be more harmful than beneficial to individuals and society. It may
p.000022: be difficult to balance the need to communicate results to other scientists with appropriate peer review and the need
p.000022: to communicate results to other interested parties without undue delay.
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p.000022: 10.3 Investigators have an ethical obligation to advocate the release of information that is in the public
p.000022: interest, even when the data is retained by governmental or commercial sponsors.
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p.000022: 10.4 Study results and advice to communities should be publicised by whatever suitable means are available.
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p.000022: 10.5 The publication of both positive and negative1 study results is important, since it helps to prevent
p.000022: publication bias and allows for additional information to be gleaned through meta-analyses.
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p.000022: 10.6 Investigators should strive to ensure that, at a minimum, study results are interpreted and reported on
p.000022: accurately.
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p.000022: 10.7 Investigators should, when possible, anticipate and avoid misinterpretation of study results, as
p.000022: misinterpretation might cause harm.
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p.000022: 10.8 Results of a study must not be published in a form that permits the identification of individual
p.000022: participants, and must be published in a form that gives due regard to cultural and other sensitivities.
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p.000022: 10.9 Conflict may arise for investigators between doing no harm and openly disclosing scientific results. Harm
p.000022: may be mitigated by presenting data in such a way that the interests of those at risk are protected and scientific
p.000022: integrity is maintained.
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p.000022: 1 For example, that no link was found between a particular study variable and disease.
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p.000022: 24 Ethical Guidelines for Observational Studies: Observational research, audits and related activities
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p.000022: 11 Features of observational studies that pose more than minimal risk
p.000022:
p.000022: 11.1 This section outlines the features of observational research that may present more than minimal risk to
p.000022: participants.
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p.000022: 11.2 More than minimal risk observational research requires ethics committee review (see Chapter 3 of the
p.000022: Ministry of Health’s SOPs on the scope of ethical review). Any observational study that has one or more of the features
p.000022: identified in the table below has potential to cause harm, and is therefore a more than minimal risk activity. In
p.000022: accordance with the SOPs, such activity requires HDEC review, unless there is an exception. The exceptions apply to
p.000022: situations where there is added protection for participants or another justification. If a study falls outside the
p.000022: scope of HDEC review and an investigator still wishes to have an ethics review, they may choose to submit the proposal
p.000022: to an alternative ethics committee.
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p.000022: Table 1: Observational studies constituting more than minimal risk
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p.000022: 11.3 Departure from normal care
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p.000022: Something withheld from or done to a patient that deviates from normal health care constitutes more than minimal risk
p.000022: (for example, when extra blood samples or biopsies are taken).
p.000022: 11.4 Use of stored samples Exception
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p.000022: Use, collection or storage of human tissue without informed consent and use of stored samples for study purposes other
p.000022: than those for which they were originally collected constitutes a more than minimal risk activity.
p.000022: Exceptions to this rule include:
p.000022: • where participants have given informed consent to future unspecified use of human tissue
p.000022: • where a statutory exception to the need to gain informed consent (as set out in the Human Tissue Act 2008,
p.000022: section 20(f) or the Code of Rights, Right 7(10)(c)) applies
p.000022: • where stored samples are used by health professionals undertaking one or more of the following activities to
p.000022: assure or improve the quality of services:
p.000022: a) a professionally recognised quality assurance programme (for example, pathologists re-reading specimens to check
p.000022: the accuracy of their own or a peer’s work)
p.000022: b) an external audit of services
p.000022: c) an external evaluation of services.
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p.000022: The justification for this is that the use is related to the primary purpose of the sample collection. See the Code of
p.000022: Rights, Right 7(10).
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p.000022: 11.5 Secondary use of identifiable health information without consent
p.000022: Investigator use of identifiable health information that was primarily collected for clinical care for a secondary
p.000022: purpose without consent constitutes a more than minimal risk activity.
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Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| children | Child |
| cioms | cioms guidelines |
| culturally | cultural difference |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| drug | Drug Usage |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| ethnicity | Ethnicity |
| gender | gender |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| illegal | Illegal Activity |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| incapacitated | Incapacitated |
| indigenous | Indigenous |
| language | Linguistic Proficiency |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| political | political affiliation |
| prisoners | Criminal Convictions |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| student | Student |
| substance | Drug Usage |
| threat | Threat of Stigma |
| tri-council | tri-council policy statement |
| undue influence | Undue Influence |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['substance'] |
| ethnic | ['ethnicity'] |
| ethnicity | ['ethnic'] |
| opinion | ['philosophy'] |
| party | ['political'] |
| philosophy | ['opinion'] |
| political | ['party'] |
| substance | ['drug'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input