79C3C34C52B45572883A05D425EB0F82
HRC Research Ethics Guidelines(2017)
https://www.hrc.govt.nz/sites/default/files/2019-10/HRC%20Research%20Ethics%20Guidelines-%20December%202017.pdf
http://leaux.net/URLS/ConvertAPI Text Files/8F9B63F5EE220707C07CFE8EB357D95A.en.txt
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This file was generated: 2020-12-01 07:41:31
| 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 / Indigenous
Searching for indicator indigenous:
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p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
p.000008: The privacy and confidentiality of research participants must be respected. In particular, ethics committees have to
p.000008: be familiar with the Privacy Act 1993 and the Health Information Privacy Code 1994 when examining precautions taken to
p.000008: safeguard the privacy and confidentiality of research participants.
p.000008:
p.000008: 2.1.7 Cultural responsiveness
p.000008: All health research is located within cultural settings that have evolved in the social and historical context within
p.000008: which the research is undertaken. It is important that research teams/units/institutions/communities reflect on the
p.000008: cultural perspectives of their organisations and workplaces in the broadest sense, as these perspectives influence the
p.000008: attitudes and behaviours that are brought into the research environment.
p.000008:
p.000008: Within New Zealand, health research is likely to impact on Māori people and their communities. To this end, research
p.000008: teams/units/institutions/communities should specifically identify how their research will support indigenous health
p.000008: gains, and demonstrate a commitment to the principles of the Treaty of Waitangi.
p.000008:
p.000008: All research teams/units/institutions/communities need to identify how their own beliefs and value systems may differ
p.000008: from those they wish to involve in their research. This will require having clear processes and procedures in place
p.000008: that allow for the inclusion of different cultural values and beliefs within the research agenda. This will provide
p.000008: other cultural groups and their viewpoints with the ability to influence the way in which the research problem is
p.000008: defined and thus the way the research is designed, conducted, analysed and disseminated. Such a process is more likely
p.000008: to lead to research that is responsive to the communities and/or populations involved which, in turn, should lead to
p.000008: better health gains for these communities and populations.
p.000008:
p.000008: Ethics committees should ensure that all research involving human participants meets ethical standards that comply with
p.000008: international best practice. Best practice includes the expectation that researchers meaningfully consult with
p.000008: participants of research about the study question(s), design and conduct of the research. As well as the HRC Research
p.000008: Ethics Guidelines, applicants
p.000008:
p.000009: 9
p.000009:
p.000009: HRC Research Ethics Guidelines
p.000009:
p.000009:
p.000009: should refer to the HRC Guidelines for Researchers on Health Research involving Māori, and the Guidelines for Pacific
...
Political / political affiliation
Searching for indicator party:
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p.000012:
p.000012: (a) An application for consideration of an appeal may only be made where:
p.000012:
p.000012: i. an approved HDEC has reviewed a proposal and issued a decision in the terms set out in the SOPs Chapter 7, and;
p.000012: ii. attempts have been made in good faith to resolve differences between the applicant and the reviewing HDEC
p.000012: (taking into account, where appropriate, provisions in the SOPs Chapter 9 (Formal complaint about the decision-making
p.000012: process and Second opinion on the merits of the decision by HRC EC), and;
p.000012: iii. subject to paragraph (e) below, a second opinion has been provided under the processes set out in the SOPs
p.000012: Chapter 9 (Second opinion on the merits of the decision by HRC EC).
p.000012:
p.000012: (b) Where the conditions in paragraph (a) have been met, the coordinating investigator named on the proposal
p.000012: under consideration may lodge an appeal with the Chair of the HRC EC.
p.000012:
p.000012: (c) The appeal must be lodged within 60 days of the date upon which the Chair of the HRC EC is satisfied that
p.000012: the conditions in paragraph (a) are met.
p.000012:
p.000012: (d) In exceptional cases upon a specific request from an applicant and following consultation with a quorum of
p.000012: the HRC EC, the Chair of the HRC EC may:
p.000013: 13
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p.000013: HRC Research Ethics Guidelines
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p.000013:
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p.000013: i. allow an interested third party to lodge an appeal where the Chair is satisfied that restricting the right to
p.000013: lodge an appeal to the coordinating investigator would be inequitable;
p.000013: ii. waive the requirement to obtain a second opinion, so allowing direct recourse to the appeal process, where he or
p.000013: she is satisfied that a binding resolution is urgent or that the second opinion process would be futile.
p.000013:
p.000013: Decisions under this paragraph will be made within 14 days of receiving an application for appeal subject only to
p.000013: reasonable delays occasioned by, for instance, the need to obtain expert advice or further information from applicants.
p.000013:
p.000013: (e) The HRC EC will meet to consider an appeal no later than 6 weeks after the application for appeal has been
p.000013: accepted.
p.000013:
p.000013: (f) An application for appeal must include:
p.000013:
p.000013: i. a copy of the original application;
p.000013: ii. written comments by the reviewing HDEC explaining their decision;
p.000013: iii. (subject to paragraph d above) a copy of the Second Opinion and all relevant correspondence; and
p.000013: iv. a description of the specific issues which form the basis of the appeal.
p.000013:
p.000013: (g) The HRC EC will have broad discretion to consider information relevant to the matter under appeal. The HRC
p.000013: EC will consider information from both the investigator who submitted the application and the ethics committee who
p.000013: completed the Primary Review and, where appropriate, further submissions made by other relevant parties. The HRC EC may
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000006: obtained should be recorded. If the participants
p.000007: 7
p.000007:
p.000007: HRC Research Ethics Guidelines
p.000007:
p.000007:
p.000007: themselves cannot provide informed consent, justification must be provided for using these participants within the
p.000007: research. Ethics committees will be required to consider if the circumstances are appropriate for the waiving of
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
...
Searching for indicator vulnerability:
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p.000019: Human materials are any organ, tissue, secretion or excretion derived from a human source whether living or dead and
p.000019: including the human foetus, placenta and human gametes.
p.000019:
p.000019: Legal and cultural aspects which need to be considered will differ according to whether the body parts and tissues come
p.000019: from deceased or living persons, or whether they are body tissues which can be described as "surplus". Regulations and
p.000019: guidelines published in the Human Tissue Act 2008, NZ Standard for Non-therapeutic Use of Human Tissue (NZS 8135:2009)
p.000019: and elsewhere, governing collection, storage and use of human specimens must always be observed. Issues of informed
p.000019: consent and privacy of information will also need to be considered.
p.000019:
p.000019: As a general rule the collection of human materials and their use in research requires the informed consent of the
p.000019: donor, if living.
p.000019:
p.000019: If the human materials are to be used for future unspecified research purposes the Guidelines for the Use of Human
p.000019: Tissue for Future Unspecified Research Purposes should be followed.
p.000019:
p.000019: If established human embryonic stem cell lines are to be used the Guidelines for using Cells from Established Human
p.000019: Embryonic Stem Cell Lines for Research should be followed.
p.000019:
p.000019: For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.7 Research involving children
p.000019: The special vulnerability of children makes consideration of involving them as research participants particularly
p.000019: important. To safeguard their interests, and to protect them from harm, special ethical considerations should be in
p.000019: place for reviewing research involving children. For more information, see Specific Considerations | Health Research
p.000019: Council.
p.000019:
p.000019: 3.8 Research involving personal health information
p.000019:
p.000019: Research which involves the use of personal health information is required to comply with the Health Information
p.000019: Privacy Code 1994. For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.9 Research involving Māori
p.000019:
p.000019: Respect for the principles of partnership and sharing implicit in the Treaty of Waitangi will be observed by
p.000019: incorporating the following requirements into health research proposals. All issues relating to Māori cultural and
p.000019: ethical values should be discussed with the whanau, hapū or iwi concerned along with matters to do with the key
p.000019: questions and aims of the research. The ownership rights of participants to personal data must be respected.
p.000020: 20
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p.000020: HRC Research Ethics Guidelines
p.000020:
p.000020:
p.000020:
p.000020: For research that involves or targets Māori research outcomes or methodologies; the Te Ara
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Health / Drug Usage
Searching for indicator influence:
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p.000008:
p.000008: 2.1.5 Payments for participation in research
p.000008: Any payment, koha or gift of money, goods or services to a research participant or to a body or organisation assisting
p.000008: in the recruitment of participants, which constitutes an undue inducement to participate in the research, is
p.000008: unacceptable.
p.000008:
p.000008: Reimbursement for participants’ out-of-pocket expenses (e.g. taxi fares, meals, parking fees) or in compensation for
p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
p.000008: The privacy and confidentiality of research participants must be respected. In particular, ethics committees have to
p.000008: be familiar with the Privacy Act 1993 and the Health Information Privacy Code 1994 when examining precautions taken to
p.000008: safeguard the privacy and confidentiality of research participants.
p.000008:
p.000008: 2.1.7 Cultural responsiveness
p.000008: All health research is located within cultural settings that have evolved in the social and historical context within
p.000008: which the research is undertaken. It is important that research teams/units/institutions/communities reflect on the
p.000008: cultural perspectives of their organisations and workplaces in the broadest sense, as these perspectives influence the
p.000008: attitudes and behaviours that are brought into the research environment.
p.000008:
p.000008: Within New Zealand, health research is likely to impact on Māori people and their communities. To this end, research
p.000008: teams/units/institutions/communities should specifically identify how their research will support indigenous health
p.000008: gains, and demonstrate a commitment to the principles of the Treaty of Waitangi.
p.000008:
p.000008: All research teams/units/institutions/communities need to identify how their own beliefs and value systems may differ
p.000008: from those they wish to involve in their research. This will require having clear processes and procedures in place
p.000008: that allow for the inclusion of different cultural values and beliefs within the research agenda. This will provide
p.000008: other cultural groups and their viewpoints with the ability to influence the way in which the research problem is
p.000008: defined and thus the way the research is designed, conducted, analysed and disseminated. Such a process is more likely
p.000008: to lead to research that is responsive to the communities and/or populations involved which, in turn, should lead to
p.000008: better health gains for these communities and populations.
p.000008:
p.000008: Ethics committees should ensure that all research involving human participants meets ethical standards that comply with
p.000008: international best practice. Best practice includes the expectation that researchers meaningfully consult with
p.000008: participants of research about the study question(s), design and conduct of the research. As well as the HRC Research
p.000008: Ethics Guidelines, applicants
p.000008:
p.000009: 9
p.000009:
p.000009: HRC Research Ethics Guidelines
p.000009:
p.000009:
p.000009: should refer to the HRC Guidelines for Researchers on Health Research involving Māori, and the Guidelines for Pacific
p.000009: Health Research.
p.000009:
p.000009: 2.2 Research requiring ethics approval
p.000009: Under the requirements of sections 25 and 31 of the Health Research Council Act 1990, every application approved for
p.000009: funding by the HRC must obtain independent ethics approval.
p.000009:
p.000009: 2.3 Scope of ethics committee review
p.000009: A broad and common sense approach is to be adopted in interpreting “health research study” to ensure adequate
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000007: research. Ethics committees will be required to consider if the circumstances are appropriate for the waiving of
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
...
Searching for indicator disability:
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p.000001:
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p.000001:
p.000001:
p.000001: Guidelines
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p.000001:
p.000001:
p.000001:
p.000001: December 2017
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p.000001: HRC Research Ethics Guidelines
p.000001:
p.000001:
p.000001:
p.000001: HRC Research Ethics Guidelines
p.000001:
p.000001:
p.000001: Table of Contents
p.000001: 1. Overview
p.000001: 1
p.000001: 1.1 Introduction
p.000001: 1
p.000001: 1.1.1 The Treaty of Waitangi 1
p.000001: 1.1.2 Human ethics
p.000001: 1
p.000001: 1.1.3 Animal ethics
p.000001: 1
p.000001: 1.2 Health Research Council Ethics Committee (HRC EC) 1
p.000001: 1.2.1 Functions
p.000002: 2
p.000002: 1.2.2 Membership
p.000002: 2
p.000002: 1.3 National Ethics Advisory Committee (NEAC) 3
p.000002: 1.4 Ethics Committee on Assisted Reproductive Technology (ECART)
p.000003: 3
p.000003: 1.5 Health and Disability Ethics Committees (HDECs) 3
p.000003: 1.6 Approval by HRC EC 3
p.000003: 1.7 Approved ethics committees 4
p.000003: 1.7.1 Institutional ethics committees 4
p.000003: 1.7.2 Health and disability ethics committees 5
p.000003: 1.8 Resource documents relevant to research ethics 5
p.000003: 1.8.1 New Zealand Acts of Parliament 5
p.000003: 1.8.2 New Zealand guidelines, regulations and documents 5
p.000003: 2. Matters relating to ethical review 7
p.000003: 2.1 Principles for research involving human participants 7
p.000003: 2.1.1 Informed consent
p.000007: 7
p.000007: 2.1.2 Scientific design and conduct of the study 8
p.000007: 2.1.3 Risks and potential benefits 8
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000008: 8
p.000008: 2.1.5 Payments for participation in research 9
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality 9
p.000008: 2.1.7 Cultural responsiveness 9
p.000008: 2.2 Research requiring ethics approval 10
p.000008: 2.3 Scope of ethics committee review 10
...
p.000026: 26
p.000026: 4.6 Civil liability
p.000026: 26
p.000026: 4.7 Practicing certificates for ethics committee members 27
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p.000026:
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p.000026:
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p.000026:
p.000026:
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p.000026:
p.000026: ii
p.000026:
p.000026: 1. Overview
p.000026:
p.000026:
p.000026: 1.1 Introduction
p.000026:
p.000026: The national system of ethics review is comprised of a number of committees with various responsibilities for human
p.000026: ethics and animal ethics.
p.000026:
p.000026: 1.1.1 The Treaty of Waitangi
p.000026: The Treaty is the founding document of New Zealand. The principles of partnership and sharing implicit in the Treaty
p.000026: should be respected by all in all health research proposals.
p.000026:
p.000026: 1.1.2 Human ethics
p.000026: (a) The following ethics committees are established under statute:
p.000026:
p.000026: i. The Health Research Council Ethics Committee, see 1.2 HRC EC;
p.000026: ii. The National Ethics Advisory Committee, see 1.3 NEAC;
p.000026: iii. The Ethics Committee on Assisted Reproductive Technology, see 1.4 ECART, and
p.000026: iv. The Health and Disability Ethics Committees, see 1.5 HDECs.
p.000026:
p.000026: (b) Ethics committees set up by organisations and which may also be approved by the HRC EC include
p.000026: Institutional Ethics Committees (IEC).
p.000026:
p.000026: See 1.7 Approved ethics committees for the list of HRC approved ethics committees.
p.000026:
p.000026: 1.1.3 Animal ethics
p.000026: The framework for animal ethics is set out in the Animal Welfare Act 1999.
p.000026:
p.000026: For more information on research involving animals or animal materials, see 3.16.
p.000026:
p.000026: 1.2 Health Research Council Ethics Committee (HRC EC)
p.000026:
p.000026: The HRC EC is an HRC statutory committee established under section 24 of the Health Research Council (HRC) Act 1990.
p.000026:
p.000026: The HRC EC requires that, prior to commencing research; all HRC funded research has received ethics approval. Avenues
p.000026: for ethical comment on HRC funded research have been established by the HRC EC through the delegated authority given to
p.000026: approved health and disability or institutional ethics committees.
p.000026:
p.000026: The HRC EC will also consider appeals against the decisions of Health and Disability Ethics Committees, a role required
p.000026: of it by the Minister of Health, under section 25(h)ii of the HRC Act 1990.
p.000026:
p.000026: For more information on appeal, see 2.7.3.
p.000026:
p.000026: HRC Research Ethics Guidelines
p.000026:
p.000026: 1.2.1 Functions
p.000026: The functions of the HRC EC are set out in section 25 of the HRC Act and include the following:
p.000026:
p.000026: (a) To consider and make recommendations to the Council on ethical issues in relation to health research,
p.000026: especially those emerging through the development of new areas of health research.
p.000026:
p.000026: (b) To provide and review ethical guidelines for the Council.
p.000026:
p.000026: (c) Subject to paragraph (d), to ensure that, in respect of each application submitted to the Council for a
p.000026: grant for the purposes of health research, an independent ethical assessment of the proposed health research is made
p.000026: either by the Ethics Committee itself or by a committee approved by the Ethics Committee.
p.000026:
p.000026: (d) Where an application for a grant for the purposes of health research is submitted to the Council in respect
p.000026: of health research that is of national importance or great complexity, to itself make an independent ethical assessment
p.000026: of the proposed health research.
p.000026:
p.000026: (e) To review, at the request of any person who has made an application for a grant for the purposes of health
p.000026: research, the independent ethical assessment made, in respect of the proposed health research, by a committee approved
p.000026: under paragraph (c).
p.000026:
...
p.000026:
p.000026: i. given by or under any enactment; or
p.000026: ii. authorised to perform by the Minister, by written notice to the Health Research Council after consultation with
p.000026: it.
p.000026:
p.000026: Additional responsibilities may be undertaken after discussion and agreement with the National Ethics Advisory
p.000026: Committee.
p.000026:
p.000026: 1.2.2 Membership
p.000026: Members of the HRC EC are appointed by the Board of the HRC.
p.000026:
p.000026: Membership is set out in section 26 of the HRC Act and must include the Chairperson of the Board or his/her nominee and
p.000026: one other member of the Board with qualifications in science. Five other persons, who are not members of the Board, are
p.000026: appointed having regard to the need to have a diversity of knowledge and experience in relation to science, ethics,
p.000026: philosophy, law, theology, nursing, women’s health, patient advocacy and tikanga Māori.
p.000026:
p.000026: The Chair of the HRC EC is appointed by the members of the HRC EC.
p.000026:
p.000002: 2
p.000002:
p.000002: HRC Research Ethics Guidelines
p.000002:
p.000002:
p.000002: During 1992, the Board resolved that the maximum term of membership for HRC EC members will be three years plus
p.000002: possible renewal for up to a further three years.
p.000002:
p.000002: 1.3 National Ethics Advisory Committee (NEAC)
p.000002: NEAC is a ministerial advisory committee established under section 16 of the New Zealand Public Health and Disability
p.000002: Act 2000 to advise the Minister of Health on ethical issues in health services and research, and determine national
p.000002: ethical standards for the health sector.
p.000002:
p.000002: 1.4 Ethics Committee on Assisted Reproductive Technology (ECART)
p.000002: ECART is a ministerial committee established under section 27 of the Human Assisted Reproductive Technology (HART) Act
p.000002: 2004 that reviews, determines and monitors applications for assisted reproductive procedures and human reproductive
p.000002: research.
p.000002:
p.000002: ECART can only consider applications for procedures that the Advisory Committee on Assisted Reproductive Technology
p.000002: (ACART) has issued guidelines and advice for.
p.000002:
p.000002: 1.5 Health and Disability Ethics Committees (HDECs)
p.000002:
p.000002: HDECs are established under section 11 of the New Zealand Public Health and Disability Act 2000. The Committees are
p.000002: administered by the Ministry of Health.
p.000002:
p.000002: The function of an HDEC is to secure the benefits of health and disability research by checking that it meets or
p.000002: exceeds established ethical standards set out in the guidelines authored by NEAC, namely: Ethical Guidelines for
p.000002: Observational Studies and Ethical Guidelines for Intervention Studies. HDECs operate in accordance with the Standard
p.000002: Operating Procedures for HDECs: http://ethics.health.govt.nz/operating-procedures
p.000002:
p.000002: 1.6 Approval by HRC EC
p.000002: It is the responsibility of the HRC EC to ensure that an independent ethical assessment of any proposed health research
p.000002: submitted for a HRC grant has been carried out either by the HRC EC itself, or an ethics committee approved by the HRC
p.000002: (see s25 of the HRC Act 1990). The HRC EC approves ethics committees to carry out this function (see 1.7 Approved
p.000002: Ethics Committees).
p.000002:
p.000002: Approved ethics committees also meet the conditions required to conduct ethical review for the following purposes:
p.000002:
p.000002: (a) to provide coverage of participants in a clinical trial who sustain injury, under Accident Compensation Act
p.000002: 2001;
p.000002:
p.000002: (b) to allow disclosure of health information for research where it is either not desirable or not practicable
p.000002: to obtain authorisation from the individual concerned under the Health Information Privacy Code 1994; and
p.000002:
p.000002: (c) to allow access to data held by the New Zealand Health Information Service database (NZHIS) in accordance
...
p.000003:
p.000003: Massey University Human Ethics Committee:
p.000003: Southern B
p.000003:
p.000003: UNITEC Research Ethics Committee http://www.unitec.ac.nz/?DE4A5BB7-704A-
p.000003: 4C5C-93B4-FE562A75B496
p.000003:
p.000003:
p.000003: University of Auckland Human Participants Ethics Committee
p.000003: http://www.auckland.ac.nz/uoa/re-uahpec
p.000003:
p.000003: University of Otago Human Ethics Committee http://www.otago.ac.nz/council/committees/
p.000003: committees/HumanEthicsCommittees.html
p.000003:
p.000003:
p.000003: University of Otago Human Ethics Committee (Health)
p.000003:
p.000003: University of Waikato Human Research Ethics Committee (Health)
p.000003:
p.000003:
p.000003:
p.000003: http://www.waikato.ac.nz/research- enterprise/ethics/human-ethics-research- committee
p.000003:
p.000003: WINTEC Human Ethics in Research Committee http://www.wintec.ac.nz/
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: HRC Research Ethics Guidelines
p.000004:
p.000004: 1.7.2 Health and disability ethics committees
p.000004:
p.000004: Central Health and Disability Ethics Committee http://www.ethics.health.govt.nz/
p.000004:
p.000004:
p.000004: Northern A Health and Disability Ethics Committee http://www.ethics.health.govt.nz/
p.000004:
p.000004:
p.000004: Northern B Health and Disability Ethics Committee http://www.ethics.health.govt.nz/
p.000004:
p.000004:
p.000004: Southern Health and Disability Ethics Committee http://www.ethics.health.govt.nz/
p.000004:
p.000004:
p.000004:
p.000004: 1.8 Resource documents relevant to research ethics
p.000004:
p.000004: 1.8.1 New Zealand Acts of Parliament
p.000004: Accident Compensation Act 2001 Animal Welfare Act 1999
p.000004: Health and Disability Commissioner Act 1994 Health Research Council Act 1990
p.000004: Human Assisted Reproductive Technology Act 2004 Human Tissues Act 2008
p.000004: Medicines Act 1981
p.000004:
p.000004: New Zealand Public Health and Disability Act 2000 New Zealand Bill of Rights Act 1990
p.000004: Privacy Act 1993
p.000004:
p.000004: 1.8.2 New Zealand guidelines, regulations and documents
p.000004: Ethical Guidelines for Intervention Studies. National Ethics Advisory Committee (2012).
p.000004:
p.000004: Ethical Guidelines for Observational Studies: Observational Research, Audits and Related Activities.
p.000004: National Ethics Advisory Committee (2012).
p.000004:
p.000004: Good Clinical Research Practice Guideline (Part 11 of the Guideline on the Regulation of Therapeutic Products in New
p.000004: Zealand). Medsafe, Ministry of Health (2011).
p.000004:
p.000004: Guidelines for Researchers on Health Research Involving Māori. Health Research Council of New Zealand (2010 version 2)
p.000004:
p.000005: 5
p.000005:
p.000005: HRC Research Ethics Guidelines
p.000005:
p.000005:
p.000005: Guidelines for the Use of Human tissue for Future Unspecified Research Purposes. Ministry of Health (2007).
p.000005:
p.000005: Guidelines for Using Cells from Established Human Embryonic Stem Cell Lines for Research.
p.000005: Ministry of Health (2006).
p.000005:
p.000005: Health and Disability Commissioner (Code of Health and Disability Services Consumers’ Rights)
p.000005: Regulations 1996.
p.000005:
p.000005: Health Information Privacy Code 1994.
p.000005:
p.000005: HRC Guidelines for Approval of Ethics Committees. Health Research Council of New Zealand (2012).
p.000005:
p.000005: Non-Therapeutic use of Human Tissue NZS 8135:2009. Standards New Zealand (2009).
p.000005:
p.000005: Pacific Health Research Guidelines. Health Research Council of New Zealand (2014)
p.000005:
p.000005: Te Ara Tika: Guidelines for Māori Research Ethics: A framework for researchers and ethics committee members. Pūtaiora
p.000005: Writing Group (2010).
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
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p.000005:
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p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: HRC Research Ethics Guidelines
p.000006:
p.000006: 2. Matters relating to ethical review
p.000006:
p.000006:
p.000006: The HRC expects investigators to conduct and report their work with objectivity and scientific honesty.
p.000006:
p.000006: The HRC, as a public funder of research, expects researchers to share primary research data with valid secondary users
p.000006: where appropriate and having given due consideration to ethical, social and other issues. Dissemination, including
...
p.000006: investigators should take into account any other research protocols involving the same individual which may already be
p.000006: in progress.
p.000006:
p.000006: The HRC EC requires investigators to review the ethics of their research at least annually or, where appropriate, more
p.000006: frequently. As part of such a review, the investigator should consider the outcome or development of similar research
p.000006: conducted elsewhere whether in NZ or overseas. If significant variations to the research proposal are to be made, or
p.000006: the interim results of the research indicate that it may not be ethical to continue, the principal investigator should
p.000006: approach the ethics committee which approved the research proposal for its comment and further discussion before
p.000006: undertaking any continuation of the research.
p.000006:
p.000006: 2.1 Principles for research involving human participants
p.000006: A number of principles should guide research that involves human participants. For a general statement of the
p.000006: principles, applicants should consult the Declaration of Helsinki. These principles include, but are not limited to,
p.000006: the following, which will be used by ethics committees to assess research proposals:
p.000006:
p.000006: 2.1.1 Informed consent
p.000006: The ethical foundation of informed consent is respect for persons. Researchers thus should make themselves familiar
p.000006: with the provisions of the Code of Health and Disability Consumers’ Rights.
p.000006:
p.000006: Informed consent is required from participants involved in human research especially if the research constitutes a
p.000006: health care procedure. If informed consent cannot be obtained in writing, the circumstances under which consent was
p.000006: obtained should be recorded. If the participants
p.000007: 7
p.000007:
p.000007: HRC Research Ethics Guidelines
p.000007:
p.000007:
p.000007: themselves cannot provide informed consent, justification must be provided for using these participants within the
p.000007: research. Ethics committees will be required to consider if the circumstances are appropriate for the waiving of
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
...
p.000008: Ethics Guidelines, applicants
p.000008:
p.000009: 9
p.000009:
p.000009: HRC Research Ethics Guidelines
p.000009:
p.000009:
p.000009: should refer to the HRC Guidelines for Researchers on Health Research involving Māori, and the Guidelines for Pacific
p.000009: Health Research.
p.000009:
p.000009: 2.2 Research requiring ethics approval
p.000009: Under the requirements of sections 25 and 31 of the Health Research Council Act 1990, every application approved for
p.000009: funding by the HRC must obtain independent ethics approval.
p.000009:
p.000009: 2.3 Scope of ethics committee review
p.000009: A broad and common sense approach is to be adopted in interpreting “health research study” to ensure adequate
p.000009: protections for all participants. In this context, “health research study” includes epidemiological research, and may
p.000009: include various types of research where contact with participants could cause harm.
p.000009:
p.000009: The primary and over-riding guideline is that applications should be reviewed by an approved ethics committee with the
p.000009: expertise required to evaluate the application, and to identify risks and the adequacy of protections for participants.
p.000009:
p.000009: (a) The scope of research that should be reviewed by an HDEC is explained in Chapter 3, the
p.000009: Standard operating procedures of Health and Disability Ethics Committee (the SOPs).
p.000009:
p.000009: (b) Ethics committees must ensure that members of their committees possess the appropriate expertise required
p.000009: for reviewing the kinds of research studies that are submitted to them, and possess the ability to identify whether
p.000009: adequate protections are in place for participants. Ethics committees reviewing health research would normally be
p.000009: expected to have a minimum of two registered health professionals with the appropriate expertise (at least one
p.000009: clinically trained and at least one in active practice).
p.000009:
p.000009: (c) In some circumstances, an IEC is the most appropriate committee to review the application if that research
p.000009: falls outside the scope of the HDEC.
p.000009:
p.000009: (d) Ethics approval for a research proposal must be obtained from a single approved ethics committee which is
p.000009: able to review a research proposal as a whole.
p.000009:
p.000009: (e) It is recognised that there may be limited circumstances where an IEC and an HDEC may each separately wish
p.000009: to review a particular research study. The policies and procedures of the committees should clearly specify those
p.000009: circumstances, and should identify which committee is to give the final approval in the circumstances.
p.000009:
p.000009: (f) The collection of human tissues to form part of an institutional anatomical collection should be dealt
...
p.000014: ii. the original reviewing Committee;
p.000014: iii. the Committee which delivered the second opinion, if there was one;
p.000014: iv. the Board of the Health Research Council of New Zealand; and
p.000014: v. the Manager, Ethics Committees, Ministry of Health.
p.000014:
p.000014: (p) Once the HRC EC has made and communicated its decision on the appeal, the primary ethics committee
p.000014: providing the original review will resume full administrative responsibilities in relation to the original application,
p.000014: such as receiving annual reports, monitoring adverse events, receiving final reports and the like.
p.000014:
p.000014: (q) The HRC EC will provide a report on appeals to the Board of the HRC and the Minister of Health on all
p.000014: appeals.
p.000014:
p.000014: (r) The Appeal Summary will contain the following information:
p.000014:
p.000014: i. the membership of the HRC EC;
p.000014: ii. the research title;
p.000014: iii. the name and position of the principal investigator;
p.000014: iv. summary of Primary Review;
p.000014: v. summary of Second Opinion provided by the secondary ethics Committee (unless an expedited appeal); and
p.000014: vi. decision of the HRC EC.
p.000014:
p.000014: 2.8 Complaints
p.000014: Complaints about research involving human participants can be made, where appropriate, to an approved ethics committee,
p.000014: the HRC EC, the relevant institution/organisation involved in the research, the Health and Disability Commissioner, or
p.000014: the Privacy Commissioner.
p.000014:
p.000014: 2.9 Independent Comment
p.000014: The HRC EC can provide independent comment on ethical problems that may arise in any aspect of health research.
p.000014: Independent comment may be sought from the HRC EC by any person, or may be provided at the HRC EC’s own initiative.
p.000014: Where appropriate, the HRC EC may advise
p.000014:
p.000015: 15
p.000015:
p.000015: HRC Research Ethics Guidelines
p.000015:
p.000015:
p.000015: relevant parties of the process that will be taken by the HRC EC, seek input from relevant parties, and provide the
p.000015: opportunity for relevant parties to comment.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
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p.000015:
p.000015:
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: HRC Research Ethics Guidelines
p.000016:
p.000016:
p.000016:
p.000016: 3. Different forms of research
p.000016:
p.000016:
p.000016: 3.1 Use of a new medicine
p.000016: Clinical trials that involve use of a new medicine require approval under Section 30 of the Medicines Act 1981. The HRC
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
p.000007: 1 In the case of research participants who are children the signature of the parent or guardian should be obtained in
p.000007: addition to the child’s assent (see section 3.7 Research involving children).
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: HRC Research Ethics Guidelines
p.000008:
p.000008:
p.000008: from participating in the research or indirectly benefit from the new knowledge derived from the research.
p.000008:
p.000008: Recruitment of research participants should be free from manipulation, coercion, deception, inducement or any other
p.000008: undue influence. Participants should be told the purpose of the research, the risks and benefits in participation and
p.000008: other relevant details that form the basis of informed consent.
p.000008:
p.000008: 2.1.5 Payments for participation in research
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
...
Health / injured
Searching for indicator injured:
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p.000025: drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural
p.000025: treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.”
p.000025:
p.000025: In order to ensure that there is cover under the Accident Compensation Act it is important that the trial is submitted
p.000025: to an approved ethics committee for approval, and that the researcher indicates to the effect that the study will not
p.000025: be carried out principally for the benefit of the manufacturer or distributor of the medicine or item in question. If
p.000025: approval is not granted by an approved ethics committee, the trial may not commence or proceed.
p.000025:
p.000025: Any agreement in writing from a person who will participate in a trial should include all the requirements necessary to
p.000025: enable that person to give his or her fully informed consent, including information on compensation cover.
p.000025:
p.000025: A claim for cover under the Accident Compensation Act is a matter for decision by ACC. In the circumstances where a
p.000025: claimant has cover and is eligible for the entitlement, the claimant’s entitlement will depend on a number of factors,
p.000025: such as whether the claimant is an earner or non-earner.
p.000025:
p.000025: 4.6 Civil liability
p.000025: Where personal injury results from negligence during a non-approved clinical trial, or a clinical trial conducted by a
p.000025: manufacturer or distributor principally for the purpose of testing or proving a product, the injured person will have a
p.000025: right to sue for common law damages.
p.000025:
p.000025: In respect of a trial that is conducted principally for the benefit of the manufacturer or distributor of the medicine
p.000025: or item being trialed, it will be necessary for the researcher to ensure that all parties (including the researcher,
p.000025: the manufacturer, the distributor and the host institution) are adequately insured to meet any potential liabilities.
p.000025: Failure to ensure that all parties have adequate insurance will make the research unethical.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: HRC Research Ethics Guidelines
p.000026:
p.000026:
p.000026: For research that is not eligible for cover under the Accident Compensation Act 2001, researchers must ensure that
p.000026: participants and the approving ethics committee are provided with evidence of adequate insurance cover in the event of
p.000026: injury resulting from participation in the research study.
p.000026:
p.000026: The Researched Medicines Industry Association of New Zealand (RMI) has published Guidelines on clinical trials
p.000026: compensation for injury resulting from participation in an industry-sponsored clinical trial.
p.000026:
p.000026: Researchers should note that insurance cover does not provide protection from civil liability unless the terms of the
p.000026: policy provide cover against such liability.
p.000026:
p.000026: 4.7 Practicing certificates for ethics committee members
p.000026:
p.000026: The Health Practitioners Competence Assurance Act 2003 provides a framework for the regulation of health practitioners
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000002:
p.000002: The function of an HDEC is to secure the benefits of health and disability research by checking that it meets or
p.000002: exceeds established ethical standards set out in the guidelines authored by NEAC, namely: Ethical Guidelines for
p.000002: Observational Studies and Ethical Guidelines for Intervention Studies. HDECs operate in accordance with the Standard
p.000002: Operating Procedures for HDECs: http://ethics.health.govt.nz/operating-procedures
p.000002:
p.000002: 1.6 Approval by HRC EC
p.000002: It is the responsibility of the HRC EC to ensure that an independent ethical assessment of any proposed health research
p.000002: submitted for a HRC grant has been carried out either by the HRC EC itself, or an ethics committee approved by the HRC
p.000002: (see s25 of the HRC Act 1990). The HRC EC approves ethics committees to carry out this function (see 1.7 Approved
p.000002: Ethics Committees).
p.000002:
p.000002: Approved ethics committees also meet the conditions required to conduct ethical review for the following purposes:
p.000002:
p.000002: (a) to provide coverage of participants in a clinical trial who sustain injury, under Accident Compensation Act
p.000002: 2001;
p.000002:
p.000002: (b) to allow disclosure of health information for research where it is either not desirable or not practicable
p.000002: to obtain authorisation from the individual concerned under the Health Information Privacy Code 1994; and
p.000002:
p.000002: (c) to allow access to data held by the New Zealand Health Information Service database (NZHIS) in accordance
p.000002: with the Current Data Access Policy.
p.000002:
p.000002: The approval of ethics committees by the HRC EC is a formal process. The HRC EC requires every approved ethics
p.000002: committee to provide an Annual report plus any other relevant
p.000002:
p.000003: 3
p.000003:
p.000003: HRC Research Ethics Guidelines
p.000003:
p.000003:
p.000003: information required as stated in the HRC Guidelines for Approval of Ethics Committees. Annual reports are due within
p.000003: three months of the reporting year end.
p.000003:
p.000003: In re-approval year (a maximum of three calendar years from approval) a Report for seeking re- approval which addresses
p.000003: the performance and functioning of the committee over the last approval period must be submitted.
p.000003:
p.000003: 1.7 Approved ethics committees
p.000003: 1.7.1 Institutional ethics committees
p.000003: Auckland Health Research Ethics Committee https://www.auckland.ac.nz/en/about/resear
p.000003: ch/re-ethics/auckland-health-research- committee.html
p.000003:
p.000003: Auckland University of Technology Ethics Committee
p.000003: http://www.aut.ac.nz/research/research- ethics
p.000003:
p.000003: Lincoln University Human Ethics Committee http://www.lincoln.ac.nz/Research-at-
...
p.000005: Regulations 1996.
p.000005:
p.000005: Health Information Privacy Code 1994.
p.000005:
p.000005: HRC Guidelines for Approval of Ethics Committees. Health Research Council of New Zealand (2012).
p.000005:
p.000005: Non-Therapeutic use of Human Tissue NZS 8135:2009. Standards New Zealand (2009).
p.000005:
p.000005: Pacific Health Research Guidelines. Health Research Council of New Zealand (2014)
p.000005:
p.000005: Te Ara Tika: Guidelines for Māori Research Ethics: A framework for researchers and ethics committee members. Pūtaiora
p.000005: Writing Group (2010).
p.000005:
p.000005:
p.000005:
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p.000005:
p.000006: 6
p.000006:
p.000006: HRC Research Ethics Guidelines
p.000006:
p.000006: 2. Matters relating to ethical review
p.000006:
p.000006:
p.000006: The HRC expects investigators to conduct and report their work with objectivity and scientific honesty.
p.000006:
p.000006: The HRC, as a public funder of research, expects researchers to share primary research data with valid secondary users
p.000006: where appropriate and having given due consideration to ethical, social and other issues. Dissemination, including
p.000006: peer reviewed publication, of research results in a manner that allows open access is encouraged by the HRC.
p.000006:
p.000006: As part of their obligation to research participants, the investigators should ensure that the results of their
p.000006: research and an account of the methods employed are adequately and appropriately disseminated in a manner accessible to
p.000006: the research participants and to the public as well as to the scientific community.
p.000006:
p.000006: Investigators should refrain from making claims or advancing conclusions that are not supported by evidence.
p.000006: Investigators should also recognise the boundaries of their professional competence and should not undertake research
p.000006: of a kind that they are not qualified to carry out.
p.000006:
p.000006: Protection of the welfare of human participants is a basic principle of ethical review of research. There is a need to
p.000006: balance potential risk of harm to individuals with the possible benefits to society at large. On occasions when there
p.000006: are major issues, there should be broader discussion with the community.
p.000006:
p.000006: When investigators are considering enrolment of persons in research studies, clinical trials or social surveys, the
p.000006: investigators should take into account any other research protocols involving the same individual which may already be
p.000006: in progress.
p.000006:
p.000006: The HRC EC requires investigators to review the ethics of their research at least annually or, where appropriate, more
p.000006: frequently. As part of such a review, the investigator should consider the outcome or development of similar research
...
Searching for indicator access to information:
(return to top)
p.000016: generally be undertaken by an independent person or committee. The HRC Data Monitoring Core Committee (DMCC) would
p.000016: welcome the opportunity to be involved where necessary (see 3.2.1 Health Research Council Data Monitoring Core
p.000016: Committee).
p.000016:
p.000016: (d) Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically
p.000016: manipulated micro-organisms, or viruses or cells into human participants is undertaken by the GTAC (see 3.2.2 Genetic
p.000016: Technology Advisory Committee).
p.000016:
p.000016: Fully informed consent with comprehensive information being available to participants is essential (see 2.1.1 Informed
p.000016: Consent).
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: HRC Research Ethics Guidelines
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Clinical trials in New Zealand should observe the Good Clinical Research Practice Guideline (Part 11 of the Guideline
p.000017: on the Regulation of Therapeutic Products in New Zealand), the Note for Guidance on Good Clinical Practice
p.000017: (CPMP/ICH/135/95)2 and the Ethical Guidelines for Intervention Studies.
p.000017:
p.000017: Before recruitment into the clinical phase of the research, researchers must register their clinical trials in a
p.000017: publicly accessible register (i.e. Australian New Zealand Clinical Trials Registry (ANZCTR) or equivalent WHO standard
p.000017: register)3. This will promote access to information about all clinical trials in New Zealand.
p.000017:
p.000017: 3.2.1 Health Research Council Data Monitoring Core Committee (DMCC)
p.000017:
p.000017: The DMCC is established to provide objective, independent monitoring of clinical trials funded by the HRC. The DMCC has
p.000017: two main functions:
p.000017:
p.000017: (a) to review the monitoring plans for trials funded by the HRC and provide advice to the HRC on whether the
p.000017: plans meet best international practice;
p.000017:
p.000017: (b) to constitute a Trial-Specific Data Monitoring Committee for any trial funded by the HRC where this is
p.000017: appropriate and is requested by the investigators. Trial-Specific Data Monitoring Committees are formed from the DMCC
p.000017: membership, plus additional co- opted members who have expertise specific to the trial.
p.000017:
p.000017: For more information on monitoring of clinical trials, see Data Monitoring Core Committee | Health Research Council.
p.000017:
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC)
p.000017: Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated
p.000017: micro-organisms, or viruses or cells into human participants is undertaken by the GTAC.
p.000017:
p.000017: GTAC is to review for the purposes of seeking an exemption under Section 30 of the Medicines Act (1981) or as required
p.000017: by an approved ethics committee or the HRC of any of its committees.
p.000017:
p.000017: For more information on GTAC approval, see Specific Considerations | Health Research Council.
p.000017:
p.000017: 3.3 Observational studies
p.000017: An observational study is either observational research, or, an audit and related activity. To determine whether an
...
Social / Child
Searching for indicator child:
(return to top)
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
p.000007: 1 In the case of research participants who are children the signature of the parent or guardian should be obtained in
p.000007: addition to the child’s assent (see section 3.7 Research involving children).
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: HRC Research Ethics Guidelines
p.000008:
p.000008:
p.000008: from participating in the research or indirectly benefit from the new knowledge derived from the research.
p.000008:
p.000008: Recruitment of research participants should be free from manipulation, coercion, deception, inducement or any other
p.000008: undue influence. Participants should be told the purpose of the research, the risks and benefits in participation and
p.000008: other relevant details that form the basis of informed consent.
p.000008:
p.000008: 2.1.5 Payments for participation in research
p.000008: Any payment, koha or gift of money, goods or services to a research participant or to a body or organisation assisting
p.000008: in the recruitment of participants, which constitutes an undue inducement to participate in the research, is
p.000008: unacceptable.
p.000008:
p.000008: Reimbursement for participants’ out-of-pocket expenses (e.g. taxi fares, meals, parking fees) or in compensation for
p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
...
Searching for indicator children:
(return to top)
p.000008: 2.7 Reviews of decisions by ethics committees 13
p.000008: 2.7.1 Reconsideration 13
p.000008: 2.7.2 Review by HRC EC (Second opinion) 13
p.000008: 2.7.3 Appeal
p.000013: 13
p.000013: 2.8 Complaints
p.000015: 15
p.000015: 2.9 Independent Comment 15
p.000015: i
p.000015:
p.000015: HRC Research Ethics Guidelines
p.000015: 3. Different forms of research 17
p.000015: 3.1 Use of a new medicine 17
p.000015: 3.2 Clinical trials
p.000017: 17
p.000017: 3.2.1 Health Research Council Data Monitoring Core Committee
p.000017: (DMCC) 18
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC) 18
p.000017: 3.3 Observational studies 18
p.000017: 3.4 Social, community-based, public health or health services interventions
p.000019: 19
p.000019: 3.5 Surveys of the general population 19
p.000019: 3.6 Collection and use of human materials 20
p.000019: 3.7 Research involving children 20
p.000019: 3.8 Research involving personal health information 20
p.000019: 3.9 Research involving Māori 20
p.000019: 3.10 International collaborations 21
p.000019: 3.11 Research undertaken at an overseas location 21
p.000019: 3.12 Genetic modification 21
p.000019: 3.13 In vivo human gene manipulation proposals 22
p.000019: 3.14 The choice of diseases for clinical therapy or research 22
p.000019: 3.15 Research involving use of placebos 23
p.000019: 3.16 Research involving animals or animal materials 24
p.000019: 4. General legal issues in research 25
p.000019: 4.1 Intellectual property rights 25
p.000019: 4.2 Copyright
p.000025: 25
p.000025: 4.3 Conflict of interest
p.000025: 25
p.000025: 4.4 Scientific misconduct 26
p.000025: 4.5 Compensation for injuries suffered by participants in research
p.000026: 26
p.000026: 4.6 Civil liability
p.000026: 26
p.000026: 4.7 Practicing certificates for ethics committee members 27
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
...
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
p.000007: 1 In the case of research participants who are children the signature of the parent or guardian should be obtained in
p.000007: addition to the child’s assent (see section 3.7 Research involving children).
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: HRC Research Ethics Guidelines
p.000008:
p.000008:
p.000008: from participating in the research or indirectly benefit from the new knowledge derived from the research.
p.000008:
p.000008: Recruitment of research participants should be free from manipulation, coercion, deception, inducement or any other
p.000008: undue influence. Participants should be told the purpose of the research, the risks and benefits in participation and
p.000008: other relevant details that form the basis of informed consent.
p.000008:
p.000008: 2.1.5 Payments for participation in research
p.000008: Any payment, koha or gift of money, goods or services to a research participant or to a body or organisation assisting
p.000008: in the recruitment of participants, which constitutes an undue inducement to participate in the research, is
p.000008: unacceptable.
p.000008:
p.000008: Reimbursement for participants’ out-of-pocket expenses (e.g. taxi fares, meals, parking fees) or in compensation for
p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
p.000008: The privacy and confidentiality of research participants must be respected. In particular, ethics committees have to
...
p.000019: authorities is of special importance.
p.000019:
p.000019: 3.6 Collection and use of human materials
p.000019: Human materials are any organ, tissue, secretion or excretion derived from a human source whether living or dead and
p.000019: including the human foetus, placenta and human gametes.
p.000019:
p.000019: Legal and cultural aspects which need to be considered will differ according to whether the body parts and tissues come
p.000019: from deceased or living persons, or whether they are body tissues which can be described as "surplus". Regulations and
p.000019: guidelines published in the Human Tissue Act 2008, NZ Standard for Non-therapeutic Use of Human Tissue (NZS 8135:2009)
p.000019: and elsewhere, governing collection, storage and use of human specimens must always be observed. Issues of informed
p.000019: consent and privacy of information will also need to be considered.
p.000019:
p.000019: As a general rule the collection of human materials and their use in research requires the informed consent of the
p.000019: donor, if living.
p.000019:
p.000019: If the human materials are to be used for future unspecified research purposes the Guidelines for the Use of Human
p.000019: Tissue for Future Unspecified Research Purposes should be followed.
p.000019:
p.000019: If established human embryonic stem cell lines are to be used the Guidelines for using Cells from Established Human
p.000019: Embryonic Stem Cell Lines for Research should be followed.
p.000019:
p.000019: For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.7 Research involving children
p.000019: The special vulnerability of children makes consideration of involving them as research participants particularly
p.000019: important. To safeguard their interests, and to protect them from harm, special ethical considerations should be in
p.000019: place for reviewing research involving children. For more information, see Specific Considerations | Health Research
p.000019: Council.
p.000019:
p.000019: 3.8 Research involving personal health information
p.000019:
p.000019: Research which involves the use of personal health information is required to comply with the Health Information
p.000019: Privacy Code 1994. For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.9 Research involving Māori
p.000019:
p.000019: Respect for the principles of partnership and sharing implicit in the Treaty of Waitangi will be observed by
p.000019: incorporating the following requirements into health research proposals. All issues relating to Māori cultural and
p.000019: ethical values should be discussed with the whanau, hapū or iwi concerned along with matters to do with the key
p.000019: questions and aims of the research. The ownership rights of participants to personal data must be respected.
p.000020: 20
p.000020:
p.000020: HRC Research Ethics Guidelines
p.000020:
p.000020:
p.000020:
p.000020: For research that involves or targets Māori research outcomes or methodologies; the Te Ara
p.000020: Tika: Guidelines for Māori Research Ethics: A framework for researchers and ethics committee
p.000020: members should be consulted along with the HRC Guidelines for Researchers on Health
p.000020: Research involving Māori.
p.000020:
p.000020: In the case of research initiated within a whanau, hapu or iwi where the investigators and research participants are
p.000020: members of that group, it may be appropriate for a kaumātua or other person of authority in the group to provide a
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000021: cell gene therapy or research only after the risks associated with this therapy have been determined by experience in
p.000021: humans over some years.
p.000021:
p.000021: (b) Diseases in which the effects of treatment or research can be measured.
p.000021:
p.000021: (c) Patients for whom long-term follow-up is available.
p.000021:
p.000021: When considering an application for somatic cell gene therapy, or introduction of DNA or RNA for research reasons, the
p.000021: researcher should ensure that the following criteria are met:
p.000021:
p.000022: 22
p.000022:
p.000022: HRC Research Ethics Guidelines
p.000022:
p.000022:
p.000022: (a) That the research team has the necessary depth and breadth of knowledge of, and experience in, molecular
p.000022: genetics.
p.000022:
p.000022: (b) That the purity of the DNA or RNA to be inserted and the methods of handling it during its preparation are
p.000022: in accord with current regulations and official guidelines, particularly if viral vectors are used.
p.000022:
p.000022: (c) That the technique of insertion has been shown by experiments in animals or cell cultures to:
p.000022:
p.000022: i. confirm the inserted DNA or RNA to the targeted somatic cells; and
p.000022: ii. achieve the intended function in a high proportion of attempts, and
p.000022: iii. rarely cause undesirable side effects.
p.000022:
p.000022: (d) That the probability of entry of the DNA into germ cells has been evaluated.
p.000022:
p.000022: In developing each protocol for somatic cell gene therapy or other uses of human genetic material there must be
p.000022: appropriate consultation with any relevant ethnic group affected by the application, paying particular attention to
p.000022: issues of cultural sensitivity. Specific advice on these aspects should be obtained from the HRC Māori Health
p.000022: Committee.
p.000022:
p.000022: For any application for research on gene therapy, or introduction of fragments of DNA or RNA for research reasons, the
p.000022: researcher must consult the official national body concerned with monitoring the safety of innovative human genetic
p.000022: manipulation techniques. The relevant New Zealand body is the HRC Genetic Technology Advisory Committee.
p.000022:
p.000022: 3.15 Research involving use of placebos
p.000022: Applicants should consult the Declaration of Helsinki on research involving use of placebos. Ethics committees should
p.000022: decide on the circumstances of each case, having regard to all relevant ethical considerations, as to whether approval
p.000022: is to be given for a placebo arm in a randomized control trial.
p.000022:
p.000022: The World Medical Association affirmed that “the benefits, risks, burdens and effectiveness of a new intervention must
p.000022: be tested against those of the best current proven intervention(s)”, except in the following circumstances:
p.000022:
p.000022: (a) Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.000022:
p.000022: (b) Where for compelling and scientifically sound methodological reasons the use of any intervention less
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000018: be respected.
p.000018:
p.000018: Where approaches involve visiting or telephoning research participants at their home, it is generally desirable that
p.000018: some advance notice be given and field staff must be provided with means of personal identification including a
p.000018: reference telephone number which the participant may call to establish the field worker's legitimacy. In some
p.000018: circumstances it may be appropriate to inform local police and other relevant authorities.
p.000018:
p.000018: Surveys may, on occasion, involve the physical examination or laboratory investigation of participants. In these
p.000018: circumstances informed consent from each participant must always be
p.000019: 19
p.000019:
p.000019: HRC Research Ethics Guidelines
p.000019:
p.000019:
p.000019: obtained before any examination is undertaken, and each participant must be informed of their right to withdraw without
p.000019: explanation from the research at any time without effect to their current or future health care.
p.000019:
p.000019: The research participant must be informed of any consequences to them due to their withdrawal from the research. Where
p.000019: clinical examination is involved, advance information about the survey for local practitioners and appropriate
p.000019: authorities is of special importance.
p.000019:
p.000019: 3.6 Collection and use of human materials
p.000019: Human materials are any organ, tissue, secretion or excretion derived from a human source whether living or dead and
p.000019: including the human foetus, placenta and human gametes.
p.000019:
p.000019: Legal and cultural aspects which need to be considered will differ according to whether the body parts and tissues come
p.000019: from deceased or living persons, or whether they are body tissues which can be described as "surplus". Regulations and
p.000019: guidelines published in the Human Tissue Act 2008, NZ Standard for Non-therapeutic Use of Human Tissue (NZS 8135:2009)
p.000019: and elsewhere, governing collection, storage and use of human specimens must always be observed. Issues of informed
p.000019: consent and privacy of information will also need to be considered.
p.000019:
p.000019: As a general rule the collection of human materials and their use in research requires the informed consent of the
p.000019: donor, if living.
p.000019:
p.000019: If the human materials are to be used for future unspecified research purposes the Guidelines for the Use of Human
p.000019: Tissue for Future Unspecified Research Purposes should be followed.
p.000019:
p.000019: If established human embryonic stem cell lines are to be used the Guidelines for using Cells from Established Human
p.000019: Embryonic Stem Cell Lines for Research should be followed.
p.000019:
p.000019: For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.7 Research involving children
p.000019: The special vulnerability of children makes consideration of involving them as research participants particularly
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000024: avoided or managed. The disclosure and, where appropriate, management of any conflict of interest should be stated in
p.000024: information sheets provided to participants. A review and audit of compliance with policies and processes relating to
p.000024: conflict of interest should be undertaken to identify areas that could be improved.
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: HRC Research Ethics Guidelines
p.000025:
p.000025: 4.4 Scientific misconduct
p.000025: Individual host institutions should ensure that there are appropriate guidelines for the conduct of research and
p.000025: procedures for dealing with allegations of misconduct in research.
p.000025:
p.000025: 4.5 Compensation for injuries suffered by participants in research
p.000025: The Accident Compensation Act 2001provides cover for treatment injuries caused as part of a clinical trial where an
p.000025: approved ethics committee has approved the trial and is satisfied that the trial was not to be conducted principally
p.000025: for the benefit of the manufacturer or distributor of the medicine or item being trialed.
p.000025:
p.000025: Treatment injuries are adverse medical events that must be causally linked to the treatment (but do not require a
p.000025: finding of fault) and are not a necessary part or ordinary consequence of the treatment.
p.000025:
p.000025: The World Health Organisation defines a clinical trial as:
p.000025:
p.000025: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related
p.000025: interventions to evaluate the effects on health outcomes.
p.000025: Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to
p.000025: drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural
p.000025: treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.”
p.000025:
p.000025: In order to ensure that there is cover under the Accident Compensation Act it is important that the trial is submitted
p.000025: to an approved ethics committee for approval, and that the researcher indicates to the effect that the study will not
p.000025: be carried out principally for the benefit of the manufacturer or distributor of the medicine or item in question. If
p.000025: approval is not granted by an approved ethics committee, the trial may not commence or proceed.
p.000025:
p.000025: Any agreement in writing from a person who will participate in a trial should include all the requirements necessary to
p.000025: enable that person to give his or her fully informed consent, including information on compensation cover.
p.000025:
p.000025: A claim for cover under the Accident Compensation Act is a matter for decision by ACC. In the circumstances where a
p.000025: claimant has cover and is eligible for the entitlement, the claimant’s entitlement will depend on a number of factors,
p.000025: such as whether the claimant is an earner or non-earner.
p.000025:
p.000025: 4.6 Civil liability
p.000025: Where personal injury results from negligence during a non-approved clinical trial, or a clinical trial conducted by a
p.000025: manufacturer or distributor principally for the purpose of testing or proving a product, the injured person will have a
p.000025: right to sue for common law damages.
p.000025:
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000009: include various types of research where contact with participants could cause harm.
p.000009:
p.000009: The primary and over-riding guideline is that applications should be reviewed by an approved ethics committee with the
p.000009: expertise required to evaluate the application, and to identify risks and the adequacy of protections for participants.
p.000009:
p.000009: (a) The scope of research that should be reviewed by an HDEC is explained in Chapter 3, the
p.000009: Standard operating procedures of Health and Disability Ethics Committee (the SOPs).
p.000009:
p.000009: (b) Ethics committees must ensure that members of their committees possess the appropriate expertise required
p.000009: for reviewing the kinds of research studies that are submitted to them, and possess the ability to identify whether
p.000009: adequate protections are in place for participants. Ethics committees reviewing health research would normally be
p.000009: expected to have a minimum of two registered health professionals with the appropriate expertise (at least one
p.000009: clinically trained and at least one in active practice).
p.000009:
p.000009: (c) In some circumstances, an IEC is the most appropriate committee to review the application if that research
p.000009: falls outside the scope of the HDEC.
p.000009:
p.000009: (d) Ethics approval for a research proposal must be obtained from a single approved ethics committee which is
p.000009: able to review a research proposal as a whole.
p.000009:
p.000009: (e) It is recognised that there may be limited circumstances where an IEC and an HDEC may each separately wish
p.000009: to review a particular research study. The policies and procedures of the committees should clearly specify those
p.000009: circumstances, and should identify which committee is to give the final approval in the circumstances.
p.000009:
p.000009: (f) The collection of human tissues to form part of an institutional anatomical collection should be dealt
p.000009: with in accordance with the Human Tissue Act 2008 (see 3.6 Collection and use of human materials and the SOPs Chapter
p.000009: 13).
p.000009:
p.000009: (g) It is recognised that cases may arise where exceptions to these guidelines may have to be considered and so
p.000009: the HRC EC should be informed accordingly in order that they can be discussed when future reviews and revisions of the
p.000009: guidelines are undertaken.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: HRC Research Ethics Guidelines
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 2.4 Special case HRC contracts
p.000010: 2.4.1 Preliminary work under an HRC contract
p.000010: The HRC may permit a contract for the purpose of a pilot study or research development to commence prior to receipt of
p.000010: ethics approval if it is clear that the funding is to enable development of the research proposal to a state where it
...
p.000010: funding for the training portion of a HRC Fellowship or Scholarship may commence before ethics approval for the
p.000010: research proposal is received. However, the research may not commence until evidence of ethics approval for the
p.000010: research has been received by the HRC.
p.000010:
p.000010: Fellows or scholars undertaking HRC-funded research overseas are required to provide evidence of appropriate ethics
p.000010: approval (see 3.10 International Collaborations).
p.000010:
p.000010: 2.5 How to obtain ethics approval
p.000010: The HRC EC considers that ethics approval is best sought before submitting an application to the HRC, but accepts that
p.000010: this may not always be possible. Every application for HRC funding must contain a fully signed ethical agreement page,
p.000010: which attests that appropriate ethics approval for the research has been or will be obtained.
p.000010:
p.000010: No application approved for funding by the HRC will have funds released until evidence of ethics approval, from an
p.000010: approved ethics committee, is received.
p.000010:
p.000010: To ensure proper ethical review, ethics approval for a research proposal must be obtained from a single approved ethics
p.000010: committee able to review the research proposal as a whole. It must not be obtained in selected parts from more than one
p.000010: ethics committee. For example, where part of a research proposal falls under the scope of HDEC review (see the SOPs
p.000010: Chapter 3 - When does a study require HDEC review?); the whole of the proposal must be submitted for ethical review to
p.000010: an HDEC.
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: HRC Research Ethics Guidelines
p.000011:
p.000011:
p.000011: An extension to an existing ethics approval may be sought if proper justification is provided. However, fresh ethics
p.000011: approval must be sought where there has been a significant change to a project. For example, the addition of the
p.000011: collection of blood to a protocol.
p.000011:
p.000011: The HRC reserves the right to request to review all relevant documents relating to the ethics review of an HRC-funded
p.000011: proposal, including the ethics application, and be satisfied that the research is ethically acceptable in accordance
p.000011: with s31 of the HRC Act 1990.
p.000011:
p.000011: 2.5.1 Application to an approved ethics committee
p.000011: The first step in obtaining ethics approval for an application for HRC research funding is to submit an application for
...
p.000021: arrangements for addressing, in New Zealand, genetic modification, genetically modified organisms, and products.
p.000021:
p.000021: The report and recommendations of Royal Commission in 2002 can be downloaded from http://www.mfe.govt.nz.
p.000021:
p.000021: 3.13 In vivo human gene manipulation proposals
p.000021: All attempts to introduce deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) into humans must be reviewed by an
p.000021: approved ethics committee.
p.000021:
p.000021: Somatic cell gene therapy involves the introduction of fragments of DNA or RNA into human somatic (non-reproductive)
p.000021: cells. The aim usually is to improve the health of people with certain grave inherited diseases, or with certain forms
p.000021: of cancer, or some virus infections. DNA or RNA may also be introduced into somatic cells to mark their distribution
p.000021: and fate in particular forms of research on serious diseases.
p.000021:
p.000021: There may also be other well justified non-therapeutic reasons for introducing DNA or RNA. The development of methods
p.000021: of introducing DNA or RNA into somatic cells is acceptable. The introduction of DNA or RNA into germ (reproductive)
p.000021: cells or fertilised ova is not acceptable at present, because there is insufficient knowledge about the possible
p.000021: consequences, hazards and effects on future generations.
p.000021:
p.000021: The following particular matters need to be taken into account when protocols for somatic cell gene therapy or research
p.000021: are being considered by an ethics committee.
p.000021:
p.000021: (a) The therapy should be attempted at present only in monogenic diseases where the cause is a defect in a
p.000021: single pair of genes, or in cancers. There should be good reason to believe that the therapy may improve clinical
p.000021: outcomes.
p.000021:
p.000021: (b) Introduction of DNA or RNA for research reasons should have a sound basis in current knowledge of the
p.000021: biological system involved.
p.000021:
p.000021: 3.14 The choice of diseases for clinical therapy or research
p.000021: The choice of diseases for clinical therapy or research is critical. For the present, evidence of hazards associated
p.000021: with the treatment can only be estimated and evaluated from experiments on animals. Initial trials in human
p.000021: participants therefore should be limited to –
p.000021:
p.000021: (a) Diseases for which there is no effective cure, and which cause a severe burden of suffering. Diseases
p.000021: causing a lesser burden, when account is taken of currently available treatment, should become candidates for somatic
p.000021: cell gene therapy or research only after the risks associated with this therapy have been determined by experience in
p.000021: humans over some years.
p.000021:
p.000021: (b) Diseases in which the effects of treatment or research can be measured.
p.000021:
p.000021: (c) Patients for whom long-term follow-up is available.
p.000021:
p.000021: When considering an application for somatic cell gene therapy, or introduction of DNA or RNA for research reasons, the
p.000021: researcher should ensure that the following criteria are met:
p.000021:
p.000022: 22
p.000022:
p.000022: HRC Research Ethics Guidelines
p.000022:
p.000022:
p.000022: (a) That the research team has the necessary depth and breadth of knowledge of, and experience in, molecular
p.000022: genetics.
p.000022:
...
Social / Police Officer
Searching for indicator police:
(return to top)
p.000018: community to which the intervention and evaluation is targeted should be informed of the study findings once the study
p.000018: has been completed.
p.000018:
p.000018: 3.5 Surveys of the general population
p.000018: Some types of research require surveys to be undertaken on "total" populations or on samples of the population selected
p.000018: from public records such as the electoral roll. It is considered that direct approaches (for example, by telephone,
p.000018: postal questionnaire or visit interview) to persons in the general population selected in this way do not require
p.000018: approval by any local health or medical body or individual practitioner.
p.000018:
p.000018: However, it may be appropriate to inform local health practitioners about the study. Investigators should consult with
p.000018: and, where appropriate, obtain ethics approval from an approved ethics committee for the research to proceed. The
p.000018: right of any person to decline to take part in such a survey, or to withdraw from the survey at any time, must always
p.000018: be respected.
p.000018:
p.000018: Where approaches involve visiting or telephoning research participants at their home, it is generally desirable that
p.000018: some advance notice be given and field staff must be provided with means of personal identification including a
p.000018: reference telephone number which the participant may call to establish the field worker's legitimacy. In some
p.000018: circumstances it may be appropriate to inform local police and other relevant authorities.
p.000018:
p.000018: Surveys may, on occasion, involve the physical examination or laboratory investigation of participants. In these
p.000018: circumstances informed consent from each participant must always be
p.000019: 19
p.000019:
p.000019: HRC Research Ethics Guidelines
p.000019:
p.000019:
p.000019: obtained before any examination is undertaken, and each participant must be informed of their right to withdraw without
p.000019: explanation from the research at any time without effect to their current or future health care.
p.000019:
p.000019: The research participant must be informed of any consequences to them due to their withdrawal from the research. Where
p.000019: clinical examination is involved, advance information about the survey for local practitioners and appropriate
p.000019: authorities is of special importance.
p.000019:
p.000019: 3.6 Collection and use of human materials
p.000019: Human materials are any organ, tissue, secretion or excretion derived from a human source whether living or dead and
p.000019: including the human foetus, placenta and human gametes.
p.000019:
p.000019: Legal and cultural aspects which need to be considered will differ according to whether the body parts and tissues come
p.000019: from deceased or living persons, or whether they are body tissues which can be described as "surplus". Regulations and
p.000019: guidelines published in the Human Tissue Act 2008, NZ Standard for Non-therapeutic Use of Human Tissue (NZS 8135:2009)
p.000019: and elsewhere, governing collection, storage and use of human specimens must always be observed. Issues of informed
...
Social / Property Ownership
Searching for indicator home:
(return to top)
p.000018:
p.000018: Although some community based interventions (e.g. an anti-smoking campaign) that do not involve personal contact
p.000018: between the researcher and the study population may not require ethics approval, the evaluation of such interventions
p.000018: which did involve personal contact with individuals or collection of data from them, will require ethics approval. The
p.000018: community to which the intervention and evaluation is targeted should be informed of the study findings once the study
p.000018: has been completed.
p.000018:
p.000018: 3.5 Surveys of the general population
p.000018: Some types of research require surveys to be undertaken on "total" populations or on samples of the population selected
p.000018: from public records such as the electoral roll. It is considered that direct approaches (for example, by telephone,
p.000018: postal questionnaire or visit interview) to persons in the general population selected in this way do not require
p.000018: approval by any local health or medical body or individual practitioner.
p.000018:
p.000018: However, it may be appropriate to inform local health practitioners about the study. Investigators should consult with
p.000018: and, where appropriate, obtain ethics approval from an approved ethics committee for the research to proceed. The
p.000018: right of any person to decline to take part in such a survey, or to withdraw from the survey at any time, must always
p.000018: be respected.
p.000018:
p.000018: Where approaches involve visiting or telephoning research participants at their home, it is generally desirable that
p.000018: some advance notice be given and field staff must be provided with means of personal identification including a
p.000018: reference telephone number which the participant may call to establish the field worker's legitimacy. In some
p.000018: circumstances it may be appropriate to inform local police and other relevant authorities.
p.000018:
p.000018: Surveys may, on occasion, involve the physical examination or laboratory investigation of participants. In these
p.000018: circumstances informed consent from each participant must always be
p.000019: 19
p.000019:
p.000019: HRC Research Ethics Guidelines
p.000019:
p.000019:
p.000019: obtained before any examination is undertaken, and each participant must be informed of their right to withdraw without
p.000019: explanation from the research at any time without effect to their current or future health care.
p.000019:
p.000019: The research participant must be informed of any consequences to them due to their withdrawal from the research. Where
p.000019: clinical examination is involved, advance information about the survey for local practitioners and appropriate
p.000019: authorities is of special importance.
p.000019:
p.000019: 3.6 Collection and use of human materials
p.000019: Human materials are any organ, tissue, secretion or excretion derived from a human source whether living or dead and
p.000019: including the human foetus, placenta and human gametes.
p.000019:
p.000019: Legal and cultural aspects which need to be considered will differ according to whether the body parts and tissues come
...
Searching for indicator property:
(return to top)
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC) 18
p.000017: 3.3 Observational studies 18
p.000017: 3.4 Social, community-based, public health or health services interventions
p.000019: 19
p.000019: 3.5 Surveys of the general population 19
p.000019: 3.6 Collection and use of human materials 20
p.000019: 3.7 Research involving children 20
p.000019: 3.8 Research involving personal health information 20
p.000019: 3.9 Research involving Māori 20
p.000019: 3.10 International collaborations 21
p.000019: 3.11 Research undertaken at an overseas location 21
p.000019: 3.12 Genetic modification 21
p.000019: 3.13 In vivo human gene manipulation proposals 22
p.000019: 3.14 The choice of diseases for clinical therapy or research 22
p.000019: 3.15 Research involving use of placebos 23
p.000019: 3.16 Research involving animals or animal materials 24
p.000019: 4. General legal issues in research 25
p.000019: 4.1 Intellectual property rights 25
p.000019: 4.2 Copyright
p.000025: 25
p.000025: 4.3 Conflict of interest
p.000025: 25
p.000025: 4.4 Scientific misconduct 26
p.000025: 4.5 Compensation for injuries suffered by participants in research
p.000026: 26
p.000026: 4.6 Civil liability
p.000026: 26
p.000026: 4.7 Practicing certificates for ethics committee members 27
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026:
p.000026: ii
p.000026:
p.000026: 1. Overview
p.000026:
p.000026:
p.000026: 1.1 Introduction
p.000026:
p.000026: The national system of ethics review is comprised of a number of committees with various responsibilities for human
p.000026: ethics and animal ethics.
p.000026:
p.000026: 1.1.1 The Treaty of Waitangi
p.000026: The Treaty is the founding document of New Zealand. The principles of partnership and sharing implicit in the Treaty
p.000026: should be respected by all in all health research proposals.
p.000026:
p.000026: 1.1.2 Human ethics
p.000026: (a) The following ethics committees are established under statute:
p.000026:
p.000026: i. The Health Research Council Ethics Committee, see 1.2 HRC EC;
...
p.000023: animal ethics committee must be documented before funding commences.
p.000023:
p.000023: If the institution/organisation has no animal ethics committee, guidance on how to set up one for accreditation can be
p.000023: obtained from the National Animal Ethics Advisory Committee (NAEAC). Alternatively, it is possible to obtain approval
p.000023: to conduct the study under the approval and supervision of an animal ethics committee in the vicinity of the
p.000023: institution/organisation. Guidance can be obtained from the Secretary of NAEAC.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: HRC Research Ethics Guidelines
p.000024:
p.000024: 4. General legal issues in research
p.000024:
p.000024:
p.000024: The following sets out general issues that may have legal relevance. The information provided below is not to be taken
p.000024: as legal advice but as an indication of matters which should be taken into consideration.
p.000024:
p.000024: 4.1 Intellectual property rights
p.000024: Intellectual Property (IP) results from creative thought, and can include any novel result, idea, device, software,
p.000024: chemical, vaccine, mono-clonal antibody, plasmid, hybridoma, diagnostic method or process.
p.000024:
p.000024: It is important for researchers to protect their IP by patenting new discoveries or processes and not signing away
p.000024: their UP rights in Materials Use Agreements or collaborative research agreements.
p.000024:
p.000024: The HRC has IP agreements with the majority of host institutions which it funds.
p.000024:
p.000024: These agreements assign the HRC’s share of any financial benefits from IP developed by an HRC- funded researcher to the
p.000024: institution to support the researcher’s group or other public good health research.
p.000024:
p.000024: 4.2 Copyright
p.000024: Copyright is automatic under New Zealand law without application to any particular body for the legal right to
p.000024: copyright original material. Copyright exists from the time of production of the original copyrighted material.
p.000024: Materials covered by copyright include but are not limited to: written, typed or printed information on any medium,
p.000024: artworks, computer source code and object code, data or results of investigations.
p.000024:
p.000024: The HRC EC expects that copyright will be respected by investigators and other persons and that New Zealand and
p.000024: international laws relating to copyright will be adhered to in all cases.
p.000024:
p.000024: 4.3 Conflict of interest
p.000024: To achieve impartiality, any member of an ethics committee who has a proposal before the committee or who has a
p.000024: conflict of interest whereby the impartiality of that member could be questioned, will declare and withdraw at the
p.000024: determination of the committee.
p.000024:
...
Social / Religion
Searching for indicator faith:
(return to top)
p.000012:
p.000012: 2.7 Reviews of decisions by ethics committees
p.000012: 2.7.1 Reconsideration
p.000012: The researcher, the funder, or where relevant, a participant, may seek a reconsideration of a decision made by an
p.000012: ethics committee from that committee itself.
p.000012:
p.000012: 2.7.2 Review by HRC EC (Second opinion)
p.000012: Ethics committees, researchers, a funder, or where relevant, a participant, may seek a second opinion from the HRC EC.
p.000012:
p.000012: For processes of HDECs, see the SOPs Chapter 9 (Second opinion on the merits of the decision).
p.000012:
p.000012: 2.7.3 Appeal
p.000012: By written notice issued in accordance with section 25(1)(h)(ii) of the Health Research Council Act 1990 on 24
p.000012: September 2010, the Minister of Health authorised the HRC EC to undertake the additional function of considering
p.000012: appeals against decisions made by the HDECs.
p.000012:
p.000012: The processes set out in this section are not intended to replace the existing provisions for complaints regarding
p.000012: decisions of committees outlined in the SOPs Chapter 9 (Formal complaints about the decision making process).
p.000012:
p.000012: (a) An application for consideration of an appeal may only be made where:
p.000012:
p.000012: i. an approved HDEC has reviewed a proposal and issued a decision in the terms set out in the SOPs Chapter 7, and;
p.000012: ii. attempts have been made in good faith to resolve differences between the applicant and the reviewing HDEC
p.000012: (taking into account, where appropriate, provisions in the SOPs Chapter 9 (Formal complaint about the decision-making
p.000012: process and Second opinion on the merits of the decision by HRC EC), and;
p.000012: iii. subject to paragraph (e) below, a second opinion has been provided under the processes set out in the SOPs
p.000012: Chapter 9 (Second opinion on the merits of the decision by HRC EC).
p.000012:
p.000012: (b) Where the conditions in paragraph (a) have been met, the coordinating investigator named on the proposal
p.000012: under consideration may lodge an appeal with the Chair of the HRC EC.
p.000012:
p.000012: (c) The appeal must be lodged within 60 days of the date upon which the Chair of the HRC EC is satisfied that
p.000012: the conditions in paragraph (a) are met.
p.000012:
p.000012: (d) In exceptional cases upon a specific request from an applicant and following consultation with a quorum of
p.000012: the HRC EC, the Chair of the HRC EC may:
p.000013: 13
p.000013:
p.000013: HRC Research Ethics Guidelines
p.000013:
p.000013:
p.000013:
p.000013: i. allow an interested third party to lodge an appeal where the Chair is satisfied that restricting the right to
p.000013: lodge an appeal to the coordinating investigator would be inequitable;
p.000013: ii. waive the requirement to obtain a second opinion, so allowing direct recourse to the appeal process, where he or
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000017: appropriate and is requested by the investigators. Trial-Specific Data Monitoring Committees are formed from the DMCC
p.000017: membership, plus additional co- opted members who have expertise specific to the trial.
p.000017:
p.000017: For more information on monitoring of clinical trials, see Data Monitoring Core Committee | Health Research Council.
p.000017:
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC)
p.000017: Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated
p.000017: micro-organisms, or viruses or cells into human participants is undertaken by the GTAC.
p.000017:
p.000017: GTAC is to review for the purposes of seeking an exemption under Section 30 of the Medicines Act (1981) or as required
p.000017: by an approved ethics committee or the HRC of any of its committees.
p.000017:
p.000017: For more information on GTAC approval, see Specific Considerations | Health Research Council.
p.000017:
p.000017: 3.3 Observational studies
p.000017: An observational study is either observational research, or, an audit and related activity. To determine whether an
p.000017: activity is observational research, public health investigations, or any other form of audit or related activity, see
p.000017: section 2 Ethical Guidelines for Observational Studies.
p.000017:
p.000017:
p.000017:
p.000017: 2 The CPMP Guideline is an international ethical and scientific quality standard for designing, conducting, recording
p.000017: and reporting clinical trials that involve human participants. The CPMP Guideline aims to provide a unified standard
p.000017: for the European Union, Japan, and the United States, as well as Australia, Canada, the Nordic countries and the World
p.000017: Health Organisation (WHO).
p.000017:
p.000017: 3 “Every research study involving human subjects must be registered in a publicly accessible database before
p.000017: recruitment
p.000017: on the first subject” (Declaration of Helsinki).
p.000018: 18
p.000018:
p.000018: HRC Research Ethics Guidelines
p.000018:
p.000018:
p.000018: More than minimal risk observational research requires ethics committee review (see the SOPs Chapter 3 - When does a
p.000018: study require HDEC review?).
p.000018:
p.000018: For further information on which observational studies require review by an ethics committee, see section 3 Ethical
p.000018: Guidelines for Observational Studies.
p.000018:
p.000018: 3.4 Social, community-based, public health or health services interventions
p.000018: When the focus of a study is a whole community (for example, to test the use of an additive in a community's water
p.000018: supply, or a new form of health care delivery); the individual will not usually have the ability to “opt-out”.
p.000018: However, individuals may refuse to submit to questionnaires or blood tests, or other instruments designed to obtain
p.000018: data to evaluate the intervention.
p.000018:
p.000018: All reasonable means should be used by the investigators to inform the population under study of the aims and intent of
p.000018: the proposed research and all possible advantages or disadvantages which may arise from it. It is normal for the
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
...
p.000022:
p.000022: 3.15 Research involving use of placebos
p.000022: Applicants should consult the Declaration of Helsinki on research involving use of placebos. Ethics committees should
p.000022: decide on the circumstances of each case, having regard to all relevant ethical considerations, as to whether approval
p.000022: is to be given for a placebo arm in a randomized control trial.
p.000022:
p.000022: The World Medical Association affirmed that “the benefits, risks, burdens and effectiveness of a new intervention must
p.000022: be tested against those of the best current proven intervention(s)”, except in the following circumstances:
p.000022:
p.000022: (a) Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.000022:
p.000022: (b) Where for compelling and scientifically sound methodological reasons the use of any intervention less
p.000022: effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or
p.000022: safety of an intervention, and
p.000022:
p.000022: (c) the patients who receive any intervention less effective than the best proven one, placebo, or no
p.000022: intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the
p.000022: best proven intervention.
p.000022:
p.000022: (d) Extreme care be taken to avoid abuse of this option.
p.000022:
p.000022: See also: Ethical guidelines for intervention studies sections 5.22 – 5.25 Use of a placebo.
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: HRC Research Ethics Guidelines
p.000023:
p.000023: 3.16 Research involving animals or animal materials
p.000023: The HRC requires all research involving animals or animal materials to be submitted for approval by the animal ethics
p.000023: committee of the institution/organisation with which the investigator is associated. Evidence of approval from an
p.000023: animal ethics committee must be documented before funding commences.
p.000023:
p.000023: If the institution/organisation has no animal ethics committee, guidance on how to set up one for accreditation can be
p.000023: obtained from the National Animal Ethics Advisory Committee (NAEAC). Alternatively, it is possible to obtain approval
p.000023: to conduct the study under the approval and supervision of an animal ethics committee in the vicinity of the
p.000023: institution/organisation. Guidance can be obtained from the Secretary of NAEAC.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
...
Social / Women
Searching for indicator women:
(return to top)
p.000026: research, the independent ethical assessment made, in respect of the proposed health research, by a committee approved
p.000026: under paragraph (c).
p.000026:
p.000026: (f) To give, in relation to ethics committees established by other bodies, advice on –
p.000026:
p.000026: i. the membership of those committees; and
p.000026: ii. the procedures to be adopted and the standards to be observed, by those committees.
p.000026:
p.000026: (g) To provide independent comment on ethical problems that may arise in any aspect of health research.
p.000026:
p.000026: (h) To perform any other functions (whether or not related to health research) it is for the time being –
p.000026:
p.000026: i. given by or under any enactment; or
p.000026: ii. authorised to perform by the Minister, by written notice to the Health Research Council after consultation with
p.000026: it.
p.000026:
p.000026: Additional responsibilities may be undertaken after discussion and agreement with the National Ethics Advisory
p.000026: Committee.
p.000026:
p.000026: 1.2.2 Membership
p.000026: Members of the HRC EC are appointed by the Board of the HRC.
p.000026:
p.000026: Membership is set out in section 26 of the HRC Act and must include the Chairperson of the Board or his/her nominee and
p.000026: one other member of the Board with qualifications in science. Five other persons, who are not members of the Board, are
p.000026: appointed having regard to the need to have a diversity of knowledge and experience in relation to science, ethics,
p.000026: philosophy, law, theology, nursing, women’s health, patient advocacy and tikanga Māori.
p.000026:
p.000026: The Chair of the HRC EC is appointed by the members of the HRC EC.
p.000026:
p.000002: 2
p.000002:
p.000002: HRC Research Ethics Guidelines
p.000002:
p.000002:
p.000002: During 1992, the Board resolved that the maximum term of membership for HRC EC members will be three years plus
p.000002: possible renewal for up to a further three years.
p.000002:
p.000002: 1.3 National Ethics Advisory Committee (NEAC)
p.000002: NEAC is a ministerial advisory committee established under section 16 of the New Zealand Public Health and Disability
p.000002: Act 2000 to advise the Minister of Health on ethical issues in health services and research, and determine national
p.000002: ethical standards for the health sector.
p.000002:
p.000002: 1.4 Ethics Committee on Assisted Reproductive Technology (ECART)
p.000002: ECART is a ministerial committee established under section 27 of the Human Assisted Reproductive Technology (HART) Act
p.000002: 2004 that reviews, determines and monitors applications for assisted reproductive procedures and human reproductive
p.000002: research.
p.000002:
p.000002: ECART can only consider applications for procedures that the Advisory Committee on Assisted Reproductive Technology
p.000002: (ACART) has issued guidelines and advice for.
p.000002:
p.000002: 1.5 Health and Disability Ethics Committees (HDECs)
p.000002:
...
Social / parents
Searching for indicator parent:
(return to top)
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
p.000007: 1 In the case of research participants who are children the signature of the parent or guardian should be obtained in
p.000007: addition to the child’s assent (see section 3.7 Research involving children).
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: HRC Research Ethics Guidelines
p.000008:
p.000008:
p.000008: from participating in the research or indirectly benefit from the new knowledge derived from the research.
p.000008:
p.000008: Recruitment of research participants should be free from manipulation, coercion, deception, inducement or any other
p.000008: undue influence. Participants should be told the purpose of the research, the risks and benefits in participation and
p.000008: other relevant details that form the basis of informed consent.
p.000008:
p.000008: 2.1.5 Payments for participation in research
p.000008: Any payment, koha or gift of money, goods or services to a research participant or to a body or organisation assisting
p.000008: in the recruitment of participants, which constitutes an undue inducement to participate in the research, is
p.000008: unacceptable.
p.000008:
p.000008: Reimbursement for participants’ out-of-pocket expenses (e.g. taxi fares, meals, parking fees) or in compensation for
p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000008: 2.2 Research requiring ethics approval 10
p.000008: 2.3 Scope of ethics committee review 10
p.000008: 2.4 Special case HRC contracts 11
p.000008: 2.4.1 Preliminary work under an HRC contract 11
p.000008: 2.4.2 Research contracts 11
p.000008: 2.4.3 Career development contracts (CDAs) 11
p.000008: 2.5 How to obtain ethics approval 11
p.000008: 2.5.1 Application to an approved ethics committee 12
p.000008: 2.5.2 Locality authorisation 12
p.000008: 2.5.3 Ethics committee decision 12
p.000008: 2.6 Retrospective approval 13
p.000008: 2.7 Reviews of decisions by ethics committees 13
p.000008: 2.7.1 Reconsideration 13
p.000008: 2.7.2 Review by HRC EC (Second opinion) 13
p.000008: 2.7.3 Appeal
p.000013: 13
p.000013: 2.8 Complaints
p.000015: 15
p.000015: 2.9 Independent Comment 15
p.000015: i
p.000015:
p.000015: HRC Research Ethics Guidelines
p.000015: 3. Different forms of research 17
p.000015: 3.1 Use of a new medicine 17
p.000015: 3.2 Clinical trials
p.000017: 17
p.000017: 3.2.1 Health Research Council Data Monitoring Core Committee
p.000017: (DMCC) 18
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC) 18
p.000017: 3.3 Observational studies 18
p.000017: 3.4 Social, community-based, public health or health services interventions
p.000019: 19
p.000019: 3.5 Surveys of the general population 19
p.000019: 3.6 Collection and use of human materials 20
p.000019: 3.7 Research involving children 20
p.000019: 3.8 Research involving personal health information 20
p.000019: 3.9 Research involving Māori 20
...
p.000011: ethically acceptable lines.
p.000011:
p.000011: Every decision, comment, or direction of an ethics committee should be made in writing to the principal investigator.
p.000011:
p.000011: When ethics approval for the research is received by the applicant, the host institution(s) must be given a copy.
p.000011: Evidence of the approval should be included with the funding application or forwarded to the HRC EC administrator as
p.000011: soon as it is received (normally) by the host institution. Where a contract is awarded, evidence of all approvals will
p.000011: be required before the HRC releases funding.
p.000012: 12
p.000012:
p.000012: HRC Research Ethics Guidelines
p.000012:
p.000012:
p.000012:
p.000012: The successful applicant must also inform the host institution about ethics approval of the research.
p.000012:
p.000012: 2.6 Retrospective approval
p.000012: No retrospective approval for any study shall be given by an approved ethics committee.
p.000012:
p.000012: 2.7 Reviews of decisions by ethics committees
p.000012: 2.7.1 Reconsideration
p.000012: The researcher, the funder, or where relevant, a participant, may seek a reconsideration of a decision made by an
p.000012: ethics committee from that committee itself.
p.000012:
p.000012: 2.7.2 Review by HRC EC (Second opinion)
p.000012: Ethics committees, researchers, a funder, or where relevant, a participant, may seek a second opinion from the HRC EC.
p.000012:
p.000012: For processes of HDECs, see the SOPs Chapter 9 (Second opinion on the merits of the decision).
p.000012:
p.000012: 2.7.3 Appeal
p.000012: By written notice issued in accordance with section 25(1)(h)(ii) of the Health Research Council Act 1990 on 24
p.000012: September 2010, the Minister of Health authorised the HRC EC to undertake the additional function of considering
p.000012: appeals against decisions made by the HDECs.
p.000012:
p.000012: The processes set out in this section are not intended to replace the existing provisions for complaints regarding
p.000012: decisions of committees outlined in the SOPs Chapter 9 (Formal complaints about the decision making process).
p.000012:
p.000012: (a) An application for consideration of an appeal may only be made where:
p.000012:
p.000012: i. an approved HDEC has reviewed a proposal and issued a decision in the terms set out in the SOPs Chapter 7, and;
p.000012: ii. attempts have been made in good faith to resolve differences between the applicant and the reviewing HDEC
p.000012: (taking into account, where appropriate, provisions in the SOPs Chapter 9 (Formal complaint about the decision-making
p.000012: process and Second opinion on the merits of the decision by HRC EC), and;
p.000012: iii. subject to paragraph (e) below, a second opinion has been provided under the processes set out in the SOPs
p.000012: Chapter 9 (Second opinion on the merits of the decision by HRC EC).
p.000012:
p.000012: (b) Where the conditions in paragraph (a) have been met, the coordinating investigator named on the proposal
p.000012: under consideration may lodge an appeal with the Chair of the HRC EC.
p.000012:
p.000012: (c) The appeal must be lodged within 60 days of the date upon which the Chair of the HRC EC is satisfied that
p.000012: the conditions in paragraph (a) are met.
p.000012:
p.000012: (d) In exceptional cases upon a specific request from an applicant and following consultation with a quorum of
p.000012: the HRC EC, the Chair of the HRC EC may:
p.000013: 13
p.000013:
p.000013: HRC Research Ethics Guidelines
p.000013:
p.000013:
p.000013:
p.000013: i. allow an interested third party to lodge an appeal where the Chair is satisfied that restricting the right to
p.000013: lodge an appeal to the coordinating investigator would be inequitable;
p.000013: ii. waive the requirement to obtain a second opinion, so allowing direct recourse to the appeal process, where he or
p.000013: she is satisfied that a binding resolution is urgent or that the second opinion process would be futile.
p.000013:
p.000013: Decisions under this paragraph will be made within 14 days of receiving an application for appeal subject only to
p.000013: reasonable delays occasioned by, for instance, the need to obtain expert advice or further information from applicants.
p.000013:
p.000013: (e) The HRC EC will meet to consider an appeal no later than 6 weeks after the application for appeal has been
p.000013: accepted.
p.000013:
p.000013: (f) An application for appeal must include:
p.000013:
p.000013: i. a copy of the original application;
p.000013: ii. written comments by the reviewing HDEC explaining their decision;
p.000013: iii. (subject to paragraph d above) a copy of the Second Opinion and all relevant correspondence; and
p.000013: iv. a description of the specific issues which form the basis of the appeal.
p.000013:
p.000013: (g) The HRC EC will have broad discretion to consider information relevant to the matter under appeal. The HRC
p.000013: EC will consider information from both the investigator who submitted the application and the ethics committee who
p.000013: completed the Primary Review and, where appropriate, further submissions made by other relevant parties. The HRC EC may
p.000013: consider other information available at the time the original decision was made, or new information that has come to
p.000013: light since.
p.000013:
p.000013: (h) Where the Chair or a quorum of HRC EC members believes there is insufficient expertise on the HRC EC to
p.000013: consider an appeal, the HRC EC will seek additional expert advice. Persons and bodies to be consulted under this
p.000013: provision will be identified by the Chair of the HRC EC in consultation with the HRC EC in order to obtain advice
p.000013: appropriate to the matter under review.
p.000013:
p.000013: (i) When considering appeals, the HRC EC is bound by the principles of natural justice and, in particular,
p.000013: must ensure that:
p.000013:
p.000013: i. all processes are open, transparent and fair;
p.000013: ii. the committee is unbiased;
p.000013: iii. all parties to the appeal are:
p.000013: • advised of the process to be undertaken;
p.000013: • given the opportunity to comment on issues (a reasonable period of time should be given for the parties to
p.000013: respond);
p.000013: • kept informed of the progress of the appeal ;
p.000013: • advised of the outcome of the review;
p.000013: iv. conflicts of interest are avoided or appropriately managed;
p.000013: v. reasons are given for any decisions or recommendations made.
p.000013:
p.000013: (j) Meetings of the HRC EC will be closed to the public.
p.000013:
p.000013: (k) Copies of appeal requests and decisions will be available to individuals outside the HRC EC, subject to the
p.000013: provisions of the Official Information Act 1982.
p.000014: 14
p.000014:
p.000014: HRC Research Ethics Guidelines
p.000014:
p.000014:
p.000014:
p.000014: (l) Wherever possible, the HRC EC should determine matters by consensus decision. Where a consensus cannot be
p.000014: reached, a decision will be made by the majority vote with the Chair having a casting vote.
p.000014:
p.000014: (m) The decision of the HRC EC will be binding. The HRC EC will take one of the following actions:
p.000014:
p.000014: i. uphold the decision of the Primary Ethics Committee; or
p.000014: ii. overturn the decision of the Primary Ethics Committee; and approve, approve with conditions, or decline the
p.000014: ethics application.
p.000014:
p.000014: (n) In addition to making a decision, the HRC EC may also give non-binding advice or recommendations clearly
p.000014: indicating which parts are non-binding.
p.000014:
p.000014: (o) All decisions of the HRC EC will be communicated to:
p.000014:
p.000014: i. the Appellant;
p.000014: ii. the original reviewing Committee;
p.000014: iii. the Committee which delivered the second opinion, if there was one;
p.000014: iv. the Board of the Health Research Council of New Zealand; and
p.000014: v. the Manager, Ethics Committees, Ministry of Health.
p.000014:
p.000014: (p) Once the HRC EC has made and communicated its decision on the appeal, the primary ethics committee
p.000014: providing the original review will resume full administrative responsibilities in relation to the original application,
p.000014: such as receiving annual reports, monitoring adverse events, receiving final reports and the like.
p.000014:
p.000014: (q) The HRC EC will provide a report on appeals to the Board of the HRC and the Minister of Health on all
p.000014: appeals.
p.000014:
p.000014: (r) The Appeal Summary will contain the following information:
p.000014:
p.000014: i. the membership of the HRC EC;
p.000014: ii. the research title;
p.000014: iii. the name and position of the principal investigator;
p.000014: iv. summary of Primary Review;
p.000014: v. summary of Second Opinion provided by the secondary ethics Committee (unless an expedited appeal); and
p.000014: vi. decision of the HRC EC.
p.000014:
p.000014: 2.8 Complaints
p.000014: Complaints about research involving human participants can be made, where appropriate, to an approved ethics committee,
p.000014: the HRC EC, the relevant institution/organisation involved in the research, the Health and Disability Commissioner, or
p.000014: the Privacy Commissioner.
p.000014:
p.000014: 2.9 Independent Comment
p.000014: The HRC EC can provide independent comment on ethical problems that may arise in any aspect of health research.
p.000014: Independent comment may be sought from the HRC EC by any person, or may be provided at the HRC EC’s own initiative.
p.000014: Where appropriate, the HRC EC may advise
p.000014:
p.000015: 15
p.000015:
p.000015: HRC Research Ethics Guidelines
p.000015:
p.000015:
p.000015: relevant parties of the process that will be taken by the HRC EC, seek input from relevant parties, and provide the
p.000015: opportunity for relevant parties to comment.
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
p.000015:
...
p.000019:
p.000019: 3.8 Research involving personal health information
p.000019:
p.000019: Research which involves the use of personal health information is required to comply with the Health Information
p.000019: Privacy Code 1994. For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.9 Research involving Māori
p.000019:
p.000019: Respect for the principles of partnership and sharing implicit in the Treaty of Waitangi will be observed by
p.000019: incorporating the following requirements into health research proposals. All issues relating to Māori cultural and
p.000019: ethical values should be discussed with the whanau, hapū or iwi concerned along with matters to do with the key
p.000019: questions and aims of the research. The ownership rights of participants to personal data must be respected.
p.000020: 20
p.000020:
p.000020: HRC Research Ethics Guidelines
p.000020:
p.000020:
p.000020:
p.000020: For research that involves or targets Māori research outcomes or methodologies; the Te Ara
p.000020: Tika: Guidelines for Māori Research Ethics: A framework for researchers and ethics committee
p.000020: members should be consulted along with the HRC Guidelines for Researchers on Health
p.000020: Research involving Māori.
p.000020:
p.000020: In the case of research initiated within a whanau, hapu or iwi where the investigators and research participants are
p.000020: members of that group, it may be appropriate for a kaumātua or other person of authority in the group to provide a
p.000020: statement that, in their opinion, the proposed
p.000020: research conforms to Māori cultural and ethical values. The HRC EC may review such research proposals and confirm that
p.000020: this mechanism will constitute adequate ethics approval.
p.000020:
p.000020: It may also be appropriate for the advice of the HRC Māori Health Committee and other appropriate expert groups to be
p.000020: sought by an ethics committee when reviewing a research proposal.
p.000020:
p.000020: In the event of issues which cannot be reconciled in discussions between the parties involved, the matter may be
p.000020: referred to the HRC EC and the HRC Māori Health Committee for joint comment.
p.000020:
p.000020: 3.10 International collaborations
p.000020: Any investigator participating in international collaborative research whose project is funded in full or in part by
p.000020: the HRC will require ethics approval from a New Zealand approved ethics committee for the research. Research conducted
p.000020: overseas having human or animal involvement will also require appropriate ethics approval from an ethics committee (or
p.000020: equivalent body) in the country concerned, where such a body exists.
p.000020:
p.000020: Any international collaborative research project, whether or not funded by the HRC, which involves investigations in
p.000020: New Zealand or its territories, should be subject to ethical review by an approved ethics committee within New Zealand.
p.000020:
...
Searching for indicator philosophy:
(return to top)
p.000026: research, the independent ethical assessment made, in respect of the proposed health research, by a committee approved
p.000026: under paragraph (c).
p.000026:
p.000026: (f) To give, in relation to ethics committees established by other bodies, advice on –
p.000026:
p.000026: i. the membership of those committees; and
p.000026: ii. the procedures to be adopted and the standards to be observed, by those committees.
p.000026:
p.000026: (g) To provide independent comment on ethical problems that may arise in any aspect of health research.
p.000026:
p.000026: (h) To perform any other functions (whether or not related to health research) it is for the time being –
p.000026:
p.000026: i. given by or under any enactment; or
p.000026: ii. authorised to perform by the Minister, by written notice to the Health Research Council after consultation with
p.000026: it.
p.000026:
p.000026: Additional responsibilities may be undertaken after discussion and agreement with the National Ethics Advisory
p.000026: Committee.
p.000026:
p.000026: 1.2.2 Membership
p.000026: Members of the HRC EC are appointed by the Board of the HRC.
p.000026:
p.000026: Membership is set out in section 26 of the HRC Act and must include the Chairperson of the Board or his/her nominee and
p.000026: one other member of the Board with qualifications in science. Five other persons, who are not members of the Board, are
p.000026: appointed having regard to the need to have a diversity of knowledge and experience in relation to science, ethics,
p.000026: philosophy, law, theology, nursing, women’s health, patient advocacy and tikanga Māori.
p.000026:
p.000026: The Chair of the HRC EC is appointed by the members of the HRC EC.
p.000026:
p.000002: 2
p.000002:
p.000002: HRC Research Ethics Guidelines
p.000002:
p.000002:
p.000002: During 1992, the Board resolved that the maximum term of membership for HRC EC members will be three years plus
p.000002: possible renewal for up to a further three years.
p.000002:
p.000002: 1.3 National Ethics Advisory Committee (NEAC)
p.000002: NEAC is a ministerial advisory committee established under section 16 of the New Zealand Public Health and Disability
p.000002: Act 2000 to advise the Minister of Health on ethical issues in health services and research, and determine national
p.000002: ethical standards for the health sector.
p.000002:
p.000002: 1.4 Ethics Committee on Assisted Reproductive Technology (ECART)
p.000002: ECART is a ministerial committee established under section 27 of the Human Assisted Reproductive Technology (HART) Act
p.000002: 2004 that reviews, determines and monitors applications for assisted reproductive procedures and human reproductive
p.000002: research.
p.000002:
p.000002: ECART can only consider applications for procedures that the Advisory Committee on Assisted Reproductive Technology
p.000002: (ACART) has issued guidelines and advice for.
p.000002:
p.000002: 1.5 Health and Disability Ethics Committees (HDECs)
p.000002:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000006: obtained should be recorded. If the participants
p.000007: 7
p.000007:
p.000007: HRC Research Ethics Guidelines
p.000007:
p.000007:
p.000007: themselves cannot provide informed consent, justification must be provided for using these participants within the
p.000007: research. Ethics committees will be required to consider if the circumstances are appropriate for the waiving of
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
p.000007: Some of the basic criteria of informed consent to participate in a health research are:
p.000007:
p.000007: (a) the participants must be competent to understand the relevant issues prior to giving to their specific
p.000007: consent;
p.000007:
p.000007: (b) information about the proposed research must be comprehensively, properly and appropriately given,
p.000007: including any likely outcomes of participation in the research;
p.000007:
p.000007: (c) the participants' consent must be voluntary and not unduly influenced by financial reward (see 2.1.5
p.000007: Payments for Participation in Research), or by duress in any manner and the involvement of dependent or vulnerable
p.000007: groups must be appropriate with measures in place to ensure they are not exploited;
p.000007:
p.000007: (d) participants must be able to withdraw from the research at any time without the waiver of any rights and
p.000007: without giving reasons; and
p.000007:
p.000007: (e) in the case of those who are unable to give their own consent, for example the mentally incapacitated, the
p.000007: unconscious patient or children, proxy consent should be sought from a person with appropriate legal authority1.
p.000007:
p.000007: 2.1.2 Scientific design and conduct of the study
p.000007: Lack of scientific quality in any research project has ethical implications. Research with insufficient scientific
p.000007: merit will waste scarce resources, will abuse the trust and commitment of participants, and may needlessly expose them
p.000007: to risk for no appropriate benefit. Ethics committees should verify that the scientific quality of proposed research
p.000007: has been assured through an appropriate peer review process. For more guidance on features of robust peer review for
p.000007: assessing the scientific validity of research, see Appendix 1 in Ethical Guidelines for Observational Studies or
p.000007: Ethical Guidelines for Intervention Studies.
p.000007:
p.000007: 2.1.3 Risks and potential benefits
p.000007: The risks of the research should be reasonable in relation to the potential benefits. Risks can be physical,
p.000007: emotional, social, psychological, or financial. Ethics committees should make sure that the proposed research poses
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
...
General/Other / Manipulable
Searching for indicator manipulated:
(return to top)
p.000016:
p.000016: For more information on SCOTT, see Standing Committee on Therapeutic Trials | Health Research Council.
p.000016:
p.000016: 3.2 Clinical trials
p.000016: Randomised controlled therapeutic trials are powerful studies for determining the value of new treatments or
p.000016: reassessing established treatments. However the following conditions must be met:
p.000016:
p.000016: (a) When the administration of effective treatment is important for the well-being of the patient, a controlled
p.000016: trial can only be undertaken where there is genuine uncertainty about whether the trial treatment is more effective (or
p.000016: has less risk) than the standard treatment with which it is being compared (referred to as being in a state of
p.000016: ‘equipoise’).
p.000016:
p.000016: (b) In general, random allocation to treatments should be conducted after the patient has given consent to
p.000016: randomisation.
p.000016:
p.000016: (c) Arrangements for monitoring the results of the trial and for the occurrence of adverse effects should be
p.000016: made at the outset. Research protocols should include stopping rules. Premature termination of the trial should take
p.000016: place if one treatment has been demonstrated to be superior, or if serious adverse effects occur. Monitoring should
p.000016: generally be undertaken by an independent person or committee. The HRC Data Monitoring Core Committee (DMCC) would
p.000016: welcome the opportunity to be involved where necessary (see 3.2.1 Health Research Council Data Monitoring Core
p.000016: Committee).
p.000016:
p.000016: (d) Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically
p.000016: manipulated micro-organisms, or viruses or cells into human participants is undertaken by the GTAC (see 3.2.2 Genetic
p.000016: Technology Advisory Committee).
p.000016:
p.000016: Fully informed consent with comprehensive information being available to participants is essential (see 2.1.1 Informed
p.000016: Consent).
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: HRC Research Ethics Guidelines
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Clinical trials in New Zealand should observe the Good Clinical Research Practice Guideline (Part 11 of the Guideline
p.000017: on the Regulation of Therapeutic Products in New Zealand), the Note for Guidance on Good Clinical Practice
p.000017: (CPMP/ICH/135/95)2 and the Ethical Guidelines for Intervention Studies.
p.000017:
p.000017: Before recruitment into the clinical phase of the research, researchers must register their clinical trials in a
p.000017: publicly accessible register (i.e. Australian New Zealand Clinical Trials Registry (ANZCTR) or equivalent WHO standard
p.000017: register)3. This will promote access to information about all clinical trials in New Zealand.
p.000017:
p.000017: 3.2.1 Health Research Council Data Monitoring Core Committee (DMCC)
p.000017:
p.000017: The DMCC is established to provide objective, independent monitoring of clinical trials funded by the HRC. The DMCC has
p.000017: two main functions:
p.000017:
p.000017: (a) to review the monitoring plans for trials funded by the HRC and provide advice to the HRC on whether the
p.000017: plans meet best international practice;
p.000017:
p.000017: (b) to constitute a Trial-Specific Data Monitoring Committee for any trial funded by the HRC where this is
p.000017: appropriate and is requested by the investigators. Trial-Specific Data Monitoring Committees are formed from the DMCC
p.000017: membership, plus additional co- opted members who have expertise specific to the trial.
p.000017:
p.000017: For more information on monitoring of clinical trials, see Data Monitoring Core Committee | Health Research Council.
p.000017:
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC)
p.000017: Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated
p.000017: micro-organisms, or viruses or cells into human participants is undertaken by the GTAC.
p.000017:
p.000017: GTAC is to review for the purposes of seeking an exemption under Section 30 of the Medicines Act (1981) or as required
p.000017: by an approved ethics committee or the HRC of any of its committees.
p.000017:
p.000017: For more information on GTAC approval, see Specific Considerations | Health Research Council.
p.000017:
p.000017: 3.3 Observational studies
p.000017: An observational study is either observational research, or, an audit and related activity. To determine whether an
p.000017: activity is observational research, public health investigations, or any other form of audit or related activity, see
p.000017: section 2 Ethical Guidelines for Observational Studies.
p.000017:
p.000017:
p.000017:
p.000017: 2 The CPMP Guideline is an international ethical and scientific quality standard for designing, conducting, recording
p.000017: and reporting clinical trials that involve human participants. The CPMP Guideline aims to provide a unified standard
p.000017: for the European Union, Japan, and the United States, as well as Australia, Canada, the Nordic countries and the World
p.000017: Health Organisation (WHO).
p.000017:
p.000017: 3 “Every research study involving human subjects must be registered in a publicly accessible database before
p.000017: recruitment
p.000017: on the first subject” (Declaration of Helsinki).
p.000018: 18
p.000018:
p.000018: HRC Research Ethics Guidelines
p.000018:
p.000018:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000026: iii. The Ethics Committee on Assisted Reproductive Technology, see 1.4 ECART, and
p.000026: iv. The Health and Disability Ethics Committees, see 1.5 HDECs.
p.000026:
p.000026: (b) Ethics committees set up by organisations and which may also be approved by the HRC EC include
p.000026: Institutional Ethics Committees (IEC).
p.000026:
p.000026: See 1.7 Approved ethics committees for the list of HRC approved ethics committees.
p.000026:
p.000026: 1.1.3 Animal ethics
p.000026: The framework for animal ethics is set out in the Animal Welfare Act 1999.
p.000026:
p.000026: For more information on research involving animals or animal materials, see 3.16.
p.000026:
p.000026: 1.2 Health Research Council Ethics Committee (HRC EC)
p.000026:
p.000026: The HRC EC is an HRC statutory committee established under section 24 of the Health Research Council (HRC) Act 1990.
p.000026:
p.000026: The HRC EC requires that, prior to commencing research; all HRC funded research has received ethics approval. Avenues
p.000026: for ethical comment on HRC funded research have been established by the HRC EC through the delegated authority given to
p.000026: approved health and disability or institutional ethics committees.
p.000026:
p.000026: The HRC EC will also consider appeals against the decisions of Health and Disability Ethics Committees, a role required
p.000026: of it by the Minister of Health, under section 25(h)ii of the HRC Act 1990.
p.000026:
p.000026: For more information on appeal, see 2.7.3.
p.000026:
p.000026: HRC Research Ethics Guidelines
p.000026:
p.000026: 1.2.1 Functions
p.000026: The functions of the HRC EC are set out in section 25 of the HRC Act and include the following:
p.000026:
p.000026: (a) To consider and make recommendations to the Council on ethical issues in relation to health research,
p.000026: especially those emerging through the development of new areas of health research.
p.000026:
p.000026: (b) To provide and review ethical guidelines for the Council.
p.000026:
p.000026: (c) Subject to paragraph (d), to ensure that, in respect of each application submitted to the Council for a
p.000026: grant for the purposes of health research, an independent ethical assessment of the proposed health research is made
p.000026: either by the Ethics Committee itself or by a committee approved by the Ethics Committee.
p.000026:
p.000026: (d) Where an application for a grant for the purposes of health research is submitted to the Council in respect
p.000026: of health research that is of national importance or great complexity, to itself make an independent ethical assessment
...
p.000019: Council.
p.000019:
p.000019: 3.8 Research involving personal health information
p.000019:
p.000019: Research which involves the use of personal health information is required to comply with the Health Information
p.000019: Privacy Code 1994. For more information, see Specific Considerations | Health Research Council.
p.000019:
p.000019: 3.9 Research involving Māori
p.000019:
p.000019: Respect for the principles of partnership and sharing implicit in the Treaty of Waitangi will be observed by
p.000019: incorporating the following requirements into health research proposals. All issues relating to Māori cultural and
p.000019: ethical values should be discussed with the whanau, hapū or iwi concerned along with matters to do with the key
p.000019: questions and aims of the research. The ownership rights of participants to personal data must be respected.
p.000020: 20
p.000020:
p.000020: HRC Research Ethics Guidelines
p.000020:
p.000020:
p.000020:
p.000020: For research that involves or targets Māori research outcomes or methodologies; the Te Ara
p.000020: Tika: Guidelines for Māori Research Ethics: A framework for researchers and ethics committee
p.000020: members should be consulted along with the HRC Guidelines for Researchers on Health
p.000020: Research involving Māori.
p.000020:
p.000020: In the case of research initiated within a whanau, hapu or iwi where the investigators and research participants are
p.000020: members of that group, it may be appropriate for a kaumātua or other person of authority in the group to provide a
p.000020: statement that, in their opinion, the proposed
p.000020: research conforms to Māori cultural and ethical values. The HRC EC may review such research proposals and confirm that
p.000020: this mechanism will constitute adequate ethics approval.
p.000020:
p.000020: It may also be appropriate for the advice of the HRC Māori Health Committee and other appropriate expert groups to be
p.000020: sought by an ethics committee when reviewing a research proposal.
p.000020:
p.000020: In the event of issues which cannot be reconciled in discussions between the parties involved, the matter may be
p.000020: referred to the HRC EC and the HRC Māori Health Committee for joint comment.
p.000020:
p.000020: 3.10 International collaborations
p.000020: Any investigator participating in international collaborative research whose project is funded in full or in part by
p.000020: the HRC will require ethics approval from a New Zealand approved ethics committee for the research. Research conducted
p.000020: overseas having human or animal involvement will also require appropriate ethics approval from an ethics committee (or
p.000020: equivalent body) in the country concerned, where such a body exists.
p.000020:
p.000020: Any international collaborative research project, whether or not funded by the HRC, which involves investigations in
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000007: minimal potential harms and negative impacts to participants.
p.000007: Ethics committees should also be aware that harm may occur at an individual, family or population level.
p.000007:
p.000007: 2.1.4 Selection of study population and recruitment of research participants
p.000007: No group or class of persons should bear more than its fair share of the burdens of participation in research, nor
p.000007: should any group or class be deprived of its fair share of the benefits of research. Ethics committees should consider
p.000007: whether the study population will directly benefit
p.000007:
p.000007:
p.000007: 1 In the case of research participants who are children the signature of the parent or guardian should be obtained in
p.000007: addition to the child’s assent (see section 3.7 Research involving children).
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: HRC Research Ethics Guidelines
p.000008:
p.000008:
p.000008: from participating in the research or indirectly benefit from the new knowledge derived from the research.
p.000008:
p.000008: Recruitment of research participants should be free from manipulation, coercion, deception, inducement or any other
p.000008: undue influence. Participants should be told the purpose of the research, the risks and benefits in participation and
p.000008: other relevant details that form the basis of informed consent.
p.000008:
p.000008: 2.1.5 Payments for participation in research
p.000008: Any payment, koha or gift of money, goods or services to a research participant or to a body or organisation assisting
p.000008: in the recruitment of participants, which constitutes an undue inducement to participate in the research, is
p.000008: unacceptable.
p.000008:
p.000008: Reimbursement for participants’ out-of-pocket expenses (e.g. taxi fares, meals, parking fees) or in compensation for
p.000008: inconvenience caused through their participation in the research may be made. Payments for inconvenience would
p.000008: typically be a nominal amount in recognition of the effort of the participant to attend the research project.
p.000008:
p.000008: 2.1.6 Protection of research participants’ privacy and confidentiality
p.000008: The privacy and confidentiality of research participants must be respected. In particular, ethics committees have to
p.000008: be familiar with the Privacy Act 1993 and the Health Information Privacy Code 1994 when examining precautions taken to
p.000008: safeguard the privacy and confidentiality of research participants.
p.000008:
p.000008: 2.1.7 Cultural responsiveness
p.000008: All health research is located within cultural settings that have evolved in the social and historical context within
p.000008: which the research is undertaken. It is important that research teams/units/institutions/communities reflect on the
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000006: balance potential risk of harm to individuals with the possible benefits to society at large. On occasions when there
p.000006: are major issues, there should be broader discussion with the community.
p.000006:
p.000006: When investigators are considering enrolment of persons in research studies, clinical trials or social surveys, the
p.000006: investigators should take into account any other research protocols involving the same individual which may already be
p.000006: in progress.
p.000006:
p.000006: The HRC EC requires investigators to review the ethics of their research at least annually or, where appropriate, more
p.000006: frequently. As part of such a review, the investigator should consider the outcome or development of similar research
p.000006: conducted elsewhere whether in NZ or overseas. If significant variations to the research proposal are to be made, or
p.000006: the interim results of the research indicate that it may not be ethical to continue, the principal investigator should
p.000006: approach the ethics committee which approved the research proposal for its comment and further discussion before
p.000006: undertaking any continuation of the research.
p.000006:
p.000006: 2.1 Principles for research involving human participants
p.000006: A number of principles should guide research that involves human participants. For a general statement of the
p.000006: principles, applicants should consult the Declaration of Helsinki. These principles include, but are not limited to,
p.000006: the following, which will be used by ethics committees to assess research proposals:
p.000006:
p.000006: 2.1.1 Informed consent
p.000006: The ethical foundation of informed consent is respect for persons. Researchers thus should make themselves familiar
p.000006: with the provisions of the Code of Health and Disability Consumers’ Rights.
p.000006:
p.000006: Informed consent is required from participants involved in human research especially if the research constitutes a
p.000006: health care procedure. If informed consent cannot be obtained in writing, the circumstances under which consent was
p.000006: obtained should be recorded. If the participants
p.000007: 7
p.000007:
p.000007: HRC Research Ethics Guidelines
p.000007:
p.000007:
p.000007: themselves cannot provide informed consent, justification must be provided for using these participants within the
p.000007: research. Ethics committees will be required to consider if the circumstances are appropriate for the waiving of
p.000007: informed consent. In cases where deception is used in research, justification must be provided as well as a method of
p.000007: debriefing participants.
p.000007:
...
p.000017:
p.000017: 3.2.2 Genetic Technology Advisory Committee (GTAC)
p.000017: Scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated
p.000017: micro-organisms, or viruses or cells into human participants is undertaken by the GTAC.
p.000017:
p.000017: GTAC is to review for the purposes of seeking an exemption under Section 30 of the Medicines Act (1981) or as required
p.000017: by an approved ethics committee or the HRC of any of its committees.
p.000017:
p.000017: For more information on GTAC approval, see Specific Considerations | Health Research Council.
p.000017:
p.000017: 3.3 Observational studies
p.000017: An observational study is either observational research, or, an audit and related activity. To determine whether an
p.000017: activity is observational research, public health investigations, or any other form of audit or related activity, see
p.000017: section 2 Ethical Guidelines for Observational Studies.
p.000017:
p.000017:
p.000017:
p.000017: 2 The CPMP Guideline is an international ethical and scientific quality standard for designing, conducting, recording
p.000017: and reporting clinical trials that involve human participants. The CPMP Guideline aims to provide a unified standard
p.000017: for the European Union, Japan, and the United States, as well as Australia, Canada, the Nordic countries and the World
p.000017: Health Organisation (WHO).
p.000017:
p.000017: 3 “Every research study involving human subjects must be registered in a publicly accessible database before
p.000017: recruitment
p.000017: on the first subject” (Declaration of Helsinki).
p.000018: 18
p.000018:
p.000018: HRC Research Ethics Guidelines
p.000018:
p.000018:
p.000018: More than minimal risk observational research requires ethics committee review (see the SOPs Chapter 3 - When does a
p.000018: study require HDEC review?).
p.000018:
p.000018: For further information on which observational studies require review by an ethics committee, see section 3 Ethical
p.000018: Guidelines for Observational Studies.
p.000018:
p.000018: 3.4 Social, community-based, public health or health services interventions
p.000018: When the focus of a study is a whole community (for example, to test the use of an additive in a community's water
p.000018: supply, or a new form of health care delivery); the individual will not usually have the ability to “opt-out”.
p.000018: However, individuals may refuse to submit to questionnaires or blood tests, or other instruments designed to obtain
p.000018: data to evaluate the intervention.
p.000018:
p.000018: All reasonable means should be used by the investigators to inform the population under study of the aims and intent of
p.000018: the proposed research and all possible advantages or disadvantages which may arise from it. It is normal for the
p.000018: investigators to secure the agreement and co- operation of the national or local body responsible for public health in
p.000018: the population to be studied. Where collective decision making is customary it is also advisable to seek the agreement
p.000018: of the community, usually through its chosen representatives. For consent to participate in the research obtained in
...
p.000022: genetics.
p.000022:
p.000022: (b) That the purity of the DNA or RNA to be inserted and the methods of handling it during its preparation are
p.000022: in accord with current regulations and official guidelines, particularly if viral vectors are used.
p.000022:
p.000022: (c) That the technique of insertion has been shown by experiments in animals or cell cultures to:
p.000022:
p.000022: i. confirm the inserted DNA or RNA to the targeted somatic cells; and
p.000022: ii. achieve the intended function in a high proportion of attempts, and
p.000022: iii. rarely cause undesirable side effects.
p.000022:
p.000022: (d) That the probability of entry of the DNA into germ cells has been evaluated.
p.000022:
p.000022: In developing each protocol for somatic cell gene therapy or other uses of human genetic material there must be
p.000022: appropriate consultation with any relevant ethnic group affected by the application, paying particular attention to
p.000022: issues of cultural sensitivity. Specific advice on these aspects should be obtained from the HRC Māori Health
p.000022: Committee.
p.000022:
p.000022: For any application for research on gene therapy, or introduction of fragments of DNA or RNA for research reasons, the
p.000022: researcher must consult the official national body concerned with monitoring the safety of innovative human genetic
p.000022: manipulation techniques. The relevant New Zealand body is the HRC Genetic Technology Advisory Committee.
p.000022:
p.000022: 3.15 Research involving use of placebos
p.000022: Applicants should consult the Declaration of Helsinki on research involving use of placebos. Ethics committees should
p.000022: decide on the circumstances of each case, having regard to all relevant ethical considerations, as to whether approval
p.000022: is to be given for a placebo arm in a randomized control trial.
p.000022:
p.000022: The World Medical Association affirmed that “the benefits, risks, burdens and effectiveness of a new intervention must
p.000022: be tested against those of the best current proven intervention(s)”, except in the following circumstances:
p.000022:
p.000022: (a) Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.000022:
p.000022: (b) Where for compelling and scientifically sound methodological reasons the use of any intervention less
p.000022: effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or
p.000022: safety of an intervention, and
p.000022:
p.000022: (c) the patients who receive any intervention less effective than the best proven one, placebo, or no
p.000022: intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the
p.000022: best proven intervention.
p.000022:
p.000022: (d) Extreme care be taken to avoid abuse of this option.
p.000022:
p.000022: See also: Ethical guidelines for intervention studies sections 5.22 – 5.25 Use of a placebo.
p.000022:
p.000022:
p.000022:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000022: (c) That the technique of insertion has been shown by experiments in animals or cell cultures to:
p.000022:
p.000022: i. confirm the inserted DNA or RNA to the targeted somatic cells; and
p.000022: ii. achieve the intended function in a high proportion of attempts, and
p.000022: iii. rarely cause undesirable side effects.
p.000022:
p.000022: (d) That the probability of entry of the DNA into germ cells has been evaluated.
p.000022:
p.000022: In developing each protocol for somatic cell gene therapy or other uses of human genetic material there must be
p.000022: appropriate consultation with any relevant ethnic group affected by the application, paying particular attention to
p.000022: issues of cultural sensitivity. Specific advice on these aspects should be obtained from the HRC Māori Health
p.000022: Committee.
p.000022:
p.000022: For any application for research on gene therapy, or introduction of fragments of DNA or RNA for research reasons, the
p.000022: researcher must consult the official national body concerned with monitoring the safety of innovative human genetic
p.000022: manipulation techniques. The relevant New Zealand body is the HRC Genetic Technology Advisory Committee.
p.000022:
p.000022: 3.15 Research involving use of placebos
p.000022: Applicants should consult the Declaration of Helsinki on research involving use of placebos. Ethics committees should
p.000022: decide on the circumstances of each case, having regard to all relevant ethical considerations, as to whether approval
p.000022: is to be given for a placebo arm in a randomized control trial.
p.000022:
p.000022: The World Medical Association affirmed that “the benefits, risks, burdens and effectiveness of a new intervention must
p.000022: be tested against those of the best current proven intervention(s)”, except in the following circumstances:
p.000022:
p.000022: (a) Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
p.000022:
p.000022: (b) Where for compelling and scientifically sound methodological reasons the use of any intervention less
p.000022: effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or
p.000022: safety of an intervention, and
p.000022:
p.000022: (c) the patients who receive any intervention less effective than the best proven one, placebo, or no
p.000022: intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the
p.000022: best proven intervention.
p.000022:
p.000022: (d) Extreme care be taken to avoid abuse of this option.
p.000022:
p.000022: See also: Ethical guidelines for intervention studies sections 5.22 – 5.25 Use of a placebo.
p.000022:
p.000022:
p.000022:
p.000023: 23
p.000023:
p.000023: HRC Research Ethics Guidelines
p.000023:
p.000023: 3.16 Research involving animals or animal materials
p.000023: The HRC requires all research involving animals or animal materials to be submitted for approval by the animal ethics
p.000023: committee of the institution/organisation with which the investigator is associated. Evidence of approval from an
p.000023: animal ethics committee must be documented before funding commences.
p.000023:
p.000023: If the institution/organisation has no animal ethics committee, guidance on how to set up one for accreditation can be
p.000023: obtained from the National Animal Ethics Advisory Committee (NAEAC). Alternatively, it is possible to obtain approval
p.000023: to conduct the study under the approval and supervision of an animal ethics committee in the vicinity of the
p.000023: institution/organisation. Guidance can be obtained from the Secretary of NAEAC.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
...
Orphaned Trigger Words
p.000002:
p.000002: The approval of ethics committees by the HRC EC is a formal process. The HRC EC requires every approved ethics
p.000002: committee to provide an Annual report plus any other relevant
p.000002:
p.000003: 3
p.000003:
p.000003: HRC Research Ethics Guidelines
p.000003:
p.000003:
p.000003: information required as stated in the HRC Guidelines for Approval of Ethics Committees. Annual reports are due within
p.000003: three months of the reporting year end.
p.000003:
p.000003: In re-approval year (a maximum of three calendar years from approval) a Report for seeking re- approval which addresses
p.000003: the performance and functioning of the committee over the last approval period must be submitted.
p.000003:
p.000003: 1.7 Approved ethics committees
p.000003: 1.7.1 Institutional ethics committees
p.000003: Auckland Health Research Ethics Committee https://www.auckland.ac.nz/en/about/resear
p.000003: ch/re-ethics/auckland-health-research- committee.html
p.000003:
p.000003: Auckland University of Technology Ethics Committee
p.000003: http://www.aut.ac.nz/research/research- ethics
p.000003:
p.000003: Lincoln University Human Ethics Committee http://www.lincoln.ac.nz/Research-at-
p.000003: Lincoln/Ethics/Human-ethics/
p.000003:
p.000003:
p.000003: Massey University Human Ethics Committee: Northern
p.000003:
p.000003: Massey University Human Ethics Committee: Southern A
p.000003: http://www.massey.ac.nz/massey/research/r esearch-ethics/human-ethics/
p.000003:
p.000003: Massey University Human Ethics Committee:
p.000003: Southern B
p.000003:
p.000003: UNITEC Research Ethics Committee http://www.unitec.ac.nz/?DE4A5BB7-704A-
p.000003: 4C5C-93B4-FE562A75B496
p.000003:
p.000003:
p.000003: University of Auckland Human Participants Ethics Committee
p.000003: http://www.auckland.ac.nz/uoa/re-uahpec
p.000003:
p.000003: University of Otago Human Ethics Committee http://www.otago.ac.nz/council/committees/
p.000003: committees/HumanEthicsCommittees.html
p.000003:
p.000003:
p.000003: University of Otago Human Ethics Committee (Health)
p.000003:
p.000003: University of Waikato Human Research Ethics Committee (Health)
p.000003:
p.000003:
p.000003:
p.000003: http://www.waikato.ac.nz/research- enterprise/ethics/human-ethics-research- committee
p.000003:
p.000003: WINTEC Human Ethics in Research Committee http://www.wintec.ac.nz/
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: HRC Research Ethics Guidelines
p.000004:
...
p.000009: able to review a research proposal as a whole.
p.000009:
p.000009: (e) It is recognised that there may be limited circumstances where an IEC and an HDEC may each separately wish
p.000009: to review a particular research study. The policies and procedures of the committees should clearly specify those
p.000009: circumstances, and should identify which committee is to give the final approval in the circumstances.
p.000009:
p.000009: (f) The collection of human tissues to form part of an institutional anatomical collection should be dealt
p.000009: with in accordance with the Human Tissue Act 2008 (see 3.6 Collection and use of human materials and the SOPs Chapter
p.000009: 13).
p.000009:
p.000009: (g) It is recognised that cases may arise where exceptions to these guidelines may have to be considered and so
p.000009: the HRC EC should be informed accordingly in order that they can be discussed when future reviews and revisions of the
p.000009: guidelines are undertaken.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: HRC Research Ethics Guidelines
p.000010:
p.000010:
p.000010:
p.000010:
p.000010: 2.4 Special case HRC contracts
p.000010: 2.4.1 Preliminary work under an HRC contract
p.000010: The HRC may permit a contract for the purpose of a pilot study or research development to commence prior to receipt of
p.000010: ethics approval if it is clear that the funding is to enable development of the research proposal to a state where it
p.000010: will be submitted for ethics approval, or for the training of personnel undertaking the study. Research may not
p.000010: commence until evidence of ethics approval is received by the HRC.
p.000010:
p.000010: 2.4.2 Research contracts
p.000010: The HRC recognises that in the case of lengthy research studies, such as programme contracts, it may not be possible or
p.000010: feasible for the investigator to fully anticipate the ultimate direction the research will take when applying for the
p.000010: contract. In such situations the committee may allow the research to commence when ethics approval for the first stage
p.000010: of the research has been obtained. Ethics approval for ongoing research resulting from this earlier portion of the
p.000010: study must be subsequently obtained following appropriate review of the latest iteration of the research proposed.
p.000010:
p.000010: 2.4.3 Career development contracts (CDAs)
p.000010: The HRC accepts that, in the case of some CDAs, a significant portion of training may be undertaken by the fellow or
p.000010: scholar before commencement of the research itself. A part of this training in research may comprise a detailed
p.000010: development of the research proposal, and the submission of that proposal for ethics approval. In such situations,
p.000010: funding for the training portion of a HRC Fellowship or Scholarship may commence before ethics approval for the
p.000010: research proposal is received. However, the research may not commence until evidence of ethics approval for the
p.000010: research has been received by the HRC.
p.000010:
p.000010: Fellows or scholars undertaking HRC-funded research overseas are required to provide evidence of appropriate ethics
p.000010: approval (see 3.10 International Collaborations).
p.000010:
p.000010: 2.5 How to obtain ethics approval
p.000010: The HRC EC considers that ethics approval is best sought before submitting an application to the HRC, but accepts that
p.000010: this may not always be possible. Every application for HRC funding must contain a fully signed ethical agreement page,
p.000010: which attests that appropriate ethics approval for the research has been or will be obtained.
...
p.000010: ethics committee. For example, where part of a research proposal falls under the scope of HDEC review (see the SOPs
p.000010: Chapter 3 - When does a study require HDEC review?); the whole of the proposal must be submitted for ethical review to
p.000010: an HDEC.
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: HRC Research Ethics Guidelines
p.000011:
p.000011:
p.000011: An extension to an existing ethics approval may be sought if proper justification is provided. However, fresh ethics
p.000011: approval must be sought where there has been a significant change to a project. For example, the addition of the
p.000011: collection of blood to a protocol.
p.000011:
p.000011: The HRC reserves the right to request to review all relevant documents relating to the ethics review of an HRC-funded
p.000011: proposal, including the ethics application, and be satisfied that the research is ethically acceptable in accordance
p.000011: with s31 of the HRC Act 1990.
p.000011:
p.000011: 2.5.1 Application to an approved ethics committee
p.000011: The first step in obtaining ethics approval for an application for HRC research funding is to submit an application for
p.000011: ethical review to an approved ethics committee.
p.000011:
p.000011: A research proposal which involves both human and animal subjects will require separate approvals from both human and
p.000011: animal ethics committees.
p.000011:
p.000011: 2.5.2 Locality authorisation
p.000011: For information on locality authorisation, see the SOPs Chapter 10.
p.000011:
p.000011: 2.5.3 Ethics committee decision
p.000011: Following review by an ethics committee, the investigator submitting the research proposal for approval will be
p.000011: informed of the outcome of the committees' deliberations. The HRC suggests that the reviewing ethics committee/s
p.000011: respond with one of the following decisions:
p.000011:
p.000011: (a) Approved, either with or without comments or questions addressed to the applicant;
p.000011: any replies to a committee’s comments or questions to be forwarded in due course;
p.000011:
p.000011: (b) Approved subject to conditions, subject to recommended revisions of the proposal and/or provide
p.000011: satisfactory answers to questions asked of the applicant. The applicant’s reply and/or revised proposal must be
p.000011: forwarded via the committee administrator to the chairperson and/or delegated committee members to consider the
p.000011: revisions that have been made and to provide final approval;
p.000011:
p.000011: (c) Approval deferred, pending substantial revisions of the proposal/study and/or
p.000011: satisfactory answers to questions asked of the applicant. The applicant’s reply and/or revised proposal must be
p.000011: forwarded to the committee for reconsideration and final approval; and
p.000011:
p.000011: (d) Approval declined. Reasons for declining approval to be forwarded to the applicant, either with or without
p.000011: an invitation to submit a substantially revised protocol for reconsideration. As well as giving reasons for declining
p.000011: the application, the ethics committee should provide suggestions for a restructuring of the research project along
p.000011: ethically acceptable lines.
p.000011:
p.000011: Every decision, comment, or direction of an ethics committee should be made in writing to the principal investigator.
p.000011:
p.000011: When ethics approval for the research is received by the applicant, the host institution(s) must be given a copy.
...
p.000018:
p.000018:
p.000018: More than minimal risk observational research requires ethics committee review (see the SOPs Chapter 3 - When does a
p.000018: study require HDEC review?).
p.000018:
p.000018: For further information on which observational studies require review by an ethics committee, see section 3 Ethical
p.000018: Guidelines for Observational Studies.
p.000018:
p.000018: 3.4 Social, community-based, public health or health services interventions
p.000018: When the focus of a study is a whole community (for example, to test the use of an additive in a community's water
p.000018: supply, or a new form of health care delivery); the individual will not usually have the ability to “opt-out”.
p.000018: However, individuals may refuse to submit to questionnaires or blood tests, or other instruments designed to obtain
p.000018: data to evaluate the intervention.
p.000018:
p.000018: All reasonable means should be used by the investigators to inform the population under study of the aims and intent of
p.000018: the proposed research and all possible advantages or disadvantages which may arise from it. It is normal for the
p.000018: investigators to secure the agreement and co- operation of the national or local body responsible for public health in
p.000018: the population to be studied. Where collective decision making is customary it is also advisable to seek the agreement
p.000018: of the community, usually through its chosen representatives. For consent to participate in the research obtained in
p.000018: hui, consult the HRC Guidelines for Researchers on
p.000018: Health Research involving Māori and Te Ara Tika: Guidelines for Māori Research Ethics: A framework for researchers and
p.000018: ethics committee members.
p.000018:
p.000018: Although some community based interventions (e.g. an anti-smoking campaign) that do not involve personal contact
p.000018: between the researcher and the study population may not require ethics approval, the evaluation of such interventions
p.000018: which did involve personal contact with individuals or collection of data from them, will require ethics approval. The
p.000018: community to which the intervention and evaluation is targeted should be informed of the study findings once the study
p.000018: has been completed.
p.000018:
p.000018: 3.5 Surveys of the general population
p.000018: Some types of research require surveys to be undertaken on "total" populations or on samples of the population selected
p.000018: from public records such as the electoral roll. It is considered that direct approaches (for example, by telephone,
p.000018: postal questionnaire or visit interview) to persons in the general population selected in this way do not require
p.000018: approval by any local health or medical body or individual practitioner.
p.000018:
p.000018: However, it may be appropriate to inform local health practitioners about the study. Investigators should consult with
p.000018: and, where appropriate, obtain ethics approval from an approved ethics committee for the research to proceed. The
p.000018: right of any person to decline to take part in such a survey, or to withdraw from the survey at any time, must always
p.000018: be respected.
p.000018:
...
p.000020: research conforms to Māori cultural and ethical values. The HRC EC may review such research proposals and confirm that
p.000020: this mechanism will constitute adequate ethics approval.
p.000020:
p.000020: It may also be appropriate for the advice of the HRC Māori Health Committee and other appropriate expert groups to be
p.000020: sought by an ethics committee when reviewing a research proposal.
p.000020:
p.000020: In the event of issues which cannot be reconciled in discussions between the parties involved, the matter may be
p.000020: referred to the HRC EC and the HRC Māori Health Committee for joint comment.
p.000020:
p.000020: 3.10 International collaborations
p.000020: Any investigator participating in international collaborative research whose project is funded in full or in part by
p.000020: the HRC will require ethics approval from a New Zealand approved ethics committee for the research. Research conducted
p.000020: overseas having human or animal involvement will also require appropriate ethics approval from an ethics committee (or
p.000020: equivalent body) in the country concerned, where such a body exists.
p.000020:
p.000020: Any international collaborative research project, whether or not funded by the HRC, which involves investigations in
p.000020: New Zealand or its territories, should be subject to ethical review by an approved ethics committee within New Zealand.
p.000020:
p.000020: For guidance on ethical research in developing countries, investigators should consult necessary documents in the
p.000020: relevant jurisdictions.
p.000020:
p.000020: 3.11 Research undertaken at an overseas location
p.000020: Investigators who undertake all or part of an HRC-funded fellowship, scholarship or contract overseas are required to
p.000020: provide evidence of appropriate ethics approval for their research.
p.000020:
p.000020: 3.12 Genetic modification
p.000020: Genetic modification has been used freely in New Zealand for more than a decade as a research tool for medical purposes
p.000020: and in food ingredients.
p.000020:
p.000020: In 2000, the Government appointed the Royal Commission on Genetic Modification to inquire into the following matters:
p.000020:
p.000020: (a) the strategic options available to enable New Zealand to address, now and in the future, genetic
p.000020: modification, genetically modified organisms, and products; and
p.000020:
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: HRC Research Ethics Guidelines
p.000021:
p.000021:
p.000021: (b) any changes considered desirable to the current legislative, regulatory, policy, or institutional
p.000021: arrangements for addressing, in New Zealand, genetic modification, genetically modified organisms, and products.
p.000021:
p.000021: The report and recommendations of Royal Commission in 2002 can be downloaded from http://www.mfe.govt.nz.
p.000021:
p.000021: 3.13 In vivo human gene manipulation proposals
p.000021: All attempts to introduce deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) into humans must be reviewed by an
p.000021: approved ethics committee.
p.000021:
p.000021: Somatic cell gene therapy involves the introduction of fragments of DNA or RNA into human somatic (non-reproductive)
p.000021: cells. The aim usually is to improve the health of people with certain grave inherited diseases, or with certain forms
p.000021: of cancer, or some virus infections. DNA or RNA may also be introduced into somatic cells to mark their distribution
p.000021: and fate in particular forms of research on serious diseases.
p.000021:
p.000021: There may also be other well justified non-therapeutic reasons for introducing DNA or RNA. The development of methods
p.000021: of introducing DNA or RNA into somatic cells is acceptable. The introduction of DNA or RNA into germ (reproductive)
p.000021: cells or fertilised ova is not acceptable at present, because there is insufficient knowledge about the possible
p.000021: consequences, hazards and effects on future generations.
p.000021:
p.000021: The following particular matters need to be taken into account when protocols for somatic cell gene therapy or research
p.000021: are being considered by an ethics committee.
p.000021:
...
p.000024: their UP rights in Materials Use Agreements or collaborative research agreements.
p.000024:
p.000024: The HRC has IP agreements with the majority of host institutions which it funds.
p.000024:
p.000024: These agreements assign the HRC’s share of any financial benefits from IP developed by an HRC- funded researcher to the
p.000024: institution to support the researcher’s group or other public good health research.
p.000024:
p.000024: 4.2 Copyright
p.000024: Copyright is automatic under New Zealand law without application to any particular body for the legal right to
p.000024: copyright original material. Copyright exists from the time of production of the original copyrighted material.
p.000024: Materials covered by copyright include but are not limited to: written, typed or printed information on any medium,
p.000024: artworks, computer source code and object code, data or results of investigations.
p.000024:
p.000024: The HRC EC expects that copyright will be respected by investigators and other persons and that New Zealand and
p.000024: international laws relating to copyright will be adhered to in all cases.
p.000024:
p.000024: 4.3 Conflict of interest
p.000024: To achieve impartiality, any member of an ethics committee who has a proposal before the committee or who has a
p.000024: conflict of interest whereby the impartiality of that member could be questioned, will declare and withdraw at the
p.000024: determination of the committee.
p.000024:
p.000024: Where an issue arises in relation to a research proposal such that an investigator may have a conflict of interest
p.000024: (whether perceived, potential, or actual), the issue must be referred to an ethics committee for appropriate comment.
p.000024: The primary ethical concern is that any conflict of interest, particularly a financial conflict of interest, may
p.000024: compromise the well-being of research participants. An investigator should disclose any relevant matters that could
p.000024: give rise to a conflict of interest and, where appropriate in the circumstances, the conflict of interest must be
p.000024: avoided or managed. The disclosure and, where appropriate, management of any conflict of interest should be stated in
p.000024: information sheets provided to participants. A review and audit of compliance with policies and processes relating to
p.000024: conflict of interest should be undertaken to identify areas that could be improved.
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: HRC Research Ethics Guidelines
p.000025:
p.000025: 4.4 Scientific misconduct
p.000025: Individual host institutions should ensure that there are appropriate guidelines for the conduct of research and
p.000025: procedures for dealing with allegations of misconduct in research.
p.000025:
p.000025: 4.5 Compensation for injuries suffered by participants in research
p.000025: The Accident Compensation Act 2001provides cover for treatment injuries caused as part of a clinical trial where an
p.000025: approved ethics committee has approved the trial and is satisfied that the trial was not to be conducted principally
p.000025: for the benefit of the manufacturer or distributor of the medicine or item being trialed.
p.000025:
p.000025: Treatment injuries are adverse medical events that must be causally linked to the treatment (but do not require a
p.000025: finding of fault) and are not a necessary part or ordinary consequence of the treatment.
p.000025:
...
p.000025: right to sue for common law damages.
p.000025:
...
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| access to information | Access to information |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| dependent | Dependent |
| disability | Mentally Disabled |
| ethnic | Ethnicity |
| faith | Religion |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| helsinki | declaration of helsinki |
| home | Property Ownership |
| incapacitated | Incapacitated |
| indigenous | Indigenous |
| influence | Drug Usage |
| injured | injured |
| manipulated | Manipulable |
| mentally | Mentally Disabled |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| police | Police Officer |
| property | Property Ownership |
| restricted | Incarcerated |
| single | Marital Status |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| union | Trade Union Membership |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['mentally'] |
| home | ['property'] |
| mentally | ['disability'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
| property | ['home'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input