National Statement on Ethical
Conduct in Research Involving Humans
Part 2 - Human Research Ethics Committees
Composition
Appointment of members
Procedures
Advocates and interpreters
Expedited review for minimal risk research
Recording of decisions
Monitoring
Complaints
Suspension or discontinuation of research
Compliance reports to the National Health and Medical Research
Council
Research proposals involving human participants must be reviewed and approved by a Human Research Ethics Committee (HREC) which is established by and advises an institution or organisation regarding ethical approval for research projects. Requirements are set out for:
- institutions or organisations in establishing HRECs;
- researchers in submitting research proposals to HRECs; and
- HRECs in considering and reaching decisions regarding those proposals and in monitoring the conduct of approved research.
2.1 Institutions and organisations in which research involving humans is undertaken must individually or jointly establish, adequately resource, and maintain an HREC composed and functioning in accordance with this Statement.
2.2 The institution or organisation must, when establishing an HREC, set out its terms of reference including the scope of its responsibilities, relationship to non-affiliated researchers, accountability, mechanisms of reporting, and remuneration, if any, for members.
2.3 The institution or organisation (individually or jointly) must accept legal responsibility for decisions and advice received from the HREC and indemnify its members.
2.4 Researchers without affiliation to an institution or organisation with an HREC must ensure that the project is approved by an established HREC. There should be an agreement between the institution or organisation and researchers that defines the approval, conduct and monitoring of research, and who carries legal responsibility for it.
2.5 The primary role of an HREC is to protect the welfare and the rights of participants in research and the primary responsibility of each member is to decide, independently, whether, in his or her opinion, the conduct of each research proposal submitted to the HREC will so protect participants.
2.6 The minimum membership of an HREC is seven members, being men and women, comprising:
(a) a chairperson;
(b) at least two members who are lay people, one man and one woman, who have no affiliation with the institution or organisation, are not currently involved in medical, scientific, or legal work, and who are preferably from the community in which the institution or organisation is located;
(c) at least one member with knowledge of, and current experience in, the areas of research that are regularly considered by the HREC (eg. health, medical, social, psychological, epidemiological, as appropriate);
(d) at least one member with knowledge of, and current experience in, the professional care, counselling or treatment of people (eg. medical practitioner, clinical psychologist, social worker, nurse, as appropriate);
(e) at least one member who is a minister of religion, or a person who performs a similar role in a community such as an Aboriginal elder; and
(f) at least one member who is a lawyer.
2.7 The institution or organisation must ensure that the membership will equip the HREC to address all relevant considerations arising from the categories of research likely to be submitted to the HREC. For example, an experienced medical practitioner should be included if the HREC considers research protocols which involve any physically invasive procedures or medical interventions, (eg. surgical, pharmacological, physiological, technological, or nutritional intervention).
2.8 An HREC must ensure that it is sufficiently informed on all aspects of a research protocol, including its scientific and statistical validity, that are relevant to deciding whether the protocol is both acceptable on ethical grounds and conforms with this Statement. This may necessitate appointment of additional members with specific expertise.
2.9 If an institution or organisation appoints additional members it should ensure that the membership continues to reflect both the diversity of the categories of members listed in paragraph 2.6, including gender, and the relative proportion of institutional to non-institutional members.
2.10 The institution or organisation may recruit members for an HREC in such a manner and shall appoint them for such a period and on such terms and conditions as it determines.
2.11 Members are to be appointed for their expertise and not in a representative capacity.
2.12 Members must receive a formal notice of appointment and
assurances
that the institution or organisation will provide legal protection in respect
of liabilities that may arise in the course of bona fide conduct of their
duties as committee members.
2.13 Institutions and organisations and their HRECs must establish working procedures concerning:
- frequency of meetings;
- preparation of agendas and minutes;
- distribution of papers prior to meetings;
- presentation of research protocols;
- timely consideration and review of research protocols;
- methods of decision making;
- prompt notification of decisions;
- reporting of adverse occurrences;
- appropriate monitoring;
- receiving complaints;
- advising institution(s) or organisation(s) to discontinue a research project;
- fees, if any, to be charged; and
- confidentiality of the content of protocols and of committee proceedings.
2.14 An HREC may approve, require amendment of, or reject a research proposal on ethical grounds. The HREC must record decisions in writing and should include reasons for rejection.
2.15 Meetings of an HREC must be so arranged as to allow, wherever possible, all members to be fully informed by receipt of all relevant papers and the opportunity to attend.
2.16 Where there is less than full attendance at a meeting, the Chairperson must be satisfied, before a decision is reached, that the minimum membership listed in paragraph 2.6 have received all papers and have had an opportunity to contribute their views and that these have been recorded and considered.
2.17 An HREC should endeavour to reach decisions by general agreement. This need not involve unanimity, but failure to agree may require an extension of time to reconsider the research protocol and its possible amendment, especially when any member is not satisfied that the welfare and rights of participants are protected.
2.18 An HREC may invite the researcher(s) to be present for discussions of the research and may request amendments to the research protocol.
2.19 An HREC may seek advice and assistance from experts to assist with consideration of a research protocol, but must be satisfied that such experts have no conflicts of interest in relation to the research project under consideration arising from any personal involvement or participation in the research, any financial interest in the outcome or any involvement in competing research.
2.20 An HREC shall ensure that no member of the committee adjudicates on research in which that member has any conflict of interest including any personal involvement or participation in the research, any financial interest in the outcome or any involvement in competing research.
2.21 A researcher must disclose to the HREC the amount and sources or potential sources of funding for the research and must declare any affiliation or financial interest when proposing and when reporting the research. The HREC must consider the extent to which it should disclose that information about funding sources.
2.22 A researcher must include, in the research proposal, a statement of the ethical considerations involved in the proposed research and an HREC must be satisfied that the research protocol gives adequate consideration to participants' welfare, rights, beliefs, perceptions, customs and cultural heritage both individual and collective.
2.23 An HREC should not communicate directly with a research sponsor on matters relating to the protocol or ethics of a project, but the institution or organisation and the sponsor may have direct communication on matters relating to administration, indemnity and insurance.
2.24 All documents and other material used to inform potential research participants should be approved by the HREC including plain language information sheets, consent forms, questionnaires, advertisements and letters of invitation.
Advocates
2.25 An HREC must consider whether an advocate for any participant or group of participants should be invited to the HREC meeting to ensure informed decision making and understanding by these participants.
Interpreters
2.26 Where research involves the participation of persons unfamiliar with the English language (or the language in which the research is to be conducted), an HREC must ensure that:
(a) the participant information statement has been translated into the participant's language; and
(b) an interpreter is present during discussions with the participants about the project. Normally the interpreter should be independent, but when the research proposed is of minimal risk, an English-speaking relative or friend may be acceptable.
Expedited Review for Minimal Risk Research
2.27 An HREC may establish procedures for expedited review of research involving minimal risks to participants and in so doing may depart from the requirements of paragraphs 2.15, 2.16 and 2.17 and if so, must determine:
(a) the class or classes of research to which an expedited review procedure is to apply;
(b) the scope of the Chairperson's authority;
(c) the delegation of tasks to sub-committees;
(d) the relationship between the Chairperson of the full Committee, and the Chairpersons of such sub-committees; and
(e) the method of reporting and ratification of decisions by the full Committee.
2.28 Research with potential for physical or psychological harm should generally not be considered for expedited review. This includes drug trials, research involving invasive physical procedures and research exploring sensitive personal or cultural issues.
2.29 Where the Chairperson of an HREC considers that research may involve a departure from any of the ethical principles in this Statement, the protocol must be considered by the full Committee and cannot be dealt with by expedited review.
2.30 An HREC shall maintain a record of all research protocols received and reviewed including:
- name of responsible institution or organisation;
- project identification number(s);
- principal researcher(s);
- title of project;
- ethical approval or non-approval with date;
- approval or non-approval of any changes to the protocol;
- the terms and conditions, if any, of approval of any protocol;
- whether approval was by expedited review;
- whether the opinion of another HREC was considered;
- action taken by the HREC to monitor the conduct of the research; and
- the relevance, if any, of the Guidelines for the Protection of Privacy in the Conduct of Medical Research.Footnote 6
2.31 For multi-centre research proposals the HREC shall also record, from information provided from the researcher (see paragraph 3.7):
- details of other centres involved;
- the approval status of the study at each centre; and
- details of any amendments required at other centres.
2.32 An HREC shall retain on file a copy of each research protocol and application for HREC approval, including any information sheets, consent forms or relevant correspondence, in the form in which they are approved.
2.33 An institution or organisation and its HREC have the responsibility to ensure that the conduct of all research approved by the HREC is monitored by procedures and/or by utilising existing mechanisms within the institution or organisation which will ensure the achievement of the goals for monitoring as determined by the institution or organisation and the HREC.
2.34 The frequency and type of monitoring determined by an HREC should reflect the degree of risk to participants in the research project.
2.35 As a minimum an HREC must require at regular periods, at least
annually, reports from principal researchers on matters including:
(a) progress to date or outcome in the case of completed research;(b) maintenance and security of records;
(c) compliance with the approved protocol; and
(d) compliance with any conditions of approval.
2.36 An HREC may recommend and/or adopt any additional appropriate mechanism for monitoring including random inspections of research sites, data and signed consent forms, and/or interview, with their prior consent, of research participants.
2.37 An HREC shall, as a condition of approval of each protocol, require
that researchers immediately report anything which might warrant review
of ethical approval of the protocol, including:
(a) serious or unexpected adverse effects on participants;(b) proposed changes in the protocol; and
(c) unforeseen events that might affect continued ethical acceptability of the project.
2.38 An HREC shall, as a condition of approval of the research proposal, require researchers to inform the HREC, giving reasons, if the research project is discontinued before the expected date of completion.
2.39 An institution or organisation with an HREC shall establish mechanisms for receiving and promptly handling complaints or concerns about the conduct of an approved research project.
2.40 An HREC must nominate a person to whom complaints from research participants, researchers, or other interested persons may be made in the first instance. This person or the HREC shall attempt to resolve these complaints.
2.41 Where a complaint made under paragraph 2.40 cannot be resolved, the HREC must refer the matter to a person nominated by the institution or organisation to handle and resolve such complaints.
2.42 When information on the research is first provided to participants, the name or position and contact details of the person nominated by the HREC to receive complaints must be included together with the procedures for raising concerns or obtaining additional information on the research.
2.43 An institution or organisation shall also establish procedures for receiving and promptly handling concerns or complaints from researchers about the consideration of their research protocol by an HREC.
Suspension or Discontinuation of Research
2.44 Where an HREC is satisfied that circumstances have arisen such that a research project is not being or cannot be conducted in accordance with the approved protocol and that, as a result, the welfare and rights of participants are not or will not be protected, the HREC may withdraw approval, inform the researcher(s) and the institution(s) or organisation(s) of such withdrawal, and recommend to the institution(s) or organisation(s) that the research project be discontinued, suspended, or that other necessary steps be taken.
2.45 A researcher must not continue the research if ethical approval has been withdrawn and must comply with any special conditions required by the HREC.
Compliance Reports to the National Health and Medical Research Council
2.46 The National Health and Medical Research Council (NHMRC), through the Australian Health Ethics Committee (AHEC), will audit the activities of HRECs to ensure compliance with this Statement.
2.47 An institution or organisation and its HREC shall provide information from its records to the NHMRC on request.
2.48 An institution or organisation and its HREC shall report annually to the NHMRC information relevant to its procedures including:
- membership/membership changes;
- number of meetings;
- confirmation of participation by required categories of members;
- the number of protocols presented, the number approved, and the number rejected;
- monitoring procedures in place and any problems encountered; and
- complaints procedures and number of complaints handled.
Footnote
6 Included in NMHRC, Aspects of Privacy in Medical Research, AGPS, Canberra, 1995 [Under review]
[Preamble] [Part 1] [Part 2] [Part 3] [Part 4] [Part 5] [Part 6]
[Part 7] [Part 8] [Part 9] [Part 10] [Part 11] [Part 12] [Part 13]
[Part 14] [Part 15] [Part 16] [Part 17] [Part 18] [Part 19]
[Appendix 1] [Appendix 2] [Appendix 3]