Chapter 5.2: Responsibilities of HRECS, other ethical review bodies, and researchers. National Statement on Ethical Conduct in Human Research (2007) - Updated 2018

Guidelines – Chapter 5.2

Review body procedures

5.2.1 Institutions that set up non-HREC levels of ethical review should ensure that they have good working procedures for those levels. These should include the procedures from paragraph 5.1.37 and paragraphs 5.2.26 to 5.2.29 that are necessary for sound review at each of those levels.

Review body member responsibilities

5.2.2 Each member of an ethical review body is responsible for deciding whether, in his or her judgement, a proposal submitted to the review body meets the requirements of this National Statement and is ethically acceptable.

5.2.3 To fulfil that responsibility, each member of a review body should:

1. (a) become familiar with this National Statement, and consult other guidelines relevant to the review of specific research proposals
2. (b) prepare for and attend scheduled meetings of the review body or, if unavailable, provide opinions on the ethical acceptability of research proposals before meetings, subject to institutional policies on absences
3. (c) attend continuing education or training programs in research ethics at least every three years.

5.2.4 Members of a review body should disclose to it any actual or potential conflict of interest, including any financial or other interest or affiliation, that bears on any research coming before the review body (see paragraph 5.4.5).

Researcher responsibilities

5.2.5 In each research proposal, the researcher/s should demonstrate that the research has merit and reflects the ethical values of justice, beneficence and respect for humans (see paragraph 1.1).

5.2.6 For relevant health research, researchers should show that the research meets the requirements of the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), ISO 14155 Clinical Investigation of Medical Devices, the World Health Organization International Clinical Trials Registry Platform and the TGA.

5.2.7 Research proposals should be clear and comprehensive, and written in lay language.

5.2.8 A researcher should disclose to the review body the amount and sources or potential sources of funding for the research.

5.2.9 A researcher developing or designing a research proposal involving two or more institutions should inform them all at an early stage in this process.

5.2.10 A researcher should keep an auditable record of any research he or she is undertaking that is exempted from ethical review in accordance with paragraphs 5.1.22 and 5.1.23.

5.2.11 A researcher should disclose to the review body any actual or potential conflicts of interest, including any financial or other interest or affiliation, that bears on the research (see Chapter 5.4: Conflicts of interest). Where applicable, this disclosure should specify:

1. (a) any business, financial or other similar association between a researcher and the supplier of a drug or surgical or other device to be used in the research
2. (b) any restrictions on publication or dissemination of research findings.

5.2.12 When reporting the research, a researcher should again disclose any actual or potential conflicts of interest, including any financial or other interest or affiliation, that bears on the research.

5.2.13 For researcher responsibilities in relation to monitoring, see Chapter 5.5: Monitoring approved research.

Good communication between review bodies and researchers

5.2.14 Good ethical review requires open communication between review bodies and researchers, and a shared commitment to the review process. The process should not be adversarial. Institutions should encourage this shared commitment by promoting:

1. (a) awareness of this National Statement among researchers
2. (b) ready accessibility of review bodies and their staff to researchers.

5.2.15 Misunderstandings can often arise when only written communication is used. From the outset review bodies should encourage informal communication with researchers, and should consider face-to-face meetings to resolve issues about research proposals that have not been resolved by written or telephone communication.

5.2.16 Open communication of these kinds has implications for the resourcing of review bodies (see paragraphs 5.1.18, and 5.1.26).

Participants' interests

5.2.17 Information about research should be presented to participants in ways that help them to make good choices about their participation, and support them in that participation. These ways must take into account:

1. (a) whether the information is best communicated through speech, writing, some other way, or a combination of these
2. (b) the need for accurate and reliable translation (written and/or oral) into a participant's first language or dialect
3. (c) culture and its effects on how language (English or other) is understood
4. (d) educational background and level
5. (e) age
6. (f) visual, hearing or communication impairment.

5.2.18 In any clinical research, a review body should be satisfied that research participants are adequately informed of the funding arrangements of the research (see also 3.1.29).

5.2.19 A review body should consider consulting a participant advocate to help it assess whether a proposal under consideration adequately provides for participants' decision making and understanding.

Researchers or experts at review body meetings

5.2.20 A review body may invite researcher/s, and researchers may request, to be present for discussion of their proposed research.

5.2.21 A review body may seek advice from experts to help in considering a research proposal (for example, as in paragraph 5.1.33). Such experts should be bound by the same confidentiality requirements as the review body members. Any conflicts of interest they may have should be disclosed and managed (see paragraphs 5.4.1 to 5.4.6).

5.2.22 Communication between a research sponsor and a review body should be avoided where it may, or may be perceived to, influence the ethical review and approval of the project.

Making and communicating decisions

5.2.23 A review body may approve, request amendment of, or reject a research proposal on ethical grounds.

5.2.24 The review body must clearly communicate its decision to the researcher/s:

1. (a) Where a proposal is approved, communication must be in writing (which may include email) and should include an explicit statement that the proposal meets the requirements of this National Statement.
2. (b) Where amendments are requested, communication may be written or, where appropriate, informal (see paragraph 5.2.15). Reasons should be given for the requested amendments.
3. (c) Where a proposal is rejected, communication of the rejection must be in writing (which may include email) and should include reasons linked to this National Statement.

Documents and records

5.2.25 All documents and other material used in recruiting potential research participants, including advertisements, letters of invitation, information sheets and consent forms, should be approved by the review body.

5.2.26 A review body should maintain a record of all research proposals received and reviewed, including at least the:

1. (a) name/s of the institution/s to which the research approval is provided
2. (b) project identification number/s
3. (c) name/s of principal researcher/s
4. (d) title of the project
5. (e) correspondence between the review body and the researcher about the review
6. (f) acceptance or rejection of any changes to the proposal
7. (g) proposed date of completion of the proposal
8. (h) formal advice of final ethical approval or non-approval, with date
9. (i) terms and conditions, if any, of approval of any proposal
10. (j) duration of the approval
11. (k) name of any other review body whose opinion was considered
12. (l) mechanisms to be used to monitor the conduct of the research
13. (m) relevance, if any, of the Commonwealth, State or Territory legislation or guidelines relating to privacy of personal or health information.

5.2.27 In addition, a review body should retain on file a copy of each research proposal and application for ethical approval, including any information sheets, consent forms or relevant correspondence, in the form in which they were approved.

5.2.28 A review body should record decisions about approval, amendment or rejection of proposals in written or electronic form, with reasons for those decisions, linking those reasons to this National Statement.

5.2.29 Where more than one review body has reviewed a research proposal, each such review body should record, as far as possible (see paragraph 5.3.3):

1. (a) details of other review body/ies involved
2. (b) the decision/s of each other review body
3. (c) details of any amendments required by each other review body.

HREC meetings

5.2.30 As far as possible, each HREC meeting should be arranged to enable at least one member in each category to attend (see paragraphs 5.1.29 to 5.1.32). Meeting papers should be provided enough in advance to enable members to be fully informed.

5.2.31 Decisions by an HREC about whether a research proposal meets the requirements of this National Statement must be informed by an exchange of opinions from each of those who constitute the minimum membership (see paragraph 5.1.30). This exchange should, ideally, take place at a meeting with all those members present.

5.2.32 Where there is less than full attendance of the minimum membership at a meeting, the Chairperson should be satisfied, before a decision is reached, that the views of those absent who belong to the minimum membership have been received and considered.

5.2.33 An HREC should endeavour to reach decisions by general agreement. This need not involve unanimity.

Authors of this National Statement

This National Statement has been jointly developed by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC) and Universities Australia (UA). This joint undertaking reflects a widely shared conviction that there is a need for ethical guidelines that are genuinely applicable to all human research and it gives expression to the shared responsibility for ethically good research described above.