5.1.1 Institutions must see that any human research they conduct or for which they are responsible is:
- designed and conducted in accordance with the Australian code for the responsible conduct of research; and
- ethically reviewed and monitored in accordance with this National Statement.
5.1.2 Each institution needs to be satisfied that:
- its human research meets relevant scholarly or scientific standards;
- those conducting its human research:
- are either adequately experienced and qualified, or supervised;
- understand the need to assess risks to their own safety and that of participants; and
- are free to withdraw from research on conscientious grounds.
5.1.3 Institutions may establish their own processes for ethical review of research, or use those of another institution.
5.1.4 Whichever option under 5.1.3 is adopted, institutions need to be satisfied that processes are in place for:
- managing conflicts of interest (Chapter 5.4);
- monitoring research (Chapter 5.5);
- handling complaints (Chapter 5.6); and
- ensuring accountability (Chapter 5.7).
5.1.5 Institutions should use and promote clearly formulated, documented, accessible and current policies and procedures for research governance and ethical review.
Processes for ethical review
5.1.6 The following types of research require review by a Human Research Ethics Committee (HREC):
- all research that involves more than low risk;
- research falling under the following chapters (except where research on collections of non-identifiable data under these chapters satisfies the conditions for exemption from review – see paragraphs 5.1.22 and 5.1.23):
Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations
Chapter 3.5: Human genetics,
Chapter 4.1: Women who are pregnant and the human fetus,
Chapter 4.4: People highly dependent on medical care who may be unable to give consent,
Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness,
Chapter 4.7: Aboriginal and Torres Strait Islander Peoples,
and some categories of research falling under Chapter 4.6: People who may be involved in illegal activities.
5.1.7 For research that carries only low risk (see paragraph 2.1.6) and does not fall under any of the chapters listed in paragraph 5.1.6, institutions may choose to establish other levels of ethical review. These levels are described in paragraphs 5.1.18 to 5.1.21.
5.1.8 Research that carries only negligible risk (see paragraph 2.1.7) and meets the requirements of paragraphs 5.1.22 and 5.1.23 may be exempted from ethical review.
Legal protection for those involved in ethical review of research
5.1.9 Institutions should provide an assurance of legal protection to all those involved in ethical review of research, for liabilities that may arise in the course of bona fide conduct of their duties in this capacity.
Oversight and review of ethical review procedures
5.1.10 Institutions that set up levels of ethical review other than HREC, as described in paragraphs 5.1.18 to 5.1.23, must establish criteria for allocating research to these different levels of review (including exemption from review), taking into account Chapter 2.1: Risk and benefit. These criteria must be readily accessible to all those involved in the conduct and review of research.
5.1.11 The ethical values and principles in this National Statement should be the basis on which institutions establish different levels of ethical review, allocate different kinds of research to them, and review those allocations.
5.1.12 Institutions must monitor any processes of ethical review of low risk research to ensure those processes continue to provide sufficient protection for participants.
5.1.13 Institutions should regularly assess all their ethical review processes, including the criteria for allocating research to different levels of review, to ensure that those processes continue to enable the institution to meet its responsibilities under this National Statement.
5.1.14 Where possible this assessment should be informed by the documented experience of research participants and/or by involving participants or the wider community in the assessment.
5.1.15 Institutions should also remain alert to emerging ethical issues in any area of human research that may warrant changing the level of ethical review required.
5.1.16 To enable assessment of their ethical review processes, institutions should prepare and make readily accessible regular reports on all of those processes.
5.1.17 Institutions should have in place an auditing process to confirm that:
- research in their institution is being reviewed at the levels of review their criteria require;
- research is being exempted from review only in accordance with the criteria set out in paragraphs 5.1.22 and 5.1.23.
Research involving no more than low risk
5.1.18 Institutions that establish any non-HREC levels of ethical review for low risk research must have the resources and capacity to carry out such review competently and professionally.
5.1.19 Where institutions establish such non-HREC levels of ethical review for low risk research, that review must:
- be carried out by people who are familiar with this National Statement and have an understanding of the ethical issues that can arise in the research under review;
- be informed by Section 1: Values and Principles of Ethical Conduct, Section 3: Ethical Considerations Specific to Research Methods or Fields and Section 4: Ethical Considerations Specific to Participants;
- take account of researchers’ judgements as to whether their research is suitable for review by a non-HREC process;
- have due regard to relevant privacy regulation.
5.1.20 The levels of ethical review referred to in paragraph 5.1.18 may include, but need not be limited to:
- review or assessment at departmental level by the head of department;
- review or assessment by a departmental committee of peers (with or without external or independent members);
- delegated review with reporting to an HREC; or
- review by a subcommittee of an HREC.
5.1.21 Those reviewing research at a non-HREC level must refer to an HREC any research they identify as involving more than low risk.
Research that can be exempted from review
5.1.22 Institutions may choose to exempt from ethical review research that:
- is negligible risk research (as defined in paragraph 2.1.7); and
- involves the use of existing collections of data or records that contain only non-identifiable data about human beings.
5.1.23 Institutions must recognise that in deciding to exempt research from ethical review, they are determining that the research meets the requirements of this National Statement and is ethically acceptable.
HRECs: research involving more than low risk
5.1.24 Each institution that conducts human research involving more than low risk must ensure that this research is reviewed and approved by an HREC that is constituted and functioning in accordance with this National Statement, whether or not that HREC is established by the institution.
Establishment of HRECs
5.1.26 Institutions that individually or jointly establish HRECs should adequately resource and maintain them. Resourcing should be sufficient to enable HRECs:
- to satisfy the requirements for sound ethical review (see paragraph 5.1.37);
- to communicate well with researchers (see paragraphs 5.2.13 to 5.2.15);
- not to charge fees where doing so would discourage research the institution has an obligation to support.
5.1.27 When establishing an HREC, an institution should set out and publicise its terms of reference, including:
- the scope of its responsibilities for ethical review;
- its relationship to other processes of research review;
- its relationship to non-affiliated researchers;
- its institutional accountability;
- its mechanisms of reporting;
- categories of minimum membership; and
- remuneration, if any, for members.
5.1.28 Where an institution has established an HREC, the institution is responsible for ensuring that:
- members have relevant experience and/or expertise;
- members undertake:
- appropriate induction, which could include mentoring by a current HREC member, and
- continuing education;
- review of research proposals is thorough;
- review processes and procedures are expeditious;
- decisions are transparent, consistent, and promptly communicated;
- actual and potential conflicts of interest that may affect research and its review are identified and managed (see Chapter 5.4: Conflicts of interest);
- membership of the HREC is made public in annual reports or by other routine processes, and is available to researchers submitting research proposals to that HREC;
- good communication between the institution/s, the HREC and researchers is promoted;
- the workload of the HREC does not compromise the quality and timeliness of ethical review; and
- any institution using the HREC can be assured the HREC is operating in accordance with this National Statement.
Composition of HRECs
5.1.29 The minimum membership of an HREC is eight. As far as possible:
- there should be equal numbers of men and women; and
- at least one third of the members should be from outside the institution for which the HREC is reviewing research.
- a chairperson, with suitable experience, whose other responsibilities will not impair the HREC’s capacity to carry out its obligations under this National Statement;
- at least two lay people, one man and one woman, who have no affiliation with the institution and do not currently engage in medical, scientific, legal or academic work;
- at least one person with knowledge of, and current experience in, the professional care, counselling or treatment of people; for example, a nurse or allied health professional;
- at least one person who performs a pastoral care role in a community, for example, an Aboriginal elder, a minister of religion;
- at least one lawyer, where possible one who is not engaged to advise the institution; and
- at least two people with current research experience that is relevant to research proposals to be considered at the meetings they attend. These two members may be selected, according to need, from an established pool of inducted members with relevant expertise.
5.1.31 No member may be appointed in more than one of the categories listed in paragraph 5.1.30, but institutions are encouraged to establish a pool of inducted members in each category. These members may attend meetings as needed to meet minimum HREC requirements, and may also be available to provide expertise for the research under review.
5.1.32 Wherever possible one or more of the members listed in 5.1.30 should be experienced in reflecting on and analysing ethical decision-making.
5.1.33 The institution should ensure that the HREC has access to the expertise necessary to enable it to address the ethical issues arising from the categories of research it is likely to consider. This may necessitate going outside the HREC membership.
Appointment of HREC members
5.1.34 Members should be appointed to an HREC using open and transparent processes. Institutions should consider reviewing appointments to the HREC at least every three years.
5.1.35 Members should be appointed as individuals for their knowledge, qualities and experience, and not as representatives of any organization, group or opinion.
5.1.36 Members should be provided with a formal notice of appointment.
5.1.37 An institution that establishes an HREC should ensure that the HREC establishes, implements and documents working procedures to promote good ethical review, including procedures for:
- frequency of meetings;
- attendance at meetings;
- conduct and structure of meetings and deliberations;
- preparation of agendas and minutes;
- timely distribution of papers before meetings;
- presentation of applications for ethical review;
- timely consideration and review of applications;
- managing conflicts of interest (see paragraphs 5.4.1 to 5.4.6);
- communicating with researchers, including face to face, by telephone and in writing (including email) (see paragraphs 5.2.13 to 5.2.15);
- reporting on its activities to the institution;
- methods of decision making;
- prompt notification of decisions;
- record keeping (see paragraphs 5.2.23 to 5.2.27);
- monitoring of approved research (see paragraphs 5.5.1 to 5.5.5);
- reporting and handling of adverse events;
- receiving and handling of complaints (see paragraphs 5.6.1 to 5.6.7);
- advising the institution/s of decisions to withdraw ethical approval of a research project (see paragraphs 5.5.7 to 5.5.9);
- attendance, as observers, of people other than members or researchers (see paragraph 5.2.18) at meetings;
- fees, if any, to be charged; and
- appropriate confidentiality of the content of applications and the deliberations of review bodies.