What sorts of organisations have HRECs?
HRECs are usually established by organisations (public, not-for-profit or private) that conduct research involving humans. Universities and hospitals are the most common of these organisations. However, not all organisations that conduct research have their own HREC. Some organisations and individual researchers use the services of HRECs that are based within other organisations. They may also use HRECs that are established by organisations that do not conduct research, but have established an HREC to provide the service of ethical review to researchers who do not have an HREC at their own organisation or who are not associated with an organisation.
When do you need to establish an HREC?
The National Statement requires all research involving human participants to undergo ethical review.
Organisations that regularly undertake research involving humans may establish an HREC to review this research. Organisations should be aware, however, that establishing and maintaining an HREC requires significant resources. It is the establishing organisation's responsibility to ensure that its HREC is adequately resourced. The organisation must also accept legal responsibility for decisions and advice received from the HREC and must appropriately indemnify its members. For these reasons, an organisation should only contemplate establishing an HREC if it is confident that it can adequately meet these ongoing requirements.
Organisations that choose not to establish an HREC may approach another organisation with an established HREC with a request for the HREC to review research proposals on its behalf, on a regular or ad hoc basis. Independent researchers may also approach HRECs with such requests. An HREC's relationship with non-affiliated researchers should be specified in its terms of reference, which should be determined by the establishing organisation. However, it should be noted that organisations are not obligated to make their HREC available to undertake reviews on behalf of other organisations or independent researchers. Organisations agreeing to provide ethical reviews on behalf of other organisations or for independent researchers sometimes require indemnification and/or charge a fee for the service.
Alternatively, organisations may wish to contact other organisations to consider jointly establishing an HREC. Organisations jointly establishing an HREC can arrange to share the responsibility for resourcing and maintaining the HREC. The National Statement does not restrict how many organisations can share an HREC; however, it should be noted that it is the responsibility of the organisations involved to establish the terms of reference of the HREC and determine legal aspects of their relationship.
Why should you register your HREC with NHMRC?
Some of the reasons why your HREC register with NHMRC are listed below.
NHMRC requires organisations that receive NHMRC funding to ensure that all research involving humans has been reviewed and approved by an HREC that has been established and operates in accordance with the National Statement.
The Australian Research Council (ARC) also requires that research proposals involving humans have approval from an HREC established and operating in accordance with the National Statement, in order to qualify for funding.
The Therapeutic Goods Administration (TGA) requires all clinical trials of unregistered therapeutic goods conducted under the Therapeutic Goods Act 1989 to be reviewed and monitored by an HREC that is notified to NHMRC and compliant with the National Statement.
Human Embryo Research
The Research Involving Human Embryos Act 2002, Section 21(3)(c), requires HRECs that approve research involving excess human embryos to be compliant with the National Statement.
HRECs that apply the Guidelines under Section 95 and the Guidelines approved under Section 95A of the Privacy Act 1988 are required to report annually to NHMRC on the application of these guidelines.
What is the minimum membership of an HREC?
The National Statement sets out the requirements for the composition of an HREC, stipulating that an HREC should consist of no less than eight members with specific qualifications and expertise [See paragraph 5.1.30 of the National Statement for details].
If an HREC does not meet the minimum membership requirements, can it still review and approach research proposals?
All research involving humans in Australia should meet the requirements of the National Statement and the Australian Code for the Responsible Conduct of Research (the Code).
While the National Statement is not a legal document, there are particular circumstances under which conformance to the National Statement is required by law. If the membership composition of an HREC does not reflect paragraph 5.1.30 of the National Statement, this gives rise to the following issues:
Commonwealth funded research
The National Statement is a federal government document that is applicable to any human research project funded by the commonwealth. As the two major research funding bodies (NHMRC and Australian Research Council) and the peak body for universities (Universities Australia) are co-authors, any funding agreements with these organisations include conformance to the National Statement as a condition of funding.
Clinical Trials research
The Therapeutic Goods Act 1989 states that a clinical trial (administration) of an unapproved drug (one that is not on the Australian Register of Therapeutic Goods) or a drug for experimental purposes can only be administered by a medical practitioner who has the approval of an ethics committee. In Chapter 1 section 3, an ethics committee is defined as:
(a) constituted and operating as an ethics committee in accordance with guidelines issued by the CEO of the National Health and Medical Research Council as in force from time to time; and
(b) which has notified its existence to the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.
As per the Research Involving Human Embryos Act 2002, if the composition of an HREC does not reflect the National Statement, this may have implications for the issuing of a licence.
Research to which the Privacy Guidelines apply
If the composition of an HREC does not reflect the National Statement, this may have implications for research to which the Guidelines approved under Section 95 and Section 95A of the Privacy Act 1988 apply.
Please note that there may be legislation within your state/territory which refers to the membership composition of an HREC under the National Statement.
If you are concerned about approving research with an ethics committee that is not constituted in accordance with the National Statement, you could consider seeking the services of another ethics committee to review the projects as an interim measure. Ethics committees are also encouraged to establish a pool of members that they can draw on should members resign at short notice or if recruitment of committee members proves difficult.
It is not necessary that all core members or all members of an HREC are present at each meeting at which research proposals are considered so long as an opportunity has been provided for the absent member to provide their comments on anything that is on the agenda for that meeting.
Who monitors the activities of HRECs?
Organisations that establish an HREC are responsible for providing resources for the HREC and ensuring that the HREC operates in accordance with the National Statement. Hence, the primary responsibility for monitoring the activities of an HREC rests with the organisation(s) that established it. [see paragraph 5.7.5 of the National Statement].
I am an independent researcher, not affiliated with an Australian Institution – How do I apply for ethical review?
Researchers who are not affiliated with an Australian institution can approach any HREC. Institutions that establish HRECs are required to set out and publicise their terms of reference, including their relationship to non-affiliated researchers.
Researchers who are from overseas wishing to conduct research in Australia who have not yet obtained ethics approval for their research are advised to consult with the overseas organisation with which they are affiliated regarding obtaining ethics approval prior to contacting an Australian HREC.
For information on application requirements that may be specific to the organisation or the HREC, researchers should contact the individual HREC.
Is ethical approval from an ethics review body in another country valid in Australia?
In principle, approval from an ethics review body in another country can be valid in Australia; however, an Australian HREC is not required to accept an approval from an ethics review body in another country and may require their own review. The onus is on the participating researcher/s to demonstrate that the ethical framework and standards in the reviewing country used to approve the intended research (in the reviewing country, overseas) satisfy the ethical principles outlined in the National Statement. The researcher/s should contact the Research, Ethics or Governance Office (or equivalent) of the organisation at which they wish to conduct the research with information about the approval process for the research that was obtained overseas.
If the HREC is not satisfied that the ethical framework and standards in the reviewing country is in-line with the principles and guidance in the National Statement, then full HREC review in Australia is advised.
How can I raise a concern about the conduct of a research project?
If you have a concern about the conduct of a research project you are participating in, you may raise your concern with the researcher responsible for the project. You will have been given the contact details for the researcher so that you can ask questions or raise concerns. If you do not feel comfortable discussing your concern with the researcher or are not satisfied with the response, you may contact the HREC that approved the research project or a nominated complaints officer. The contact details for the HREC or complaints officer will also have been given to you (usually within the written information sheet or consent form).
You do not need to be a participant in a research project in order to raise a concern about the conduct of the project. If you are not a participant, you can raise your concern with the researcher, the HREC that approved the project, or the researcher's organisation. Contact details for the HREC of the researcher's organisation can usually be obtained from the organisation's website or by contacting the organisation's switchboard. Ask for the 'HREC contact officer' or for the 'Research Office'. If the project was approved by an HREC that is not based at the researcher's organisation, the Research Office should be able to assist you in contacting the relevant HREC.
Institutional responses regarding complaints
Institutions are required to have a complaints handling policy in place. Any complaints about the conduct of a research project should be handled in accordance with the institution's policy and the requirements of the National Statement and the Code.
NHMRC does not have the capacity to receive or investigate concerns or complaints about individual researchers, research projects or the processes that an HREC or organisation may have used in response to a complaint from a participant or non-participant. Departments of Health or Offices of the Ombudsman in some states or territories may be available for this purpose.