The Department of Health Human Research Ethics Committee (the Committee) was set up in 1986 to deal with matters of human research ethics for projects carried out under the aegis of the Department of Health, in accordance with guidelines provided by the National Health and Medical Research Council (NHMRC).
The National Health and Medical Research Council Act 1992 requires that all research 'involving or impacting on humans' conforms to the National Statement on Ethical Conduct in Human Research (2007). Research that does not conform to these guidelines cannot be approved. Research must also comply with the Australian code for the responsible conduct of research (2007), which replaced the Joint NHMRC/AVCC Statement and Guidelines on Research Practice (1997). Research that does not conform to these guidelines cannot be approved.
Terms of reference
The functions of the Committee are:
- To consider the ethical implications of research proposals submitted to it for review.
- To evaluate the ethical conduct of relevant research involving humans according to National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2018) (NS) and The Australian Code for the Responsible Conduct of Research (2018) (Australian Code). “Relevant research” is research involving humans which meets the criteria for referral to the Committee.
- To comply with all guidelines and legislation relevant to research proposals considered.
- To provide advice on matters of an ethical nature, as required by the Secretary of the Department of Health (the Secretary).
- To provide a report annually to the Secretary.
The Committee will:
- Be appointed for a period of three years, with members able to apply for reappointment.
- Have power to co-opt experts suitable to its needs.
- Notify the Department of Health whenever a vacancy occurs in its membership so that a replacement may be appointed.
- Be provided with Secretariat support.
- Be remunerated in accordance with the rates for Group C Organisations as set out in the Department of Premier and Cabinet Guidelines on Appointment and Remuneration (1 July 2019).
- Be an insured entity under the Department of Health Corporate Insurance Program. Committee members will be protected by comprehensive insurance cover, which includes public liability and professional indemnity insurance.
Criteria for referral of research to the Committee
Organisations that conduct human research must ensure their research is approved by a Human Research Ethics Committee (HREC) which is constituted in accordance with the National Statement (NS s5.1.24) – such organisations usually have their own institutional HREC.
The Committee is an institutional HREC and the following criteria determine whether a research proposal of more than ‘low or negligible risk’, as defined (NS s2.1.6) should be referred to it for consideration.
Where research involving human subjects is being undertaken by the Department of Health and the research cannot be considered by another HREC which is properly constituted in accordance with the National Statement.
Where the Department of Health is providing funding to other organisations for the provision of services, the research relates to the clients of such an organisation, that organisation does not have its own HREC, and the research cannot be considered by another properly constituted HREC.
Where the Department of Health has funded research to be conducted by another organisation, that organisation does not have its own HREC, and the research cannot be considered by another properly constituted HREC.
Where there is a formal agreement signed by an authorised delegate of the Department and that of other organisation to accept research proposals for consideration by the the Committee, but that other organisation does not have its own ethics committee.
The Committee considers proposals in the portfolios of the former Department of Health and Human Services which now sit in the Department of Families Fairness and Housing including child protection, prevention of family violence, housing, disability, ageing and carers.
Principles governing the Committee’s responses to complaints
The Committee will only attempt to resolve issues that raise concerns of an ethical nature or involve the ethical review process itself. In cases of possible research misconduct, investigations will be conducted according to processes specified in the Australian Code (2018) and its Guide to Managing and Investigating Potential Breaches of the Australian Code for the Responsible Conduct of Research (2018).
Matters of complaint or concern which do not appear to involve violation of some ethical principle will be referred to a relevant person nominated by the institution or organisation, for example, the head of the sponsoring department or relevant research unit, or the institution’s human resources officer (for disputes regarding salary or employment conditions), or a designated officer in relation to anti-discrimination policies or freedom of information matters and the like.
Complaints will, in the first instance, be submitted in writing to the Executive Officer of the Committee. This is so that a clear statement of the issue may be put to researchers for a response.
As a matter of due process, those about whom a complaint has been made should be given an opportunity to respond.
The Chair should play an active role in formulating and signing requests for further information.
The Complaints Sub-Committee comprises the Chair, the Committee’s Executive Officer and a Committee member who initially reviewed the research proposal or to whom the proposal has since been allocated and about which the complaint has been made.
Matters should be brought before the Committee, if not resolved.
The institution has nominated a person to whom complaints from research participants, researchers, or other interested persons may be made. The Committee shall attempt to resolve these complaints (NS s5.6.1 (a) (b)). The individual to receive complaints relating to the Committee is the Committee’s Executive Officer.
All written complaints will be promptly acknowledged by telephone and follow-up email indicating, in general terms, that the response of the researchers will be sought prior to determining what further action should be taken.
Prior to forwarding the complaint or concern to the principal researcher, the Executive Officer will consult with the Chair, both as to the adequacy of the details of the complaint and the appropriate wording of a covering letter. The Chair will sign the letter calling for a response to the complaint.
The Chair will convene the Complaints Subcommittee to consider the issues which have arisen prior to approaching the researcher.
The Complaints Sub-Committee may determine that additional information should be sought from the person complaining and may, before seeking the response of the principal researcher, appoint a Committee member to investigate and resolve the complaint, or bring the matter to the next meeting of the Committee for its advice on how to proceed.
The complainant and/or the researcher may be asked to a full Committee meeting to further discuss the complaint and its resolution. If this is required, such invitations will be made for the next available regular Committee meeting and the discussion cannot exceed half an hour.
Any documentation required for the discussion from either the complainant or the researcher must be submitted two weeks prior to the meeting. Invitees should also have documented proposed measures to resolve the issues which have arisen. The Committee will not provide a final response at the meeting but will inform all parties concerned of the outcome as soon after the meeting as possible. All parties will be kept informed of the progress of the complaint resolution throughout the process.
Complaints about the Committee’s consideration of research proposals
The Department of Health has established procedures for receiving and promptly handling concerns or complaints from researchers about the consideration of their research protocols by the Committee (NS s5.6.4).
Where such concerns are expressed or complaints are made, they should, in the first instance, be addressed to the Executive Officer of the Committee. The complaint or concern should be submitted in writing to enable consideration of the complaint by the Committee itself.
The Committee will make all reasonable attempts to resolve complaints in collaboration with researchers as promptly as possible.
In attempting to resolve complaints, the Committee may consider obtaining specialist advice itself if deemed necessary.
If the complaint remains unresolved, the general approach to be taken is that set out in (NS s5.6.5) with appropriate adaptations as required. The complainant will be advised in writing by the Committee of the outcome of its investigations and deliberations concerning the matter raised. The Committee must provide reasons for its determination.
The complainant, if not satisfied with the Committee’s decision, may raise the matter directly with the Secretary of the Department of Health.