National Health and Medical Research Council

Organisations that establish Human Research Ethics Committees, as well as the Australian Health Ethics Committee monitor activities of the HRECs.

Who monitors the activities of Human Research Ethics Committees?

HRECs are established by organisations which are responsible for adequately resourcing them and ensuring that they operate in accordance with the National Statement on Ethical Conduct in Human Research (2007). Hence, the primary responsibility for monitoring the activities of an HREC rests with the organisation(s) that established it.

AHEC has a role in Monitoring HRECs activities as indicated in the National Statement. The National Statement stipulates that "the National Health and Medical Research Council (NHMRC), through the activities of the Australian Health Ethics Committee (AHEC), will audit the activities of HRECs to ensure compliance with this Statement" [NS 2.46].

The National Statement further requires that "[a]n 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 [in the review of research protocols] 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" [NS 2.48].

The NHMRC, through AHEC, gathers information about HRECs and assesses the compliance of HRECs with the National Statement, and other guidelines, by requiring HRECs registered with the NHMRC to complete an Annual Report Form for the reporting period (1 July to 30 June).

This HREC Annual Report Form asks organisations and their HRECs to retrospectively self-report on the procedures of the HREC, including those mentioned in Section 2.48 of the National Statement, relevant to the reporting period. In addition, the HREC Annual Report Form assesses the compliance of an HREC with the Guidelines Under Section 95 of the Privacy Act 1988 and the Guidelines approved under Section 95A of the Privacy Act 1988

The information supplied to the NHMRC in the Annual Report Form is assessed and the organisation and its HREC are informed of the outcome of this assessment. AHEC reports annually on this information to the Research Committee of the NHMRC to assist in the allocation of NHMRC funding, and to the Office of the Federal Privacy Commissioner in relation to HRECs application of the guidelines under Section 95 and 95A of the Privacy Act 1988.

The information supplied in the Annual Report Form also helps AHEC identify problematic areas of compliance, about which additional information or guidance can be provided for HRECs, and provides an overview of the ethical review system in Australia, such as information about workload and processes used by HRECs.

See also:

• Information about HRECs held by AHEC

Raising concerns about a research project or an HREC

Participants

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, you may contact the Human Research Ethics Committee (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).

Non-participants

You do not need to be a participant in the 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 which 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 which is not based at the researcher's organisation, the Research Office should be able to assist you in contacting the relevant HREC.

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 on Ethical Conduct in Human Research (2007) and the Australian Code for the Responsible Conduct of Research.

Further information