The Human Research Ethics Committee (HREC) is responsible for assessing the ethical acceptability of a proposal to conduct a clinical trial within the requirements of the NHMRC: National Statement on Ethical Conduct in Human Research and relevant national and jurisdictional legislation including guardianship legislation and the roles of civil and administrative tribunals for participation of people without the capacity to provide consent.
HRECs also monitor compliance, during ongoing trial conduct for the ethical conduct of the trial, in accordance with the National Statement and provide advice on strategies to promote awareness of the ethical conduct of clinical trials and research more broadly.
HRECs that review and approve clinical trials are registered with NHMRC and may or may not be co-located with public and private health service organisations. HRECs that review and approve clinical trials must have 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 and performance against standard metrics of clinical trials..
