Raise awareness of the Laws and Regulations that apply to ethics review and research governance

As part of the initiative to ensure timely and efficient research governance authorisation, NHMRC has undertaken a number of projects to clarify the major legal and regulatory requirements that apply to human research in Australia, including clinical trials.

An important element of expediting the commencement of clinical trials is identifying, and where possible resolving, any legal and policy barriers to the approval and conduct of clinical trials. For example, a Hospital ethics committee may need to be aware that a secondary review will need to be conducted by a State-based committee, such as a coronial or forensic research committee, prior to commencement of research. Likewise, a researcher and institution may need to be aware of rules that apply to participants who lack capacity to give consent and withhold final approval to commence, until approval has been obtained from a Guardianship Tribunal. Alternatively, the enrolment of certain participants may not be permitted in one State, while another State permits their participation.

Major laws and regulations that apply to ethics review and governance of human research

To assist researchers, HRECs and institutions have a better understanding of which laws and rules may impact on research, NHMRC engaged a consultant to conduct a review to identify laws, regulations and Standard Operating Procedures that apply to both research governance and ethics review and that may have an impact on the adoption of a nationally consistent process for the review and approval of clinical trials.

The outcome of the review comprised reference tables, that differentiated between the obligations of researchers, institutions and HRECs with respect to the conduct of research involving humans, and including clinical trials.

Please note: the documents and tables prepared as part of this review are provided for general information only. They do not constitute legal advice and researchers and institutions in particular should discuss their specific proposal with their own legal advisors.

Consent and Guardianship Laws in Australia (Resource for HRECs and Researchers)

In 2016, NHMRC engaged a consultant to produce a Report on the relevant State, Territory and National laws that relate to consent and guardianship requirements for human research, including clinical trials. The consultant has also produced a series of practical, plain-English guides/checklists to consent and guardianship laws for use by HRECs and researchers. Except as indicated, these documents have been reviewed by the relevant State or Territory.

The following Report and Factsheets are available for use by HRECs, researchers, sponsors and other interested parties:

Please note: the documents and factsheets prepared as part of this review are provided for general information only. They do not constitute legal advice and researchers and institutions in particular should discuss their specific proposal with their own legal advisors. Any opinions expressed in the Report or factsheets are those of the author and may not reflect the views and opinions of NHMRC.