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Dear Colleague
The National Health and Medical Research Council (NHMRC) is proposing to include a revised Chapter 2.1 in the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018).  Developed by the Australian Health Ethics Committee (AHEC), the revised chapter provides advice for both researchers and Human Research Ethics Committees (HRECs) addressing ethical considerations related to risk and benefit and will support use of the guidance in Section 5 of the National Statement. The revisions to Chapter 2.1 are consequential changes to the definitions of risk categories resulting from revisions to Section 5 following public consultation in 2020. 

I am pleased to release the draft guidance for public consultation, and welcome feedback from interested parties, in particular whether the revised chapter:

  • provides sufficient guidance to address the key ethical issues in relation to risk and benefit arising from the design and conduct of research
  • is presented and written in a manner that is appropriate for the target audience (researchers, HRECs).

The revised Chapter 2.1 is accompanied by a revised final version of Section 5 (for background purposes only), incorporating changes made in response to the previous public consultation on in 2020.

Under Section 13 of the National Health and Medical Research Council Act 1992, NHMRC is required to undertake public consultation prior to finalising its human research guidelines. NHMRC is keen to ensure that the Australian community has the best opportunity to participate in developing guidance on the ethical design, review and conduct of human research, and seeks your feedback on the proposed changes to the National Statement.

I encourage you to bring this public consultation to the attention of anyone whom you believe would be interested. Submissions received as part of the public consultation will be considered in the final revisions to the sections.

The closing date for this public consultation is 5:00pm (AEST) Monday 1 August 2022.

We look forward to receiving your comments.

Yours sincerely

Professor Anne Kelso AO
Chief Executive Officer

Consultation date

Please note the time zone is AEST.

Opening date: 5:00pm (AEST)  Wednesday, 1 June 2022
Closing date: 5:00pm (AEST)  Monday, 1 August 2022
Contact: ethics@nhmrc.gov.au
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