NHMRC Public Consultation | National Statement on Ethical Conduct in Human Research Sections 4 and 5

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NHMRC is proposing to include new and revised chapters in Section 4 and Section 5 of the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018) (the National Statement). Developed by the Australian Health Ethics Committee (AHEC), the revised sections provide advice for both researchers and Human Research Ethics Committees (HRECs) addressing ethical considerations related to potentially vulnerable participants in research (Section 4) and research governance and ethics review (Section 5).

We are pleased to release the draft guidance for public consultation, and welcome feedback from interested parties, in particular whether the revised sections:

  • provide sufficient guidance to address the key ethical issues in relation to the conduct of research involving potentially vulnerable research participants;
  • provide sufficient guidance on research governance and ethics review, and
  • are presented and written in a manner that is appropriate for the target audience (researchers, HRECs).

The revised sections are accompanied by explanatory material to provide clarity about the changes in structure and content that have been introduced to these sections.

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.

We 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.

Since partial save or save as draft functionality is not available when completing this survey online and completed submissions cannot be saved, you may find it helpful to first complete your responses offline using the response template below (under Consultation Documents) and then complete your submission online by copying text from the response template and pasting it into the survey. This will also allow you to retain a copy of your submission for your records.

Please note that we will not accept submission of the response template or other Word or PDF document in lieu of completing the survey.

Please also note that you will be asked at the end of the survey whether you agree for your submission to be published.

We thank you for your participation and look forward to receiving your comments.

Consultation documents
Consultation date

Please note the time zone is AEDT

Closing date: Friday 30 October 2020, 5:00pm (AEDT)
Extension: For extensions please contact ethics@nhmrc.gov.au to discuss.
Contact for further information
How to provide feedback

We are seeking feedback on the questions in the Issues Paper through the use of an online survey. Please click on Next Page to begin the survey.