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Update to National Statement
The NHMRC has recently released a revised version of the National Statement on Ethical Conduct in Human Research. The National Statement released in July 2018 includes a fully revised Section 3. Changes have also been made to Chapters 5.1, 5.2 and 5.5 in Section 5, the Glossary and the Index as a consequence of revisions to Section 3.
Chapter 3.2: Human biospecimens in laboratory based research (formerly Chapter 3.4) was not revised; however, the Australian Health Ethics Committee (AHEC) approved minor amendments to this chapter to align it with the new structure in Section 3. Further information on the changes to Chapter 3.2 is available here.
It is the responsibility of all users of the National Statement, including HRECs, research offices and researchers to ensure that the current version is being used in developing research proposals, making submissions for ethics review and undertaking ethics review that occurs on or after the date of release of any update.
However, as a consequence of the revisions to Section 3 it is expected that users of the National Statement will gradually integrate these revisions into their proposals, submissions and review over the period from July to December 2018, with full implementation expected by 1 January 2019. This timeline is intended to give researchers and HRECs an opportunity to familiarise themselves with the new guidance prior to the revocation of the version of the National Statement updated most recently in 2015.
Further information and a downloadable version of the revised National Statement is available here.
Swinburne researchers are bound by Swinburne values, codes, policy and procedure including that relating to human research activity. A minimum standard for any research activity conducted with or about people, or their data/information or tissue, is that given in the National Statement on Ethical Conduct in Human Research (2007) - updated 2018. To this end, researchers will need to:
- Be familiar with relevant Swinburne policies and procedures that concern human research activity.
- Be familiar with applicable sections and details in the National Statement and any applicable legislation or other guidelines.
- Plan for their research activity with due regard to realistic timeframes and methods and outcomes that are academically, professionally and ethically sound.
- Depending on the type of research activity involving (or significantly impacting upon) humans and using the appropriate form(s), apply for prior ethical review from the appropriate or designated ethical review body, eg, Swinburne’s Human Research Ethics Committee (SUHREC), a SUHREC Sub-Committee or other authorised body.
- Commence human research activity only after ethics clearance has been expressly issued and in full compliance with the terms of the clearance.
- Notify SUHREC and/or other relevant people as soon as possible if research protocols need amendment to meet an emergency, eg, to ensure safety
- Otherwise apply for prior clearance for proposed amendments to current approved protocols.
- Report at least annually and at the conclusion (or cessation) of any approved human research project/activity.
Researchers must examine the effect of their research on all participants—whether a person is a knowing participant or not—as well as any adverse effect the research may have on the lives of those who may be connected with, but not directly participating in, the research.
The Swinburne Human Research Ethics Committee reviews human research proposals to ensure that they accord with the National Statement on Ethical Conduct in Human Research and are ethically acceptable before giving approval for the project’s commencement.