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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

ID: 
9
This submission reflects the views of
Organisation Name: 
Griffith University
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

(Submission lodged on behalf of Professor Ned Pankhurst Senior Deputy Vice Chancellor, Griffith University)

 

Dear Professor Anne Kelso AO
I write in response to the call for public submissions in response to the consultation draft of the new/revised Chapters 3.1 and 3.5, section 5 and the Glossary of the National Statement on Ethical Conduct in Human Research.
 
Griffith University is supportive of the proposed changes. 

In response to your specific questions:
 
Provide sufficient guidance to address the key ethical issues in relation to the design, development, review
and conduct of research; and
 
Chapter 3.1 - Since the initial release of the second edition of the National Statement universities have struggled to helpfully apply the provisions of the chapters in section 3 to research conducted outside of the health sciences. This is particularly the case for qualitative research and participant-directed designs in the humanities, broad social sciences and the fine arts. Another limitation of the category approach used by the current Section 3 is that it can never keep pace with and address emergent areas of research (e.g. in recent years the use of social media in research designs, nanotechnology based device trials and novel experiments in areas such as engineering).  The removal of category specific chapters and their replacement with a design element based approach enables 3.1 to provide useful, relevant and helpful guidance for the conception, design, ethics review and conduct of all human research.

Chapter 3.5 - The contents of 3.5 are helpful (especially the decision tree diagram with regard to the reporting of results. The chapter both complements the new chapter 3.1 and usefully identifies the additional specific genetic research matters that need to be considered by researchers and ethics reviewers, The issue of personally identified information is obviously increasingly problematic and may difficult to predict.

Glossary - Griffith University supports the framing of the new glossary entries.

Section 5 - The changes in section 5 are welcome and necessary given the changes to section 3. Griffith University supports the relocation of these governance matters.
 
Are presented and written in a manner that is appropriate for the target audience (researchers, HRECs).
 
The language of the introduction of Section 3 is helpful for researchers and reviewers (not just HREC).
 
The existing 3.1 seemed to be addressed primarily to reviewers and not to researchers. By contrast the new Chapter 3.1 is more clearly a helpful resource for both reviewers and researchers.  
 
As noted above the clear language and presentation of the issues in 3.5 is appropriate. The decision tree graphic will is an especially helpful inclusion.
 
The additions to section 5 do add a significant number of provisions relevant only to clinical trials, but this is probably unavoidable given the removal of chapter 3.3.
Griffith University would be pleased to provide further commentary on why we support the changes if useful and necessary.

Regards
Professor Ned Pankhurst, Senior Deputy Vice Chancellor, Griffith University
Please direct any enquiries to Dr Gary Allen, Senior Policy Officer, Griffith University | g.allen@griffith.edu.au | [NHMRC has removed personal information]
3. Chapter 3.5
Chapter 3.5 - The contents of 3.5 are helpful (especially the decision tree diagram with regard to the reporting of results. The chapter both complements the new chapter 3.1 and usefully identifies the additional specific genetic research matters that need to be considered by researchers and ethics reviewers, The issue of personally identified information is obviously increasingly problematic and may difficult to predict.
As noted above the clear language and presentation of the issues in 3.5 is appropriate. The decision tree graphic will is an especially helpful inclusion.
4. Section 5
Section 5 - The changes in section 5 are welcome and necessary given the changes to section 3. Griffith University supports the relocation of these governance matters.
5. Glossary

Glossary - Griffith University supports the framing of the new glossary entries.

1. Introduction to Section 3

Griffith University is supportive of the proposed changes. 

Page reviewed: 10 July, 2018