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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: 
12
This submission reflects the views of
Organisation Name: 
Sydney Children's Hospitals Network HREC
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3

The Sydney Children’s Hospitals Network (SCHN) Human Research Ethics Committee (HREC) felt that the introduction to Section 3 provides a comprehensive and relevant overview of the section with appropriate guidance to researchers and HRECs to navigate through the information.

2. Chapter 3.1

Overall the changes proposed to Chapter 3.1 are welcomed by the SCHN HREC. The language of the revised chapter is simpler, clearer and more succinct. The additional details provided throughout the section on complex areas of research are helpful.  

The SCHN HREC also felt that the revised chapter is more educational in that it provides explanatory information to help the audience understand the rationale behind the guidance. The addition of the key questions at the start of each element provides valuable guidance to both researchers in designing their research projects and HRECs in reviewing human research ethics applications. It also provides a basic framework which could create some consistency amongst the HRECs in their reviews.

Recommendations for possible revisions

a)  3.1.6 – Reviewers should be aware that some research designs will be informed and shaped by the experience, insights and/or needs of participants, including any co-researchers. The structure of this sentence may imply that co-researchers could also be participants in the research project.

b)  Element 2 – Key question: How will the recruitment strategy ensure participants can make an informed decision about participation? The SCHN HREC recommends revising this question to add the word ‘voluntary’ to the phrase “an informed & voluntary decision”.

c)  Element 3 – Consent - The SCHN HREC recommends adding a reference to consent for children and young people in research and chapter 4.2 in the National Statement.

d)  Section 3.1.30 - The SCHN HREC recommends emphasising that information should be expressed in plain English and in terms understandable to lay persons. It however must not be so simplified as to be or likely to be misleading.

e)  Page 16, foot note 2 – Question regarding whether it is advisable for the National Statement to use language that is consistent with privacy legislation: Yes, the SCHN HREC recommends that the National Statement uses language that is consistent with privacy legislation.

f)  Sections 3.1.67 – 3.1.68  - The SCHN HREC recommends providing further guidance regarding the criteria for when results will not be reported to participants.

3. Chapter 3.5

The SCHN HREC welcomes the proposed changes to chapter 3.5. The revised chapter provides further clarity and greater guidance to researchers and HRECs in designing and reviewing genomic research projects. The decision tree was considered to be a valuable tool.

Recommendations for possible revisions

a)  The SCHN HREC recommends for the revised chapter 3.5 to provide further guidance to HRECs and researchers regarding the possible criteria for not returning incidental findings. The provision of a few examples could be very useful.

b)   Section 3.5.39.8 - Researchers should note that there is no general expectation that there is a role for a biobank in the return of findings of genomic research: The SCHN HREC recommends providing a more specific advice regarding open-access Biobanks that distribute samples nationally and internationally. In this case, it is recommended for the researchers or the Biobank to have an ethically defensible plan or for both?

c)   Personalised medicine: The decision tree for the management of findings in genomic research and health care will assist in addressing specific ethical issues that may arise during personalised medicine investigations. However further guidance on this is important as personalised medicine becomes more common.

4. Section 5

a)  Section 5.1.6 (b) – The first dot point still refers to the previous title for Chapter 3.5 (i.e. Human Genetics rather than Genomic Research).

General Comments
Comments: 

Overall the SCHN HREC considered these changes to have improved the clarity of the guidance document by drawing together common elements of research into a framework that enables HRECs and researchers to more easily identify ethical issues.

Page reviewed: 10 July, 2018