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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: 
14
Personal Details
First Name: 
Andrew
Last Name: 
Crowden
Specific Comments
Comments: 
1. Introduction to Section 3

Good to see Indigenous guidelines referenced. Important to note that the Values and Ethics: Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Research 2003 and Keeping Research on Track: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics 2005 have recently been reviewed and updates have been recommended. The Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) are likely to be updated this year. It would be useful incorporate all the Indigenous guideline updates into the NS.

2. Chapter 3.1

Element 3: Consent

Suggest that more should be said about the actual process re the importance of a broader processes of consultation, engagement and negotiation, particularly in the context of research involving Aboriginal and Torres Strait Islander Peoples at page 13.

 

Element 4: Data Collection and Management 

The language related to data identifiability, specifically, the terms ‘individually identifiable data’, ‘re-identifiable data’ and ‘non-identifiable data’ are consistent with Chapter 3.2 of the current National Statement. However, they do contrast with the categories of information used in privacy legislation where confusing terms like ‘potentially identifiable data’ and ‘de-identified data’ are also used.  I strongly support the NS retaining its current definitions re data identifiability. There are good reasons to recognise that data is stored in three forms as ‘individually identifiable data’, ‘re-identifiable data’ and ‘non-identifiable data’. These terms provide clarity and are philosophically sound. The de-identification of data describes a researcher initiated process whereby data is coded or encrypted. When it is stored, data is either identifiable, non-identifiable or re-identifiable. Moreover, we need to recognise that genomic data is often stored in genomic biobanks. These “hybrid infrastructures”, are organized collections of human biological material combined with associated health information: physical measurements, outcome data in medical records, epidemiological information, and genomic data derived from samples. The NS rightly identifies that human tissue samples should always be regarded as, in principle, re-identifiable. Clarity requires us all, including those involved in developing and updating privacy legislation, to adopt terminology that is consistent with the considered position taken in the NS – not the other way around. Keeping to the terms as currently used in the NS is practically useful for researchers, HRECs and research governance professionals. Thus the terms  ‘individually identifiable data’, ‘re-identifiable data’ and ‘non-identifiable data’ should remain. An education response re the reasons why this is important may be required here.

3. Chapter 3.5

A practically useful chapter. The process re element 5 and the decision tree will be practically useful for HRECS, researchers and governance professionals.

General Comments
Comments: 

Thank you for the opportunity to make comments.

 

Associate Professor Andrew Crowden

School of Historical and Philosophical Inquiry Forgan Smith Rm E349 

| The University of Queensland | Brisbane Queensland 4072 | Australia 

telephone [NHMRC has removed personal information]

email a.crowden@uq.edu.au | web www.hapi.uq.edu.au 

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Page reviewed: 10 July, 2018