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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: 
57
Personal Details
First Name: 
Jonnie
Last Name: 
Kennedy
Specific Comments
Comments: 
2. Chapter 3.1

3.1.61 When data are being collected with the intention of sharing the data with other researchers (such as by adding them to an open access repository) or by adding them to a databank, researchers should clearly describe to reviewers how the collection of their research data will conform to the requirements for consent set out in paragraphs 2.2.14 to 2.2.18.

 

Drawing the focus of researchers and HRECs more specifically to possible implications of data sharing for participants would be helpful at this point, for example, particular reference to or comment about 2.2.16 When unspecified consent is sought, its terms and wide ranging implications should be clearly explained to potential participants.

 

3.1.63 Typo - researchers

 

3.1.64 Before publishing re-identifiable or non-identifiable data, or adding such data to a repository, researchers should consider the degree to which it may be possible for the data to become identifiable through efforts made by other researchers or third parties.

 

What should they do with their consideration? eg. This consideration should extend to informing participants of the possibility that, despite the study/repository taking certain measures (of which the participant should be made aware) to protect their privacy, a participant’s data may be linked back to them through the efforts of unknown future others.

 

3.1.65 Shared or banked data that is stored in an identifiable form can sometimes be used in research that qualifies as negligible or low risk research; however, it cannot be used in research that is exempt from ethical review.

 

Query why this is not “…identifiable or re-identifiable..”

 

And a thought experiment relating to the ethical review of research using shared data:

A HREC (sometimes with limited comprehension of genomic research) gives approval for researchers to carry out a study which involves obtaining access to a genome database. Does the presence of a database Data Access Committee (DAC) cause the HREC to deliberate less on the implications of data sharing? Does DAC approval signal to the HREC that the data sharing scenario is ethical? Is the DAC effectively providing ethical review of this part of the project?

Is a mention of DACs appropriate?

3. Chapter 3.5

3.5.25 Genomic information can sometimes be misused to stigmatise people or to discriminate against them unfairly. Researchers should therefore take special care to protect the privacy of participants

 

Although being prescriptive here is not appropriate, the terminology of “special care” comes across as particularly vague.

HRECs and participants should be made aware of provisions towards the protection of privacy (though reference to this was later found at 3.5.39.25).

Researchers should be transparent in informing participants that genetic/genomic data may be uniquely identifying and, as such, the sharing of genomic data may present a potential for re-identification, particularly when linked to other personal data (reference to this was also later found - 3.5.39.24 - which made me think the section on privacy, presumably placed at the end of the chapter due to its relevance across genomic research, might be better served earlier in the chapter or incorporated more thoroughly throughout).

 

The decision tree

 

The decision tree appears to leave behind the return of secondary and incidental findings (when a study has agreed to provide), in branching to “Are the findings pertinent findings?”

With pertinent findings defined as those that were the object of the investigation, it doesn’t follow that the return of secondary and incidental findings flow to this question.

 

 

1. Introduction to Section 3

I thought this was particularly well written for the intended audience.

General Comments
Comments: 

This is a well-articulated and helpful document. It covers ethical considerations in genomics research clearly and efficiently. Focusing considerations relating to the sharing of genomic data more comprehensively at potential implications for the participant would strengthen the document. 

Page reviewed: 10 July, 2018