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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: 
56
This submission reflects the views of
Organisation Name: 
Australasian Leukaemia & Lymphoma Group
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3

in one pager attachment

2. Chapter 3.1

in one pager attachment

3. Chapter 3.5

Greater clarity and detailed information surrounding the area of genomics. It is clearer for researchers how best to handle data, and the return of any such relevant research findings. 

3. Chapter 3.5

3.5.32 Results or findings to be validated in a NATA accredited lab. Very clear validity requirement guideline.

3. Chapter 3.5

3.5.33 Researchers are required to consider genomic findings within their project design.

This is an important aspect to research having the researcher take onus and some responsibly for findings.

Researchers accessing samples and performing research should be provided with and fully informed of the research organisations EDP.

These NHMRC guidelines will assist uniformed EDP development and implementation, the flow diagram shows a clear guideline outlining the process.

3. Chapter 3.5

3.5.37/3.5.38 Obligation to return and analysis of data related to participant information ceases at end of project.

It should be noted that some research does not begin for many years post end of trial and this will be difficult define. 

3. Chapter 3.5

3.5.39.18 Noted that researchers should indicate the timeframe for establishing validity and return of research findings.

This may be difficult to ascertain a timeframe as some results may take longer than others to validate. 

3. Chapter 3.5

3.5.39.19 Research findings should be respected and confirmation of participant preference not to receive information should be respected.

Previous guidelines required that regardless of participant wishes at time of consent, participant was required to be contacted and asked if they wished to receive findings. This guideline is now clearer for researchers and demonstrates greater respect for the participant giving an informed consent for any such relevant research findings to their own person.

2. Chapter 3.1

3.1.38 Data collected, stored or disclosed as identifiable, re-indentifiable, or non-identifiable data

The National statement does not use the term de-indentified data as its meaning is considered unclear. Noted that the guidelines differ from the legal language context but it is difficult in the context of research to make them consistent/the same. We do not consider it a requirement to make these consistent.

Duration and storage of samples. Some countries are now giving the participant the option to decide the length of sample storage at time of consent eg: Korea. The period of research and storage of sample should be considered within the project development.

Research findings/return of results, what is considered a significant’ result is unclear? Should this be disease specific and may need to be defined within protocol.

Of note researchers who might want research a certain population eg: Aboriginal or Torres Strait Islander people clearer information via the Guidelines for Ethical Research in Australian Indigenous Studies (GERAIS) produced by the Australian Institute of Aboriginal and Torres Strait Islander Studies are available.

The proposed changes all seem to be well informed and thorough and will assist further in guiding research in the future.

General Comments
Comments: 

in the one pager attachment

Supporting attachments

Page reviewed: 10 July, 2018