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National Statement on Ethical Conduct in Human Research 2007 Human biospecimens submission

Personal Details
First Name: 
Last Name: 
Additional Information
Individual Background: 
Researcher – biomedical
Specific Comments
Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

In reference to section 3.4.9. The further use of human biospecimens previously obtained with consent for their use in research may
be regarded as being of low risk, and hence subject to non-HREC review (see paragraphs 5.1.18-21,
page [to be inserted in final layout]) If:

I do not have access to paras 5.1 etc but would propose that any non-HREC review provisions need to formally consider the crieria for low risk status as not all further/secondary use is low risk, and many consent forms i(at least in canadian research) that collect biospecimens state that 'your biospecimens will only be used for research approved by an REB/HREC'. Therefore;

1. risk of loss of privacy may be low for indiivudal projects but combinations of anonymous data from two low risk studies may create higher risk (eg a very rare tumor type associated with year of diagnosis and genomic data might be noted in one study and the same very rare tumor associated with an unusal surgical approach in another would create a small but raised risk of identifciation by a close relative or assocaited physician). This risk is very rare itself and can be adequately assessed by an appropriately structured and knowledgable review process associated with the biospecimen source (ie appropriately governed/consitituted biobank review) and does not neccessarily require review by an HREC, but needs to be considered in the provisions of section 5.1..

2. in 3.4.9.a may need to state that both the nature and the new research proposed are both consistent with the committment on the orginal consent. This is perhaps covered in 3.4.11 but needs clarification


General Comments

I fully support 3.4.12

Page reviewed: 3 June, 2013