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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
Cost recovery for human biospecimens – paragraph 3.4.12

My principal area of interest and expertise is in the area of biobanks for research and the ability to cost recover for supply of biospecimens and related data for research.The report generated by the Working Group which looked at commercialisation and human tissue (E103) was comprehensive in it's approach and identified some key issues of importance to Cost Recovery.  In particular, the report notes the need to address governance issues and provide ethical guidelines to clarify responsiblities.

I am concerned that HRECs may not be sufficiently resourced to make determinations on appropriate cost recovery schemes.  It is not clear from paragraph 3.4.12 whether cost recovery must have ethical approval in-principle or whether in fact the full detail of such a scheme is to be reviewed and approved.  Indeed, should the latter be true, then it follows that any change to costs must be submitted as an amendment to the relevant HREC (not necessarily a problem) but where problems will arise is if dispute arises around the quantum.  What appeal mechanisms will need to be in place?

Will the requirement be retrospectively applied?  It is not clear to me whether biobanks currently operating will need to submit their current cost recovery scheme for approval by the governing HREC or whether the requirement will be for new applications.

Page reviewed: 3 June, 2013