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

ID: 
11
Personal Details
First Name: 
Merle
Last Name: 
Spriggs
Additional Information
Individual Background: 
Ethicist
Specific Comments
Comments: 
Potential for identification

This is not clear in terms of the potential for identification (e.g. for whom is the cost or effort of re-identifcation prohibitive?)  

Prospective collection of human biospecimens for research – paragraphs 3.4.1 – 3.4.4

How or where can those ‘proposing to collect human biospecimens prospectively for research’ acquire the required ‘understanding of the ethical issues’?

3.4.4 (a) – Point (a) is a key point in relation to the information provided to people before they consent to donation of biospecimens and where extended or unspecified consent is sought.  Given that this is a guideline, it warrants a clear statement with complete sentences rather than ‘to meet the requirements of paragraphs 2.2.1 and 2.216. It would make sense to note at this point in the guidelines that people need sufficient information and adequate understanding of both the proposed research and the implication of participation in it – and that the wide-ranging implications of unspecified consent are clearly explained .  

3.4.4 (i) – Additional questions: Will those who would benefit have access? Could the cost be prohibitive for those who would benefit?

Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

3.4.10 (d) What is the ethical significance of research results generated in the primary researcher’s lab or through secondary analyses by other researchers (i.e. the reason that this is a consideration in the plan to be approved by the HREC) 

General Comments
Comments: 

I would like to comment on custodians in relation to biospecimens.

I am part of a research team with [third-party information removed by NHMRC] which has recently conducted a pilot study on ethical responsibilities in paediatric biobanking (not yet published).  We conducted key informant interviews with people selected for their expertise in the area of paediatric biobanking (researchers, reviewers of research and others involved in developing guidelines/policy).  Despite their expertise and the guidance in the National Statement, informants demonstrated uncertainty about the role of the custodian at the level of practice.  They were unclear about:

  • Who is the custodian?
  • Who should be the custodian?
  • What is the custodian’s role?
  • What is the extent and what are the limits of the custodian’s role?

Some thought the custodian is the researcher, some thought it is the person in charge of the samples and some suggest it is a role for the HREC – just as the HRECs will be asking about ‘robust processes for storing etc’ and ‘pain administration procedures’.  In terms of biospecimens as a scarce precious resource, this raises questions such as who can samples be released to and who should be deciding.  Is a well-designed study and HREC approval an adequate reason to give out a scarce a precious resource such as brain tumour samples?

Page reviewed: 3 June, 2013