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

This submission reflects the views of
Organisation Name: 
General Ethical Issues Sub-Com of Alfred Hospital Ethics Com
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Specific Comments

Introduction, paragraph 2, says that the definition of ‘human biospecimens’ “does not include extraneous material such as micro-organisms that live on or in a person”.  However, acquiring such material may involve processes similar to those used to acquire biospecimens.  Earlier on, the introduction speaks of research involving biospecimens requiring “special ethical considerations because of … the way the biospecimens are obtained” – why would these considerations not extend to other ‘extraneous material’ which might also be obtained in a similar way?

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

Section 3.4.6: Add the underlined words: “Researchers, institutions, and other organisations that hold biospecimens have a responsibility to ensure that any research involving human biospecimens is given ethical consideration in accordance with this National Statement.”  The reason for this addition is to reinforce the importance of ethical review to organisations that don’t conduct research (or have their own ethics committee) but do hold specimens – such as pathology labs.

Section 3.4.9: This addresses the further use of previously obtained biospecimens with consent for research use.  Point (b) specifies that “the donor/s cannot practicably be identified by those using the biospecimens”.  Perhaps this could be more flexible because it might be that donors have given their consent to the use of identified samples in future research.  If that research is very low risk and will not generate information relevant to the donors (as required by (c) & (d)), there seems no reason to exclude ‘consented’ identified biospecimens.

Section 3.4.11: This section - on consent waivers for ‘unconsented’ biospecimens - would be much clearer if it was separated out into dot points or sub-sections.

General Comments

General comments and suggestions

1. The proposed revised chapter is largely focussed on the prospective collection of biospecimens for research.  It is considered that more attention needs to be given to existing sources – e.g. stored biospecimens originally obtained for a clinical purpose – and to the banking of biospecimens for research.

2.The accepted approach to the use of stored biospecimens should be that these are not released and/or used in (further) research without some form of ethical approval of the proposed research.

3. Ethical consideration of the establishment of a biobank and its primary function should separate to ethical consideration of further use of the resource for other/future research.

4. The proposed revised chapter refers to additional ethical guidance on biospecimen use in Chapter 3.2 Databanks.  It would be preferable to have a ‘Biobanking’ sub-section in the new chapter, with references to relevant points in Ch 3.2, rather than treating biobanks and databanks as if they were interchangeable.  See also comments in point 3.2 below.

5. It would be helpful to make a distinction between the following sources of biospecimens:

(a) formal biobanks, established for research purposes

(b) repositories of samples collected for clinical testing, such as hospital pathology departments, commercial pathology services, etc.  These facilities are increasingly being recognised as a source of biospecimens but access/release for research use is largely unregulated in commercial facilities and at the discretion of directors of pathology in hospitals.  Reasonable guidelines need to be established for the access to/use of these sources.

(c) surgical tissue and test samples (e.g. ‘by-products’ such as urine, sputum) for discard.
A ‘generic’ consent, via a hospital’s standard surgical consent form, for the use of non-identified surgical tissue (which would otherwise be discarded as surgical waste) in ethically approved research, is a simple way of making this valuable resource accessible.  Such research might often be appropriately subject to non-HREC review (depending on the type of biospecimen and whether there are associated sensitivities).

6. Independent pathology facilities should be required to sight approval from a properly constituted HREC before releasing samples for research purposes.

7. The use of an opt out consent process may be appropriate to enable access to some biospecimen collections; e.g. collections associated with a registry.

Page reviewed: 3 June, 2013