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National Statement on Ethical Conduct in Human Research Chapters 3.4 & 3.6 submission

Personal Details
Organisation Name: 
Bioethics Committee, St Vincents and Mater Health, Sydney
Additional Information
Organisation description: 
E. Submission
Submission methods: 
Online Submission (specific questions)
General Comments

Thank you for the invitation to comment further on these parts of the National Statement.  In preparing this submission we draw on both our previous submissions and discussion with colleagues.

Re Chapter 3.4_6

1                     The term ‘human biospecimen’ conflates (a) human tissue with (b) human tissue product/human tissue attenuated product.  We recommend that this term be dropped and these self-explanatory terms be used (even though this will make the text a little longer): clarity is part of ethical soundness.  The glossary of terms should be revised accordingly.

2                     As it stands, the heading ‘Uses of human biospecimens in research and application of this chapter’ does not make sense to us.   Is the heading intended to indicate that it is about use of human tissue/human tissue products in research and in clinical practice? If so, then that would be worth making explicit. If not, and the section is intended to be about the use of human tissue/human tissue products in research only, then we recommend that their use in clinical practice also be specifically addressed: there is an enormous amount of clinical/therapeutic work with stem cells going on around the world: the NS should address this. Indeed human tissue/human tissue products stored in biobanks could themselves be used for clinical purposes (and not just for research): the revisions focus exclusively on ethical issues associated with their use in research.

3                     We recommend that the current advice, in Chapter 3.6 of the National Statement, to the effect that the clinical use of stem cells, whilst it holds great therapeutic potential, also carries significant risks, be restored. It is common knowledge that people travel overseas for stem cell ‘therapies’ which have not been subjected to our own Australian standards of ethical review.   Reference in the National Statement to the potential risks currently inherent in stem cell therapy would strengthen the arm of clinicians engaging with people contemplating going overseas for such a treatment. 

4                     Re ‘Commercial uses of human biospecimens’: We recommend revision to the first sentence in this paragraph because, as it is currently written, it implies some difference between ‘persons’ and their bodies: we suggest you delete the words ‘and their bodies’.

5                     We recommend that the guidelines here make explicit the idea that researchers must (as part of the information process) convey to potential participants that human tissue remains in principle identifiable.  

6                     We recommend that 3.4.4 (c) (v) be revised to say: ‘not give rise to a reasonable perception that the human body is being commodified’.

7                     We recommend that 3.4.6 be revised so that the responsibility falls on the HREC to assure itself that the researchers have considered the likely impact on the donor(s), their families, and relevant others.

8                     We do not support 3.4.8: it goes against the spirit of recognizing that all genetic material is in principle re-identifiable and thus against the contemporary and sound norm for research practice that respect for individual privacy is of paramount importance.

9                     For the same reason, we do not support the inclusion of 3.4.9: since human genetic material is in principle re-identifiable, research involving it should go to full ethics review.

10                 For the same reasons, we do not support 3.4.10.  Its premise again seems to be the (false) idea that, if markers are removed, human genetic material is not re-identifiable.

11                 In 3.4.11 delete ‘discover’ and replace with ‘uncover’.

12                 Re 3.4.16: This clause needs to be further clarified.  We assume that it refers to researchers rather than to research participants (for whom the possibility of conscientious objection should already have been covered by the consent process).

Page reviewed: 4 September, 2012