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

ID: 
24
Personal Details
First Name: 
Mary
Last Name: 
Winkels
Specific Comments
Comments: 
Introduction

National Statement on Ethical Conduct in Human Research 2007 Human Biospecimens

Submission

Thank you for the opportunity to comment on the proposed amendments to the third chapter of the National Statement on Ethical Conduct in Human Study.

Some of the changes are certainly welcome, however in general I find the amalgamation of the two chapters to have created some obscure sentences and omitting important points. Further changes are needed to include all relevant information regarding stem cells; alongside all other human tissue. I find that the ‘human biospecimen’ is not a sufficient term to cover all contexts for ethical consideration here.

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

The welcome changes include 3.4.1, the listed prospective necessary for research and 3.4.4, the information necessarily given to people who donate human bio-specimens, although this section also has some serious limitations. Also an improvement is 3.4.12, under the new title ‘Cost recovery for human biospecimens’ and sentences 3.4.14 and 3.4.15 under “Import and Export of human biospecimens’, all of which are not mentioned in either 3.4 or 3.6 of the current statement. The implications of each those points are clear; the inclusion of 3.4.1 is a clear reminder the standards maintained in human research must include sound scientific purpose and standards alongside the ethical considerations of the handling and obtainment of human biospecimens, while 3.4.13-3.4.15 expands upon the current sentence 3.4.4 regarding imported tissue from overseas and the ethical review thus necessary of the origins of  now all human biospecimens obtained from overseas in keeping with the Australian National Statement of Ethical Conduct in Human Research. 3.4.12 is also well to be included as this now includes the need for an HREC to assess the cost recovery at all stages of the process from collection, handling through to distribution of human biospecimens.

Import and export of human biospecimens – paragraphs 3.4.13 – 3.4.15

Among those guidelines omitted are most notably the removal of the current statement “There should be no trade in human tissue for research purposes”, and its topic heading ‘Commercialisation’. While the reviewed edition allegedly does not allow for the trade of human tissue (question 7 of the Q and A for the Public Consultation) this statement must be re-included as a necessary safeguard and for clarity of the subject.

General Comments
Comments: 

3.6 Human Stem cells

The other serious statement to be omitted is 3.6.7: “Those who conscientiously object to being involved in conducting research with embryos, foetuses or embryonic or foetal tissue should not be obliged to participate, nor should they be put at a disadvantage because of their objection.”

My concern is that the term human biospecimen is too broad to allow for adequate ethical consideration to be given to human species derived from embryonic and foetal tissue, for which some may still find themselves ethically opposed to in ways not equivalent to other human tissues collected or derived. While the tissue once collected or derived from embryos is governed by this chapter and not the first obtainment of embryonic and stem cell tissue, conscientious objections may still hold and this must be given necessary inclusion in the proposed chapter.

 

In brief, while the changes may appropriately simplify guideline applications in the experience of researchers and clinicians in various contexts, the amended changes risk losing important statements and confusing the meaning at times. In particular, the move to amalgamate the two chapters under the heading ‘human biospecimens’ must not remove or obscure the content within the current chapters, especially in relation to the use of embryonic tissue. The declared ban on trade in human tissue must be included once more.

Page reviewed: 3 June, 2013