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

ID: 
14
This submission reflects the views of
Organisation Name: 
Coalition for the Defence of Human Life
Personal Details
Additional Information
Please identify the best term to describe the Organisation: 
Ethics / Bioethics organisation
Specific Comments
Comments: 
Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

Paragraph 3.4.11 proposes that "Where identifiable human biospecimens were obtained without consent for research (e.g. in a clinical investigation), or where the proposed research is not consistent with the original consent, the human biospecimens may be used only if an HREC is satisfied that the conditions for waiver of consent are met (see Chapter 2.3: Qualifying or waiving conditions for consent)." 

This approach allows a fairly broad use of human biospecimens originally collected for diagnostic purposes rather than for research. Most people would not be anticipating that a biospecimen taken for diagnostic purposes would subsequently be used for research. I am familiar with the distress of family members of organ donors who subsequently learned that the brains or parts of the brains of the donor -taken for the purpose of autopsy prior to or in conjunction with organ donation - were retained and subsequently used for unrelated research.

If biospecimens taken for diagnostic purposes are a desirable and useful source of biospecimens for research then obtaining consent for such use should be made part of the consent process to taking the biospecimen in the first place for diagnosis.


Introduction

"However, once stem cell lines or tissue products have been derived under a licence, they should be considered in the same way as other human biospecimens covered in this chapter."

This is an extraordinary statement from an ethical point of view. The original means of deriving a stem cell line or tissue product has profound ethical implications for its subsequent use. 

The previous draft for a revision of Chapter 3.4 acknowldged this by providing protection for staff in research facilities who exercised a conscientious objection to working with cell lines derived in what they considered to be an unethical manner, notwithstanding they were obtained legally and in accordance with relevant NHMRC guidelines.

Such a provision is necessary and should be included in this revision.

As cell lines are increasingly being derived by or in association with the intentional killing of human persons at the embryonic or fetal stage it is vital that ethically upright persons be entitled to refuse any involvement in research or experimentation using such cell lines.

The provision should read "Those who conscientiously object to being involved in conducting research with human biospecimens, whether generally or of a particular kind or derivation, should not be obliged to participate, nor should they be put at a disadvantage because of their objection."

Page reviewed: 3 June, 2013