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

Personal Details
Organisation Name: 
Coalition for the Defence of Human Life
Additional Information
Organisation description: 
Ethics / Bioethics organisation
E. Submission
Submission methods: 
Online Submission (specific questions)
Comment on specific Sections
Specific Comments: 
Chapter 3.4_6 paragraph 3.4.10

It seems to be a very broad exemption to allow an HREC to waive the need for consent to the use of human biospecimens simply on the grounds that the specimens were 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 -talen for the purpsoe of autopsy prior to or in conjunction with organ donation - were retained and subsequently used for unrelated research. If biospecimesn taken for diagnostic purposes are a desirbale 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 palce for diagnosis.

Chapter 3.4_6 paragraph 3.4.16

This provision is very welcome. 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 could be clarified by inserting the phrase "whether generally or of a particular kind or derivation" after the word "biospecimens". This would avoid a possible interpretation taht the right to conscientious objection only applied to those who had a broad objection to invovlement with any human biospecimens.


Page reviewed: 4 September, 2012