Page 1025 - Week 03 - Thursday, 10 April 2014
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HREC Review of the Amended Stem Cell Treatment Research Proposal
HREC concluded that the amended research proposal failed to satisfy the Code criteria in Research Merit and Integrity, Justice, Beneficence and also Respect. Specifically:
Research Merit and Integrity
- No justifiable benefit to participants or contribution to knowledge and understanding of the condition being studied.
- Methods not appropriate to achieve aims of proposal.
- No basis in literature or previous clinical trials.
Justice
- Recruitment process not well defined and not supported by Department.
Beneficence
- Potential benefit of participation does not justify risk of harm to participants.
- Study design lacks integrity, does not clarify risks to participants and their welfare.
Respect
- Concern that self-selected patients have been misinformed regarding the nature of the proposed therapy. Specifically, there is limited insight regarding the experimental nature of the therapeutic regimen and therefore the requirement for its evaluation in a well-designed clinical trial.
I have no reason to question the independent decisions of the HREC. ACT Health has constituted its HREC in accordance with the Code and membership includes an independent chairperson, lay people, current researchers, health care workers from a variety of professions, including medicine, pharmacy, nursing and midwifery, a minister of religion and a lawyer.
It is open to the researchers to put forward a third research proposal for the HREC to consider. The HREC may approve, require amendment of, or reject that research proposal on ethical grounds and it will do so once it is sufficiently informed on all aspects of the research protocol (including its scientific and statistical validity) that are relevant to deciding whether the research protocol conforms with the Code and is acceptable on ethical grounds.
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