I am involved in a "big database-s" clinical trial project - where I have good reason to believe there has been a potential violation(s) of patient informed consent. I plan to share details in an upcoming amstat news article - I will skip the longer discussion of the "big databases" for this question. And in advance, I have notified the relevant stakeholders and database owners of the potential violation. I would appreciate advice from the section members as to who are the individual(-s) or what are the entities - considered to be the most authoritative experts on ethics of, conduct of clinical trials in humans. and that includes appropriate definition and use of informed consent for pharmaceutical clinical trials. I know of some resources with links below. I'm basically looking for the perhaps up to five individual(s), or the entities considered to be experts in clinical trial ethics (sometimes called bioethics).
A recent example of the relevance of trial design and conduct ethics and informed consent, were all of the Vaccine phase III. At the public (zoom) FDA advisory hearings - Dr Steve Goodman from Stanford (and a few other experts) described the ethical issues of vaccine trial conduct, and the implications for patients about detecting a favorable vaccine effect and unblinding at an interim. And there was discussion at advisory of the research interest of trial sponsors and FDA and others about the implications of unblinding the trial and patients on placebo-vaccine should "cross over" and receive active vaccine. Goodman's (and other experts) specific comments about informed consent will be in the transcripts of the advisory hearing.
Thank you
My sources from google searching
NIH
https://clinicalcenter.nih.gov/recruit/ethics.html UPenn has a center for medical ethics
https://medicalethicshealthpolicy.med.upenn.edu/medical-ethics On a google search SANOFI has a public description of clinical trial ethics, but the document does not give specific names of people
ttps://www.sanofi.com/dam/jcr:36096c9d-5748-4c8a-a830-4e41473540ee/Medical-Ethics-Bioethics-and-Clinical-Trials.pdf
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Chris Barker, Ph.D.
2022 Statistical Consulting Section
Chair-elect
Consultant and
Adjunct Associate Professor of Biostatistics
www.barkerstats.com---
"In composition you have all the time you want to decide what to say in 15 seconds, in improvisation you have 15 seconds."
-Steve Lacy
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