This item from retraction watch crossed my news radar, a very important change to the Declaration of Helsinki. The addition of "research integrity" and "research misconduct"

https://retractionwatch.com/2024/10/28/declaration-of-helsinki-revision-adds-nod-to-research-misconduct/

excerpting -----------------------------------------------------

Declaration of Helsinki revision adds nod to research misconduct

The Declaration of Helsinki on ethical principles for research involving human participants now includes a statement on scientific integrity and research misconduct. 

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A sheer coincidence.  i will not provide further details - other than.  I have at a prior time reviewed a paper in a disease specific journal where I noted in comments for the editor that I had substantial ethical concerns about the lapses and errors in the statistical methods in light of the fact that "patients had sacrificed to participate in the clinical trial". 

Those of us who review for medical and related journals as appropriate, may already request to have authors provide a copy of the informed consent. 

Generally throughout all the clinical trial work in humans I did in my  pharma career before I retired. It  was routine for all involved in the  clinical trial (medical, regulatory , manufacturing (CMC) , statisticians, pk, data managers, and others as needed) in addition to the attorney's to review the informed consent before it was finalized and sent to the clinical investigators for patients to sign.

-thx

--chris

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Chris Barker, Ph.D.
Past Chair
Statistical Consulting Section
Consultant and
Adjunct Associate Professor of Biostatistics
www.barkerstats.com


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"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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