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  • 1.  Conflict of Interest

    Posted 02-Jan-2020 17:35

    An investigator is all of the above:
    * the Prime Awardee on the Department of Defense grant,
    * the CEO of the company running the study,
    * the Chair of the IRB that approved the study
    * the reviewer and "approver" of the IRB protocol application
    * the PI of the FDA-regulated cancer study
    * the spouse of the Co-PI
    * the Co-PI/Spouse is the Co-founder of the company
    * the Co-PI/Spouse is the Vice Chair of the IRB
    * the IRB was made for the company of the PI so that they could approve their own studies.

    This PI has left our institution and is asking for us to transfer the study over to their new company and claim their IRB has approved it.

    The study is now closed to enrollment with no research related interventions. They just want to use the samples and data to finalize their work with the DoD (analysis, etc.) but will use the samples for future research work.

    Thoughts?



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    Tamiko Eto
    Acting Director, HRPP Manager, IRB Chair
    Menlo Park CA
    United States
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  • 2.  RE: Conflict of Interest

    Posted 02-Jan-2020 22:32
    I"m confused by the situation as you describe it.  If the study is with your institution (so it must be transferred to the new company):

    How is the CEO still running the study if he has left your institution?  Was the he running the study when he was with your institution? 
    Wouldn't your IRB have had to approve it?  Were the CEO and spouse chair and co-chair of your IRB at the time?





    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 3.  RE: Conflict of Interest

    Posted 03-Jan-2020 02:55
    Hi Tamiko.

    Hmmm sounds like a complicated situation.  My first reaction is the PI says they have approval from the new IRB, I would definitely ask first for their approval or document showing this as such.  If the study is done recruiting and enrollment is closed, then I guess my other question is what is the new IRB looking at?  If the PI is going to only doing analysis, then it should centre around the data analysis plan.  A final thought is sounds not so much a regulatory issue as much as a business issue, because of patient data protection, access to data, who would be publishing the study, etc.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Conflict of Interest

    Posted 03-Jan-2020 07:02
    Dear Tamiko,

    You are certainly correct in raising a conflict of interest concern, and it may rise to level of whistleblower reporting (hate to use that term, but it fits here).  This is due to the malfeasance of the principals involved, despite the fact that the study is closed although you state that they want to continue their work with the DoD and use the "samples" for further research.  You do not state whether this is a drug or device.

    The regulation concerning the membership of IRBs (21 CFR § 56) is clear, and it is a straightforward case that the IRB you describe is likely violating it.  You do not mention the other composition of the IRB, but it must include at least 5 members who are socially diverse, non-discriminatory, and knowledgeable of the subject's condition.  The most salient clause of the regulation is 21 CFR § 56.107(e), which states "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB."  It would appear that there are at least 2 members of the IRB that would have a conflicting interest.

    Regards,
    James

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    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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    Original Message


  • 5.  RE: Conflict of Interest

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jan-2020 09:18
    This message was posted by a user wishing to remain anonymous

    I am curious to see what other posters have to say about this. I had a similar situation (although not quite so many potential conflicts) with a client who told me they had their own IRB, of which the CEO was the chair, PI, protocol author, paten holder and application submitter, etc. My knee-jerk reaction is that it is a conflict of interest...but, there are 8 members of an IRB, and you only describe 2 of them as having a potential conflict. Shouldn't the other 6 be objective and decide what is appropriate by reviewing the submitted info about potential conflicts? If the IRB determines that a conflict exists that could influence or jeopardize the well being of subjects, the IRB may require additional information about the conflict or may require that the conflict be resolved before research is approved. Or, they may decide that the conflict is acceptable or non-existent. In the real world, I had to roll my eyes at that, because I assume the other 6 IRB members are just "Yes-men" who are there for the sole purpose of approving the study. But, the arrangement might still be in keeping with the letter of the law.
    Original Message


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