Charles E. Graham, Ph.D. writes:

>In our
>discussion we realized there is no readily definable end to the list of
>individuals who _could_ have a disclosable conflict of interest, including
>not-yet-recruited graduate students. One of the problems becomes how to
>ensure these unidentified individuals consider whether they should make a
>disclosure.

 Our interp. of the regs is that they cover all persons involved in
 the conduct and reporting of research/research results, e.g., PIs,
 co-PIs, techs, post-docs, grad/med/dent students, visiting faculty,
 etc.  The only place where sufficient familiarity with the situation
 exists, is at the dept./div. head level.  Hence we're placing the
 responsibility of deciding who fills out the disclosure forms on the
 shoulders of the dept. heads.

>As we consider this issue here, I am wondering whether to extend the
>disclosure requirement to named investigators "and other key personnel".

 What exactly is a "key personnel"?  Without a succinct definition
 you run the risk of inconsistent application of the policy.

>To make this work, the PI would sign an assurance on the Proposal Routing
>and Approval Form saying "I have read the financial disclosure policy
>will ensure that my associates on this project are informed of the
>requirements for disclosure" (I recognise the language needs refinement).
>Given the difficulties, I don't see much alternative to shifting some of
>the burden to the PI, as in fact we do for some other compliance issues
>(e.g. disbarment), if we wish to be more inclusive.

 Shifting responsibility is fine, as long as the "shiftees" take
 the responsibility seriously.  For years, UCHC's proposal approval
 form has had a PI certification that "all project staff have read
 the proposal".  I'm sure you know the rest of this story...  I can't
 tell you the number of times "madder'na wet hen" investigators have
 complained because they didn't know they're names were listed in an
 app.

>I would be interested to know if others think this is a
>workable and reasonable improvement on the minimalist "named investigator
>approach" that at least shows a genuine effort to cover other personnel.

 I guess one  question to ponder is where do the feds place the
 responsibility for compliance?  As I read the regs, the responsibility
 is with the grantee.  If you shift the responsibility to the PIs, the
 you'd better have a way to ensure that the responsibility will be
 taken seriously.  We think that delegating the responsibility to
 dept. heads is more realistic, because then it might get done, and
 there is a somewhat greater degree of accountability at that level.
 Its also easier to audit and enforce departmental compliance, than it
 is for PI compliance.

This is a great discussion topic!  I hope more folks check in with their views
and how their policies address this and related COI issues.

Len

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Leonard P. Paplauskas    Assistant Vice President for Research     |
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FAX 679-2670             Farmington, CT   06030-5355               |
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