Currently VCU has a Draft Research Conflicts of Interests Policy built on a
previous COI policy conforming to NIH/NSF regulations.  The Office of
Research is implementing COI review in accordance with it.  It refers to
individual COI only.

We DO require a disclosure with EACH research proposal and each IRB and
each IACUC protocol.  We cannot meet DHHS or NIH COI requirements without a
disclosure for each proposal to those agencies.  We cannot meet DHHS
guidance for IRB related COI without a disclosure for each protocol.  The
disclosure form is attached.

The form provides for noting all proposals/protocols (by internal number)
to which it applies.  We also have office procedures for cross correlating
when COI disclosures for related items come in at different times, and are
improving our crosswalk procedures in our Research Office information system.

We must meet two basic externally imposed COI policies; an "ethical" one
concerning COI that might appear to affect the planning, conduct and
reporting of research (note the words from federal regulations -- we apply
them to all organized research and protocols.  We must also meet a state
COI law which precludes agreements where ANY VCU employee has a financial
interest in the agreement other than his own contract of employment.  There
is a procedure for exception to this, but COI Committee has to see the COI
disclosure before this is implemented.  (There is a hole in our disclosure
process in that we cannot pick up this prohibited relationship unless the
PI who submits knows of the relationship, though we often pick it up
because administrators who handle the disclosures often do know of these
relationships if the PI does not -- but not always.)

We also have two standards of the level of financial interest that triggers
review/management: $10,000/ yr and or 5% equity (3% for state) is basic,
but we have a 0 standard in cases involving human subjects.

You are right that cross checking, followup and review is labor intensive,
but we find no other way to meet federal regulations (and we have elected
to apply essentially those regulations to all activities) except case by
case reporting.  And we find no way to collect valid information except by
self-report.  We do consider it a breach of scientific misconduct to
provide a knowingly false report, and there are additional criminal laws
applicable to a state employee knowingly supplying a false certification of
anything related to job responsibilities.  (Hope we never have to use that
last big stick, but it is there!)

We have found that certain COI relationship situations recur, and our COI
Committee has adopted the practice that identical management applies in
like cases; this speeds that part of the review/management.

Chuck

At 02:30 PM 6/18/2004, you wrote:
>Hello Everyone,
>
>Our institution is thinking about revising our Conflict of Interest
>Policies and Procedures.  We are curious how other institutions handle the
>disclosure of information.  Currently we require that all key personnel
>complete a COI form when a proposal is submitted to outside funding
>sources.  As you can imagine this a paperwork and follow up hell.  We are
>looking for a more streamlined approach and would appreciate and guidance.
>
>
>Thanks,
>
>Anita
>
>
>_____________________________________
>Anita Mills, MA, CRA
>Regulatory Affairs Coordinator
>Cincinnati Children's
>3333 Burnet Avenue
>Rm  3327, ML 7040
>Cincinnati, OH 45229
>(513) 636-6714 -- Phone
>(513) 636-1321 -- Fax
>
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Herbert B. Chermside, CRA
Special Asst. to VP-Research
Virginia Commonwealth University
PO BOX 980568
Richmond, VA  23298-0568
Voice:  804-827-6036
Fax     804-828-2051
e-mail xxxxxx@vcu.edu

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