Just an educated guess, not over 0.05 FTE in each of sponsored programs and
Subject Protection (almost all in Human Subjects protection), to identify
"positive" responses and forward to the COI Committee.  Determining mere
presence of disclosure is part of the intake process for each
proposal/protocol; no FTE estimate.  Another 0.1 FTE for each of 3 senior
persons from Sponsored Programs, Industry Partnerships and Subject
Protection for gathering additional information.  Committee of about 15
spend 3 to 5 hours reviewing and meeting to make decisions.  Committee
Chair (an administrator) another 0.1 FTE (plus secretarial support, maybe a
further 0.1 FTE) beyond meetings to write responses detailing individual
Committee decisions, ranging from "no COI" to how to manage.  Possibly
another 0.5 FTE by administrators notifying NIH/NSF of "presence of COI and
management in place" for their affected awards.  Maybe another 0.02 % of
VP-R or other senior administrators related to a specific problem caused by
a state COI Act that has a process for providing an exception to what is
prohibited by the Act (which is having a contractual relationship with any
entity owned by any VCU employee; exception is provided for research or IP
development if considered in the best interests of the U.)

And the Committee chair and I (I'm preparing for retirement very soon)
another amount working on background matters leading to a new formal policy
(we are working under a proposed policy) and directing Committee regarding
background responsibilities they have as the "conscience" of the
University.  We're still developing our system!

Self report information is NOT followed up for accuracy except as it may be
developed in some of the interactions prior to Committee action.

Ensuring compliance with management is limited.  Mostly it is delegated to
Chairs and Deans except to the extent that specific action is required or
documented for specific proposals.  That's a problem we have to face sooner
or later, but we've got to get other things done first.

Our annual external research support is on the order of $185M.

I believe that an administrator CANNOT do the whole thing.  Basically, you
are dealing with ethical matters.  Ethical decisions must be made in the
context of the shared community values of the institution.  You need a
faculty committee (with administrator input) to define those values.  No
single administrator can do this.

As an example of that last, I am attaching, in confidence, a draft of a
charge we will polish and give the Committee in a few days.  It is provided
only to clarify how we go about this "shared values" matter.  I also
suggest that you may want to consider expecting conflicted individuals to
suggest appropriate management strategies, which might be accepted or
expanded on by the Committee.  This removes a lot of the feeling
researchers may have that management strategies are dictated.

For your information, most of our management is, "disclose, disclose,
disclose!"  Most of the situations we see are not egregious real conflicts,
but things which, if undisclosed, might appear to be conflicts that are hidden.

Chuck

At 09:36 AM 6/22/2004, you wrote:
>Hi Chuck,
>
>Thanks for all the helpful info.  I have a few other questions. It sounds
>like you guys have a great system in place.  How many FTE's are devoted to
>reviewing, collecting and following up on the disclosure of Conflict of
>Interest information?  Specifically what ratio of FTE to total dollar
>research dollar at the institution would  you guess is necessary to
>support a system like VCU has in place.  Currently we are doing about 100
>Million in research and will likely grow by 33% in the next 2 years.   As
>it stand only about 10% of my job is devoted to managing COI and the
>institution doesn't seem to understand why our system is failing.  Any
>suggestions/guidance you may have would be greatly appreciated.
>
>Thanks Again,
>
>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
>
>
> >>> xxxxxx@VCU.EDU 06/18/04 03:50PM >>>
>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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