Re: Conflict of Interest Management Herbert B. Chermside 18 Jun 2004 14:50 EST
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 > >====================================================================== >Instructions on how to use the RESADM-L Mailing List, including >subscription information and a web-searchable archive, are available via >our web site at http://www.hrinet.org (click on "Listserv Lists") >====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
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 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================