1. Forum on Conflicts of Interest in Academe: September 16-18, 2007 Camille A. McWhirter, J.D. Director, Research Compliance USF Health

2. Composition of Forum 166 attendees/5__ institutions 166 attendees/5__ institutions COI Committee Chairs (M.D.s), COI Administrators, Vice Deans and VPs for Research COI Committee Chairs (M.D.s), COI Administrators, Vice Deans and VPs for Research Johns Hopkins (host), AAMC, NIH, UMich, WashU, Emory, Northwestern, UAB, MD Anderson, Mayo Clinic, Duke, UNC-Chapel Hill, Stanford, UPitt, Cleveland Clinic were all prominently represented (presenting or had 2 or more attendees) Johns Hopkins (host), AAMC, NIH, UMich, WashU, Emory, Northwestern, UAB, MD Anderson, Mayo Clinic, Duke, UNC-Chapel Hill, Stanford, UPitt, Cleveland Clinic were all prominently represented (presenting or had 2 or more attendees)

3. Current Topics and Trends Institutional COI (only 35% of institutions have an ICOI policy, expected to double by next year’s meeting) Institutional COI (only 35% of institutions have an ICOI policy, expected to double by next year’s meeting) Policies on COI in Clinical Practice (influence of industry on decision-making in clinical practice via gifting and other support to medical profession) Policies on COI in Clinical Practice (influence of industry on decision-making in clinical practice via gifting and other support to medical profession) COI in Medical Education (meals, site access, gifts, travel opportunities, CME sponsorships— how much will we tolerate?) COI in Medical Education (meals, site access, gifts, travel opportunities, CME sponsorships— how much will we tolerate?)

4. Current Topics and Trends (con’t) Recent research data on industry influence, reciprocation and effect of disclosure on research subjects Recent research data on industry influence, reciprocation and effect of disclosure on research subjects Media perspectives on COI Media perspectives on COI “Reporting” versus “Disclosure”. “Reporting” is what employees do internally to advise employer of their outside activities. “Disclosure” is what the institution or individuals do publicly to make the community aware of the outside activity (informed consent, statements in journals, etc.) Terms are currently used interchangeably--trend will be to apply these definitions universally. “Reporting” versus “Disclosure”. “Reporting” is what employees do internally to advise employer of their outside activities. “Disclosure” is what the institution or individuals do publicly to make the community aware of the outside activity (informed consent, statements in journals, etc.) Terms are currently used interchangeably--trend will be to apply these definitions universally.

5. Current Topics and Trends (con’t) Online reporting, user friendly policies and procedures— ”just tell me what I have to do” Online reporting, user friendly policies and procedures— ”just tell me what I have to do” Overlooked area of COI where a faculty member works on a research project in which the faculty member’s supervisor has an interest Overlooked area of COI where a faculty member works on a research project in which the faculty member’s supervisor has an interest Complexity/avoidance of sub recipient COI monitoring, notwithstanding NIH targeted site focus on this area Complexity/avoidance of sub recipient COI monitoring, notwithstanding NIH targeted site focus on this area NIH expects more focus by OIG on COI in institutions in future work plans, states: “It is critical that we base research decisions on scientific evidence and not on inappropriate influences”. NIH expects more focus by OIG on COI in institutions in future work plans, states: “It is critical that we base research decisions on scientific evidence and not on inappropriate influences”.

6. Proposed USF Response Substantial COI policy and process revisions: Substantial COI policy and process revisions: –One universal COI policy covering outside activities generally AND financial interests in research –On-line reporting system –Implement annual and transactional reporting –Make access to information and reporting more user-friendly

7. Proposed USF Response (con’t) Develop and implement an Institutional COI Policy Develop and implement an Institutional COI Policy Develop a Policy on COI in Clinical Practice and Medical Education Develop a Policy on COI in Clinical Practice and Medical Education Identify and implement effective means of sub recipient monitoring and reporting to NIH Identify and implement effective means of sub recipient monitoring and reporting to NIH Consolidate COI Committees and expand membership and duties of University COI Committee to include review of all types of COI and not just financial interests in research Consolidate COI Committees and expand membership and duties of University COI Committee to include review of all types of COI and not just financial interests in research