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You Have a Conflict of Interest: Now What?Sponsored bythe Conflicts of Interest and Transparency Affinity Group (COIT AG) of the Teaching Hospitals and Academic Medical Centers (TH/AMC) Practice GroupFriday, December 2, 2011 12:00-1:00 pm EasternPresenters: Juliann Tenney, Institutional Research Compliance Officer, Director, Institutional Research Compliance Program, HIPAA Privacy Officer, University of North Carolina at Chapel Hill, Chapel Hill, NC, juliann_tenney@unc.eduKristin H. West, Associate Vice President and Director, Office of Research Compliance, Senior Associate General Counsel, Office of General Counsel, Emory University, Atlanta, GA, kwest02@emory.eduModerator:C. Elizabeth O’Keeffe, JD, MPH, LLM, CHC, CHSP, Associate General Counsel, Office of General Counsel, University of Mississippi Medical Center, Jackson, MS, Email@umc.edu
Managing Financial Conflicts of Interest Impact of the New PHS Rule
Overview Focus – Individual Financial Conflicts of Interest Key Definitions Key Differences Between Old & New Rules Related to Management Management Plan Requirements Under the New Rule Management Tools Case Study
Focus of New Rule Focus of “New PHS Rule” (42 CFR Part 50 Subpart F; 45 CFR Part 90) and this presentation: Individual Investigator Conflict of Interest But in terms of larger management issues, also keep in mind: Institutional Conflicts of Interest, Physician Sunshine Act and governing state statutes as well as Institutional Policies
“New Rule”: Key Definitions Investigator Significant Financial Interest Financial Conflict of Interest Manage
Key Differences between Old & New Rules Related to Management “Manage, reduce or eliminate” now rolled up into “Management”
When is Management Plan Required? • Institution determines that Investigator has Significant Financial Interest that “could directly and significantly affect the design, conduct, or reporting of PHS-funded research,” i.e. Investigator has a Financial Conflict of Interest
Design, Conduct, or Reporting Design Issues: Is the research plan likely to produce findings that affect the SFI? Conduct Issues: Is analysis of data performed by personnel sufficiently removed from those with an SFI (both from a dominance and a financial perspective)? Reporting Issues Is publication restrained or controlled in any way?
Timelines Prior to Expenditure of PHS Funds New Significant Financial Interest that arises during PHS funded project OR new Investigator added to PHS funded project: 30 Days Identification of Significant Financial Interest not disclosed in a timely manner: 60 Days
“Remedial” Management Plans • Additional steps required to handle non-timely disclosed Significant Financial Interests that turn out to be Financial Conflicts of Interest • Management Plan + • Retrospective Review + • Documentation – Mitigation Plan + • Interim Measures
Retrospective Review 60 Days from time of discovery of non-disclosure to conduct Review; if determination of Conflict, must be reported to Awarding Component with mitigation plan
Management Plan Elements • Plan setting forth actions that have been and will be taken to manage the Financial Conflict of Interest • Identify (describe) and document the conflict • Specify management tools, required procedures, e.g., “conditions and restrictions” • Investigator agreement to plan (required for research to go forward) • Monitoring (establish frequency – quarterly, biannually, yearly, etc.)
Management Plan Tools • Disclosure • Public Disclosure • Disclosure to Participants • Pros & Cons
Management Plan Tools Independent Monitoring Pros & Cons
Management Plan Tools Reduction or Elimination of Financial Interest Terminate relationship that created Financial Conflict of Interest Pros & cons
Management Plan Tools Modification of Proposed Research Plan Modification of Personnel Monitoring and Oversight Reporting to leadership Don’t forget need to update website
Management Plan – Monitoring & Reporting Requirements • Financial Conflict of Interest Report • Role/duties of conflicted Investigator in project • Conditions • Description of how plan will safeguard objectivity • Confirmation that Investigator agrees to plan • Monitoring – establish schedule for regular reviews
Auditing and Reporting Requirements How many “requests” will there be?
The Travel Issue Travel – The following is from the extremely helpful NIH table located at: http://grants.nih.gov/grants/policy/coi/index.htm “Disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration). NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value.”
Using the Tools Case Study - Fictional Sally Smart is on the faculty at Progressive University where she teaches in the dental school. Dr. Smart provides clinical services and has a lab where she conducts research. Her research is supported by the NIH, and is focused on understanding whether children who are fed a vegetarian diet have fewer cavities than those whose dining practices include consumption of meat. Dental students and post-doctoral students also work in her lab. (continued on the next slide)
A colleague in the affiliated medical school collaborates on the research and is a co-investigator in a clinical trial. Dr. Smart additionally serves as a consultant to companies that manufacture oral care products. One of these companies is interested in her research and would like to know if a particular formulation of toothpaste would better protect vegetarian children. Dr. Smart is eager to undertake this research and is committed to compliance. Her institution seeks guidance from you. How would you advise the parties involved?
