Conflict of Interest in Research Richard Waddell, DSc, MSc Associate Professor The Dartmouth Institute for Health Policy and Clinical Practice DMRET Principal Investigator

Conflict of Interest in Research Acknowledgment: The Dartmouth Conflict of Interest PPT guidelines are provided by the Chair of the COI Committee, Office of the Provost

Conflict of Interest in Research Dartmouth and MUHAS, as recipients of grants from the United States Government either directly or through sub-contracts, are required to manage financial Conflicts of Interest in Research according to Federal regulations and university policies.

Background Bayh-Dole Act, 35 U.S.C. § 200 (1980) led to accelerating commercialization of research First set of PHS/NSF COI Rules implemented in 1995 In response to concerns, new COI regulations that broadened disclosure & reporting requirements for PHS funded research adopted in 2011 Senator Grassley “Universities receive NIH dollars with the understanding that they will manage their researchers’ conflicts of interest… Universities need to take this issue more seriously, and the NIH should monitor its grants more closely for this problem.” A potential conflict of interest occurs when an individual’s personal or private interest might lead an independent observer to reasonably question whether or not the individual’s professional actions or decisions are influenced by considerations of significant personal interest, financial or otherwise. The Bayh-Dole Act of 1980 gave universities the right to elect ownership of the inventions made in the course of federally funded research

US Public Health Service Agencies NIH National Institutes of Health AHRQ Agency for Health Care Research & Quality ATSDR Agency for Toxic Substances & Disease Registry CDC Centers for Disease Control & Prevention FDA Food & Drug Administration HRSA Health Resources & Services Administration IHD Indian Health Service SAMHS Substance Abuse & Mental Health Services Administration OASH Office of the Assistant Secretary for Health BARDA Biomedical Advanced Research & Development Authority …and many more!

Major provisions for PHS funded research Researchers required to disclose to the Institution every Significant Financial Interest related to their Institutional Responsibilities (IR) (not just those related to research) Travel: Disclose travel paid by outside entity on behalf of investigator (does not include travel paid for by University, federal agencies, etc.) Reporting Requirement: Institution must report COIs to sponsoring agencies Transparency: Public accessibility of reportable Financial COIs Education Requirement: Initial & every four years, change in policy, or non-compliance

Definitions: Significant Financial Interests Any equity in or remuneration from a publicly held entity related to IR Equity work > $5k Remuneration received >$5k Equity interest plus any remuneration >$5k 2. Any equity interest or remuneration from a privately held company related to IR Any equity at all and/or remuneration >$5k 3. Intellectual Property: if related IR except authorship in scholarly works where royalties >$5k not received 4. Travel: if >$5k received from/sponsored by same entity over last 12 months or expected over next 12 months A potential conflict of interest occurs when an individual’s personal or private interest might lead an independent observer to reasonably question whether or not the individual’s professional actions or decisions are influenced by considerations of significant personal interest, financial or otherwise. The Bayh-Dole Act of 1980 gave universities the right to elect ownership of the inventions made in the course of federally funded research

Definitions: Significant Financial Interests Significant Financial Interests DO NOT include: Income from a grant held by the University Income from mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions Income from seminars, lectures or teaching engagements, or from services on advisory boards or review panels for a Federal, state or local government agency, a US-based institution of higher education, or an affiliated academic teaching hospital/medical center or research institute

Definitions: Institutional Responsibilities (IR) Institutional Responsibilities are professional responsibilities on behalf of the Institution, including: Research Performance of consulting services on behalf of the Institution Teaching Professional practice Institutional committees (e.g., IRBs/RECs, DSMB, etc.) Academic administration activities

Definitions: Significant Financial Interest (FCOI) A Financial Conflict of Interest is a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of research. FCOIs must be managed and reported to the sponsor (where required)

Who Must Disclose? Investigators: Principal Investigator, Project Director, any other person regardless of title or position, who is responsible for the design, conduct, or reporting of research that may include, for example, graduate students, post-docs, collaborators or consultants. It is the responsibility of the Principal Investigator (PI) to ensure that key personnel on his/her projects are aware of Institutional COI policies.

When to Disclose? No later that at the time of application for sponsored research Within thirty days of discovering or acquiring a new Significant Financial Interest (e.g., through purchase, marriage or inheritance) For PHS-funded investigators, at least annually during the award time period.

Dartmouth COI Policy & Procedures Dual Approach, slightly different rules for PHS sponsored research Mirrors NIH regulations Review Process Research Compliance Office Conflict of Interest Committee Management of Conflicts Reporting

Dartmouth Disclosure & Review Process Investigators submit disclosures through online system no later than when applying for research funds Disclosures are received and screened by the Research Compliance Officer (ROC) ROC determines 1. Is a significant financial interest (SFI) disclosed? 2. Is the SFI related to the discloser’s research? If YES, submitted to Conflict of Interest Committee (COIC) COIC decides if FCOI is present and how to manage

Management Strategies for FCOIs Public Disclosure (e.g., when presenting or publishing) Consent form disclosure (human subject research) Independent monitor Modification of the research plan Change of personnel or responsibilities Disqualifications of personnel from participation in all or a portion of the research activities Reduction or elimination of the financial interest (e.g., sale of an equity interest) Severance of relationships that create financial conflicts

Reporting and Transparency If a reportable FCOI related to funded research is present, the Institution if required to report the FCOI and a management plan to the sponsor with designated timeframe (for NIH that is before any funds are spent or 60 days after a COI is identified. The Institution may be required to make information about the FCOI and management publicly available upon request via written response within five days.

http://www.newscientist.com/blog/shortsharpscience/2006_10_01_archive.html

Presented by Judith Ward, BScN, MA-HPM, MBE Case Study Presented by Judith Ward, BScN, MA-HPM, MBE