Balancing Outside Interests & Activities with Institutional Responsibilities Taren Ellis Langford Conflict of Interest Officer September 26, 2018

Individual Conflict of Interest in Research Policy Missing disclosures Proposal Holds Out of compliance Award holds FY2018: $15,713,290.50 in awards held FY2019: $3,754,476.00 in awards held

What are some examples of Conflicts of Interest in Research? Individual Conflict of Interest in Research Policy What are some examples of Conflicts of Interest in Research?

Individual Conflict of Interest in Research Policy Why do we care?

Are conflicts bad? Do we need to avoid them? Individual Conflict of Interest in Research Policy Are conflicts bad? Do we need to avoid them?

Relatedness “Relatedness is not a judgment on whether the Covered Individual would deliberately make choices in the Conduct of Research or the performance of his/her Institutional Responsibilities based on considerations related to his/her Significant Financial Interests or Significant Personal Interests.”

What does the Conflict of Interest Program do? Individual Conflict of Interest in Research Policy What does the Conflict of Interest Program do?

Individual Conflict of Interest in Research Policy What are the regulations? Public Health Agency regulations (2012) National Science Foundation followed (2014) Since then lots of other federal and non-federal agencies have adopted similar conflict of interest policies: Non-PHS Agencies (updated 3/10/2015) Alliance for Lupus Research (ALR) Alpha-1 Foundation American Asthma Foundation American Cancer Society (ACS) American Heart Association (AHA) American Lung Association (ALA) Arthritis Foundation (AF) CurePSP Juvenile Diabetes Research Foundation (JDRF) Lupus Foundation of America (LFA) Patient-Centered Outcomes Research Institute (PCORI) Susan G. Komen for the Cure

INDIVIDUAL CONFLICT OF INTEREST IN RESEARCH POLICY

Who is an “investigator”? Any person who is responsible for the design, conduct, or reporting of research.

Requirements Training Complete conflict of interest training every four years Disclosure On an annual basis between June 1 and June 30 of every year Within 30 days of a change to the existing disclosure (ex. acquiring a new SFI) If the Investigator has one or more disclosed outside interests, then prior to proposal submission for any federally funded proposal

What do investigators need to disclose? Outside Interests of the Investigator that would reasonably appear to be related to his or her Institutional Responsibilities; and Outside Interests in entities whose financial interests would reasonably appear to be affected by the Research.

Institutional Responsibilities Research Teaching and instruction Development and commercialization of research results Administrative service to the University Membership on institutional committees All other work and activities that the University considers in its review of an individual’s performance in the course and scope of his or her University employment or other obligations 

Significant Personal Interest Significant Financial Interests Outside Interests Significant Personal Interest Significant Financial Interests

Significant Personal Interest Any managerial, professional, or fiduciary position held in any Third-Party Organization (e.g., as an officer, director, trustee, advisory board member, board of directors, or other managerial position), whether or not he or she is compensated.

Significant Personal Interest Significant Financial Interests Outside Interests Significant Personal Interest Significant Financial Interests

Significant Financial Interests With respect to any publicly traded entity: (i) Remuneration from any publicly traded entity in the twelve months prior to disclosure; or (ii) has any Equity Interest in the publicly traded entity as of the date of disclosure and the combined total of all such Remuneration and Equity Interests exceeds $5,000 in value when aggregated

Significant Financial Interests With respect to any non-publicly traded entity: (i) Received Remuneration from a non-publicly traded entity in the twelve months prior to a disclosure, and the value of all such Remuneration exceeds $5,000 when aggregated; or (ii) Holds any Equity Interest in a non-publicly traded entity, regardless of the percentage of equity or value.

Significant Financial Interests Intellectual Property Interests: Income related to intellectual property rights or interests (e.g., as owner of a patent or copyright or as a licensee of such rights)

Investigators funded by a PHS Agency Significant Financial Interests Investigators funded by a PHS Agency Any reimbursed or sponsored travel Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to 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.

Excluded Interests Salary, royalties, or other Remuneration paid by the University to a current University employee or appointee; Payments made by the University in exchange for the transfer of intellectual property rights assigned to the University and from agreements by the University to share any royalties related to such rights; Income from investment vehicles such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made by the investment managers within these funds or accounts; and Income from seminars, lectures, teaching engagements, or service on advisory committees or review panels sponsored by (i) a government agency (federal, state, or local); or (ii) an institution of higher education as defined at 20 USC § 1001(a); or (iii) an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education.

Conflict of Commitment Policy Other Applicable University Policies Conflict of Commitment Policy Conflict of Commitment relates to an individual’s distribution of time and effort between his/her full-time duties as a University Employee, and his/her responsibilities resulting from Outside Employment and Outside Professional Commitments.

Conflicts of Interest in the Research Context Institutional Conflict of Interest Policy “Institutional conflicts of interest arise when an institution’s own financial interests or those of its senior officials pose risks of undue influence on decisions involving the institution’s primary interests.” Source: Conflict of Interest in Medical Research, Education, and Practice (http://www.ncbi.nlm.nih.gov/books/NBK22934/ )

Other Policies regarding Conflicts of Interest College of Medicine (both Tucson and Phoenix): Policy on Interactions with Industry / Conflict of Interest Procurement and Contracting Services Conflict of Interest Policy University Handbook for Appointed Personnel Management of Personal Conflicts of Interest Organizational Conflicts of Interest

Contact Information General COI Email: coi@email.arizona.edu Conflict of Interest Officer: Taren Ellis Langford tmellis@email.arizona.edu To confidentially report suspected unethical or illegal conduct: 866-364-1908

Discussion Questions How does conflict of interest fit into the larger effort to ensure the responsible conduct of research? What was the awareness of COI back when you started your research career? How has it evolved? Why do faculty serve on the IRC?  What do you get out of it? How well do you think the COI regulations and policies match what you believe is the ethically appropriate approach?  Are they too burdensome? Do you think the perception of bias creates an actual conflict, or just a potential conflict? Where and how do you draw the line? How do you approach your role on the ERC differently than your role on the IRC?