Conflicts of Interest in Research: Policies and Regulations Marie Barron, M.A., COI Program Specialist Rick Lyons, M.D., Ph.D., COI Committee C Chair

Sources  UNM Conflicts of Interest in Research Policy (E110)  Code of Federal Regulations, 42CFR50, subpart F  Steneck, N.H. ORI (Office of Research Integrity) Introduction to the Responsible Conduct of Research

Purpose  To promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research funded under PHS grants or cooperative agreements will be biased by any conflicting financial interest of an investigator (42CFR50, subpart F)  To protect the integrity, trust and respect of UNM, its academic community and its research activities (UNM COI Policy E110)

Definitions  Conflict of interest: A situation associated with an investigator’s participation in UNM research where it reasonably appears, on a actual or potential basis, that: The investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of UNM research activities; or The investigator’s significant financial interest could directly and significantly affect the design, conduct, or reporting of UNM research activities; or The investigator’s situation could directly and significantly compromise professional commitments or allegiance to UNM The investigator’s situation could directly and significantly compromise professional commitments or allegiance to UNM UNM COI Policy

 Investigator: Principal investigator, the co- principal investigator and any person (faculty, staff, students) who is responsible for the design, conduct, or reporting of UNM research  Non-UNM Investigator: Any person responsible for the design, conduct, or reporting of UNM research employed by an entity other than UNM. This includes a sub-award recipient, independent contractor or collaborator not employed by UNM UNM COI Policy

 UNM Research: Systematic investigation designed to develop or contribute to generalized knowledge. Includes basic and applied investigations and product development that is: Funded by or through UNM (includes outside sponsored funding) Funded by or through UNM (includes outside sponsored funding) Conducted at UNM, regardless of funding Conducted at UNM, regardless of funding Non-sponsored and conducted off campus by UNM employees Non-sponsored and conducted off campus by UNM employees  Significant Financial Interest (SFI): Anything of monetary value belonging to the investigator and the investigator’s spouse, domestic partner, dependent children which includes payment for services, equity interests, and intellectual property rights UNM COI Policy

Types of Conflicts of Interest  Financial Conflicts  Conflicts of Commitment

Financial Conflicts  SFI includes but is not limited to: Aggregated salary, royalties, or other payments such as consulting fees or honoraria, unless expected to be < $10,000 over the next 12 month period Aggregated salary, royalties, or other payments such as consulting fees or honoraria, unless expected to be < $10,000 over the next 12 month period Equity interests (stocks, stock options, other ownership interests) unless < $10,000 and represents < 5% ownership interest in a single entity Equity interests (stocks, stock options, other ownership interests) unless < $10,000 and represents < 5% ownership interest in a single entity Intellectual property rights (e.g. patents, copyrights) or royalties from these rights other than through UNM or the Science & Technology Corporation (STC) Intellectual property rights (e.g. patents, copyrights) or royalties from these rights other than through UNM or the Science & Technology Corporation (STC) UNM COI Policy

 SFI does not include the following: Salary, royalties, other remuneration from UNM (including payments or other technology commercialization proceeds through UNM Science & Technology Corporation, [STC]) Salary, royalties, other remuneration from UNM (including payments or other technology commercialization proceeds through UNM Science & Technology Corporation, [STC]) Income from seminars, lectures, teaching engagements sponsored by public or non-profit entities Income from seminars, lectures, teaching engagements sponsored by public or non-profit entities Income from service on advisory committees or review panels for public or non-profit entities Income from service on advisory committees or review panels for public or non-profit entities Interests in widely held investment funds if the investigator does not exercise or have the ability to exercise control over the funds financial interests and the fund is publicly traded or available or the assets are widely diversified Interests in widely held investment funds if the investigator does not exercise or have the ability to exercise control over the funds financial interests and the fund is publicly traded or available or the assets are widely diversified Interests in blind trusts if the investigator has no knowledge of the trust assets Interests in blind trusts if the investigator has no knowledge of the trust assets UNM COI Policy

Conflicts of Commitment  Situations that place competing demands on an investigator’s time and loyalties may lead to conflict of commitment  Situations that may lead to this conflict include: Working on 1 or more funded projects Working on 1 or more funded projects Teaching and advising students Teaching and advising students Attending professional meetings and giving lectures Attending professional meetings and giving lectures Serving as a peer reviewer Serving as a peer reviewer Sitting on advisory boards Sitting on advisory boards Working as a paid consultant, officer, or employee in a private company Working as a paid consultant, officer, or employee in a private company ORI

Types of Conflicts of Commitment  Allocation of time Research projects must be balanced with other institutional and professional activities Research projects must be balanced with other institutional and professional activities  Specified percentage of time to university obligations, grants, or contracts should be honored  Sponsors should not be charged for the same time  Relationships with students Mentored students hired to work in their mentor’s start- up companies Mentored students hired to work in their mentor’s start- up companies  Possible conflict between obligations to student’s research education and benefits to start-up company should either be avoided or managed ORI

 Use of resources Equipment and supplies purchased with public funds Equipment and supplies purchased with public funds  Can be used for other university research  Cannot be used for private research interests unless permission to do so  Disclosure of affiliations Outside affiliations that create a conflict should be listed on academic publications and in scientific presentations Outside affiliations that create a conflict should be listed on academic publications and in scientific presentations Investigators should not use institutional research affiliation to advance private interests by implying private work has the support of the institution Investigators should not use institutional research affiliation to advance private interests by implying private work has the support of the institution  Representing outside entities Products (e.g. software, drugs, consultation service) commercialized in private ventures might be used by the primary employer Products (e.g. software, drugs, consultation service) commercialized in private ventures might be used by the primary employer ORI

Management of Conflicts of Interest  Conflicts are managed to assure that interests do not adversely influence research  If a researcher has a conflict of interest in UNM research: Conflicts of Interest Committee may impose conditions or restrictions to control, reduce or eliminate the conflict Conflicts of Interest Committee may impose conditions or restrictions to control, reduce or eliminate the conflict The conflict must be managed to in order for research to proceed and funding, if any, is accepted The conflict must be managed to in order for research to proceed and funding, if any, is accepted  If a conflict cannot be managed: Investigator must withdraw from the research and UNM may need to decline acceptance of an award or terminate the sponsored agreement Investigator must withdraw from the research and UNM may need to decline acceptance of an award or terminate the sponsored agreement UNM COI Policy

Examples of Management Plans  Public disclosure of the conflict  Monitoring of the research by independent reviewers  Modification of research plans  Divestiture of the investigator’s conflicting financial interests or placement in a blind trust  Escrow of an equity interest until certain conditions are met  Prohibition of on the investigator’s involvement in contract negotiations for the research  Severance of the investigator’s relationships that create the conflict  Disqualification of the investigator from participation in part of the research UNM COI Policy

COI Process for UNM  COI disclosure forms are included in HRRC, IACUC, Pre-Award and RAC submissions & renewals  COI decision required for approvals and funding  Description of the endorsed COI situation(s) is attached to the disclosure form  COI review is conducted by the Conflicts of Interests Committee (C & D) via: Committee review Committee review Administrative review Administrative review Electronic vote Electronic vote  Committee C (HSC) & D (main campus): Meet once per month Meet once per month Review proposals/protocols from their respective campus Review proposals/protocols from their respective campus

 Committee C & D are comprised of: 10 voting members from the HSC and main campus faculty and upper management (financial services) and the community 10 voting members from the HSC and main campus faculty and upper management (financial services) and the community Committee C & D chairs are from the HSC and main campus, respectively Committee C & D chairs are from the HSC and main campus, respectively COI program specialists from HSC and main campus COI program specialists from HSC and main campus Legal counsel Legal counsel  Committee decisions: No conflict No conflict Conflict: Management plan to control, reduce or eliminate conflict Conflict: Management plan to control, reduce or eliminate conflict Conflict: Unmanageable Conflict: Unmanageable

Web links for additional sources of information  UNM main campus Conflicts of Interest in Research homepage:  UNM Conflicts of Interest in Research Policy (E110):  UNM Business Policy and Procedures Manual (UPB) regarding conflicts of interest: see UPB 3715, 3720, 4000 (4.11, 4.12), and 4325 (4);  NIH Conflict of Interest homepage:  Code of Federal Regulations DHHS/PHS 42 CFR, Part 50: