IACUC Member Conflict of Interest
IACUC Policy: 042-04, Effective Date: 03/18/2011, Last Revision: 08/16/2024
Overview/Purpose
Federal regulations do not permit an Institutional Animal Care and Use Committee (IACUC) member to participate in the review of research in which he/she has a conflicting interest, except to provide information requested by the IACUC. This requirement helps to ensure that financial or other personal interests do not compromise the welfare of animals used in research or the objectivity of the IACUC review process. This policy describes when IACUC members are considered to have conflicts of interest and the procedures that must be followed for disclosure and IACUC review of research when such conflicts exist.
Definitions
- Conflict of Interest: A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual's professional judgment in exercising any University duty or responsibility, including the review of research. Note: For IACUC members, financial and non-financial interests/opportunities are included.
- Financial Conflict of Interest: An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Note: Financial interests include (but are not limited to) salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
- Non-Financial Conflict of Interest: An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IACUC member’s obligation to protect animals and potentially compromises the objectivity and credibility of the research review process.
- Immediate Family: For purpose of this policy, an IACUC member’s spouse or domestic partner and dependent children.
Requirements
- Conflicts of interest must not compromise the welfare of research animals or the integrity of the research review process. Federal animal care and use regulations do not provide flexibility in the management of an IACUC member’s conflicting interest. Specifically, the regulations require that IACUC members must not participate in the review of research in which they have a potentially conflicting interest, except to provide specific information requested by the IACUC.
- Financial relationships with entities involved in research and the financial interests these relationships create (e.g., equity interests, payments for services) may lead to financial conflicts of interest. Such conflicts of interest may affect the welfare of animal subjects. However, financial interests are not prohibited and not all financial interests cause conflicts of interest. The financial interests that are considered conflicting interests for IACUC members are the same as those for investigators and key personnel involved in research. For more information on financial conflicts of interest, see the Ohio State University's Faculty Financial Conflict of Interest
- Conflicts of interest may also be non-financial, such as when an IACUC member is asked to review research in which he/she is also participating as a member of the research team. Other “personal or professional” conflicting interests include any of the following:
- IACUC member (or member of his/her immediate family) is a member of the research team or advisory committee involved in the design, conduct, or reporting of the research
- IACUC member (or member of his/her immediate family) is related to a member of the research team or advisory committee involved in the design, conduct, or reporting of the research
- Other conflicting interest that appears to preclude objective assessment, at the IACUC’s discretion. Examples may include:
- Principal investigator of the research is the IACUC member’s immediate supervisor or the supervisor of the member’s immediate family member
- IACUC member (or member of his/her immediate family) has an interest in competing research or is competing directly for resources such as funding or sponsorship
- IACUC member personal biases may interfere with an impartial judgement. A Principal Investigator (PI) submitting a protocol may request that a member be excluded from review if the PI believes the IACUC member has a potential conflict.
- An individual may opt out of a review for any reason, including a conflicting interest not specifically described by this policy. Departmental or unit affiliation is not automatically considered to be a conflicting interest, except as described above. Veterinary consultation would not be considered a conflicting interest.
- When a conflict of interest is identified, an IACUC member may not participate in any type of review of the research conducted by the IACUC, including initial or continuing reviews, review of amendments, or other reviews (e.g., event reports, potential noncompliance). This requirement applies to reviews conducted by the convened IACUC and those performed by designated member procedures. Any member with an identified conflict of interest at a convened meeting will be asked to leave the room during the discussion and voting, unless asked to be present to answer questions or provide information to the IACUC.
- IACUC support office staff are responsible for documenting that an IACUC member did not participate in the convened review of research in which the member had a conflicting interest. IACUC minutes will record when the member left the room, with the reason noted as being because of a “conflict of interest.” IACUC members out of the room due to a conflict of interest are not counted toward the meeting quorum. IACUC support office staff are responsible for monitoring IACUC meeting attendance to ensure that quorum is maintained. If an alternate is present for the IACUC member with the conflict, that person can vote and be counted toward the meeting quorum for that review item only.
Applicable Regulations
- Animal Welfare Act (AWA, Public Law 89-544, 7 U.S.C. § 2131 et seq.)
- Animal Welfare Act Regulations (AWAR, 9 CFR, Chapter 1, Subchapter A, §2.31 (d)(2))
- Health Research Extension Act of 1985 and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
- National Research Council Guide for the Care and Use of Laboratory Animals, Eighth Edition. National Academy of Sciences, 2011
- The Federation of Animal Science Societies Guide for the Care and Use of Agricultural Animals in Research and Teaching, 2010
Additional Information/Guidance
- NIH Frequently Asked Questions: Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR Part 50 Subpart F).
- NIH Frequently Asked Questions: PHS Policy on Humane Care and Use of Laboratory Animals
Revision History
- 042-00 – new policy approved 03/18/2011
- 042-01 – removed procedures on how IACUC handles and documents conflict of interests during meetings, removed definition of organizational conflict and allow several potential nonfinancial conflicts to be determined by the IACUC 11/20/2015
- 042-02 – minor grammatical corrections 07/20/2018
- 042-03 – minor reference and additional information updates 07/16/2021
- 042-04 – Replaced ORRP with IACUC Support Office and replaced Faculty Financial Conflict of Interest with Outside Activities and Conflicts policy 08/16/2024
Article ID: 73
Created: July 3, 2024
Last Updated: August 19, 2024
Online URL: https://ohiostateresearch.knowledgebase.co/article/iacuc-member-conflict-of-interest-73.html