ACAPAC Policy Number: 2010-039
Policy Title: Identifying and Managing Conflicts of Interest

Purpose: This policy is for identifying and managing conflicts of interest (COI) of Animal Care and Use Committee (ACUC) members and consultants that may affect or appear to affect their contributions to protocol review, facility inspections, the suspension or termination of animal activities or privileges, or other ACUC-related activities. Federal regulations under the Animal Welfare Act (9 CFR 2.31(d)(2)) provide: “No [ACUC] member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity), except to provide information requested by the IACUC, nor may a member who has a conflicting interest contribute to the constitution of a quorum.” Similarly, the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Section IV.C.2) provides: “No [ACUC] member may participate in the IACUC review or approval of a research project in which the member has a conflicting interest (e.g., is personally involved in the project) except to provide information requested by the IACUC; nor may a member who has a conflicting interest contribute to the constitution of a quorum.”

Definitions:

• immediate family member – a spouse, domestic partner, parent, child, or sibling.
• member – a person duly appointed as a voting or nonvoting member to the ACUC.
• consultant – a nonmember asked by the ACUC to provide advice.
• key personnel – a person who contributed or contributes substantively to the scientific development or execution of a research activity. Key personnel typically includes, but is not limited to, principal investigator (PI), co-investigator (Co-PI), and other personnel listed on the protocol as research or teaching staff expected to work with the animals.

POLICY: A voting member with a COI as determined by this policy does not count towards quorum for voting on the conflicted matter.

1. Identification and Management of COIs during Protocol Review
   1. Identification: An ACUC member or consultant has a COI with respect to a protocol when that member or consultant, or an immediate family member of that member or consultant, meets any of the following criteria:
      1. Is key personnel for, or has substantially contributed to the design or authorship of, the protocol under review.
      2. Has an interest that is related to the research described in the protocol, and that interest meets or exceeds one or more of the following thresholds defined by the UW-Conflict of Interest Committee:
         1. Compensation and/or ownership in a publicly traded company that, either individually or combined, equals $5,000 or more in a calendar year.
         2. Compensation of $5,000 or more from a privately held company in a calendar year.
         3. Any ownership interest in a privately held company.
         4. Any leadership position, where leadership positions are defined as positions with fiduciary responsibility including senior managers (presidents, vice presidents, etc.), and members of boards of directors. Membership on a scientific advisory board is not a leadership position.
      3. Has a proprietary interest of any value including but not limited to a patent, trademark, copyright, or licensing agreement except those managed by the Wisconsin Alumni Research Foundation (WARF).
      4. Has a competitive conflict with the research activity, whether financial, scholarly, or professional. The PI on a protocol may request that an ACUC member be declared as having a competitive COI, and such a request will be decided by a vote of the ACUC. The ACUC member with the potential conflict may not participate in such vote.
      5. Is in a subordinate position within the direct supervisory chain of management to the named Principal Investigator of the animal protocol.
   2. Management:
      1. An ACUC member or consultant who has a COI must disclose that COI to the ACUC chair in advance of the meeting when possible. If the ACUC member with a COI is the ACUC chair, disclosure must be made to the vice-chair of the ACUC.
      2. An ACUC member or consultant who has a COI may be present to provide information about the protocol requested by the ACUC, but will be requested to leave the room for further discussion or vote on the protocol. If the ACUC member with a COI is the ACUC chair, the vice-chair of the ACUC will preside over ACUC discussion and action on the protocol.
2. Identification and Management of COIs during Facility Inspections
   1. Identification: An ACUC member or consultant has a COI with respect to the inspection of (II.A.1) a room or (II.A.2) a facility when that member or consultant, or an immediate family member of that member or consultant, meets any of the following criteria:
      1. Is key personnel on a protocol with activities listed as occurring within the room.
      2. Is a manager of the facility, or has a substantial role in managing, directing, or otherwise providing animal care within the facility.
   2. Management:
      1. An ACUC member or consultant who has a COI may be present during the inspection of the room or facility, but should not be a member of the inspection team. If, however, that member must act as member of the inspection team for the purpose of satisfying regulatory requirements, then action on all deficiencies and correction dates must be referred to the full ACUC.
      2. If an inspection matter is referred to the full ACUC for action, the conflicted ACUC member or consultant may be present to provide information about the matter requested by the ACUC, and will be requested to leave the room for further discussion or vote on that matter.
3. Identification and Management of COIs during Deliberations Regarding the Suspension or Termination of Animal Activities or Animal Use Privileges, or the Restoration Thereof
   1. Identification: An ACUC member or consultant has a COI during deliberations regarding the suspension or termination of animal activities or animal use privileges, or the restoration thereof, when that member or consultant, or an immediate family member of that member or consultant, meets any of the following criteria:
      1. Is the subject of the deliberations or has a COI as defined in Section I.A. with respect to a protocol implicated in the deliberations
      2. Has significant research collaborations (e.g., co-author, grant collaborator) with the subject of the deliberations.
   2. Management:
      1. An ACUC member or consultant who has a COI may be present to provide information requested by the ACUC, and will be requested to leave the room for further discussion or vote.
4. Identification and Management of Other COIs
   1. Identification: On any matter, any ACUC member may request a determination of whether an ACUC member or consultant has a COI with respect to that matter. The ACUC will vote on that request. The ACUC member with the potential conflict may not participate in such vote.
   2. Management: If a COI is determined to exist, the ACUC will decide by vote on how that COI should be managed. The ACUC member with the potential conflict may not participate in such vote.

Author: Rob Streiffer, Bill Barker, Isabelle Girard, Tony Lucchesi, Lisa Wilson
ePublication Date: 10-18-2010
History: Amended 2-1-2013, 6-7-2013, 6-12-2015