|IACUC Policy:||IACUC Member Responsibilities|
|Policy #||IBT-103.00||IACUC Approval:||January 27, 2014|
The Animal Welfare Act (AWA), Public Health Service (PHS) Policy, and the Guide for Care and Use of Laboratory Animals (Guide) require the Institutional Animal Care and Use Committee (IACUC) to provide oversight of the animal care and use program. The roles and duties of the IACUC members are described in this document.
This policy applies to all members of the IACUC (regular, alternate or ex officio), as well as the Institutional official for the Texas A&M Health Science Center.
IACUC members are expected to:
- Uphold the precepts of humane and compassionate animal care and use.
- Follow all applicable federal, state, local and institutional laws, guidelines and policies.
- Be engaged in fulfilling the institutions responsibilities to the NIH/PHS, USDA, AAALAC, the researchers, the animals, and the public.
- Be on guard for real or potential “Conflicts of Interest” that could impact the integrity of the IACUC process of animal care and use oversight.
- Be on guard for real or potential breaches in “Confidentiality” that could impact the integrity of the IACUC process of animal care and use oversight, and institution’s and/or researcher’s intellectual property.
The IACUC Chair has the responsibility for overseeing the coordination and implementation of effective, efficient systems for protocol review and program review by the IACUC in compliance with the PHS policy and the AWA. Responsibilities of the Chair:
- Convene and chair meetings, ensure that there is a quorum present, and declare the loss of a quorum resulting in the end of official business if a sufficient number of members depart
- Prepare and/or oversee the preparation of meeting minutes, agendas and reports and submit appropriate documents to the IO in accordance with PHS policy and the AWA
- Report to the IO any activities which have been suspended by the IACUC for non-compliance as required by PHS policy. Recommends IACUC membership changes to the IO.
- Ensure the establishment of a written system of communication for the IACUC with the investigators concerning the approval status of protocols and the steps necessary to secure approval.
- Evaluate and champion policy and practice initiatives to improve the animal care and use program
- Participate in the assignment of designated reviewers for protocols
- Educate, advise and support IACUC members, PIs and others regarding the IACUC process
- Communicate regularly with the IO, Attending Veterinarian, IACUC Administrator and staff
- Serve as spokesperson for the IACUC
Conflict of interest - a situation in which a person has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties; or exploits the relationship for personal benefit.
Confidentiality - ensuring that information is accessible only to those authorized to have access; non disclosure of sensitive information (i.e. meeting deliberations, investigations) with persons not affiliated with the IACUC.
I. Expectations of Committee Participation
1. IACUC Members and/or Alternates
a. IACUC members are expected to participate regularly in the business of the IACUC; a quorum of members must be present (in person, via teleconference, or via videoconferencing) for business to be conducted.
b. Targeted Participation
i. Program review and Facility inspections: participate in semi-annual program review and inspection for each semiannual review cycle
ii. Help implement governmental and Institutional policy regarding animal research.
iii. Actively participate in meeting discussions
iv. Serve as primary reviewer-as delegated
v. Serve as Designated Member review-as delegated
c. Protocol Review - provide a complete and thorough protocol review (see Protocol Review policy)
i. Prepare prior to the meeting, by reading thoroughly and evaluating the protocols, amendments, and progress reports based on the principles and guidelines for the ethical care and use of animals as described in the federal regulations and Institutional policies. ii. Vote to approve, require modifications to secure approval, or withhold approval for research activities reviewed, with full explanation to applicants.
2. Primary Members are expected to participate regularly in the business of the IACUC. Primary Members are encouraged to attend a minimum of 60% of scheduled IACUC meetings each year.
3. Alternate Members are expected to participate regularly in the business of the IACUC. The Alternate member will assume all decision and voting privileges of the primary member, in the absence of the primary member (if the primary and alternate are both present, both can express opinion but only the primary can vote).
II. Failure to Achieve IACUC Member Expectations
Those members (primary or alternate) who are not able to meet the “Expectations of Committee Participation” may be encouraged to reconsider their role on the committee (attendance and participation will be monitored by the IACUC office):
- Members may choose to increase their participation or may choose to request removal from the IACUC
- The IACUC may request the Chairman to reconsider the recommendation of the individual to the committee.
- With continued disengagement, the IACUC may recommend the Institutional Official reconsider the appointment to the IACUC of the disengaged member.
III. Expectations of Member Conflict of Interest (COI)
The IACUC membership is engaged in fulfilling the institution’s responsibilities to the NIH/PHS, USDA/APHIS, AAALAC, the researchers, the animals, and the public. The IACUC must remain above conflicts of interest to assure the integrity of the institution’s animal care and use program. IACUC members are responsible for making known any potential or perceived conflict of interest (COI).
1. Member roles where a conflict of interest could occur: while no list can be exhaustive, IACUC member participation in any of the following categories could result in a COI for a specific protocol under review, or a COI for specific business issues under discussion.
a. Principal Investigator (PI)
b. Co-Investigator, or Sponsor
c. Investigator receiving funding from the study, as listed in the study budget
d. In a supervisory role over the PI of the study
e. Family member of the PI
f. IACUC members listed on the accompanying grant proposal
g. A financial interest in the sponsor funding the project
Note: Peripheral knowledge or indirect involvement in certain activities may not rise to the level of COI, but might result in member abstention from a vote or discussion.
2. If a conflict of interest is recognized by the member
a. Committee members should make known any conflict of interest prior to the beginning of the committee’s discussion of the business. This can be accomplished by notifying the Chairman, Vice-Chairman, IACUC manager, or Institutional Official. Members with a specific conflict are obligated to leave the meeting room prior to the committee’s deliberation on the conflicted issue.
b. If the COI is recognized during discussion of the issue, declare the potential conflict and depart the meeting room for the remainder of the discussion and vote. The nature of the conflict does not need to be disclosed.
c. Members unsure of whether a particular situation is a potential conflict may present the issue to the IACUC for consideration during the meeting, or prior to the meeting they may present the issue to the Chairman, Vice-Chairman, IACUC manager, or Institutional Official.
Note: The IACUC meeting minutes will reflect any declarations of COI made by members.
IV. Expectation of Member Confidentiality
IACUC members have the role of assessing the humane use of animals in research, teaching or training conducted at Texas A&M Health Science Center. IACUC members ensure that the use of animals or testing on animals is conducted in a humane, ethical manner, with the highest standard of care according to applied Federal, State, local regulations and institutional policies and guidelines. To adequately evaluate the humane and ethical use of animals a free and open exchange of information is necessary. To protect the integrity of the institution and its researchers:
- Members must not disclose confidential or proprietary information (protocol or investigator specific information) to any non-IACUC member
- Members must not discuss, communicate, or disclose any details of IACUC business (e.g. protocol reviews, non-compliance discussion, subcommittee investigations or reviews, etc.) to third parties without the consent of the IACUC Chair or Institutional Official.
Note: Use of IACUC discussion concepts or issues in faculty and staff meetings are considered acceptable and encouraged uses of the member’s experience.
- Animal and Plant Health Inspection Service, USDA. US Animal Welfare Act (AWA 1990) and Regulations (PL-89-544, as amended, 7USC Ch. 54) 2008. CFR Title 9, Subchapter A - Animal Welfare. U.S. Government Printing Office, Washington, D.C.
- National Research Council. Institute for Laboratory Animal Research. 2011. Guide for the Care and Use of Laboratory Animals. Public Health Service, Bethesda, MD.
- Public Health Service Policy on Humane Care and Use of Laboratory Animals http://grants.nih.gov/grants/olaw/references/phspol.htm.
- Silverman, Jerald, et.al. 2000. The IACUC Handbook: The Basic Unit of an Effective Animal Care and Use Program, 2nd. Ed. Baltimore, MD.
- ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd Ed. 2002.
Version 00 - Initial approval – January 27, 2014