Unit Standard
Title
University of North Carolina at Chapel Hill Institutional Animal Care and Use Committee (IACUC) Program – Mission, Responsibility, Membership
Introduction
Purpose
The standards and procedures described below provide guidance regarding expectations for the Institutional Animal Care and Use Committee (IACUC) Program's mission, responsibility, and membership at the University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University").
Scope
This Standard applies to all UNC-Chapel Hill IACUC members.
Standard
Mission Statement
UNC-Chapel Hill IACUC oversees the University’s animal care and use program. The IACUC is:
- Responsible for reviewing all applications using vertebrate animals,
- Ensuring compliance with federal animal welfare regulations,
- Inspecting animal facilities and investigator laboratories,
- Investigating animal concerns, and
- Overseeing training and educational programs.
Regulatory Overview
In the United States, the use of live vertebrate animals in research and educational programs must comply with the Public Health Service (PHS) policy on Humane Care and Use of Laboratory Animals (if the institution receives NIH funding) and the Animal Welfare Act and the regulations of the United States Department of Agriculture (USDA) if the institution works with USDA-regulated species.
Authority and Functions
Under the federal regulations [CFR 9, Animal Welfare Act and Regulations], IACUCs have the following authority:
- Review, at least once every six months, the research facility's program for humane care and use of animals;
- Inspect, at least once every six months, all of the research facility's animal facilities, including animal study areas.
- Prepare reports of its evaluations conducted and submit the reports to the Institutional Official (IO) of the research facility. The reports shall be reviewed and signed by a majority of the members and must include any minority views. The reports shall be updated at least once every six months upon completion of the required semiannual evaluations and shall be maintained by the research facility and made available to Animal and Plant Health Inspection Service (APHIS) and to officials of Federal funding agencies for inspection and copying upon request. The reports must distinguish significant from minor deficiencies. A significant deficiency is one which is or may be a threat to the health or safety of the animals. If program or facility deficiencies are noted, the reports must contain a reasonable and specific plan and schedule with dates for correcting each deficiency. Any failure to adhere to the plan and schedule that results in a significant deficiency remaining uncorrected shall be reported in writing within 15 business days by the IACUC, through the IO, to APHIS and any Federal agency funding that activity.
- Review, and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees.
- Make recommendations to the IO regarding any aspect of the research facility's animal program, facilities, or personnel training.
- Review and approve, require modifications in (to secure approval), or withhold approval of those components of proposed activities related to the care and use of animals.
- Review and approve, require modifications (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities.
- Be authorized to suspend an activity involving animals in accordance with the specifications set forth in Animal Welfare Act and Regulations.
Chair of IACUC
The UNC‐Chapel Hill IO, in consultation with the Office of Animal Care and Use (OACU) Director, appoints a Chair and may appoint a Vice Chair of the IACUC to serve for a renewable four‐year term. Any change in appointment, including reappointment or removal, requires written notification. The Vice Chair’s roles and responsibilities are the same as a Chair.
The IACUC Chair should be a highly respected individual, from within UNC‐Chapel Hill, fully capable of managing the IACUC, and the matters brought before it with fairness and impartiality. The task of making the IACUC a respected part of the research community falls primarily on the shoulders of the Chair. The IACUC must be perceived to be fair, impartial, and immune to pressure by the administration, investigators whose research plans are brought before it, and other committees and professional and nonprofessional offices.
The IACUC Chair is responsible for conducting meetings and full committee reviews, and may serve as signatory for correspondence generated by the IACUC.
The IACUC Chair is authorized to convene an IACUC meeting to take immediate action to suspend a study or studies if information is presented regarding animal welfare or for any other reason where such action is deemed appropriate. Such action requires a majority vote of the IACUC quorum present in a convened meeting.
The IACUC Chair may designate other experienced IACUC members to perform duties such as protocol reviews and other IACUC functions.
The IACUC Chair and the OACU Director advise the IO about IACUC member performance and competence.
The performance of each IACUC Chair will be reviewed on an annual basis by the OACU Director in consultation with IACUC members and the Office of the Vice Chancellor for Research (OVCR). Feedback from this evaluation will be provided to the Chair. If the Chair is not acting in accordance with the IACUC’s mission, or following these policies and procedures, has an undue number of absences, or is not fulfilling the responsibilities of the Chair, they may be removed.
Vice Chair of IACUC
The Vice Chair serves as the Chair of the IACUC in the absence of the Chair, and has the same qualifications, authority, and duties as the Chair.
The performance of IACUC Vice Chair will be reviewed on an annual basis by the OACU Director in consultation with IACUC members and the OVCR. Feedback from this evaluation will be provided to the Vice Chair. If the Vice Chair is not acting in accordance with the IACUC’s mission, or following these policies and procedures, has an undue number of absences, or is not fulfilling the responsibilities of the role, the Vice Chair may be removed.
Office of Animal Care and Use (OACU)
All OACU employees are expected to execute the IACUC’s overarching goal of enhancing the conduct of biomedical and behavioral research involving laboratory animals at Chapel Hill by: (1) implementing the decisions, providing administrative support for, and administering the policies of the IACUC fairly and objectively; (2) advocating and maintaining high ethical standards that create a humane animal research environment; (3) training investigators, students and staff members in proper research techniques; (4) communicating to research faculty and University personnel the institutional animal welfare policies, practices, and standards, federal and state regulations, and accrediting agency requirements, and ensuring adherence to these policies, regulations and requirements.
IACUC Members
The role of an IACUC member is to ensure that animal research activities comply with federal regulations, state and local laws, and organizational policies and procedures by:
- Completing member education and training, both initial and on‐going.
- Maintaining the confidentiality of IACUC deliberations and research review by the IACUC.
- Conducting and documenting reviews of assigned research and fulfilling post-meeting review follow-up in a timely fashion.
- Attending IACUC meetings as scheduled.
- Members should attend all meetings which they have previously indicated they will attend. If a member is unable to attend a scheduled meeting, they should inform an OACU staff member, the IACUC Chair, or Vice Chair.
- If an IACUC member is to be absent for an extended period of time, they must notify the OACU as soon as possible in advance so that an appropriate alternate can be obtained. The alternate can serve during the primary member’s absence.
- Recusing self from final deliberations and vote when they have a conflict of interest.
- Participating in subcommittees of the IACUC if requested and available.
- Conduct themselves in a professional and collegial manner.
The performance of IACUC members will be reviewed by the IACUC Chair, IACUC Vice Chair, and the OACU Director. Members who are not acting in accordance with the IACUC’s mission, not following policies and procedures, or who are not actively participating in IACUC responsibilities or have an undue number of absences may be removed.
Refer to the ‘Institutional Animal Care and Use Committee (IACUC) Standard Operating Procedure (SOP) Regarding Expectations for IACUC Member Participation’ for details regarding expectations regarding member participation in IACUC activities.
Alternate Members
The appointment and function of alternate members is the same as that for primary IACUC members. An alternate member’s expertise and perspective should be comparable to those of the primary member. The role of the alternate member is to serve as a voting member of the IACUC when the regular member is unavailable to attend a convened meeting. An alternate member will receive and review similar materials for the IACUC meeting that the primary member receives or would have received.
The IACUC roster identifies the primary member(s) or class of members (e.g., non-scientist, non-affiliated scientist) for whom each alternate member may substitute. The alternate member will not be counted toward meeting quorum as a voting member unless they are substituting for the primary member.
Experienced alternate members will be designated by the Chair to conduct protocol reviews.
IACUC Subcommittees
The IACUC Chair, in consultation with the OACU Director, may designate other IACUC members to an IACUC subcommittee to perform duties, as appropriate, to undertake other IACUC functions, and to make recommendations to the IACUC (e.g., to supplement the IACUC’s initial review, continuing review, review of modifications, and/or review of reports of unanticipated problems or of serious or continuing non‐compliance). The IACUC Chair, in consultation with the OACU Director, will appoint IACUC members to serve on each IACUC Subcommittee created under this Section. The number and composition of the IACUC Subcommittee members will depend on the scope of duties delegated by the IACUC Chair to such IACUC Subcommittee (e.g., making recommendations, conducting an inquiry, etc.). Any such Subcommittee cannot approve research that requires approval at a convened IACUC meeting.
IACUC Membership
The structure and composition of the UNC-Chapel Hill IACUC is appropriate to the amount and nature of the research that is reviewed. Every effort is made to have member representation that understands the areas of specialty that encompasses most of the research performed at UNC‐Chapel Hill.
The IACUC must promote respect for its advice and counsel in safeguarding the welfare of animal subjects, as well as possess the professional competence necessary to review specific research activities.
Composition of IACUC
- The IACUC will have at least five members with varying backgrounds to ensure complete and adequate review of research activities commonly conducted by the organization.
- The IACUC will be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of the members, including race, gender, cultural backgrounds, and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of animal subjects.
- The IACUC will be able to ascertain the acceptability of proposed research in terms of regulations, applicable law, and standards of professional conduct and practice and will include persons knowledgeable in these areas.
- The IACUC will include at least one member whose primary concerns are in scientific areas, and at least one member whose primary concerns are in non-scientific areas.
- The IACUC will include at least one member who is not otherwise affiliated with the organization, and who is not part of the immediate family of a person who is affiliated with the organization.
- The IACUC may not have a member participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IACUC.
- The IACUC may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IACUC. These individuals may not vote with the IACUC.
- One member may satisfy more than one membership category.
- The IACUC Chair and Vice Chair are voting members of the IACUC.
- The Director and staff of the OACU can be voting members of the IACUC.
- On an annual basis, the IACUC Chair and the OACU Director will review the membership and composition of the IACUC to ensure that regulatory and organizational requirements continue to be met.
Appointment of Members to IACUC
When the IACUC Chair, Vice Chair and/or the OACU Director identifies a need for a new, replacement, or alternate member, they send the names of candidates to the OVCR. Department Chairs and others may forward nominations to the IO or to the OACU Director.
The final decision in selecting a new member is made by the IO, in consultation with the OACU Director and IACUC Chair.
Membership appointments are typically made for a renewable four‐year period of service, although this may vary. Any change in appointment, including reappointment or removal before the end of a member’s term, requires written notification. Members may resign by written notification to the IO, IACUC Chair, or OACU Director.
Use of Consultants
When necessary, the IACUC Chair or the OACU Director may solicit individuals from the organization or the research community with competence in special areas to assist in the review of issues or research plans, which require appropriate scientific or scholarly expertise beyond or in addition to that available on the IACUC. The OACU will ensure that all relevant materials are provided to the outside reviewer prior to the convened meeting.
Written statements from consultants will be kept in the IACUC records. Key information provided by consultants at meetings will be documented in the minutes. Written reviews provided by the outside reviewer will be filed with the study records.
Consultants must confirm that they do not have a conflict of interest prior to review. Individuals who have a conflicting interest or whose spouse or immediate family members have a conflicting interest in the sponsor of the research will not be invited to provide consultation.
The consultant’s findings will be presented to the convened IACUC for consideration either in person or in writing. If in attendance, these individuals will provide consultation and may assist in the deliberation but may not participate in the vote.
Ad hoc or informal consultations requested by individual members (rather than the convened board) will be processed by the OACU in a manner that protects the investigator’s confidentiality and complies with the IACUC conflict of interest policy.
Liability of Coverage for IACUC Members
The UNC‐Chapel Hill insurance coverage applies to employees and any other person authorized to act on behalf of UNC‐Chapel Hill for acts or omissions within the scope of their employment or authorized activity.
Exceptions
Requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Primary Contact
Office: Office of Animal Care and Use
Telephone: 919-966-5569
Email: iacuc@med.unc.edu