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A.2. Authority, Composition and Functions Each institution that receives PHS support for activities involving verte-brate animals or is subject to the authority of the Animal Welfare Act (AWA), must operate an animal care and use program with clear lines of authority and responsibility. The program must include:
a properly constituted and functioning Institutional Animal Care and
appropriately maintained facilities for housing and support.
PHS requires an institutional Animal Welfare Assurance that provides details on the institutional program in order to award funds; USDA requires registration of facilities. Section E.1. and E.1. Table B include additional detail concerning PHS assurances and USDA registration.
Authority IACUCs derive their authority from the law. They are mandated by the Health Research Extension Act (HREA) of 1985 and the AWA. The laws require the Chief Executive Officer (CEO) of an organization to appoint the IACUC, whose responsibilities are delineated in the law and federal policy and regulations. Office of Laboratory Animal Welfare (OLAW) considers the CEO to be the highest operating official of the organization. The CEO may delegate authority to appoint the IACUC if the delegation is specific and in writing.
Once appointed, IACUCs report to a senior administrator known as the Institutional Official (IO). The IO must have administrative and operational authority to commit institutional resources to ensure compliance with the PHSPolicy and other requirements. The CEO and IO may be the same
individual, although at large institutions the CEO is typically somewhat removed from operational program involvement. Occasionally IOs are also appointed to serve on IACUCs but this is not advisable because the IACUC reports to the IO, creating potential for conflict of interest.
The IACUC’s mandate to perform semiannual program evaluations as a means of overseeing the animal care and use program puts the IACUC in an advisory role to the IO. In its semiannual reports the IACUC advises the IO of the status of the institution’s compliance, establishes plans and schedules for correcting deficiencies necessary to either maintain or achieve compliance, and makes recommendation to the IO regarding any aspect of the institution’s animal program, facilities, or personnel training. This approach of “enforced self-regulation” requires that the IACUC have the full support of the IO responsible for the program.
The IACUC’s authority to review and approve protocols is independent of the IO who may not overrule an IACUC decision to withhold approval of a protocol. (The converse is not true, i.e., if an IACUC approves a protocol, the institution is not required or obligated to conduct the research activity.) An institution may also subject protocols to additional institutional review (e.g., department head, biosafety committee, etc.)
Some IACUC members fulfill specific regulatory requirements (e.g., veterinarian with program responsibility, an individual nonaffiliated with the institution); others have unique roles by virtue of their position (e.g. chairperson).
There are no specific prohibitions regarding individuals filling more than one role on the IACUC, but OLAW strongly recommends against the same person serving multiple roles because the responsibilities and authorities vested in each of the positions are distinct and often require different skills. Appointing one individual to more than one of these roles may circumvent intended checks and balances. Also of importance is the perception of conflict of interest, which can lead to allegations of impropri-eties from various sources.
Veterinarian: The PHSPolicy and AWRs mandate the appointment of a veterinarian with direct or delegated program responsibility to the IACUC. CEOs may appoint more than one veterinarian to the IACUC but the veterinarian with direct or delegated program responsibility must be
designated as such. The veterinarian with program responsibility must have training or experience in laboratory animal science and medicine or in the care of the species being used.
Chair: A knowledgeable and effective leader is crucial to an effective IACUC. This individual needs the full support of the IO. A chair with suffi-cient stature (e.g. seniority or tenure) can perform the functions of this position without jeopardy to his/her career. In the case of a large program of animal care and use, a co-chair may be desirable.