The IO must have the authority to allocate organizational resources needed to maintain a smoothly functioning animal care and use program based on the recommendations and advice received from:
the veterinarian, and
the IACUC professional and administrative staff.
The IO should also clearly define and assign responsibilities and reporting channels for other essential program elements such as:
occupational health and safety, and
maintenance of facilities.
The IACUC, appointed by the organization’s Chief Executive Officer (CEO), must report directly to the IO and be empowered to perform its duties without undue interference. OLAW’s experience is that it is usually best for the veterinarian also to report directly to the IO in connection with his or her responsibility for implementing the animal care and use program. In order to provide the intended checks and balances in the system of self-regulation, it is advisable that the veterinarian not serve as Chair of the IACUC or as IO. While it is important that there be a collegial and effective working relationship between the IACUC and the veterina-rian, it is important to avoid the potential for real or perceived conflicts of interest.
Role and Responsibilities of the IACUC staff
The nature of the institution and the volume of animal-based research determine the staffing requirements of an IACUC and the animal care program. Institutions with a high volume of proposals involving animals may require full time IACUC staff. A professional staff with expertise in animal welfare laws, regulations and policies is especially important to provide stability and continuity to animal care and use programs where IACUC chairs and members serve on a rotating basis.
The role of the IACUC staff is to provide administrative support to the IACUC and the IO. It is important however, that neither the IO nor the IACUC Chair over-invest authority or responsibility in the IACUC staff.
The IACUC staff often serve as the gatekeepers of information and com-munications for the IO, the IACUC Chair and members, the veterinarian, the animal resource program, the investigators, and other offices within the institution such as public relations and sponsored research. It is important that training and continuing education be provided to program staff so they are knowledgeable of current animal care and use policies and regulations and aware of proposed changes. OLAW workshops, ARENA and PRIM&R annual meetings, ARENA IACUC 101 Training, and SCAW meetings, are examples of useful training and educational opportunities.
IACUC staff responsibilities range from clerical and administrative to pro-fessional, depending on the size and complexity of the program.
Some examples of clerical tasks are:
In order to approve a protocol that involves the use of animals, the IACUC must review the proposed care and use of animals and determine that federal criteria have been met. PHS requires that the project be conducted in accordance with the PHS Policy, the AWA, the Guide, the institution's Assurance, and all other applicable federal statutes and regulations related to animals. The project should also comply with all institutional policies.
Most IACUCs require use of a standardized protocol application form to assist the investigator in providing the information necessary to ensure compliance. While there is no explicit requirement for the IACUC to do a side-by-side comparison of the information contained in the IACUC proto-
col review form and the information submitted to PHS, it is imperative that the protocol that the IACUC approves is consistent with the information submitted to PHS. Institutions should devise a mechanism to verify that consistency. If the IACUC requires changes to the protocol that are not
reflected in the grant application, then the PHS funding component must be notified in the follow-up certification of IACUC approval.
Institutions are required to provide PHS with the date of IACUC approval. There is no provision for providing a contingent approval date; the date provided must signify full approval by the IACUC. If an institution has a PHS Assurance, then in most cases the PHS allows a 60-day grace period following the receipt deadline date during which the investigator may secure IACUC approval; otherwise, the application cannot be peer reviewed. If the IACUC review occurs subsequent to the grant submission, then a letter verifying IACUC approval, and stating any modifications required by the IACUC, must be submitted to the funding agency. This grace period is non-existent for some non-federally funded projects and investigators are required to submit evidence of IACUC approval coincident with the grant or contract submission.
If an institution does not have a PHS Assurance, the signature of the official signing the grant application for the organization constitutes a declaration that the institution will submit an Assurance and verification of IACUC approval upon request by OLAW.
Responsibility for Collaborations and Subcontracted Research
Collaborations between institutions can sometimes create ambiguity regarding responsibility for animal welfare. In cases where an individual investigator has appointments at several institutions, or where collabora-tions occur between institutions, it is advisable to have a formal written agreement, contract or memorandum of understanding between the institutions. This document should originate from the primary collaborative institution (i.e., the institution primarily responsible for directing and/or funding the research) and signed by the secondary institution.
When an institution receiving PHS funds contracts with a commercial vendor using animals to produce a product, there may need to be IACUC involvement. If a company produces standard antibodies for general sale, that company is not required to file an Assurance with OLAW. However, if a supplier or contractor produces antibodies in animals using an antigen provided by or at the request of an investigator, the antibodies are con-sidered “custom” and the vendor must have an Assurance on file. The vendor Assurance must be identified on the PHS grant application, and the awardee institution is responsible for verifying that the work is done at an Assured institution.
In addition, while the approaches of funding and regulatory agencies are complementary, they also differ. The PHS Policy invests responsibility for animals in the entity that receives PHS funding, known in grant parlance as the "awardee" or "grantee" institution. Accordingly, if there is a concern about a PHS-funded animal activity PHS will likely "follow the money" to determine institutional accountability. Under the AWRs, responsibility generally resides with the institution that houses the animals and with the institution that owns the animals, which may not be the same institution.
PHS may award funds for an activity involving animals only to an entity that has an approved PHS Assurance. When more than one institution is involved, one of the following four scenarios generally apply:
An awardee institution and/or a subcontractor or collaborating insti-tution can both have PHS Assurances. In this situation, two assured entities are responsible for determining which IACUC will review the research and under which institutional program the research will be covered. While PHS and USDA do not require dual review by both awardee and subcontractor IACUCs (i.e., only one of the assured IACUCs must review and approve the research), OLAW recommends the IACUC of the awardee institution have a mechanism for obtaining a copy of the performance site's IACUC approval. Many times however, both IACUCs will elect to review the research as evidence of shared responsibility and to ensure the research will be conducted in compliance with their own institutional policies and practices in addition to meeting the federal laws and regulations.
If the awardee institution has a PHS Assurance, but the subcontrac-tor or collaborating institution does not, the latter may be required to obtain one. The grant or contract may not be awarded until the Assurance is solicited by OLAW, submitted by the subcontractor, and approved by OLAW. The subcontractor must also submit the date of IACUC review.
If the awardee institution has a PHS Assurance but the subcontractor or collaborating institution does not, the latter may be brought under the awardee institution's Assurance by an amendment to the Applica-bility section of that Assurance. The IO signing the Assurance would then be responsible for the facilities and activities of the subcontrac-tor, and the IACUC would be required to include relevant aspects of the subcontractor's facility and program in its semi-annual program review. The subcontractor, in turn, would be required to recognize the authority of the IO and the IACUC of the awardee institution. Most awardee institutions do not elect this option.
Another possible collaboration, that may or may not involve sub-contracting, occurs if an awardee institution does not have an animal program or facility and is therefore not assured, but the investigator will use the facilities of an assured institution. Under these circum-stances OLAW requires an "Interinstitutional Agreement Assurance" whereby both IOs agree that the project will be conducted in accor-dance with the assured institution's Assurance and the investigator will abide by the determinations of the assured institution's IACUC. The effect of such an agreement is to extend the IACUC's oversight to include the particular project, and to meet the PHSPolicy require-ment that the grantee institution be assured.
References Garnett, N.L., and W.R. DeHaven. Commentary: Protocol ReviewWho's to Blame? Lab Animal 28(7), 1999.
NIH Guide for Grants and Contracts, Notice OD-01-017, February 12, 2001.
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A.4. Training for Members For the IACUC to discharge its responsibilities a program of education and training is essential. A well-defined and implemented program, while primarily directed to the IACUC member, would also be of value to researchers, administrators and others with responsibilities associated with research involving animals.
It is the responsibility of the institution to provide suitable orientation, appropriate materials, adequate resources and training to enable IACUC members to carry out their duties consistent with the Guide, the PHS Policy and the Animal Welfare Regulations (AWRs). It is important to provide the tools necessary to assist members in understanding and evaluating issues that are brought before them. Appropriate training depends on the size, scope and needs of the research facility, but must incorporate the federal mandates of the IACUC.
Local institutional policies and procedures need to be a part of the training and education program. Frequently, new members find it confusing to understand the differences between the federal policies and requirements and institutional policies and procedures. It is useful to provide an insti-tutional policy manual as well as the Web sites for pertinent federal rules and regulations.
Although the plan for training and education can take many different forms, a recommended syllabus with suggested topics for the orientation module and the continuing education module follows.
In addition, ARENA sponsors a basic one-day training course for new IACUC members and persons with IACUC responsibilities – ARENA IACUC 101 – and ARENA IACUC 101 “On the Road”. To learn more about this training program, contact the ARENA office at (617) 423-4112 or OLAW at (301) 496-7163, or visit the ARENA or OLAW Web sites (see Appendix A).