|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Guidance for Reviewers|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
|From: ILAR News 35(3-4):47-49, Summer/Fall, 1993
Issues for Institutional Animal Care and Use Committees (IACUCs)
Prepared by the staff of the Division of Animal Welfare, Office for Protection from Research Risks, National Institutes of Health, Bethesda, Maryland. [The Animal Welfare Division of OPRR was renamed Office of Laboratory Animal Welfare (OLAW) in 2000.]
The Office for Protection from Research Risks (OPRR) of the National Institutes of Health (NIH) develops, implements, and oversees compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) (PHS, 1986). The PHS Policy and the U.S. Department of Agriculture's (USDA's) Animal Welfare Regulations, are the two principal federal documents setting forth requirements for animal care and use by institutions using animals in research, testing and education. One of OPRR's primary functions is to assist institutions in implementing PHS Policy by responding to policy-related questions.
The following represent several frequently asked questions from institutions and the OPRR responses:
1. What standards does the PHS Policy require our institution to follow in conducting survival rodent surgery, and how do they differ from those applicable to other species?
The PHS Policy requires that the recommendations of the Guide for the Care and Use of Laboratory Animals (Guide) (NRC, 1985) be adhered to regarding survival surgical procedures and the environments in which they are conducted. The Guide presents slightly different standards for rodent and nonrodent species. Briefly, the current requirements are as follows. Survival surgery may be conducted on rodents in an area that is used solely for this purpose while the surgery is being performed (such as a room or a portion of a room). The surgery must be performed using sterile instruments, surgical gloves, and aseptic procedures designed to prevent contamination of the operative site. In addition to the above requirements, survival surgery involving higher vertebrate species must use aseptic surgical techniques such as wearing sterile surgical gloves, gowns, caps, face masks; using sterile instruments; and preparing an aseptic surgical field. Furthermore a separate, dedicated surgical area, subdivided into a surgical support area, preparation area, and operating room is mandated. Safeguards against hazards surrounding the use of explosive gases are required, and anesthesia scavenging devices or exhaust hoods must be used to eliminate waste anesthetic gases regardless of the species on which surgery is being performed.
2. In the experience of OPRR, what form of administrative organization works best for directing the animal programs and ensuring compliance with the PHS Policy?
It has been OPRR's observation that organizations having simple, clear, direct lines of responsibility and corresponding authority function well and are better able to respond quickly and effectively to the requirements of the PHS Policy. The key components in such organizations are the Institutional Official (IO), the IACUC, and the participating veterinarian. The IO should have the authority to allocate organizational resources needed to maintain a smoothly functioning animal care and use program based on recommendations and advice received from the IACUC and the veterinarian. The IO should also clearly define and assign responsibilities and reporting channels for other essential program elements such as training, occupational health, and maintenance. The IACUC, appointed by the organization's chief executive officer, usually reports directly to the IO and is empowered to perform its duties without undue interference. OPRR's experience suggests that it is usually best for the veterinarian also to report directly to the IO in connection with his or her responsibilities for implementing those parts of the animal care and use program that are set forth in the PHS Policy, the Animal Welfare Act (Animal Welfare Act of 1966), and the Guide.
OPRR recognizes that the size and complexity of Assured institutions vary, and that no single organizational or administrative structure will be compatible with the needs of all institutions. While the Policy allows for such institutional flexibility, OPRR strongly recommends that its organizational channels for implementation be as direct and straightforward as possible. In OPRR's experience, unclear or inappropriate lines of authority and responsibility have been the underlying cause for serious cases of programmatic failure.
3. What is the difference between IACUC animal study proposal review in a convened meeting and "expedited" review, and when is it appropriate to use the latter?
Paragraph IV. C. 2. of the PHS Policy and Part 2, Section 2.31 (d)(2) of the USDA's Animal Welfare Regulations require that, as a minimum, all IACUC members be given for their review a list of proposed research protocols involving the care and use of animals and that written descriptions of the projects be available to them. Any member of the IACUC may then request full review of any protocol by the full committee. In the absence of such a request, the chairperson may appropriately designate at least one qualified person to review, approve, require modifications, or request full committee review.
This process, protocol review by less than the full committee in a convened meeting, is often referred to as an "expedited" review. This does not correspond, however, to the expedited review process of the Institutional Review Board applicable to Human Subjects Protection. In order to comply with the PHS Policy, no animal work may begin before the full committee has either been given the opportunity to review the protocol and call for a full committee review or before the protocol has been approved by (1) the majority of a quorum of the members or (2) the designated reviewer in the absence of a call for full committee review. In this regard, it should be kept in mind that neither the PHS Policy nor the Animal Welfare Regulations recognize "provisional" or "interim" approval of any animal study proposal.
4. Does the PHS Policy place any proscriptions on filling the positions of IO, attending veterinarian, and IACUC Chairperson with the same individual?
While there are no specific prohibitions, OPRR strongly recommends against having more than one of these positions filled by the same individual. OPRR considers that the responsibilities and authorities vested in each of the aforementioned positions are distinct, often requiring different skills. Also, the assignment of more than one of these roles to the same individual circumvents the intended checks and balances designed by the framers of the PHS Policy. Circumstances arising from having the same person serving as the IACUC Chair, the institutional veterinarian, and the IO have, in the past, been an underlying factor in some of our most serious cases of noncompliance with the PHS Policy. In addition, the mere perception of conflict of interest may lead to allegations of improprieties from various sources. However, the intent of the PHS Policy is to provide levels of responsibility and authority within institutions which would provide an optimal environment for its implementation. Hence, the attending veterinarian, as the only member appointed by virtue of position, serves on the IACUC under the IACUC Chairperson, with the later reporting directly to the IO. This arrangement, however, should not preclude the veterinarian from performing the appropriate management and administrative functions as the institutional veterinarian with direct access to (and preferably reporting channels to) the IO.
5. Under the conditions of the Animal Welfare Assurance, is it necessary for our IACUC to report to OPRR any suspensions of animal-related activities or other sanctions imposed by the IACUC if the subject activities are not PHS supported?
While a few institutional laboratory animal care and use programs can be subdivided into physically and operationally distinct entities, program oversight is almost always exercised institution-wide under a single institutional standard for animal care and use. OPRR has found that deviations from IACUC policies and procedures, whether sufficiently serious to impose protocol suspensions or minor in nature, generally include issues that have bearing on compliance with the PHS Policy. Unless OPRR has approved an Institutional Assurance that exempts specific facilities or programs, it is expected that protocol suspensions or other sanctions imposed by the IACUC on non-PHS supported work will be reported. This will allow an evaluation of the potential impact of the infraction on studies that are conducted with PHS support. An additional reason for such reporting is to provide OPRR with advanced knowledge of an incident prior to having it appear in the form of an official complaint or congressional inquiry. This knowledge allows OPRR to respond positively to outside inquiries that the system of animal welfare oversight is working as intended.
6. Our institution's animal care and use program is constantly undergoing modification, much of which we consider to be minor. In its Annual Report to OPRR, how extensively must institutional facility and program changes be described?
The approved Animal Welfare Assurance is the key document in defining the relationship between the institution and the PHS. Institutions should therefore consider any program or facility modification that results in a change to any item described in its Assurance to OPRR as reportable. Facility modifications generally involve changes in gross square footage resulting from the addition (either newly-constructed or otherwise acquired) or elimination of animal space.
Normally, it is not necessary to report preventive maintenance items or remodeling that does not result in changes to the gross square footage or carrying capacity of the facility. Annual Reports should identify the affected areas, the number of square feet involved, and resultant changes in the average daily animal populations. Concerning program matters, OPRR needs to be kept informed of any modifications in institutional lines of authority and responsibility and of any changes in key personnel such as the institutional official, the IACUC chairperson, and the veterinarian. Another consequential programmatic consideration includes changes in the composition and procedures of the IACUC that represent departures from those described in the Assurance. Similarly, any significant changes made in the occupational health and training or instruction programs should be brought to the attention of OPRR in the annual report. Finally, the Report should include significant changes in the numbers and species of animals maintained by the institution. These elements are especially important in OPRR's evaluation of the adequacy of veterinary resources, credentials, and support facilities.
The extent to which program or facility modifications or changes need to be described in an annual report will depend on the degree to which they differ from the corresponding items described in the Assurance. OPRR recommends that the descriptions be comprehensive and in sufficient detail to allow replacement of the affected items as they were described in the original Assurance.
7. Implementing regulations of the Animal Welfare Act require that animal study protocols be reviewed and acted upon by the IACUC annually. The PHS Policy requires that such reviews be conducted every three years. For the purpose of complying with OPRR's oversight policy, how frequently must our IACUC perform such reviews?
The PHS Policy requires that de novo IACUC reviews of all
PHS-supported protocols be conducted on a triennial basis. The Policy also
states that "... institutions are required to comply ... with the Animal
Welfare Act, and other Federal statutes and regulations." To be compliant
with the USDA's Animal Welfare Regulations, the IACUC must review those
protocols involving dogs, cats, nonhuman primates, rabbits, guinea pigs, and
hamsters each year to assure active status and to identify significant changes.
Although annual reviews of protocols involving other species are not required
under the PHS Policy, many institutions will choose to establish a uniform
method covering all vertebrate species that satisfies the USDA's requirement for
annual review and the PHS requirement to review and approve proposals for
significant changes to ongoing protocols. A relatively simple monitoring
mechanism, which meets USDA requirements and serves to monitor animal activities
covered by the PHS Policy, can be implemented by the use of a standard form
containing basic protocol information (including title, approval number, date,
and species). This form is then sent to the PI to (1) verify active status, (2)
verify that completed activities were conducted in accordance with the approved
protocol, (3) describe any proposed departures from the approved protocols, and
(4) solicit information about activities projected for the upcoming year.
Information pertaining to the future would indicate either that no changes were
proposed or describe changes that the PI would like to implement.
Any proposed changes deemed to be significant would then be brought before the IACUC for its consideration and documented as an official IACUC action. [This document would then be brought before the IACUC for its consideration and documented as an official IACUC action. All protocols must be reviewed by the IACUC and those protocols with significant changes must be reviewed and approved by the IACUC.] Such a monitoring
system, however, does not preclude the requirement for triennial review or for
PIs to seek IACUC approval when they want to make significant changes in
approved protocols at other than the regularly scheduled monitoring periods.
Such approval must be obtained prior to implementing the changes. Both
the USDA and PHS requirements, of course, may also be satisfied by conducting
complete de novo reviews of all animal study proposals on an annual
NRC (National Research Council). 1985. Guide for the Care and Use of Laboratory Animals. A report of the Institute of Laboratory Animal Resources Committee on Care and Use of Laboratory Animals. Washington, D.C.,: U.S. Department of Health and Human Services.
Public Health Service (PHS). 1986. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Washington, D.C.: U.S. Department of Health and Human Services. (Available from: Office for Protection from Research Risks, Building 31, Room 4B09, National Institutes of Health, Bethesda, MD 20892).
Health Research Extension Act of 1985. P.L. 99-158.
Animal Welfare Act of 1966 (P.L. 89-544) inclusive of amendments; 1970 (P.L. 91-579; 1976 (P.L. 94-279); 1985 (P.L. 99-198).