July 20, 2021
NOT-OD-12-148 - Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals
NOT-OD-19-136 - Report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research
Office of The Director, National Institutes of Health (OD)
Through this Request for Information (RFI), the NIH Office of Laboratory Animal Welfare (OLAW) is seeking input on clarifying guidance to Assured institutions regarding the Institutional Animal Care and Use Committee (IACUC) reporting requirements for departures from the Guide for the Care and Use of Laboratory Animals (Guide).
The 21st Century Cures Act, Section 2034(d), directed the NIH to conduct a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. The public identified departures from the Guide as an area to reduce administrative burden by eliminating the Public Health Service (PHS) requirement for compliance with the Guide. Because the PHS Policy on the Humane Care and Use of Laboratory Animals (Policy) IV.A.1. requires institutions to use the Guide as a basis for developing and implementing an institutional program for activities involving animals, the requirement for adherence to the Guide remains in effect for Assured institutions. The PHS Policy IV.B.3. requires, among other things, that semiannual reports to the Institutional Official (IO):
IACUC-approved departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues. The PHS Policy IV.F.3. requires that Assured institutions report noncompliant, unapproved departures from the Guide to OLAW.
The public also recommended that deviations from should statements no longer be considered departures and therefore, not be reportable. The PHS Policy incorporates by reference the Guide, which is a widely accepted and respected primary reference on animal care and use, written by the Institute for Laboratory Animal Research of the National Academy of Sciences. It provides the best practice standards for biomedical animal care and use programs. The purpose of the Guide is to assist institutions in caring for and using animals in a scientifically, technically, and humanely appropriate manner. It also assists investigators in fulfilling their obligation to plan and conduct animal experiments according to the highest scientific and ethical principles. Recommendations in the Guide, including should statements, are based on published data, scientific principles, expert opinion, and experience with methods and practices that have proven to be consistent with both high-quality research and humane animal care and use. These recommendations should be used as a foundation for the development of a comprehensive animal care and use program, recognizing that the concept and application of performance standards, according to the goals, outcomes, and considerations defined in the Guide, are essential to this process. In the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research, developed in response to the 21st Century Cures Act, OLAW committed to clarifying the guidance for the reporting requirements of departures from the Guide.
The provisions of the Guide are stated as standards that:
The Guide is written in general terms so that its recommendations can be applied across diverse institutions and settings. It encourages a balance of engineering and performance standards, setting a target for optimal practices, management, and operations while encouraging flexibility and judgment, if appropriate, based on individual situations. This approach requires that users, IACUCs, veterinarians, and technicians apply professional judgment in making decisions regarding animal care and use.
The NIH is seeking input on the following:
The NIH is seeking input on the following clarifications to IACUC reporting requirements for departures from must, should, and may statements in the Guide.
Reporting to the Institutional Official (IO) in the semiannual report is not required for:
Example: A PI requests single housing for her rats to measure individual urine output post-treatment with a test article. After considering the specific details of the proposed experiment, the IACUC approves the protocol.
OLAW and the Guide advocate using outcome-based performance standards by applying professional judgement and experience to should statements to ensure humane animal care and use. Performance standards can only be applied to should statements. They cannot be applied to must statements.
A performance standard means a standard or guideline that, while describing a desired outcome, provides flexibility in achieving this outcome by granting discretion to those responsible for managing the animal care and use program, the researcher, and the IACUC. The performance approach requires professional input, sound judgment, and a team approach to achieve specific goals. Performance standards can be advantageous because they accommodate the consideration of many variables, such as the species and previous history of the animals, facilities, staff expertise, and research goals, to optimize animal welfare. Implementation of performance standards allows the recommendations of the Guide to be tailored to meet unique needs of the research and the animal care and use program. Performance standards are one of the most important components of the infrastructure of PHS oversight of animal programs at Assured institutions. They can be applied to virtually any area of animal care and use, including veterinary care, environmental enrichment, training, exercise, and housing.
Development and validation of performance standards need not be complex and should objectively determine the appropriate assessment outcomes using data and facts. Institutions that do not currently have performance standards that meet the following criteria are expected to use the benchmarks provided by the Guide to develop performance-based policies and procedures. A performance standard should:
The National Academy of Sciences workshop Design, Implementation, Monitoring and Sharing of Performance Standards for Laboratory Animal Use summarized the following important considerations. When developing a performance standard, it is essential to first clearly define the desired outcomes and goals (p 7). This can involve conducting a review of the current literature and industry best practices to identify appropriate performance measures to evaluate the alternative method (p 54). The IACUC should compare the alternative approach to the Guide recommendations by critically evaluating the objective measures of outcome-based performance and identifying performance indices to assess the adequacy of the performance standard while ensuring that it does not negatively impact animal well-being. The IACUC then reviews and requires revisions as needed. Once the IACUC is satisfied with the revisions and allows implementation of the performance standard, a plan is developed to regularly monitor the established performance outcome.
Example 1: A PI proposes to forgo cage sanitization for a 5-week study because mice are exposed to a biohazardous infectious agent. A standard operating procedure (SOP) was developed based on data collected at the institution addressing species, cage density, parameters for sanitary conditions, regular ammonia level testing, and use of specialized bedding that facilitates cleanliness. Both the SOP and protocol were reviewed and approved by the IACUC.
Example 2: All mouse wire bar lids are sanitized once every 4 weeks according to performance standards established by the institution. The SOP was reviewed and approved by the IACUC.
Reporting in the semiannual report to the IO is required for:
Reporting to OLAW is required for:
Please see OLAW’s webpage: Departures from the Guide.
How to Submit a Response
Comments must be submitted electronically on the RFI webpage. Comments must be received on or before November 1, 2021, at 11:59 PM ET. The comments may be made available on the OLAW website.
Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in responses. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.
Office of Laboratory Animal Welfare