Key Dates

Related Announcements

NOT-OD-21-164 - Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities

NOT-OD-24-076 - Guidance on Flexibilities for Conducting Semiannual Program Review

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

Through this Request for Information (RFI), the NIH Office of Laboratory Animal Welfare (OLAW) is seeking input on flexibilities for conducting semiannual program reviews.

Background

OLAW oversees animal activities at Assured institutions by the authority of the Health Research Extension Act of 1985 (HREA), the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), and memoranda of understanding with the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and the Department of Veterans Affairs (VA). The HREA and PHS Policy IV.B.1. require that Institutional Animal Care and Use Committees (IACUCs) review the humane care and use of animals at least semiannually. The Animal Welfare Regulations (AWRs) 2.31(c)(1) require the evaluation to be based on the standards described in the regulations.

The PHS Policy requires that Assured institutions base their animal care and use programs on the Guide for the Care and Use of Laboratory Animals (Guide). The Guide (p. 6) defines the animal care and use program as the policies, procedures, standards, organizational structure, staffing, facilities, and practices put into place by an institution to achieve the humane care and use of animals in the laboratory and throughout the institution.

The report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, describes the recommendations of the 21st Century Cures Act, Section 2034(d) Working Group.

Though not expressly identified for action in the report, this RFI highlights flexibilities for conducting semiannual program reviews as an additional opportunity to reduce administrative burden. Resources may be found on our Semiannual Program Review webpage. These flexibilities may be used alone or in combination to meet the individual needs and circumstances of each institution.

The USDA Animal and Plant Health Inspection Service has reviewed and concurs with the guidance provided in this Notice.

Information Requested

The NIH is seeking input on the flexibilities described in items 1-7 below that are available to IACUCs for conducting semiannual program review (program review).

Flexibilities for Conducting Semiannual Program Review

OLAW and USDA offer flexibilities for conducting program reviews. However, regardless of the flexibilities used:

• No IACUC member should be involuntarily excluded from the program review.
• The IACUC remains responsible for the evaluation and report to the Institutional Official (IO).
• The report to the IO must be reviewed and signed by a majority of the IACUC members. Digital and scanned signatures are acceptable.

IACUCs may consider the following flexibilities when conducting semiannual program reviews:

1. The program review may be conducted at a convened IACUC meeting (e.g., in person, using teleconferencing or video conferencing) with a quorum. It is equally acceptable for the program review to be conducted by a subcommittee with no requirement for a quorum.
   
   For example, IACUC member(s) may be assigned various program elements using the OLAW checklist and provide written reviews that can then be compiled and shared via email for the entire IACUC to consider. Members may add any comments to the compiled report.
   
   However, a committee member or qualified individual should not be the only person assigned to review the aspects of the program for which that individual is responsible. This provides the checks and balances in the system of self-regulation and avoids biased evaluations that may arise when an individual is personally involved in the review. The PHS Policy and AWRs are silent on determining conflicts of interest regarding program review. Therefore, the IACUC may determine which situations require additional personnel, recusal, or other methods to minimize bias, based on the extent of the reviewer’s involvement and the nature of the activity.
   
2. The PHS Policy Footnote 8 and 9 C.F.R. 2.31(c) (3) of the AWRs allow IACUCs discretion to determine the best means of conducting the program review. For program reviews that do not involve AWA-regulated species, IACUCs may use as few as one qualified individual as an ad hoc consultant to conduct the program review. Ad hoc consultants need not be IACUC members or institutional employees. Qualifications should include training and a working knowledge of the PHS Policy and Guide to appropriately evaluate the program and identify deficiencies and animal welfare issues.
   
   For program reviews involving Animal Welfare Act-regulated species, the IACUC may use subcommittees of at least two IACUC members and may invite ad hoc consultants to assist IACUC members in conducting the evaluation.
   
3. Standard operating procedures (SOPs) need not be reviewed every six months. IACUCs may choose the frequency and method for regular review of animal facility SOPs as part of the overall review of the animal care and use program. However, SOPs referenced in protocols should be reviewed by the IACUC at appropriate intervals, or at least once every three years according to PHS Policy IV.C.5. to ensure that they are current and accurate.
   
4. The USDA and OLAW agree that the timing of program reviews can include flexibility of within 30 calendar days of the six-month interval from the last program review, provided there is no forward drift of the date from year to year.
   
5. IACUCs may review the entire program once every six months or on a staggered schedule. On a staggered schedule, different portions of the program are reviewed over time until the entire program review is completed by the end of the six-month period. The 30-day flexibility also applies to each area of program review on a staggered basis.
   
6. IACUCs may use an AAALAC International site visit to meet the requirements for a program review, provided it meets the requirements of the PHS Policy and AWRs. The subsequent program review must be conducted no later than six months from when the AAALAC site visit occurred with a 30-day flexibility in timing.
   
   The IACUC must ensure the following provisions of the PHS Policy and AWRs, as applicable, are met:
   
   For institutions covered by the PHS Policy that use the AAALAC site visit report as the semiannual report to the IO, the report must comply with all requirements in PHS Policy IV.B.3. and IV.E.1.d., which may require modifying the site visit report.
   
   For institutions covered by AWRs, the process and report must comply with 2.31(c)(3) of the AWRs and:

• The AAALAC International site visit should not be conducted later than the time the IACUC semiannual program review was to be conducted
• At least two members of the IACUC assisted in conducting the program review
• All members are informed of the program review to be conducted by the appointed subcommittee in sufficient time to request participation
• No IACUC member wishing to participate in any evaluation was excluded
• The report was signed by a majority of the IACUC members (individual digital signatures are acceptable)
• The program of humane care and use addresses all the required areas of the animal care and use program
• Any identified departure from the AWA Regulations and Standards includes a description of and reason for the departure
• The report distinguishes significant from minor deficiencies.

7. OLAW has developed a checklist to help IACUCs conduct the program review and facility inspection. Institutions are not required to use this checklist, and it can be amended as necessary to reflect the institution’s program and needs.

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare
Telephone: 301-496-7163
Email: [email protected]