Guidance on Flexibilities for Conducting Semiannual Program Review
Notice Number:
NOT-OD-23-129

Key Dates

Release Date:

June 2, 2023

Related Announcements

  • April 19, 2022 - Request for Information (RFI) on Flexibilities for Conducting Semiannual Program Review. See Notice NOT-OD-22-114
  • December 23, 2021 - Notice of Clarification of Reporting Requirements for Animal Welfare Act Regulated Institutions, "Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities". See Notice NOT-OD-22-048
  • August 2, 2021 - Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities. See Notice NOT-OD-21-164

Issued by

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

Purpose

This Notice provides Assured institutions with flexibilities that may reduce administrative burden when conducting semiannual program review.

Background

The Office of Laboratory Animal Welfare (OLAW) oversees animal activities of Assured institutions by the authority of the Health Research Extension Act of 1985 (HREA) and the Public Health Service (PHS) Policy on the Humane Care and Use of Laboratory Animals (Policy). Through memoranda of understanding, OLAW also has oversight authority for animal activities at the National Aeronautics and Space Administration (NASA), National Science Foundation (NSF), and the Department of Veterans Affairs (VA).

The HREA (Public Law 99-158 b.3.A) requires that each animal care committee review the care and treatment of animals in all animal study areas and facilities at least semiannually to evaluate compliance with applicable guidelines. The requirement for Institutional Animal Care and Use Committees (IACUCs) to review at least once every six months the institution's program for humane care and use of animals is further described in PHS Policy IV.B.1.

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 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 Animal Welfare Regulations (AWRs) 9 C.F.R. 2.31(c)(1) require the evaluation to be based on the standards described in the regulations.

The PHS Policy IV.B.3. and AWRs 2.31(c)(3) require the IACUC to prepare and submit a report of the semiannual program review to the Institutional Official (IO). The report must be signed by a majority of the IACUC members. Among other things, the report must include the following:

  • A description of the nature and extent of the institution’s adherence to the PHS Policy, Guide, and AWRs
  • A description of, and reason for, each departure identified
  • Deficiencies distinguished as minor or significant with a reasonable and specific plan and schedule with dates for correcting each deficiency
  • Any minority views
  • Identification of facilities that are accredited by AAALAC International

The 21st Century Cures Act, Section 2034(d), directed the NIH, United States Department of Agriculture (USDA), and Food and Drug Administration (FDA) 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 the administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. Though not expressly identified for action in the report, Reducing Administrative Burden for Researchers: Animal Care and Use in Research, this guidance highlights flexibilities for conducting semiannual program reviews as an additional opportunity to reduce administrative burden.

Additional details and resources may be found on the Semiannual Program Review page of the OLAW website.

Flexibilities for Conducting Semiannual Program Review

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

  • No IACUC member may be involuntarily excluded from the program review.
  • The IACUC remains responsible for the evaluation and report to the IO.
  • The report to the IO must be reviewed and signed by a majority of the IACUC members. Digital and scanned signatures are acceptable. Alternatively, an email acknowledgement from the member(s) may serve as their acceptance with the semiannual report. USDA will also accept an email acknowledgement directly from the IACUC member in lieu of a digital or wet ink signature that states This serves as my signature for the semiannual report (or related statement). These emails should be retained for the record by the IACUC.

This Guide Notice highlights flexibilities that are available to IACUCs when conducting semiannual program review. These flexibilities may be used alone or in combination to meet institutional needs and circumstances, provided that animal welfare and the quality and rigor of the program review are not compromised.

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

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

  1. The PHS Policy Footnote 8 and 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 Animal Welfare Act (AWA)-regulated species, the IACUC may use as few as one qualified individual or an ad hoc consultant in accordance with Footnote 8 of the PHS Policy. Qualified individuals need not be IACUC members or institutional employees but should have a working knowledge of the PHS Policy, Guide and AWRs to appropriately evaluate the program and identify deficiencies and animal welfare issues.

    For program reviews involving AWA-regulated species, the IACUC may use subcommittees of at least two IACUC members and may also invite ad hoc consultants to assist IACUC members in conducting the evaluation.
  2. 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. Use of the checklist, which covers the major topics of the Guide and the requirements of the PHS Policy, is not required but may be used as a tool to assist in conducting thorough semiannual program reviews. The IACUC member(s) may then provide written reviews that can later 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. Both the PHS Policy IV.C.2 and AWRs 2.31(d)(2) state that no IACUC member may participate in the IACUC review or approval of an activity in which the member has a conflicting interest (e.g., is personally involved in the activity) except to provide information requested by the IACUC. Although the PHS Policy and AWRs are silent on determining conflicts of interest regarding program review, it is equally important to avoid actual or perceived conflicts of interest when conducting semiannual program reviews which can lead to allegations of improprieties from various sources. 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.
  3. Although the PHS Policy and AWRs do not specifically identify the review and approval of Standard Operating Procedures (SOPs) as a requirement for IACUCs, the Guide clearly defines the animal care and use program as including SOPs and assigns responsibility for regular review of the program to the IACUC. In accordance with PHS Policy IV.C.5., SOPs referenced in protocols should be reviewed by the IACUC at appropriate intervals, or at least once every three years. For those institutions that refer to SOPs in their training programs for research personnel, animal care and facility staff, such SOPs should be evaluated by the IACUC at a frequency considered adequate to ensure that personnel are qualified and trained to carry out their duties. For animal facility SOPs and other SOPs, particularly those unrelated to animal care and welfare, IACUCs also have the discretion to determine the frequency and method of review based on institutional needs and to ensure accuracy and applicability with current practices.
  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. When using 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 findings of the AAALAC site visit in the semiannual report to the IO, the IACUC report:
    • must comply with PHS Policy IV.B.3., which requires that the report contain certain information regarding the institution's adherence to the Guide, including a plan and schedule for correcting each deficiency identified in the AAALAC findings
    • must be endorsed by the IACUC as an official IACUC report and submitted by the IACUC to the IO

    For institutions covered by AWRs, the report must comply with 2.31(c) of the AWRs, including:
    • The AAALAC International site visit may not be conducted later than the time the IACUC semiannual program review was to be conducted
    • All members must be informed of the evaluation to be conducted by the appointed subcommittee in sufficient time to request participation
    • No IACUC member wishing to participate in any evaluation may be excluded
    • The report must be signed by a majority of the IACUC members (individual digital signatures are acceptable)
    • The review of the program of humane care and use and facility inspection addresses all the required areas of the animal care and use program
    • Any identified departure from the AWA Regulations and Standards must include a description of and reason for the departure
    • The report must distinguish 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, but it may be used as a tool to assist in conducting thorough semiannual reviews. It can be amended as necessary to reflect the institution’s program and needs. USDA concurs with the voluntary use of the checklist where applicable.

Inquiries

Please direct all inquiries to:

Office of Laboratory Animal Welfare
Telephone: 301-496-7163
Email: olaw@mail.nih.gov