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Semiannual Program Review

The Health Research Extension Act, Animal Welfare Regulations, and PHS Policy require that IACUCs conduct semiannual program reviews. 

In response to the 21st Century Cures Act, OLAW and USDA clarified flexibilities for conducting semiannual program reviews as an opportunity to reduce administrative burden while maintaining protection for research animals and data integrity (see NOT-OD-24-076). 

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Policies and Laws

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Health Research Extension Act of 1985 Sec. 495 (b)(3)(A): "Each animal care committee of a research entity shall review the care and treatment of animals in animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment;"

PHS Policy IV.A.2.: "Each institution must assure that its program and facilities are in one of the following categories:

Category 1 - Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated and accredited by AAALAC, or another accrediting body recognized by the PHS.4  All of the institution's programs and facilities (including satellite facilities) for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports prepared in accordance with IV.B.3. of this Policy.

Category 2 - Evaluated by the Institution. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC. These programs and facilities will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports will be prepared in accordance with IV.B.3. of this Policy. The most recent semiannual report of the IACUC evaluation shall be submitted to OLAW with the Assurance.​"

PHS Policy IV.B.:"As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities:

1. review at least once every six months the institution's program for humane care and use of animals, using the Guide as a basis for evaluation;7"

3. prepare reports of the IACUC evaluations conducted as required by IV.B.1. and 2. of this Policy, and submit the reports to the Institutional Official; 8 "

A pole with three signals: guidance, assistance and support

Guidance

Notice NumberDescriptionDate
NOT-OD-24-076

Guidance on Flexibilities for Conducting Semiannual Program Review

(This replaces rescinded Notice NOT-OD-23-129 with the same name.)

March 22, 2024
NOT-OD-20-114Request for Information (RFI) on Flexibilities for Conducting Semiannual Animal Program ReviewApril 19, 2022
NOT-OD-00-007Office of Extramural Research Guidance Regarding Reduction of Regulatory Burden in Laboratory Animal WelfareDecember 21, 1999

Quick References

Definitions

The Guide (p. 6) defines the program as "the policies, procedures, standards, organization 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 institutions. It includes the establishment and support of an IACUC or equivalent ethical oversight committee and the maintenance of an environment in which the IACUC can function successfully to carry out its responsibilities under the Guide and applicable laws and policies."

Resources

FAQs

FAQ E.2 How does the IACUC distinguish between significant and minor deficiencies?

PHS Policy requires the IACUC to make this distinction in its semiannual reports to the Institutional Official. A significant deficiency is defined as one which is or may be a threat to the health or safety of animals. Examples include inoperable HVAC, electrical or watering systems, failure of such systems sufficient to affect critical housing and operational areas, and situations such as natural disasters that cause injury, death, or severe distress to animals. Significant program deficiencies can result from an institution's failure to fully understand or implement some aspect of its animal care and use program required by the PHS Policy, or failure to function according to commitments made in its Assurance, and may reach the level of reportable noncompliance. Generally, a minor deficiency refers to a problem for which an immediate solution is not necessary to protect life or prevent distress (e.g., peeling or chipped paint). Ongoing inattention to a minor deficiency may result in a chronic problem indicative of a programmatic failure and may constitute a significant deficiency. [A7]

FAQ E.3 May the IACUC use an AAALAC International site visit as its semiannual evaluation?

See paragraph entitled “Utilization of AAALAC activities as Semiannual Program Evaluation” in the NIH Guide for Grants and Contracts NOT-OD-00-007.

Webinars

Webinar LinkWebinar Date
What Every IACUC Should Know About AAALAC InternationalSeptember 9, 2021
Building a Research Occupational Health ProgramMarch 12, 2020
Semiannual Program ReviewDecember 13, 2018
Departures from the GuideOctober 4, 2012
IACUC Responsibilities Beyond Protocol Review and Facilities InspectionMarch 10, 2011

Articles

TitleDescriptionDate
Lab Animal 41(2)IACUC Approval of SOPs2012
Contemporary Topics; 36(2):47-50, question #1Could You Provide Examples of "Significant" and "Minor" Deficiencies and Suggest Appropriate Methods for Reporting Them in the Institutional Semiannual and Annual Reports?1997

Sample Documents and Landing Pages

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Questions?

Call (301-496-7163) or e-mail ([email protected]) OLAW for answers to your questions.