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 identified clarifying 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-22-114).
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Policies and Laws
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 "
|NOT-OD-20-114||Request for Information (RFI) on Flexibilities for Conducting Semiannual Animal Program Review||April 19, 2022|
|NOT-OD-00-007||Office of Extramural Research Guidance Regarding Reduction of Regulatory Burden in Laboratory Animal Welfare||December 21, 1999|
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."
FAQ E.2 How does the IACUC distinguish between significant and minor deficiencies?
FAQ E.3 May the IACUC use an AAALAC International site visit as its semiannual evaluation?
|Webinar Link||Webinar Date|
|What Every IACUC Should Know About AAALAC International||September 9, 2021|
|Building a Research Occupational Health Program||March 12, 2020|
|Semiannual Program Review||December 13, 2018|
|Departures from the Guide||October 4, 2012|
|IACUC Responsibilities Beyond Protocol Review and Facilities Inspection||March 10, 2011|
|Lab Animal 41(2)||IACUC Approval of SOPs||2012|
|Could You Provide Examples of "Significant" and "Minor" Deficiencies and Suggest Appropriate Methods for Reporting Them in the Institutional Semiannual and Annual Reports?||1997|
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