Semiannual Program Review and Inspection

Semiannual Program Review

Introduction

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). 

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"

Guidance

Semiannual Facility Inspections

Introduction

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

In the report Reducing Administrative Burden for Researchers: Animal Care and Use in Research, developed in response to the 21st Century Cures Act, OLAW and USDA have clarified existing flexibilities for conducting semiannual facility inspections while maintaining protection for research animals and data integrity (see NOT-OD-24-075). 

Policies and Laws

Facility inspections are covered under the same policies and laws from semiannual program review policy.

Guidance

Semiannual Program Review and Facility Inspection Checklist 

Introduction

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), section IV.B.1.-2., requires the Institutional Animal Care and Use Committee (IACUC) to review the institution's program for humane care and use of animals and inspect all of the institution's animal facilities at least once every 6 months using the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide) as a basis for evaluation. We have developed the Semiannual Program Review and Facility Inspection Checklist to help you conduct your semiannual reviews of programs and facilities for the care and use of animals.

How to use the checklist

This checklist is a tool to help you conduct thorough semiannual reviews. You are not required to use it. We encourage you to amend it as necessary to reflect institutional programs and needs, or develop your own checklist. If the checklist is modified, you should review it periodically to be sure that relevant topics are considered as the animal care and use program changes.

The checklist covers the major topics of the Guide and the requirements of the PHS Policy. The checklist does not replace the Guide, but you should use it along with the Guide. The Guide provides the standards, recommendations, and descriptions of desired outcomes necessary to evaluate and inspect an animal care and use program. We have referenced relevant pages in the Guide and sections in the PHS Policy. We have highlighted topics that are new to this version of the checklist or are indicated as a “must” in the Guide. Endnotes reference specific U.S. Department of Agriculture (USDA) regulatory requirements that differ from the PHS Policy.

Semiannual Program Review Checklist is the program review section. It consists of these parts:

• Institutional Policies and Responsibilities
• Veterinary Medical Care

Semiannual Facility Inspection Checklist is the facility inspection section. It consist of these parts:

• terrestrial animal housing and support areas
• aquatic animal housing and support areas
• cagewash
• aseptic surgery
• procedure areas, non-survival surgeries, laboratories, and rodent surgeries

Semiannual Program Review and Facility Inspection Deficiencies is a table for you to organize and track information regarding deficiencies, and plans and schedules for correction. This table is not a substitute for the semiannual report to the Institutional Official (IO). 

Download the sample checklist

If you wish to use the sample checklist as a template, click one of the formats below to download.

• Sample Checklist (PDF, 601.37 KB)
• Sample Checklist (DOCX, 151 KB)

Semiannual Report to the Institutional Official

Introduction

The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), section IV.B.3., requires the IACUC to prepare and submit a report of their semiannual evaluation to the Institutional Official (IO).

You must include the following information in your report to the IO:

• Description of the nature and extent of the institutions adherence to the Guide for the Care and Use of Laboratory Animals (Guide) and the PHS Policy, including any departures and reason for each departure.
• Identification of any deficiencies in the program or facility, including classification as either significant or minor and a reasonable and specific plan and schedule for correction.
• Minority views of the IACUC.
• Identification of facilities accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) .
• Signature of a majority of the IACUC members, if applicable.

The IACUC may determine the best means of conducting an evaluation of the institution's programs and facilities and is responsible for the evaluation and report. Final reports of the semiannual evaluations and inspections are considered full committee actions and should be reviewed and endorsed by a majority of the IACUC.

The U.S. Department of Agriculture (USDA) also requires that the reports be reviewed and signed by a majority of the IACUC members. USDA regulations further require that the reports include any minority IACUC views. Any failure to adhere to the plan and schedule that result in a significant deficiency remaining uncorrected is required by USDA to be reported in writing within 15 business days by the IACUC, through the IO, to the Animal and Plant Health Inspection Service (APHIS) and any Federal agency funding that activity.

How to use the sample document

We have developed this sample document to help you prepare the semiannual report to the IO. Specific instructions and information are provided in italicized text and should be deleted from the final document.

Semiannual reports should be submitted to OLAW only if requested, or if the institution is submitting a new or renewal Assurance and is not accredited by AAALAC International.

Download the sample semiannual report to the IO

If you wish to use the sample semiannual report as a template, click one of the formats below to download.

• Sample semiannual report template (PDF, 179 KB)
• Sample semiannual report template (WORDX, 78 KB)