OLAW publishes the checklist for evaluating the program and inspecting the facility against the Guide and the Animal Welfare Act Regulations. It is the reference point for that part of the semiannual obligation, and this assessment is provided to complement this checklist.
What it covers are the questions that surround the review and are not visible from a facility walkthrough: whether the committee that signed the last report was properly constituted, whether the intervals hold, whether the applicable framework was correctly identified for the species and funding in use, and what happened to each finding after it was written down. Those answers sit in the committee's own records rather than in the animal rooms.
Twenty checks, most of them answered by producing a single document. Allow about two hours, with the IACUC Chair, the Attending Veterinarian, and the Facility Manager available for the sections that need them.
Note: This guide is a companion to the OLAW checklist. It does not substitute for the program review, the facility inspection, or the report required by federal regulation and policy. AAALAC accreditation preparation and pre-award Assurance verification for performance sites are separate exercises owned by different offices.
The two frameworks, and how they apply together
Animal care and use at a research institution is governed by two separate federal frameworks, and they are triggered by different things. The Animal Welfare Act and its implementing regulations apply on the basis of species: an institution using species covered by the Act registers with the Animal and Plant Health Inspection Service (APHIS) and is inspected against those regulations. PHS Policy applies on the basis of funding: an institution conducting Public Health Service-supported activities involving live vertebrate animals holds an Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) and evaluates its program against the Guide for the Care and Use of Laboratory Animals.
Most research institutions are subject to both. The two frameworks do not cover the same animals, and they are not alternative versions of the same rule, so each applicable requirement is met in its own right. Satisfying one framework does not discharge the other, and the question is never which of the two is stricter. A committee at an institution that holds a PHS Assurance and also uses species covered by the Animal Welfare Act meets the five-member composition requirement under PHS Policy, including the member whose primary concerns are nonscientific, and meets the composition requirements of the Animal Welfare Act Regulations as well.
Read the comparison below before working through the checks, then record applicability row by row rather than once for the document as a whole. A row can apply under one framework, under both, or under neither.
Requirement
Animal Welfare Act Regulations (USDA)
PHS Policy (OLAW)
Minimum IACUC membership
Three members. 9 CFR 2.31(b)(3)
Five members. PHS Policy IV.A.3.b
IACUC roles that must be filled
Chairperson; a Doctor of Veterinary Medicine with training or experience in laboratory animal science and medicine who holds direct or delegated program authority; and a member not affiliated with the institution other than as an IACUC member. 9 CFR 2.31(b)(3)
Chairperson; a Doctor of Veterinary Medicine with direct or delegated program responsibility; a practicing scientist experienced in research involving animals; a member whose primary concerns are in a nonscientific area; and a member not affiliated with the institution other than as an IACUC member and not an immediate family member of an affiliated person. PHS Policy IV.A.3.b
Standard used to evaluate the facility
9 CFR Subchapter A.
The Guide for the Care and Use of Laboratory Animals.
Housing areas outside the core facility that must be inspected
A study area is any building, room, enclosure or other containment outside a core facility or centrally designated or managed area in which animals covered by the Animal Welfare Act are housed for more than 12 hours. Every study area is inspected as part of the semiannual facility inspection. 9 CFR 1.1
A satellite facility is any containment outside a core facility or centrally designated or managed area in which live vertebrate animals are housed for more than 24 hours. Every satellite facility is inspected as part of the semiannual facility inspection. PHS Policy III.B
Continuing review of approved activities
At committee-set intervals, not less than 3 years. 9 CFR 2.31(d)(5)
Complete review at least once every three years. PHS Policy IV.C.5
Reporting deficiencies and noncompliance
A significant deficiency not corrected within the plan and schedule set out in the semiannual report is reported in writing, within 15 business days, by the IACUC through the Institutional Official, to APHIS and any federal agency funding the activity. 9 CFR 2.31(c)(3)
Serious or continuing noncompliance with PHS Policy, serious deviation from the Guide, and suspension of an activity by the IACUC are reported promptly to OLAW through the Institutional Official. PHS Policy IV.F.3
How to use the checklist tables
The twenty checks are set out in four tables: Part 1 covers committee standing and the review cycle, Part 2 review practice, Part 3 the evidence that has to be producible on the day, and Part 4 what happens to a finding. Each row is one check. The first three columns are already filled in. The remaining five are completed during the session, and every check that is not fully met carries into the correction plan on the last page. Allow about two hours, with the IACUC Chair, the Attending Veterinarian, and the Facility Manager available for the sections that need them.
What each column covers :
- Ref: the check number. Use it when recording a gap in the correction plan, so that each entry traces back to the check that produced it.
- What to check: the item under assessment, and the record or practice to look at.
- Basis: where the requirement comes from. AWR is the Animal Welfare Act Regulations, PHS is PHS Policy, GUIDE is the Guide for the Care and Use of Laboratory Animals, IP is institutional policy, and BP marks good practice that cannot by itself produce a regulatory deficiency.
- Applies: Y, N, or N.A., decided from the comparison table above together with the species and funding in use. Record N.A. rather than leaving the cell blank, so that an unaddressed row stays visible.
- Status: M for met, P for partially met, NM for not met. Assign a status only after the evidence has been seen.
- Evidence reviewed: the record, observation, or interview relied on, with its date.
- Finding: what the evidence showed. Where the status is P or NM, state the gap in the words that should carry into the correction plan.
- Action owner and due date: the named individual accountable for closing the gap, and a specific date. Required for every check marked P or NM.
Part 1. IACUC membership, meetings and the review cycle
Ref
What to check
Basis
Applies ? (Y / N / N.A.)
Status (M / P / NM)
Evidence reviewed
Finding
Action owner and due date
1
Confirm the committee as currently constituted meets the applicable minimum size and that every required role is filled. Identify the member holding each role.
AWR 2.31(b)(3); PHS IV.A.3.b
2
List members whose appointment has lapsed or expires within six months. Where one lapsed during the period, confirm whether any meeting fell short of quorum as a result.
PHS IV.A.3.a; IP
3
Verify from the minutes that each convened meeting met quorum and that recusals for conflict of interest are recorded.
AWR 2.31(d)(2); PHS IV.C.2
4
Record the dates of the last three program reviews and facility inspections. Confirm no interval exceeded six months, and that any use of the 30 calendar day flexibility did not move the date forward year on year.
NOT-OD-24-075; NOT-OD-24-076
5
Compare the program description against the program as operated. Record changes in species, scope
PHS IV.A.1
6
Compare the inspection location list against the Assurance and the USDA registration. Record any satellite facility, study area, or surgical area opened, moved, or repurposed since the last inspection.
PHS III.B; AWR 1.1, 2.30
Part 2. Protocol review, amendments and approvals
Ref
What to check
Basis
Applies ? (Y / N / N.A.)
Status (M / P / NM)
Evidence reviewed
Finding
Action owner and due date
7
List amendments classified as minor during the period. For each, record the basis for that classification against the institution's written definition of a significant change.
PHS IV.C; IP
8
Select three random protocols spanning different USDA pain and distress categories, and record which ones. Confirm the review pathway applied to each matches the written criteria for designated member review and full committee review.
AWR 2.31(d)(2); PHS IV.C.2
9
Confirm the applicable continuing review interval is current for each ongoing activity: not less than annually under the Animal Welfare Act Regulations, and a complete review at least every three years under PHS Policy.
AWR 2.31(d)(5); PHS IV.C.5
10
Identify any activity that continued past its approval date. Confirm the lapse, the halt to work, and the resolution are documented.
PHS IV.C; AWR 2.31(c)(8)
11
Confirm personnel added to a protocol by amendment had training recorded before work began, and record how training expirations are flagged and to whom.
AWR 2.32; PHS IV.A.1.g
Part 3. Evidence that has to be producible on the day
These four are not record-keeping checks. They test whether the records can be located, produced, and explained on request during an inspection, rather than whether they exist somewhere in the program.
Ref
What to check
Basis
Applies ? (Y / N / N.A.)
Status (M / P / NM)
Evidence reviewed
Finding
Action owner and due date
12
Take one animal currently under treatment. Confirm the clinical record, the authorizing protocol, and the approved humane endpoints can be produced and read together.
AWR 2.33(b); GUIDE ch.4
15
Confirm the contingency plan has been reviewed and personnel trained within the period required, and record the date of the last drill or exercise.
AWR 2.38(l)
Part 4. What happens to a finding
Ref
What to check
Basis
Applies ? (Y / N / N.A.)
Status (M / P / NM)
Evidence reviewed
Finding
Action owner and due date
16
List every deficiency from the last two semiannual reports with its current status, named owner, and target date.
BP
17
Trace one closed deficiency end to end: what was found, what the committee decided, who acted, who verified completion, and on what date.
BP
18
Identify any deficiency appearing in more than one review period. Record whether the plan was revised or escalated, or whether it was closed again on the same plan.
BP
19
Confirm each significant deficiency was classified in consultation with the Institutional Official, and that every deficiency carries a specific plan and schedule with dates.
AWR 2.31(c)(3); PHS IV.B.3
20
Confirm the last report was signed by a majority of members, that minority views were carried into it as submitted, and that the Institutional Official holds it on file.
AWR 2.31(c)(3); PHS IV.B.3
Correction plan
Before completing this
A significant deficiency is one which, with reference to 9 CFR Subchapter A and in the judgment of the IACUC and the Institutional Official, is or may be a threat to the health or safety of the animals. 9 CFR 2.31(c)(3). The classification is a joint judgment, and it decides what has to be reported and when.
Check
Gap
Significant or minor
Corrective action
Owner
Due date
Verified by and date
Reporting decisions for this cycle
Trigger
Report to
Timing
Triggered this cycle? (Y / N, date)
Significant deficiency not resolved beyond its stated plan and schedule
APHIS and any federal funding agency, through the Institutional Official
Within 15 business days
Serious or continuing noncompliance with PHS Policy, or serious deviation from the Guide
OLAW, through the Institutional Official
Promptly
Suspension of an activity by the committee
OLAW, and APHIS for regulated activities, with a full explanation
After Institutional Official review
Semiannual report of the review and inspection
Institutional Official
At least every six months
Sign-off
What to do with the completed sheet
The completed sheet is a working document. Use it first within the IACUC to agree what has to change, who owns each action and by when, then bring it to the Institutional Official as supporting evidence alongside the correction plan and the sign-off page.
Two points deserve direct mention: which gaps require a decision from outside the IACUC, usually anything in parts 1 and 4, and which have appeared in a previous review period, since a check marked NM for the second time is a different conversation from a first finding. Carry the dated actions into the next semiannual report so that closure is evidenced rather than assumed.
How Key Solutions supports ongoing readiness
If parts 3 and 4 took longer than the rest, the question worth raising internally is how much of that record assembly is manual. Key Solutions provides research compliance and laboratory animal software covering IACUC protocol review, IACUC-PAM, and animal health records. See how a current record environment can support ongoing readiness at keyusa.com/iacuc-software.
