The PHSPolicy and AWRs include recordkeeping and reporting require-ments. The responsibility for these functions should be clearly delegated. Usually the IACUC office is assigned this task. The individuals responsible should understand federal animal use requirements and the institution's program, and should also be aware of the Freedom of Information Act (FOIA) and any state open records laws. Many of the reports written may be accessible under such laws, and care should be taken to use language that is clear and precise to ensure accurate interpretation.
Recordkeeping Minutes The PHSPolicy and the AWRs require that the institution maintain "minutes of IACUC meetings, including records of attendance, activities of the Committee, and Committee deliberations" (PHS Policy IV. E; 9 CFR Part 2 Subpart C 2.35 (a)(1)). The IACUC has some latitude in the degree of detail in these minutes.
Records of attendance: Although members may arrive late or leave during a meeting, generally a member is marked as either present or absent. An exception would be when the IACUC member leaves the meeting room during discussion of a protocol on which that member is a participant. If the temporary absence of a member drops the number of members present below the quorum, this should be noted in the minutes. Certain official IACUC actions require a quorum (See Section A.2. Quorum Requirements).
Activities of the Committee include corrections or approval of previous minutes; presentation of program, policy, facility and compliance reports; and decisions on policies, protocols, and amendments.
Deliberations refers to the discussion and reasons leading to particular IACUC decisions. Although some IACUCs maintain a verbatim record (e.g., audio or videotapes), minutes should include as a minimum a summary of the key points discussed prior to a committee decision.
Protocols: The PHSPolicy and the AWRs require that animal applications and pro-posed significant changes be retained for the duration of the animal activity and for an additional three years after the end of the activity. Proposals submitted to the IACUC must be kept for three years even if approval was not granted or animals were not used. The records must show whether or not IACUC approval was given.
Other records Both the PHS Policy and the AWRs require that semiannual IACUC reports and recommendations be retained by the institution. PHS also requires that the OLAW Assurance and reports of accrediting agencies (e.g., AAALAC) be kept on file. USDA requires additional records on dogs and cats acquired, transported, sold, or euthanized by the research facility. Animal health records are not usually maintained by the IACUC but are kept in the animal facility. All these records must be kept for at least three years; and must be accessible to PHS, APHIS, and funding agencies for inspection or copying (see Table A).
Reporting Requirements PHS Assurance In order to qualify for support from the PHS for activities involving animals, institutions must provide an Assurance of Compliance with the PHSPolicy. The Assurance is a written agreement that fully describes the institution’s program and commits the organization to comply with the PHS Policy, and in which the institution outlines in detail its policies and procedures. A sample Assurance is available at the OLAW Web site. Institutions that are not accredited by AAALAC must submit, with their Assurance, the most recent IACUC semiannual program evaluation. The completed Assurance, signed by the IO with appropriate authority, is submitted to and evaluated by OLAW. Upon final approval by OLAW an Assurance number (in the format A####-01 where # is a digit) is assigned to the institution. Assurances are approved for a period of up to five years, after which time the institution must submit a new Assurance. A list of institutions with approved Assurances is available on the OLAW Web site.
It is important that the approved Assurance document is distributed appro-priately within the institution and that members of the IACUC are familiar with this document, as compliance with the Assurance is required to be eligible for PHS funding.
USDA Registration Institutions that use species of animals covered by the AWRs for research, testing, experiments, or teaching on its premises as specified in the AWA are required to be registered with the Animal Care division of the Animal and Plant Health Inspection Service APHIS), using APHS form 7011. The form is submitted to APHIS via the Regional Director of Animal Care (AC) for the state in which the facility has its principal place of business. At academic institutions, the submission is usually made by the institution, not the individual departments or schools, and signed by the IO. An approved USDA registration is given a number in the format ##-X-####, where X is a letter (R for research institution) and # is usually a digit. The registration may be renewed every three years. The institution is required to notify the AC Regional Director within ten (10) days of any change in the name, address, ownership or operations affecting its status as a research facility. The Regional Director may place a facility that has not housed animals for two years in inactive status. The registration can be cancelled by written request if a facility no longer uses, or intends to use, animals (see Table B).
Semiannual Facility Inspections and Program Evaluations The PHSPolicy and the AWRs require that the IACUC evaluate the insti-tution’s animal program at least once every six months, including an inspection of facilities, and submit a report to the IO. The PHSPolicy allows the IACUC discretion in how it evaluates its facilities and program. The report format is not mandated, but OLAW offers models for both facility inspections and program reviews on its Web site.
The report must contain a description of the nature and extent of the insti-tution's compliance with the PHSPolicy and Guide; any departures must be identified and modifications proposed, with a plan and timetable for correction. Any minority views of IACUC members must be included.
Minor and significant deficiencies must be distinguished. A significant de-ficiency is defined as one that "is or may be a threat to the health or safety of animals.” Program or facility deficiencies, including accidents or natural disasters, which cause injury, death, or severe distress in animals, are, by definition, 'significant.' Examples of minor deficiencies include chipped paint and burnt-out light bulbs. The report must also identify any facilities that are AAALAC accredited.
The IACUC may utilize AAALAC program status evaluations, accreditation, or pre-assessment preparation activities as a semiannual evaluation. To be used as the semiannual report, the report must include all the information required in Section IV.B.3 of the PHSPolicy (see Table C), and be approved by vote of the IACUC.
Semiannual reports are only submitted to OLAW under two circumstances:
If an institution is not accredited by AAALAC, a copy of the most recent semiannual report must be submitted to OLAW with a new or renewal Assurance.
Upon request by OLAW or other PHS representatives.
USDA requirements are essentially the same as those for PHS with three exceptions:
The AWRs include additional reporting requirements if the schedule and plan for correcting a deficiency is not followed. Failure to correct a significant deficiency in accordance with the specified schedule and plan must be reported in writing within fifteen business days by the IACUC, through the IO, to APHIS and any federal agency funding the activity.
USDA requires that reports be reviewed and signed by a majority of IACUC members.
USDA does not require the identification of facilities accredited by AAALAC.
As with the PHS semiannual review, AAALAC processes may also fulfill the requirements for the USDA semiannual report provided Section 2.31 (c) requirements are met, as listed in Table C.
The IACUC at an institution with an approved PHS Assurance must submit an annual report to OLAW through the IO. This report details changes in the animal care and use program, IACUC membership, and AAALAC accreditation status. Minority reports from IACUC members must be included. It also includes the dates of semiannual review and reports submitted to the IO. The PHS and AAALAC annual reporting dates may be synchronized with the USDA reports.
A sample annual report format is provided on OLAW’s Web site and may be utilized, but is not required.
On or before December 1, each facility registered with the USDA must submit an annual report to the APHIS, AC Regional Director, for the state in which the facility is registered. Form 7023 is usually prepared by the IACUC and signed by the CEO or IO. It lists the number of each covered species used, by pain categories. The report includes assurances that animal care and use are at professionally accepted standards, that alternatives to painful procedures have been considered (see Section C.2.a. Alternatives) and that AWRs are followed.
When an IACUC-approved deviation from USDA standards and regulations is required for scientific or other reasons, the report must address the reasons for the deviation, and the number and species of animals affected.
Suspension and Noncompliance At an institution with an approved PHS Assurance, the IACUC must report promptly, through the IO, the circumstances and actions taken in the fol-lowing instances:
any serious or continuing non-compliance with the PHSPolicy;
any serious deviation from the provisions of the Guide, and
any suspension of any activity by the IACUC.
It is recommended that the institution contact OLAW immediately following the event, and send a formal report describing the circumstances and any actions taken, to OLAW after IACUC and IO review. Similarly, accredited institutions must report promptly to AAALAC serious issues relating to the animal care and use program, such as investigations by the USDA or OLAW, or other serious incidents or concerns that negatively affect animal well-being.
If the IACUC suspends any activities involving USDA-covered animals, the IO files a report with the AC Regional Director, in consultation with the IACUC. After reviewing the reasons for the suspension and taking appro-priate corrective actions, the IO is responsible for submitting a full explanation to APHIS and any federal agency funding the activity (see Tables E and A.2.B.)