Reporting Noncompliance

Sanctions imposed by the IACUC or by an institutional official due to serious or continuing noncompliance or serious deviations from the Guide must be reported to OLAW. Guidance on reporting noncompliance is in the NIH Guide for Grants and Contracts NOT-OD-05-034.

The Freedom of Information Act (FOIA), 5 U.S.C.522, provides individuals with a right of access to records in the possession of the federal government. All documents submitted to OLAW are subject to the FOIA. However, the government may withhold information pursuant to the exemptions and exclusions contained in FOIA. To learn more about the NIH FOIA process, see the OLAW Online Seminar: Openness and Transparency and Biomedical Research Oversight.

In a ruling by the US District Court for the District of Columbia Div. No 99-3024, In Defense of Animals v. Department of Health and Human Services (HHS), 9/28/2001, the Court ruled that HHS (NIH’s parent organization) may withhold IACUC members’ names. NIH does release the names of the IACUC Chairperson, veterinarian, and Institutional Official as reported in Assurances.

Note also that footnote 6 in the PHS Policy allows institutions to represent the name of IACUC members other than the chair and veterinarian by using numbers or other symbols, provided there is sufficient information to allow OLAW to determine that appointees are appropriately qualified. Identities of members must be readily ascertainable by the institution and available to OLAW upon request.

In providing the facility and species inventory as part of the Assurance submitted to OLAW, institutions may identify animal areas in any manner, e.g., initials, ID number. It is not necessary to provide OLAW with detailed diagrams of facilities or room numbers, unless specifically requested by OLAW.

Institutions are also advised to consult the Guidance on Prompt Reporting to OLAW under the PHS Policy (NIH Guide for Grants and Contracts NOT-OD-05-034) with respect to what information is expected to be reported when reporting noncompliance. Disciplinary documents (e.g., letters of reprimand) and correspondence between the IACUC and investigators are generally not required by OLAW, although they may be requested.

Additional information about the FOIA, including guidelines for submitting FOIA requests, is available at: https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office

The Freedom of Information Act (FOIA) is a federal law that provides individuals with a right of access to records in the possession or control of the federal government. That means that OLAW is required to release information in its possession or control unless that information is specifically exempted from release as described in section 522(b) of the FOIA. There is no federal requirement for institutions (other than the federal government) to comply with the federal FOIA. State or local laws, sometimes referred to as “Sunshine Laws” may govern the release of information by institutions. These vary widely from state to state. Even within a state, different regulations may govern disclosure for public and private institutions. Institutions are encouraged to seek the advice of their legal counsel regarding disclosure of information.

The IACUC must review and approve departures from the Guide. IACUC approval of departures from the Guide must be based on scientific, veterinary medical, or animal welfare issues. Semiannual reports from the IACUC to the Institutional Official (IO) must identify specifically any departures from the Guide (PHS Policy IV.B.3.). Read the Guide carefully; it establishes exceptions in specific situations; these are not departures from the Guide and are not required to be reported to the IO.

Guidance in the Eighth Edition of the Guide is stated in terms of standards that must be met, standards that should be met, and standards that may be met.

PHS Policy IV.B.4. requires the IACUC to review concerns involving the care and use of animals at the institution. The Guide for the Care and Use of Laboratory Animals (Guide, page 24) states that a program for reporting animal welfare concerns should “include a mechanism for anonymity, compliance with applicable whistleblower policies, nondiscrimination against the concerned/reporting party, and protection from reprisals.” OLAW expects institutions to enforce protections afforded by institutional policy and applicable law for any individual(s), who in good faith, reports an animal welfare concern.

• Once an incident has been reported to the IACUC and verified as a noncompliance, OLAW recommends that an authorized individual at the institution provide a preliminary report as soon as possible (see NOT-OD-05-034). This includes any reports made by whistleblowers and/or allegations of retaliation.
• It is important for institutions to have a feedback mechanism notifying the complainant of the outcome to assure whistleblowers that their concerns have been acknowledged (Guide, page 23-24).
• Whistleblowers are encouraged to use the institution’s internal reporting structure to report animal welfare concerns but may also contact OLAW to either make a report or receive anonymous consultation. OLAW may withhold identifying information to protect whistleblowers but cannot guarantee that individuals making a report will remain anonymous or be protected from adverse institutional actions. Even with identifying information withheld, individuals may be identified by others due to the circumstances surrounding the report.
• Institutions are expected to comply with applicable USDA regulations. The Animal Welfare Regulations require the IACUC, as an agent of the research facility, to review and, if warranted, investigate concerns involving the care and use of animals at the research facility resulting from public complaints or reports from research facility personnel (9 CFR § 2.31(c)(4)). Furthermore, personnel training must include guidance in “methods whereby deficiencies in animal care and treatment are reported ... No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the [Animal Welfare Act]” (9 CFR § 2.32 (c)(4)).

Because discrimination and reprisal can discourage individuals from reporting and delay correction of animal welfare concerns, OLAW takes allegations of retaliation seriously. OLAW’s response to allegations of reprisal may include, but is not limited to, confirming that the institution’s policy and process for responding to reports complies with the institution’s Animal Welfare Assurance and the Guide, or additional action as necessary, based on the severity and nature of the allegations.