Reporting Noncompliance

Thank you for your comments in response to the Request for Information (RFI) on updates to NOT-OD-05-034 Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals. The comment period is now closed and we will announce when the final guidance has been released.

The following resources are provided to assist Public Health Service (PHS) awardee institutions in meeting reporting requirements.

Introduction

OLAW oversees PHS-funded animal activities by the authority of the Health Research Extension Act of 1985 and the PHS Policy on Humane Care and Use of Laboratory Animals (Policy). The PHS Policy, section IV.F.3., requires that:

“The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to:

any serious or continuing noncompliance with this Policy;
any serious deviation from the provisions of the Guide; or
any suspension of an activity by the IACUC.”

All institutions with Animal Welfare Assurances (Assurance) are required to comply with the provisions of PHS Policy IV.F.3. NIH Guide Notice NOT-OD-05-034 provides the following guidance on reporting requirements. Here you will find:

Examples of reportable situations
Examples of situations not normally reported
Timeframe for reporting
Information to be reported

Institutions should be aware that documents submitted to OLAW are subject to the Freedom of Information Act (FOIA). To learn more about the NIH FOIA process, see FAQ C4.

Preliminary Report

Institutions should notify OLAW promptly of reportable situations. As such, it is appropriate to submit a preliminary report prior to the completion of a full investigation and implementation of a corrective plan. Preliminary reports may be phoned, faxed, or e-mailed to the Division of Compliance Oversight. The following information is requested:

Name and contact information of person reporting
Name of institution
Assurance number (see list of domestic and foreign Assured institutions)
Funding component and if contacted (for situations related to PHS-supported activities)
Brief description of incident (e.g., species, category of personnel involved, dates, times, animal deaths)
Plan and schedule for correction and prevention (if known)
Timeframe for final report from the Institutional Official

Final Report

Institutions must provide a final report of reportable situations that includes a detailed explanation of the circumstances and actions taken. A final report must be signed by the Institutional Official and must specify:

Name of institution
Assurance number (see list of domestic and foreign Assured institutions)
Reporting requirement: Identify the reporting requirement of the PHS Policy IV.F.3. under which the incident qualifies (i.e., serious or continuing noncompliance with the PHS Policy, serious deviation from the provisions of the Guide, or suspension of an activity by the IACUC).
Preliminary report: Note when, by whom, and to whom a preliminary report was made, if applicable.
Explanation of incident: Explain in detail what happened, when and where, the species of animals(s) involved, and the category (but not the names) of the individuals involved.
Corrective actions: Describe the corrective and preventative actions taken to address the situation. Include all the short or long-term corrective plans along with the implementation schedule. Indicate whether the IACUC reviewed and accepted the corrective actions submitted by the responsible party and any ongoing actions taken by the IACUC (e.g., enhanced oversight).
Grant/contract number: Include the relevant grant or contract number (for situations related to PHS-supported activities).
Impact on PHS-supported activities: Describe any potential or actual effect on PHS-supported activities. This also applies to incidents that have occurred in a functional, programmatic, or physical area not supported by the PHS that could affect PHS-supported activities (see also NOT-OD-05-034).
Compliance with terms and conditions: If the incident involved PHS-supported activities and was not compliant with the terms and conditions of grant award, confirm that the situation was reported to the funding component and that all unauthorized costs initially paid from the grant have been removed and covered by other sources (see also NOT-OD-10-081). Or, certify that no unallowable costs were charged during the noncompliant period.

Example Final Report

An example of a final report is provided to assist institutions in preparing a noncompliance report. Click on one of the versions below to view or download.

PDF (368 KB)
Word (38 KB)
HTML

Submit Final Report

Beginning December 31, 2013, paper reports submitted by postal or express mail will no longer be accepted. Submit your signed final report electronically by e-mail in PDF format to olawdco@mail.nih.gov or by fax to 301-480-3387.

OLAW Review

OLAW evaluates and reviews noncompliance reports and the actions taken. OLAW may ask for clarification or other information to assess the case; or recommend certain actions to enhance compliance and prevent recurrence. After OLAW has completed its evaluation of the situation, a report of the findings and acceptance of the corrective actions is e-mailed to the Institutional Official and copied to the IACUC office/contact and any complainants in the case.

The PHS Policy and the Guide (pp. 23-24) require the submission of animal welfare concerns to the IACUC for investigation. Relevant findings of the investigation are reported to OLAW by the IACUC through the IO. However, concerns may be submitted directly to OLAW from any source through any communication method, including telephone, fax or e-mail. Reports may be anonymous and should be submitted to the Division of Compliance Oversight. Regardless of the source, OLAW will investigate the concern following established compliance oversight procedures (PDF - 129 KB). OLAW may withhold identifying information to protect whistleblowers, but protection from reprisal for whistleblowers must be addressed at the institutional and/or state level. OLAW cannot guarantee that individuals making a report will be protected from adverse institutional actions.

Additional References

Compliance Oversight Procedures, 2007 (PDF - 128 KB) - this memorandum updates and summarizes the procedures utilized by OLAW in conducting compliance oversight activities.
Reporting Noncompliance - this section of the Topic Index provides additional guidance on reporting noncompliance found in Commentaries, Articles, FAQs, and NIH Guide Notices.
Terms & Conditions - this section of the Topic Index provides guidance to grantees when animal activities have been conducted which do not meet the terms and conditions of grant award.

Questions?

Not sure what to report? Call or e-mail the Division of Compliance Oversight for answers to your questions.

Contact the Division of Compliance Oversight

Phone: 301-594-2061, 301-594-2921, or 301-594-3657.
E-mail: olawdco@mail.nih.gov
Fax: 301-480-3387