|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
The following resources are provided to assist Public Health Service (PHS) awardee institutions in meeting reporting requirements.
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:
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:
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:
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:
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.
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 firstname.lastname@example.org or by fax to 301-480-3387.
OLAW reviewOLAW 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.
Not sure what to report? Call or e-mail the Division of Compliance Oversight for answers to your questions.
Phone: 301-594-2061, 301-594-2921, or 301-594-3657.
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