Alert to Research Institutions with PHS-approved Animal Welfare Assurances: OLAW Issues Clarification on Prompt Reporting Guidance
Newly published Guidance from OLAW
OLAW recently published a notice that it has updated its guidance to the regulated community about their reporting requirements to the agency. “Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals,” NOT-OD-05-034, issued on February 24, 2005, now rescinded, has been replaced with the new Guidance, “Notice on Update to Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals,” NOT-OD-25-148, “to refine and update examples of reportable situations, examples of situations where reporting is not normally required, the time frame for reporting, and the information to be reported.”
What are the clarifications?
The most important clarifications for your review include the following:
An institution that specifies in its PHS Approved Assurance that it will report any incident it determines to be reportable, must report that incident regardless of the funding source of the research involved.
Any situation in a functional, programmatic, or physical area that could affect activities subject to the PHS Policy, regardless of funding source (e.g., inadequate sanitation due to malfunctioning cage washer, room temperature extremes due to HVAC failures, etc.)
OLAW adds the following examples of incidents where reporting is not normally required:
Animal injury by conspecifics during social housing when proper introduction and subsequent monitoring occurred.
Expired medications identified after the expiration date, but not administered to animals after expiration.
Moderate fluctuations in temperature and humidity, when brief and infrequent, where no animal health or welfare issues resulted, and when a program of required daily monitoring was in place.
OLAW clarifies that information about award numbers and funding sources required to be reported includes:
Award numbers for National Science Foundation (NSF) funded activities. Only NSF award numbers must be included in the report. Other award numbers need not be included unless requested by OLAW or if determined to be applicable by the reporting institution.
Funding source for all PHS supported activities, including those having an MOU with OLAW. E.g., NIH, NSF, National Aeronautics and Space Administration (NASA), U.S. Department of Veterans Affairs (VA).
For federal agencies conducting or supporting animal activities governed by OLAW, the funding source for all PHS supported activities, including those having an MOU with OLAW. E.g., NIH, NSF, National Aeronautics and Space Administration (NASA), U.S. Department of Veterans Affairs (VA) must be provided when reporting incidents.
The signature of the Institutional Official (IO) on the final report to OLAW provides verification that the institution has complied with its reporting requirements in compliance with PHS Policy section IV.F.3.
What should Research Institutions do now?
Based on this guidance, research institutions may consider amendments to their PHS-Approved Animal Welfare Assurance and any internal policies, guidance and/or standard operating procedures to ensure that reporting to OLAW meets but does not exceed these guidelines.
For example, institutions that currently specify it will report to OLAW any “reportable” adverse incident, regardless of the funding source of the relevant research, may want to limit its reporting requirements to incidents involving animals funded by relevant federal funding sources.
Any amendment to the Assurance must be properly approved and any changes incorporated into all internal reporting policies, guidance and operating procedures to ensure internal consistency.
If you have questions about this Client Alert or are interested in additional details or guidance, please reach out to Dr. Nancy Halpern (nancy.halpern@pierferd.com) or your regular PierFerd contact for assistance.
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