NIH Updates Guidance on Prompt Reporting to OLAW

Overview

The National Institutes of Health (NIH) has issued NOT-OD-25-148, Notice on Update to Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. This notice rescinds and replaces the 2005 guidance (NOT-OD-05-034) while retaining its core expectations and clarifying key areas to support consistent institutional compliance.

The updated guidance reflects a review conducted under the 21st Century Cures Act, which directed NIH, in collaboration with federal partners, to reduce unnecessary administrative burden while maintaining protections for research animals and the integrity of PHS-supported research.

Overview of Key Updates

After a comprehensive review, OLAW determined that much of the previous guidance remains applicable and has been incorporated into the revised Notice. To improve clarity and consistency, six substantive updates were made, including:

• Clarification of how reporting requirements apply based on the scope of an institution’s Animal Welfare Assurance, including when incidents must be reported regardless of funding source
• Clarification that certain functional, programmatic, or physical issues may require reporting if they could affect activities subject to the PHS Policy
• Addition of new examples of situations that are not normally required to be reported
• Updated expectations for including award numbers and funding sources in reports to OLAW
• Clarification of reporting responsibilities when federal entities operate under memoranda of understanding (MOUs) with OLAW
• Confirmation that the Institutional Official’s (IO) signature on the final report verifies compliance with PHS Policy reporting requirements

OLAW Oversight and Institutional Reporting Responsibilities

OLAW oversees animal activities at institutions with an approved Animal Welfare Assurance under the Health Research Extension Act of 1985 and the PHS Policy. Through MOUs, OLAW also provides oversight for animal activities supported or conducted by other federal agencies.

Under PHS Policy section IV.F.3., institutions must promptly report, through the IO, a full explanation of:

• Any serious or continuing noncompliance with the PHS Policy
• Any serious deviation from the Guide for the Care and Use of Laboratory Animals
• Any suspension of an activity by the IACUC

Prompt reporting supports institutional self-monitoring and enables OLAW to assess corrective actions, monitor compliance trends, and provide guidance when needed.

Examples of Situations That Should Be Reported

The Notice provides illustrative examples to help institutions determine when reporting is expected, while recognizing that a comprehensive list is not feasible. Situations that may require reporting include:

• Conditions that jeopardize animal health or well-being and result in harm or death.
• Animal-related activities conducted without appropriate IACUC review or approval.
• Failure to adhere to, or implementation of significant unapproved changes to, IACUC-approved protocols.
• Conduct of IACUC business without a quorum or while the committee is improperly constituted.
• Failure to correct deficiencies identified during semiannual program reviews.
• Participation in animal activities by individuals not appropriately qualified or trained.
• Inadequate post-procedural monitoring, failed euthanasia, or failure to follow veterinary orders.
• Facility or programmatic failures (e.g., sanitation or HVAC issues) that could affect activities subject to the PHS Policy.

Situations identified by external entities, such as USDA or AAALAC International, or by individuals outside the institution, are not exempt from reporting.

Examples of Situations Not Normally Requiring Reporting

OLAW also recognizes that not all adverse outcomes associated with animal research rise to the level of reportable noncompliance. Examples that normally do not require reporting include:

• Natural death at the end of an animal’s lifespan.
• Spontaneous disease when appropriate veterinary oversight was in place.
• Outcomes that fall within the parameters of an IACUC-approved protocol.
• Infrequent mechanical issues that are promptly identified and addressed.
• Minor deviations without animal welfare impact, such as expired medications that were not administered.

Institutions are expected to evaluate the specific circumstances, intent, and actual impact on animal welfare when determining whether reporting is required.

Reporting Time Frames and Required Information

Institutions should notify OLAW of reportable matters promptly. When a full investigation and corrective action plan will take time, OLAW recommends submitting a preliminary report as soon as possible, followed by a final report once actions are completed. Reports should not be delayed or bundled with the Annual Report.

Reports typically include:

• The institution’s Animal Welfare Assurance number.
• Relevant NSF award numbers, when applicable.
• Funding sources for all PHS-supported activities.
• A clear explanation of what occurred, including when, where, and which species were involved.
• Actions taken and corrective plans with implementation timelines.

Final reports must be submitted by the IACUC through the IO. The IO’s signature confirms compliance with PHS Policy section IV.F.3.

What Institutions Should Do Now

To align with the updated NIH guidance, institutions may wish to:

• Review their Animal Welfare Assurance language to confirm how reporting obligations apply across funding sources.
• Revisit internal IACUC and IO reporting procedures to ensure timely preliminary and final reporting.
• Ensure staff understand which situations require reporting and which do not.
• Confirm processes are in place to capture the required funding source and award information.
• Reinforce training on institutional self-reporting expectations and when to consult OLAW.

Key Takeaway

NIH Notice NOT-OD-25-148 clarifies expectations for prompt reporting to OLAW while reinforcing long-standing principles of institutional accountability and animal welfare oversight. By reviewing internal processes and engaging proactively with OLAW when questions arise, institutions can continue to support both compliance and high standards of animal care.