Animal Welfare Noncompliance: Data and Process

Brent Morse headshot
Brent C. Morse, DVM, DACLAM, Director, OLAW Division of Compliance Oversight Office of Extramural Research, NIH

As part of proper stewardship of taxpayer funds, we at NIH are obligated, both legally and ethically, to ensure the welfare and reduce risks for those involved in our supported research activities. This obligation includes research animals. Their humane care and use is something we take very seriously. We appreciate that Congress, the research community, interest groups, and other members of the public look towards us to observe this commitment. Today we are taking some time to touch upon our policies to protect animal welfare, discuss how we process reports of noncompliance, and provide resources to help recipients and researchers ensure their work involving animals is conducted appropriately.

Institutions that receive funds from the Public Health Service (PHS), which includes NIH, must conduct research involving live vertebrate animals in accordance with the PHS Policy on the Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy requires all institutions to comply, as applicable, with the Animal Welfare Act and other Federal statutes and regulations relating to animals. Our Animals in NIH Research page discusses relevant policies in more detail and has other resources which may be of interest.

Proper animal welfare means, among other things, appropriate environments, husbandry, veterinary care, and minimization of pain and distress. Proper animal welfare also strengthens the rigor, reproducibility, and translatability of research findings (see also this recent webinar on the ARRIVE guidelines).

When potential animal welfare concerns arise, recipients and researchers are required to promptly report to the NIH Office of Laboratory Animal Welfare (OLAW), via their Institutional Official and Institutional Animal Care and Use Committee (IACUC). We also receive and review allegations from current or former employees, interest groups, the public, other funders, and oversight agencies. More on reporting non-compliance can be found in the section on institutional reporting to OLAW in OLAW’s Topic Index.

The purpose of self-reporting and OLAW oversight is to improve procedures and practices at institutions to ensure animal welfare and ultimately the quality of science. While we understand that an institution may be cautious when sharing compliance information, it shows transparency and a willingness to quickly and effectively correct any issues. When taken together, this goes a long way to strengthening public trust and assures the community that potential animal welfare concerns are evaluated.

Figure 1. NIH Process for Handling Reports of Potential Noncompliance with the PHS Policy

Figure 1 is an image of a flowchart showing the life cycle of a report to OLAW. The process begins with receiving a report from the Institutional Official (IO), then OLAW evaluates the incident and IACUC proposed corrective actions. OLAW may put additional measures into place for serious incidents and repeated patterns of noncompliance, such as requesting enhanced reporting.

OLAW uses the PHS Policy and the Guide when evaluating reports. OLAW takes a collaborative and solutions-oriented approach to work with recipients to address animal welfare concerns (see Public Law 99-158). As part of a system of enforced self-regulation, institutions have the flexibility to develop corrective measures that fit their needs, which must then be approved by the IACUC. For serious issues, corrective measures may require immediate attention. If quick corrections are not feasible, interim measures may be necessary. If appropriate efforts are not taken, we can consider restricting or withdrawing an institution’s Assurance or terminating grants. If their Assurance is removed, they can no longer conduct research with PHS funds that involve animals. However, in accordance with the Health Research Extension Act of 1985, institutions are provided “a reasonable opportunity to take corrective action” which is based on realistic timelines developed in response to the infraction. Assurance removal or grant termination would be considered only if no actions are taken by the institution.

OLAW opened 870 cases of potential non-compliance with the PHS Policy in calendar year (CY) 2020, 966 in 2021, and 1,111 in 2022 (Figure 2). We suspect the increase seen in 2022 (compared to earlier years) was due in part to more research activities ramping up as the effects of pandemic shutdowns lessened. There were also more allegations submitted by interest groups.

Figure 2. OLAW Opened Cases related to Noncompliance with PHS Policy: CYs 2020-2022

Figure 2 is a bar chart showing the number of cases OLAW opened. The X axis is the Calendar Year between 2020-2022, while the Y axis is the Number of Cases opened. Each bar is labeled with a number representing the number of cases.

Figure 3 breaks down the types of institutions submitting reports. The majority in CY 2022 come from academic institutions / institutions of higher learning (70% in 2022). Other types of institutions, such as non-profit research organizations and hospitals that are not part of the other categories, made up 16% of reports in 2022. Federal, state, and local government institutions were 12%, while commercial research organizations represented 2%. Similar proportions were seen for CYs 2021 and 2020.

Figure 3. Types of Institutions Submitting Reports: CYs 2020-2022

Figure 3 is a horizontal cluster graph chart showing percentage of cases by institution type. The X axis represents the type of institution, including Institution of Higher Learning, Government, Commercial, or Other. The Y axis represents the percentages of reports opened in a particular calendar year, from 0% to 80%. Blue bars indicate the percentage for 2020, orange for 2021, and gray for 2022. Each bar is labeled with the percentage of cases opened.

Figure 4 shows that the majority of reportable issues stem from members of the research team (68%) in 2022. Considering this, investigators should ensure all members of the research team are acquainted with approved animal procedures. Reports also came from Animal Care Staff such as vivarium care staff and husbandry technicians (13%), IACUCs (3%), veterinarian staff (2%), other institutional staff (1%), and other functional units such as facility maintenance (2%). Reports referenced in the “None” group include natural disasters and other adverse events involving animal subjects not related to a noncompliance event (11%). The findings were similar for each group in CY 2021 and 2020.

Figure 4. Breakdown of Where Reportable Issues Originate: CYs 2020-2022

Figure 4 is a vertical cluster bar chart showing where reportable issues originate. The X axis represents the calendar year from2020-2022. Within each year, there are separate bars representing members of the research team (light blue), animal care staff (orange), veterinarian staff (gray), IACUC members (yellow), other institutional staff (red), others not included in those groups (green), or none (dark blue). The Y axis represents the percentage of cases opened in that year, ranging from 0 to 80%.

Figure 5 shows a breakdown by the type of animals referenced in the reports. In 2022, rodents were involved in 76% of reports, non-human primates in 6%, fish in 4%, ungulates in 3%, and carnivores such as dogs, cats, and ferrets in 1%. Birds, amphibians, and reptiles are captured in the “other” group at 6%. Animals that were not specified in the reports were in 4%. Similar proportions were seen in CYs 2021 and 2020.

Figure 5. Breakdown of Types of Research Animals Identified in Non-Compliance Allegations: CYs 2020-2022

Figure 5 is a vertical cluster bar graph describing the types of research animals involved in allegations of non-compliance. The X axis depicts rodents, non-human primates, fish, carnivores, ungulates, all other species, and animals that were not specified. For each animal group, individual bars represent the calendar years 2020 (blue), 2021 (orange), and 2022 (gray). The Y axis represents the percentage of cases opened in the calendar year, from 0 to 80.

Issues arising during animal studies comprised a quarter of the reportable incidents during 2022 (Figure 6). Examples of such issues are failing to follow study protocols and performing animal activities before receiving approval. Reportable issues also include failing to follow institutional policies (20%) as well as concerns around animal husbandry (12%), clinical veterinary medical issues (12%), the physical plant (3%) and IACUCs (1%). Human error, natural disasters, and other issues made up 23% of reportable cases, and 4% of reported cases actually involved no violation. Similar proportions were seen for CYs 2021 and 2020.

Figure 6. Types of Reportable Incidents OLAW Received in 2022

Figure 6 is a horizontal cluster chart describing the types of reportable incidents. The Y axis represents the types of incidents, such as animal study issues, clinical issues, animal husbandry, failure to follow institutional policies, IACUC issues, physical plant, other issues, and no violation found. Each group includes individual bars representing the calendar years 2020 (blue), 2021 (orange), and 2022 (gray). The X axis represents the percentage of cases opened in the calendar year, ranging from 0 to 35.

Though we provide these aggregate data in the spirit of transparency, it should be noted that we do not publicly discuss individual reports of potential non-compliance. Institutions should understand, however, that certain information provided on self-reports may be released as part of a Freedom of Information Act request. Those records may be released if the compliance case is resolved/closed, and appropriate adequate measures have been taken to prevent recurrence. This webinar and podcast explain more about what information may or may not be released if a request is made.

Our goal is to continue ensuring institutional self-reporting in good faith, addressing issues collaboratively, and promptly taking appropriate corrective measures to ensure animal welfare in NIH-supported research. We appreciate the research community’s continued efforts to -meet the expectations under the PHS Policy and animal welfare Assurance. If researchers, institutions, or IACUCs have any questions or concerns about these requirements and expectations, please contact OLAW.

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