Animal Use in Research: NIH Should Strengthen Oversight of Projects It Funds at Foreign Facilities
Fast Facts
The National Institutes of Health provided $2.2 billion in contracts or grants in FYs 2011-2021 to foreign organizations for research involving animals. Foreign facilities conducting this research must follow U.S. or international animal welfare standards.
NIH relies on annual reports submitted by funding recipients to monitor the foreign research facilities' compliance with these standards. But NIH doesn't verify the reliability of the information in these reports.
We recommended that NIH take steps, such as visiting foreign facilities, to ensure that it has reliable information about the welfare of the animals used in research that it funds.
Highlights
What GAO Found
From fiscal year 2011 through fiscal year 2021, the National Institutes of Health (NIH) provided approximately $2.2 billion in contracts or grants to foreign organizations for research projects involving animals. NIH contracts, totaling about $1.9 billion, supported foreign animal research projects in 10 countries. About 90 percent of this contract funding supported research in the Netherlands, Denmark, and the United Kingdom. NIH grants, totaling about $318 million, supported foreign animal research projects in 44 countries. About 66 percent of this grant funding supported research in Australia, Canada, and the United Kingdom.
Examples of Animals That May Be Used in NIH-Funded Foreign Animal Research
Foreign facilities must meet several requirements to perform NIH-funded animal research. For example, the facilities are required to comply with U.S. policy governing animal care and use or provide evidence that acceptable standards for the humane care and use of animals will be met. Each facility must also commit to follow international principles for animal care and use and must certify compliance with relevant laws, regulations, and policies in the country where it operates. NIH has proposed two additional requirements for foreign facilities. These include a requirement that each facility submit an annual report affirming either that there was no reportable noncompliance with animal care and use standards during the year or that it notified NIH of any noncompliance.
NIH has established processes for oversight of foreign animal research, but it does not verify the reliability of annually reported information it uses to monitor compliance for ongoing projects. Before it awards funding, NIH takes some steps to identify, assess, and mitigate any animal welfare risks it identifies. After projects begin, NIH has processes to investigate and, if necessary, remediate any reported noncompliance with animal care and use standards. In addition, NIH uses annual reports submitted by award recipients to monitor foreign research facilities' ongoing compliance with these standards. However, because the award recipients self-generate the information in the annual reports, there are risks that any animal welfare issues may be misrepresented. Yet NIH does not take steps, such as conducting site visits or requiring third-party verification, to ascertain the reliability of this information. As a result, NIH may be missing opportunities to identify and respond to possible instances of noncompliance with animal care and use standards at foreign research facilities.
Why GAO Did This Study
The Department of Health and Human Services' NIH awards over 84 percent of its $45 billion annual budget to support research projects conducted by external organizations. Such projects include laboratory research involving the use of live vertebrate animals in foreign facilities. NIH funds these projects through agreements with domestic and foreign award recipients.
GAO was asked to examine NIH's oversight of the foreign animal research projects it funds. This report (1) identifies the amount of funding NIH awarded to foreign institutions in fiscal years 2011 through 2021 for animal research projects overseas, (2) describes the requirements that foreign facilities must meet to be eligible to perform animal research for NIH-funded projects, and (3) examines NIH's procedures for overseeing the foreign animal research it funds.
GAO analyzed NIH documents and data, including policies and processes related to oversight of, and requirements for, foreign animal research. GAO also interviewed NIH officials and experts in animal research from several organizations.
Recommendations
GAO recommends that NIH take steps—such as conducting site visits or requiring third-party verification—to provide reasonable assurance that award recipients' annual self-reported project information is reliable and adequate to ensure the humane care and use of laboratory animals. The Department of Health and Human Services concurred with this recommendation.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| National Institutes of Health | The Director of NIH should take steps—such as conducting site visits to foreign facilities that perform NIH-funded animal research or requiring third-party verification—to provide reasonable assurance that award recipients' annual self-reported project information is reliable and adequate to ensure the humane care and use of laboratory animals. (Recommendation 1) |
HHS concurred with this recommendation. As of September 2023, HHS noted that NIH's Office of Laboratory Research (OLAW) plans to initiate virtual site visits including a review of award recipients' annual Research Performance Progress Reports for a subset of foreign facilities that perform NIH-funded animal research beginning in Spring 2024. In addition, HHS stated that beginning in Spring 2024, the NIH OLAW will additionally confirm third-party documentation from national, regional, state, and/or local oversight entities as well as documentation of assessment by independent bodies, as available. NIH officials noted that as of August 2024, they are working on providing information to GAO on the status of NIH's efforts. After receiving such information, GAO will assess NIH's progress toward implementing this recommendation.
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