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Home Back Issues No. 9: COMPLIANCE: Do U.S. regulations apply to U.S. scientists in other countries?

May 24

No. 9: COMPLIANCE: Do U.S. regulations apply to U.S. scientists in other countries?

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Do U.S. regulations apply to U.S. scientists who conduct lab-animal research outside the country?

Reader Question: My U.S.-based research institution also maintains excellent animal-lab facilities in a foreign country. I would like to conduct some of my current experiments there. Would U.S. regulations still apply?

Expert Comments:

Depending on the type of research being performed and the funding source, U.S. regulations might indeed apply.

Let us assume that the research in question is funded by the National Institutes of Health (NIH). In this case, Public Health Service (PHS) animal-welfare regulations will apply to any portion of the research performed at another institution, either within or outside the United States.

In particular, the grantee is responsible for all animal work performed and the grantee’s Institutional Animal Care and Use Committee (IACUC) is responsible for reviewing and approving this work prior to its commencement.

In this regard, the PHS Office of Laboratory Animal Welfare (OLAW) notes that, while the IACUC retains responsibility for the review, it has the option of accepting the approval of the foreign institution’s IACUC. The grantee institution’s IACUC also retains responsibility for continuing review of the NIH-funded activity. If the grantee’s IACUC accepts the initial review and approval of the foreign institution’s IACUC, it should require the foreign IACUC to forward promptly all documents pertaining to continuing review of the protocol.

Additionally, OLAW requires that the foreign institution complete a “Statement of Compliance with Standards for Humane Care and Use of Laboratory Animals by Foreign Institutions.” This document, which can be obtained from OLAW, “certifies that the institution will comply with the applicable laws, regulations, and policies of the jurisdiction in which the research will be conducted, and that the institution will be guided by the International Guiding Principles for Biomedical Research Involving Animals.” (See OLAW Web site, http://grants.nih.gov/grants/olaw/faqs.htm#d13).

Regulations and, in particular, interpretive policies are subject to change. Readers who are considering the option of performing animal studies at any institution, foreign or domestic, other than their home institution should consult with their funding agencies prior to commencing such studies.

Comments by Peggy J. Danneman, VMD, MS, Dipl. ACLAM, Senior Director, Laboratory Animal Health Services, The Jackson Laboratory, Bar Harbor, Maine.

Additional information: Other agencies that support lab-animal and other research, such as the U.S. Department of Agriculture and the National Institute for Allergies and Infectious Diseases (NIAID, part of NIH), also have regulations that apply to research conducted abroad.

The NIAID Web site (http://funding.niaid.nih.gov/ncn/qa/selagentfor.htm#plan), which answers a number of frequently asked questions about research at foreign institutions, explains:

"NIAID-supported researchers abroad must comply with NIH grants policy, which includes research requirements of the United States and the foreign country, providing the foreign requirements do not contradict U.S. laws.

"Laboratory visits are required for foreign laboratories receiving NIAID awards. ... If (inspectors) find deficiencies based on Centers for Disease Control requirements (or USDA requirements in the case of plants and animals), the review group can recommend a restriction on the award, prohibiting funding until issues are resolved."

Comments (1)
US Regulations abroad
written by Denis English, Ph.D., June 01, 2010
I have been asked by many if US (FDA) regulations regarding stem cell research, in animals, in vitro and clinically, apply to 1) US investigators at foreign institutes or at their own institute outside US borders and 2) if US (FDA) regulations regarding stem cell research apply to foreign institutes, as well as foreign investigators. FDA officials I contacted in Bethesda stressed to me that FDA regulations only "are enforced" within the US. However, a quick reading of the laws that enforce FDA policies in this matter(and I am sure on matters of animal research) suggest differently, as do recent historical events.

PHS regulations as well as those of the NIH and other funding agencies are in fact reduced to laws enacted by congress and signed by the President and specified in the PHS Code, the Federal Code and the US Code of Federal Regulations (CFR). These laws are carefully written. With regard to FDA regulations specified in the PHS code, the regulations cover "your performance site". In the case of NIH funded research, these regulations further apply to research performed at the "PI's performance site" (CFR) and make no exception for the location of the performance site. These regulations and the penalties for violating them would therefore apply to anyone, regardless of where the research is carried out. That investigator would not by law be immune from prosecution in the US if they were either US residents or citizens or, in fact, if they came here on a visit. An investigator may use "lack of juristiction" as a defense, but that hasn't worked in the past. The topic is murky as Dr. Danneman suggests, but it is very clear that no US investigator can "get around" FDA or HHS policies by carrying out that research, regardless of the source of funds, by setting up shop in a foreign country.

In the cases of specific things one can do regarding animals, stem cell, viral or clinical studies, the law makes no reference to "applicant" or "awardee institute". They state what is allowed and not allowed at "the research performance site".

Legally, the situation would seem to be clear if the research involves only foreign nationals working at their performance sites abroad, not funded by the US. But it is not. While it may seem that this research would not fall under the juristiction of US law, it does whereever the US can enforce it, and that encoumpasses practically the entire planet. Taken to its fullest extent, such research could be viewed as terroristic, or potentially harmful to humanity. In these cases, the US has successfully both arrested and extradited individuals from foreign countries to stand trial in the US. Similar results could be expected for any individual who violated an important ban on any research activity addressed as illegal in US law.

Finally, the most recent example of our ability to enforce US law is reflected by the activities of both individuals and nations who publically declared their intention to violate US law restrictingg research on embryonic stem cells. At the onset, many countries, including Britain, Canada and China, as well as many individuals in the US --claiming they were exempt from the President's proclaimation because they were not supported by US funds declared their intention to defy the ban. Institutes were constructed with careful attention to detail so as to appear that the institute was not funded by US governmental funds. All proceeded in a manner that led to the belief that they would soon initiate embryonic stem cell research, here and abroad. Yet, in the final analysis, none did.

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