hands. For example, an investigator may be listed as key personnel under a grant. Even though the investigator might not be getting paid for it, it still can be a foreign component as long as there is a significant element in the work that is being performed for that project. So a foreign component involves human or animal subjects. It also includes what we would consider field studies, if somebody is going to a foreign site and collecting samples from animals. If the investigator is acting as a consultant, the institutions must grapple with that, because consultants are not included in the NIH foreign component entity.

Looking at the terms or conditions of a subaward or subcontract language related to animals, there are several points to consider. One is that the foreign entity must file a PHS assurance or provide evidence that acceptable standards for the humane care and use of animals will be met. All performance sites have to be operating under an assurance and there has to be verification of an IACUC approval. What does the foreign assurance entail? It is essentially a one-page document with three major components: a statement that the institution must comply with whatever the local regulations are; the institution needs to be guided by the International Guiding Principles for Biomedical Research Involving Animals issued by the Council for International Organizations of Medical Sciences (CIOMS), which are very similar to the US Government Principles; and the institution has to make a reasonable effort to ensure that the people doing the work understand the regulations and their responsibilities.

The foreign assurance is now in the process of revision. In contrast to a domestic assurance, the foreign assurance does not have a statement about the Animal Welfare Act, does not mention the need for accordance with the Guide for the Care and Use of Laboratory Animals, does not address lines of authority for administering a program, does not ask for the qualifications of the veterinarian, and does not have reporting requirements. The IACUC review, reporting and understanding the qualifications, falls to the primary recipient, which is the institution receiving the grant.

From an institutional perspective, the initial challenge is knowing that there is a grant with a foreign component. In an IACUC protocol, the investigator may forget to check the box for off-site research or may forget to indicate all the locations where the research will be done. There also may be some confusion as to whether the work being performed off-site has to be listed in the IACUC protocol.

The IACUC protocol is often one way to monitor off-site research, but the key is to ensure that your institution is doing a congruency review, i.e., certifying that what is in the grant matches the IACUC protocol. When doing a congruency review, the person reviewing the grant will see the subcontract including a description of the work and the justification for having it done off-site. The reviewer will determine whether there are procedures in the grant that are not in the IACUC protocol. So this is a very good protection mechanism that needs to occur.

Another important issue to consider is export control, not necessarily with respect to animals but other things that can go back and forth. This is highly



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