Overview

Investigators who conduct research outside the United States may encounter regulations and policies different than those that govern research in the U. S. Regulations may differ in the areas of human subjects, taxation, employment, real estate, licensing, or other matters. Additionally, U.S. export-control laws and regulations may apply to research activities that take place outside the U.S. and that involve the use of technology or the development of certain items (e.g., products, goods, hardware, software, and materials). Because of these differences, Harvard researchers must be aware of their individual responsibilities when conducting research abroad, including the possibility of formal approval by the Provost’s Office.

Investigators should consult Harvard's Guidance for International Projects for information about operational issues surrounding international projects.

External Oversight

No single federal entity oversees international research. However, most agencies require that their domestic regulations extend to research conducted in a foreign country, while also restricting the use of sponsored funding for particular foreign activities.

The NIH has outlined the guidelines that apply to projects with a foreign component, including grants made to foreign institutions and international organizations.

When working with human subjects, the Department of Health and Human Services (HHS) has declared that the requirements of HHS regulations must be satisfied for all HHS-conducted or supported research covered by a federalwide assurance, regardless of whether the research is conducted domestically or internationally. The local regulations regarding the use of human subjects may differ from those in the United States and it is the responsibility of the researcher to educate him or herself of those differences. A useful resource is the International Compilation of Human Subject Research Protections, which summarizes the various regulations and guidelines in more than 90 countries around the world.

Harvard Policies, Procedures & Guidance

Provost Review

The Provost has established criteria to determine whether an activity needs Provostial review, among which are several criteria that apply specifically to international projects, including those that propose the establishment of a new international site and those that involve human subjects research abroad.  To determine whether your project needs review by the Provost’s Office, see the full set of criteria. An additional criterion of particular note is the aggregate budget of the proposed international program/project. If the budget exceeds the following thresholds, it requires review by the Provost's Office:

• FAS, HMS > $5 million
• HBS > $3.8 million
• HSPH > $3 million
• HLS > $1.5 million
• HKS > $1.3 million
• HGSE, HSDM, GSD, HDS, SEAS, RIAS > $1 million

In general, these criteria are designed to facilitate research abroad by providing clear procedures for University-level review of certain projects and, in the case of international projects, to manage the unique risks associated with research that takes place outside the U.S., such as:

• the physical safety of faculty and students who spend anywhere from a few days to an entire year in foreign countries;
• the protection of Harvard’s name and identity;
• the compliance by Harvard and its agents with the laws, regulations, and customs of foreign jurisdictions;
• the management of operational logistics in remote locations; and
• adherence to the high standards of accountability that are established here in Cambridge and Boston.

Some proposals that meet the Provost Review Criteria will need review by the University Committee on International Projects and Sites (UCIPS), a committee established by the Harvard Corporation to review proposals for significant activities abroad, discuss University-wide policy issues that affect Harvard’s international activities, and review ongoing international activities at the request of the President or Provost.  Chaired by the Vice Provost for International Affairs, the UCIPS is comprised of faculty representatives from each Harvard School.  UCIPS reviews proposals that meet the budget thresholds above or that involve the establishment of an office outside the U.S., among other criteria.  The Provost’s staff can help researchers determine whether a proposal that meets Provostial review criteria also needs review by the UCIPS.