International Research - An Abstract

February 1998


The Office for Protection from Research Risks (OPRR) fulfills responsibilities set forth in the U.S. Public Health Service Act. These include (i) developing and monitoring guidance relative to regulations of the U.S. Department of Health and Human Services (DHHS) - one of several Executive Branch Departments and Agencies bound by common minimum standards for the protection of human research subjects; (ii) exercising compliance oversight; and (iii) establishing criteria for and negotiation of assurances to comply submitted by institutions that are to engage in DHHS-conducted or supported research prior to involvement of human subjects.

In brief, ethical standards, Institutional Review Board (IRB) functions, and informed consent expectations are generally compatible with those of the International Ethical Guidelines for Biomedical Research Involving Human Subjects which were published in 1993 by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO).

In general, OPRR requires (i) prior assurances to abide by minimal ethical, IRB, and consent standards as a prior condition to begin; (ii) that changes in IRB membership reported as they occur; (iii) reasonable provision for IRB reviews to be knowledgeable about the immediate context in which subjects participate; (iv) that subjects not be involved in research without prior IRB approval; and (v) full board convened IRB meetings for initial and continuing reviews of clinical trials. All institutions engaged in DHHS-conducted or supported research must be found by OPRR to comply with at least equivalent protective procedures, regardless of national or international location.

The jurisdiction of OPRR frequently overlaps with that of the U.S. Food and Drug Administration (FDA), an agency with which international investigators may be more familiar. Administrative requirements for the protection of subjects were designed to be comparable where common definitions, procedures, and minimum expectations of both the FDA and OPRR are involved. However, the different missions of the two agencies are accompanied by differences in requirements, notably OPRR's requirement for prior written assurance to comply with relevant regulations. The degree of OPRR oversight prior to initiation of research depends on the nature of the research and OPRR's prior experience with the judgment of an institution's IRB.

Several formats exist for an institution to assure compliance, depending on the nature of the institution and/or the type of research activity in which it is engaged; however, the basic concept is the same. Assurance documents can be: (i) limited to an individual DHHS-conducted or supported research protocol; (ii) include certain groups of multi-site, multi-protocol studies; or (iii) apply to all research of a specified class (e.g., biomedical or behavioral) which is undertaken at established research centers. Much of DHHS's international research is conducted or supported by the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC). OPRR has conducted business in about 110 countries which are distributed across all six inhabited continents.

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Updated June 23, 2000