International Populations
The review of foreign site research presents several challenges to the IRB. The IRB is required to have and document knowledge of the "local research context" and may require additional information from investigators before final approval of foreign site projects can be given. Information about local laws and customs, local IRBs, agencies, or "gatekeeper" organizations, and informed consent alternatives must usually be provided for international research. The FDA requires compliance with "the laws and regulations of the country in which the research is conducted."
Under the UIUC's Assurance of compliance, federally funded projects that will recruit subjects through foreign institutions must provide formal assurance of compliance with federal regulations. Additional paperwork may be required by OHRP before the UIUC IRB can approve such projects.
OHRP Guidebook
Research involving international populations is addressed in Chapter 6, Part K of OHRP's IRB Guidebook.
Participation in International Activities—UIUC Policy
International activities must have academic merit; they may not violate pertinent laws or professional principles of conduct; and only competent and qualified individuals may participate.During the past several years, some problems have arisen in the international activities of universities. These problems have been occasioned by staffing criteria not in keeping with university standards being imposed by foreign governments. Although the University of Illinois has not experienced such problems directly, it seems appropriate to forestall their occurrence by adopting a policy position which makes the University's standards and obligations clear. Accordingly, on March 17, 1976, the Board of Trustees approved the adoption of the following policy concerning the participation of the University of Illinois in international activities:
I. Preamble
The growing interdependencies among the world's peoples and institutions increase the need for identifying appropriate processes to enable groups with different heritages, cultures, values and styles of behavior to work effectively together to solve mutual problems, to learn from each other and to join in cooperative programs.
The University of Illinois, as one of the world's major universities, attaches high priority to encouraging its staff to participate in international activities generally recognized by academic institutions as beneficial to the teaching, research and public service needs within the state and throughout the world.
A key element in the process of enabling the University of Illinois to make its contribution to our international needs is to recognize and develop ways of meeting the special responsibilities required for cooperation with scholars and institutions throughout the world. One responsibility is our obligation not to impose our political, social, or other values on others abroad. At the same time we expect others not to impose their values on us. Accordingly, a second responsibility is to reject requests or agreements which commit the University of Illinois to actions that conflict with our fundamental values. A third responsibility is to take adequate steps to insure the high academic quality of specific activities and to avoid nonacademic tests for programs and participating program personnel.
To satisfy these responsibilities, in the operation of agreed upon joint programs, the University of Illinois will propose for participation in such programs only those individuals who possess special competence and qualifications for the tasks. Likewise, it expects that the criteria of competence and qualifications will be employed by other groups when evaluating University of Illinois personnel for participation in a project. Adherence to these criteria implies that neither the University of Illinois nor any cooperating institution will discriminate against University of Illinois project personnel because of race, color, religion, sex, or ethnic origin, nor will political tests be applied.
II. Statement of Policy
In entering into collaborative arrangements (agreements, contracts, or other such arrangements) with foreign countries or institutions, international agencies, or their representatives, and in negotiating for grants from such countries or organizations, the University of Illinois, its constituent units, and those acting on its behalf should not knowingly enter into any agreement which contravenes any of the following principles:
The particular program, project, or other undertaking should be judged by appropriate officers and staff members of the University who are most directly concerned to have academic merit and to contribute to the established purposes of the University.
Nothing in the contract, letter of agreement, or other document, or in understandings not committed to print, may be (a) in violation of the pertinent state or federal laws regarding discrimination, use of human subjects, or other relevant issues, or (b) contrary to the generally prevailing ethics of the disciplines or professions involved, or those principles of conduct generally shared by members of academic institutions.¹
III. Remedy When Integrity of Activities is Challenged
If a formal allegation is made by an aggrieved party that the University of Illinois has engaged in illegal or unprofessional conduct or has contravened the above principles either by (a) entering into a particular collaborative relationship with a foreign country, a foreign institution, an international agency, or their representatives, or (b) the conduct of any collaborative activity, project, or program, then such allegation will be reviewed by an ad hoc committee appointed by the Chancellor. If the review sustains the allegation, the Committee shall advise the Chancellor to recommend to the President appropriate remedial steps, including suspension of work, refusal to renew or extend the contract, or outright termination unless the University obtains assurances from the other contracting party that such practices will not occur in the future.
Date Issued: April 9, 1976
Approved by: Chancellor
General Campus Policies
Section IX/C - 27
¹Under current practices, this is accomplished by the proposal approval process. International exchange agreements must be reviewed by the Office of Overseas Projects and Foreign Visitors.
TopInternational Research—OPRR Policy
An Abstract—OPRR Policy
February 1998The 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 US 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 US 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.