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Review of the HIVNET 012 Perinatal HIV Prevention Study
the federal government, these efforts have included the formation in 1974 of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the activities in the early 1980s of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
The research community itself has largely supported two essential protections for human participants: independent review of research to assess its risks and potential benefits, and an opportunity for people to voluntarily and knowledgeably decide whether to participate in a particular study.
Independent review is essential because it improves the likelihood that decisions are free from inappropriate influences that could distort the central task of evaluating risks and potential benefits. No one should participate in research unless independent review concludes that the risks are reasonable in relation to the potential benefits for both participants and society. This is a precondition to offering people the opportunity to volunteer, as informed consent alone cannot justify enrollment. In the United States, the institutional review board, or IRB, has been the principal structure responsible for conducting such reviews.
In U.S.-supported international research—that is, research by U.S. investigators working in another country—U.S. investigators subject to regulation either by the National Institutes of Health (NIH) or the U.S. Food and Drug Administration (FDA) may adopt the ethical standards and procedures of the host country, provided that such protections are substantially equivalent to those in the United States.3 In its own study of this
participants, must be fair in both conception and implementation, and must maximize potential benefits while minimizing possible harms. The report’s recommendations provided a coherent rationale for the federal policies and rules that underlie the current U.S. system of decentralized, independent research review, coupled with some degree of federal oversight (Office of Human Subjects Research and National Institutes of Health, 1979).
3
The procedures and standards for reviewing the study can be changed where the United States has recognized the host country as having a system of equivalent protections. 45 CFR Part 46.101(h) states: “When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Association Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a Department or Agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the Department or Agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the Department or Agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in Department or Agency procedures” (DHHS, 2004).
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