Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

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INTRODUCTION, BACKGROUND, AND DEFINITIONS 36 The Centrality of Informed Consent The first sentence of the Nuremberg Code is “The voluntary consent of the human subject is absolutely essential” (Nuremberg Code, 1949). To achieve this goal, the legal doctrine of informed consent was imported into research and medical care. The 1962 Kefauver-Harris Amendments made informed consent part of U.S. law by mandating that experimental drugs be used only if physicians obtained informed consent.10 Informed consent relies on the triad of (1) a voluntary (uncoerced) choice (2) made by a person (or a formally designated surrogate) competent to do so and (3) informed by understanding of risks and potential benefits (Faden and Beauchamp, 1986). Informed consent is the centerpiece of the Common Rule and the focus of one of FDA's two main human subject protection regulations (21 CFR 50). IRBs spend more time and effort examining informed-consent documents than any other function (Bell et al, 1998), and the process of informed consent, to ensure that the three criteria above are met, is even more important than ensuring that informed-consent forms are clearly worded, signed, and archived. Informed consent is the bedrock for the ethical conduct of research. Informed consent is therefore also the heart of HRPPPs. It is directly pertinent to accreditation standards and their use in the accreditation process because many of the most detailed aspects of federal regulations—and, consequently, of both NCQA and PRIM&R standards—deal with the documentation of informed consent. This is an area in which the standards may be most onerous and in which a shift to the use of performance measures—ways of getting and documenting genuine informed consent that do not rely as heavily on formal written, signed documents, as current practice does—would be most welcome. The current formal, “contractual” practice is one of the most alien to investigators and study participants in many foreign countries (Marshall, forthcoming), and documentation is one of the most nettlesome issues that breeds conflict between investigators and IRBs despite nearly universal acceptance of the underlying ethical principle. The empirical literature about the informed-consent process, cultural variations in how to interpret the ethical conduct of research, and diverse methods for obtaining and documenting informed consent will be reviewed in the committee's subsequent report. Even before that report appears, however, the committee notes that retrieval and documentation of informed consent are essential and are required by federal regulations, but accreditation bodies should strive to permit and even encourage experimentation with alternative methods to ensure informed consent within the parameters of current regulations. The waiver authority already present in the regulations for research involving minimal risk to participants (45 CFR 46.117(c)) could be used to accumulate experience, with an eye to developing less 10Federal Food, Drug, and Cosmetic Act of 1938. P.L. No. 75-717, 52, Stat. 1040, as amended 21 U.S.C. 31 et seq. 

INTRODUCTION, BACKGROUND, AND DEFINITIONS 37 FIGURE 1-1 Human research participant protection programs. The components in the large box are all parts of an HRPPP. Arrows represent information flow pathways, not organizational responsibilities. All units within an HRPPP should have formalized communication procedures.