Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
INTRODUCTION, BACKGROUND, AND DEFINITIONS 41 any research conducted under an investigational new drug application (IND) subject to FDA approval. If sponsors are operating under an IND or otherwise agree to abide by ICH-GCP guidelines, particularly if those guidelines were strengthened to ensure a stronger voice for research participants, independent IRBs could be accredited for their capacity to do a thorough review, leaving oversight of research sponsors and investigators to FDA under existing regulations. Independent IRBs would be accredited only if they made their review contingent on the sponsors' agreement to ensure the ethical conduct of research under the sponsors' direct control, including the use of investigators who agree to abide by accepted standards. Sponsors To accredit HRPPPs as a system representing the complement of necessary activities that ensure the protection of human research participants, the responsibilities of research sponsors must also be included within the accreditation structure. Although existing FDA regulations, for example, assign the ultimate accountability for ensuring the management of ethical research to the sponsor, this does not alleviate the need for organizations seeking to run an HRPPP from incorporating this responsibility into their programs. In instances of clinical research involving drugs, devices, and other products under the purview of FDA regulations, the FDA would continue to be the locus of enforcement. Another option would be to consider organizational units within sponsoring organizations as the unit for accreditation, but this would be an entirely new strategy and would entail the use of accreditation strategies drastically different from those used in the accreditation models that the committee considered. The Role of the Research Participant Those in the best position to judge the interests of individuals participating in research are the participants themselves or informed representatives of participant perspectives. This is both a moral principle and a practical fact. The central tenet of the Nuremberg Code and the first principle of The Belmont Report center on individual autonomy, honoring Immanuel Kant's categorical imperative to âAct so that you treat humanity, whether your own person or another, always as an end and never as a means onlyâ (Kant, 1999, p. 566). Those participating in research are also in the best position to appreciate their wants and needs as a practical matter, and the principle of autonomy suggests that their wishes should be respected (Faden and Beauchamp, 1986). Although participants are often not in a position to judge the scientific value of a protocol, participant perspectives can improve the study design, review of protocols, and oversight of ongoing research. They may identify procedures that add only marginal technical value but that cause serious inconvenience or increase the risk to participants. Study designs
