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Part III

Chapter 15


Methodology of the RPRP

Findings of the RPRP

Independent Review of Proposals


Chapter 15: Introduction

Two of the biggest differences between research involving human subjects today and research involving human subjects as it was conducted in the 1940s, 1950s and 1960s, are the presence of applicable federal regulations and the articulation of rules of professional and research ethics. There is little question that these developments have had a significant effect on the protection of the rights and interests of human subjects. At the same time, however, there has been little systematic investigation of how much protection these developments have provided. As an Advisory Committee charged both with looking at the past and making recommendations about the future, we hoped to learn as much as we could about the state of contemporary human subjects research. We were particularly interested in exploring the extent to which the rights and interests of people currently involved as subjects of radiation research conducted or supported by the federal government appear to be adequately protected and whether the level of protection afforded these subjects was the same as that afforded the subjects of nonradiation research. The Advisory Committee's Research Proposal Review Project (RPRP) was designed to address these questions. By examining documents from a wide variety of research projects funded by many agencies of the federal government, we hoped to offer insight into the general state of the protection of the rights and interests of human subjects.

During the course of the RPRP, the Committee reviewed documents from a random sample of research proposals involving human subjects and ionizing radiation that were approved and funded in fiscal years 1990 through 1993 by the Departments of Health and Human Services (DHHS), Defense (DOD), Energy (DOE), Veterans Affairs (VA), and the National Aeronautics and Space Administration (NASA); these are the only federal agencies that currently conduct human subjects research involving ionizing radiation.[1] We also reviewed a comparison sample of studies that did not involve ionizing radiation funded by the same agencies during the same period.

In this chapter, we first present the methodology and findings of the Research Proposal Review Project. We then report the results of an independent review of research proposals and documents conducted by one member of the Committee who also acted as a reviewer in the RPRP. The chapter closes with a discussion of our results in the context of current policies and practices in research involving human subjects.

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