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ACHRE Report

Part III

Chapter 14


The Federal Policy for Human Subject Protections (The Common Rule)

Research Involving Ionizing Radiation

Scope of Programs of Research Involving Human Subjects

Administravtive Structures and Procedures for Research Oversight

Federal Responses to Violations of Human Subjects Protections

Protections for Human Subjects in Classified Research


Chapter 14: Conclusion

The Common Rule, adopted by the sixteen federal agencies and departments that conduct human subjects research, is another step in the evolution of human subject research protections policies begun in the 1940s. While those protections are crucial, gaps still remain.

With respect to classified research, the current requirement of informed consent is not absolute; if consent is waived, the research may proceed in ways that do not adequately protect the research subject. Also, military research involves special considerations because of the nature of the subject population, whose voluntary participation must be especially guarded. In addition, nonfederally funded research is not subject to the Common Rule, except under the umbrella of an institution's multiple project assurance.

Further, oversight mechanisms generally are limited to audits for cause and review of paperwork requirements. These offer little in the way of assurances that the prospective review process is working and do not give an indication of the quality or consistency of IRB review, either among IRBs or within a single board. An effective system of oversight relies on the detection of violations of policies and the imposition of appropriate sanctions.

The Committee's recommendations for remedying these and other shortcomings are discussed in chapter 18 of the final report. The remaining two chapters of part III report what documents used by IRBs suggest about the protection of human subjects and what patients think about the enterprise of human subject research.

Table 1. Human Subjects Research & Protections in Seven Departments and Agencies

Table 1. Part I (34K gif)

Table 1. Part II (43K gif)

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