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ACHRE Report
Roadmap to the Project
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ACHRE Report

Part I

Chapter 3


The Development of Human Subject Research Policy at DHEW

The Development of Requirements for Human Subject Research in Other Federal Agencies

Supreme Court Dissents Invoke the Nuremberg Code: CIA and DOD Human Subjects Research Scandals


Chapter 3: Conclusion

The 1960s and early 1970s witnessed an extraordinary growth in government, institutional, and public awareness of issues in the use of human subjects, fueled by scandals and an increasing emphasis on individual expression. The branches of the military had articulated policies during this period, in spite of numerous problems in implementation. By 1974 the DHEW had established a set of regulations and a system of local review, and Congress had established a commission to issue recommendations for further change to the DHEW. Together, these advances created a model and laid the groundwork for human subjects protections for all federal agencies.

Many conditions coalesced into the framework for the regulation of the use of human subjects in federally funded research that is the basis for today's system. Described further in chapter 14, this framework is undergirded by the three Belmont principles that were identified by the National Commission as governing the ethics of research with human subjects: respect for persons, beneficence, and justice. The federal regulations and the conceptual framework built on the Belmont principles became so widely adopted and cited that it might be argued that their establishment marked the end of serious shortcomings in federal research ethics policies. Whether this position is well supported is evaluated in light of the Advisory Committee's contemporary studies in part III.

By 1974, DHEW had extensive policies to protect human subjects within its purview. Policies were more variable among other government agencies. By 1975, the branches of the military set about developing their own more comprehensive policies for human subject research, and the CIA was required by executive order to comply with consent requirements in human subject research in light of scandalous practices in the past. In order to evaluate the adequacy of the efforts taken to protect people before these policies were established, we must take into account both the government's policies and rules and the norms and practices of medicine reviewed in chapters 1 through 3. The Advisory Committee's framework for the consideration of these factors is presented in the next chapter.

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