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The Evolution of Regulatory Influences on Research with Human Subjects

  • Joseph V. Brady
  • Albert R. Jonsen

Abstract

For at least the past two decades, ethical considerations involving experimentation with human subjects have become national issues of law and public policy. The federal government, sponsor of so much basic and clinical research in medicine, behavioral sciences, and other fundamental and applied fields, has promulgated guidelines and regulations of increasing explicitness and strictness (Frankel, 1972; Swazey, 1978). Despite efforts to provide guidelines for protocol review, informed consent, and risk/benefit assessment, many critical questions remain at every level of the academic and bureaucratic hierarchy. It is to these ubiquitous regulatory influences that the present volume is addressed, and it is fitting that some attention be directed to the historical antecedents which contributed to their evolution.

Keywords

Government Printing Behavioral Research National Commission Human Subject Research Regulatory Influence 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Plenum Press, New York 1982

Authors and Affiliations

  • Joseph V. Brady
    • 1
  • Albert R. Jonsen
    • 2
  1. 1.Department of Psychiatry and Behavioral SciencesThe Johns Hopkins University School of MedicineBaltimoreUSA
  2. 2.Department of BioethicsUniversity of California School of MedicineSan FranciscoUSA

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