Skip to main content
SpringerLink
Log in

The Legal Background of the Institutional Review Board

  • Chapter
Human Subjects Research

  • 52 Accesses

Abstract

The past decade has seen the development of a new area of law dealing with biomedical research. While impetus for such a development was provided by federal and state efforts to regulate human research activities, judicial concern with human experimentation has been apparent since the eighteenth century. This chapter will review some of the legal background that underlies the current IRB regulations.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 39.99
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 54.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

Reference Notes

  1. Slater v. Baker v. Stapleton, 2 Wils 359, 95 Eng. Rep 860 (K.B. 1767).

    Google Scholar 

  2. Slater v. Baker v. Stapleton, 2 Wils 359, 95 Eng. Rep. 860 (K.B. 1767).

    Google Scholar 

  3. Carpenter v. Blake, 60 Barb (481) (N.Y. 1871).

    Google Scholar 

  4. Carpenter v. Blake, 60 Barb (481) (N.Y. 1871).

    Google Scholar 

  5. United States v. Karl Brandt et al, Trials of War Criminals before Nuremberg Military Tribunals under Control Council Law No. 10 (October 1946–April 1949.

    Google Scholar 

  6. The Institutional Guide to DHEW Policy on Protection of Human Subjects, 1971, Department of Health, Education, and Welfare, Washington, D.C.

    Google Scholar 

  7. Pub. Law 93–348, The National Research Act.

    Google Scholar 

  8. Pub. Law 87–781 87–781; 21 CFR Part 312.

    Google Scholar 

  9. Hyman v. Jewish Chronic Disease Hospital, 206 N.E. 2d 338 (1965).

    Google Scholar 

  10. Kaimowitz v. Department of Mental Health, Civil No. 79-1934 AW, Circuit Court for the County of Wayne, State of Michigan, July 10, 1973.

    Google Scholar 

  11. Wyatt v. Stickney, 344 F. Supp. 373 (M.D. Ala. 1972), 344 F. Supp.

    Google Scholar 

  12. 43 Federal Register 53950, Nov. 17, 1978.

    Google Scholar 

  13. Wyatt v. Stickney, 344 F. Supp. 373 (M.D. Ala. 1972).

    Google Scholar 

  14. New York Association for Retarded Children v. Carey, 393 F. Supp. 715 (E.D. N.Y. 1975).

    Google Scholar 

  15. 42 Federal Register 3076, Jan. 14, 1977.

    Google Scholar 

  16. The Institutional Guide to DHEW Policy on Protection of Human Subjects, 1971, Department of Health, Education, and Welfare, Washington, D.C.

    Google Scholar 

  17. Tunkl v. Regents of California, 60 CAL 2d 92, 383.

    Google Scholar 

  18. 45 CFR 46 Subpart C.

    Google Scholar 

  19. 45 CFR 46.206–46.210.

    Google Scholar 

  20. 43 Federal Register 31786, July 21, 1978.

    Google Scholar 

  21. 43 Federal Register 53950, Nov. 17, 1978.

    Google Scholar 

  22. 43 Federal Register 56174, Nov. 30, 1978.

    Google Scholar 

  23. Federal Register, Jan. 26, 1981.

    Google Scholar 

  24. 45 CFR 46.107 (a).

    Google Scholar 

  25. 45 CFR 46.107 (a).

    Google Scholar 

  26. 45 CFR 46.111 (a) (1).

    Google Scholar 

  27. 45 CFR 46.112.

    Google Scholar 

  28. 45 CFR 26.112.

    Google Scholar 

  29. Board of Regents v. Roth, 408 U.S. 564 (1972).

    Google Scholar 

  30. Mat hews v. Eldridge, 424 U.S. 319 (1976).

    Google Scholar 

  31. Nielsen v. Regents of the University of California, Civil No. 665-049 (Superior Court of California, County of San Francisco, Sept. 11, 1973).

    Google Scholar 

  32. Bailey v. Mandel, Civil Action No. K-74-110 (D.C. M.D. 1974).

    Google Scholar 

References

  • Gray, B. H., 1977, Human Subjects in Medical Experimentation, p. 11, John Wiley, New York.

    Google Scholar 

  • Hershey and Miller, R. D., 1976, Human Experimentation and the Law, p. 8, Aspen Systems, Germantown, Maryland.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Lahey Clinic Medical Center, Burlington, Massachusetts, 01803, USA

    Marien E. Evans

Authors
  1. Marien E. Evans
    View author publications

    You can also search for this author in PubMed Google Scholar

Editor information

Editors and Affiliations

  1. Long Island Jewish-Hillside Medical Center, New Hyde Park, New York, USA

    Robert A. Greenwald  & Mary Kay Ryan  & 

  2. University of Connecticut Health Center, Farmington, Connecticut, USA

    James E. Mulvihill

Rights and permissions

Reprints and permissions

Copyright information

© 1982 Plenum Press, New York

About this chapter

Cite this chapter

Evans, M.E. (1982). The Legal Background of the Institutional Review Board. In: Greenwald, R.A., Ryan, M.K., Mulvihill, J.E. (eds) Human Subjects Research. Springer, Boston, MA. https://doi.org/10.1007/978-1-4684-4157-4_2

Download citation

  • DOI: https://doi.org/10.1007/978-1-4684-4157-4_2

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4684-4159-8

  • Online ISBN: 978-1-4684-4157-4

  • eBook Packages: Springer Book Archive

Publish with us

Policies and ethics

Search

Navigation