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.
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Reference Notes
Slater v. Baker v. Stapleton, 2 Wils 359, 95 Eng. Rep 860 (K.B. 1767).
Slater v. Baker v. Stapleton, 2 Wils 359, 95 Eng. Rep. 860 (K.B. 1767).
Carpenter v. Blake, 60 Barb (481) (N.Y. 1871).
Carpenter v. Blake, 60 Barb (481) (N.Y. 1871).
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.
The Institutional Guide to DHEW Policy on Protection of Human Subjects, 1971, Department of Health, Education, and Welfare, Washington, D.C.
Pub. Law 93–348, The National Research Act.
Pub. Law 87–781 87–781; 21 CFR Part 312.
Hyman v. Jewish Chronic Disease Hospital, 206 N.E. 2d 338 (1965).
Kaimowitz v. Department of Mental Health, Civil No. 79-1934 AW, Circuit Court for the County of Wayne, State of Michigan, July 10, 1973.
Wyatt v. Stickney, 344 F. Supp. 373 (M.D. Ala. 1972), 344 F. Supp.
43 Federal Register 53950, Nov. 17, 1978.
Wyatt v. Stickney, 344 F. Supp. 373 (M.D. Ala. 1972).
New York Association for Retarded Children v. Carey, 393 F. Supp. 715 (E.D. N.Y. 1975).
42 Federal Register 3076, Jan. 14, 1977.
The Institutional Guide to DHEW Policy on Protection of Human Subjects, 1971, Department of Health, Education, and Welfare, Washington, D.C.
Tunkl v. Regents of California, 60 CAL 2d 92, 383.
45 CFR 46 Subpart C.
45 CFR 46.206–46.210.
43 Federal Register 31786, July 21, 1978.
43 Federal Register 53950, Nov. 17, 1978.
43 Federal Register 56174, Nov. 30, 1978.
Federal Register, Jan. 26, 1981.
45 CFR 46.107 (a).
45 CFR 46.107 (a).
45 CFR 46.111 (a) (1).
45 CFR 46.112.
45 CFR 26.112.
Board of Regents v. Roth, 408 U.S. 564 (1972).
Mat hews v. Eldridge, 424 U.S. 319 (1976).
Nielsen v. Regents of the University of California, Civil No. 665-049 (Superior Court of California, County of San Francisco, Sept. 11, 1973).
Bailey v. Mandel, Civil Action No. K-74-110 (D.C. M.D. 1974).
References
Gray, B. H., 1977, Human Subjects in Medical Experimentation, p. 11, John Wiley, New York.
Hershey and Miller, R. D., 1976, Human Experimentation and the Law, p. 8, Aspen Systems, Germantown, Maryland.
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© 1982 Plenum Press, New York
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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
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DOI: https://doi.org/10.1007/978-1-4684-4157-4_2
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