. Nuremburg Code- response to Nazi "research" by Mengele
& supporters NIH guidelines established in 1966 became regulations in
1974. Further refinements since then & international
agreements in therapeutic research. B. Informed Consent C. Selection of Subjects- special classes of subjects,
consent issues D. Privacy and Confidentiality E. Monitoring and Observation F. Additional Safeguards- laws & regulations G. Incentives for Participation- compensation for
"inconvenience" only H. Continuing Review Legislative action & court test cases- break new
ground as the need arises Supreme Court- not the last word- E.g.: Roe v. Wade
[30 yrs ago] Criminal cases vs. civil cases- variations on many
themes Patents; malpractice; environmental impact 1. James H. Jones, 1993. Bad Blood: The Tuskegee
Syphilis Experiment, New York: Free Press 2. The Tuskegee Syphilis Experiment - http://www.infoplease.com/ipa/A0762136.html 3. The Troubling Legacy of the Tuskegee Syphilis Study-
http://hsc.virginia.edu/hs-library/historical/apology/ .
& the Legal System
See Office for Human Research Protections' IRB
Guidebook:http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
IRB charge: Protect human subjects- medical
treatment, biomedical & behavior researchNote: US has its own history: Tuskegee study of
syphilis continued into the early 1970's. [1-3]
[See also the docudrama movie Miss Evers'
Boys, 1997.]
IRB Review of proposals:A. Risk/Benefit Analysis
Legal system: The focus on bioethics is distributed
on many levels. [Go to Links
page for multiple resources.]Uphold existing laws & regulations
Something to think about: Will GATTACA [1997]
become reality?
References:
Updated 2/17/03 by thatcher@sonoma.edu