Publication Cover
Accountability in Research
Ethics, Integrity and Policy
Volume 8, 2001 - Issue 3
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Original Articles

Are new laws needed to protect human subjects?

Pages 235-244 | Published online: 11 Jun 2008

  • 1995 . “Postwar Professional Standards and Practices for Human Experiments” . In Final Report, Advisory Committee on Human Radiation Experiments Chapter 2
  • 1995 . “Government Standards for Human Experiments: The 1960s andl970s.” . In Final Report, Advisory Committee on Human Radiation Experiments Chapter 3
  • Donna Shalala , Ph.D. 2000 . “Protecting Research Subjects—What Must Be Done,” . New England Journal of Medicine , 342 ( 11 ) September 14
  • “Findings letters of the Office of Human Research Protection.”; Online Posting. Office of Human Research Protections. < http:llohrp.osophs.dhhs.govldetrmjctrs/lindex.htm (http:llohrp.osophs.dhhs.govldetrmjctrs/lindex.htm) > (Accessed March 6, 2001)
  • Division of Compliance Oversight “OHRP Compliance Activities: Common Findings and Guidance‐9/1/2000, “Online Posting. < littp://ohrp.osophsdkhs.gov/detrm_letrs/lindex.hhn (littp://ohrp.osophsdkhs.gov/detrm_letrs/lindex.hhn) > (Accessed March 15,2001).
  • 2001 . “A term applied to the action, discretion, etc., of public administrative officers or bodies, who are required to investigate facts, or ascertain the existence of facts, hold hearings, weigh evidence, and draw conclusions from them, as a basis for their official action, and to exercise discretion of a judicial nature.” . In Black's Law Dictionary Westlaw
  • Lind , Stuart E. 1996 . Financial Issues and Incentives Related to Clinical Research and Innovative Therapies , Edited by: Vanderpool , Harold Y. University Publishing Group . The Ethics of Research Involving Human Subjects
  • Davis , Robert . 1998 . “Humans test subjects not tracked, but USDA knows how many animals suffer for research.” . USA TODAY , June 8
  • The drug was pulled from the market because of safety concerns. See Press Release, “FDA Announces Withdrawal of Fenfluramine and Dexfenfluramine (Fen‐Phen),”; Online Posting. < http:llfda.gov/cilerlnews/fenphenpr81597.htm (http:llfda.gov/cilerlnews/fenphenpr81597.htm) > (September 15, 1997).
  • Pine , Daniel S. 1997 . Neuroendocrine Response to Fenfluramine Challenge in Boys . Arch. Gen. Psych. , 54 September : 839
  • Weiss , Rick . 1998 . “Research Volunteers Unwittingly at Risk,” . Washington Post , August 1 : A.1
  • Kerr , Kathleen . 1998 . “Drug Study Questioned: All subjects in city test were minorities,” . Newsday , April 14 : A32
  • Selingo , Jeffrey . 1998 . “2 Academic Hospitals in New York Accused of Unethical Experiments on Children,’ . The Chronical of Higher Education , April 15
  • Hilts , Philip J. 1998 . “Experiments on Children Reviewed,” . New York Times , April 15
  • The author is an attorney and Executive Director of Disability Advocates, Inc., a not‐for‐profit public interest law firm, which advocates for the rights and protection of persons with disabilities. For ten years, Disability Advocates has advocated for the rights and protection of human subjects of medical experiments, and in particular, the rights of children and mentally disabled human subjects in psychiatric research. He was one of the attorneys who represented the plaintiffs in T.D. v. New York State Office of Mental Health, 650 N.Y.S.2d 173, 65 U.S.L.W. 2439 (1st Dept. 1996), appeal dismissed, 91 N.Y.2d 860 (1997), a case which invalidated the human subject research regulations of the New York State Office of Mental Health.

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