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Accountability in Research
Ethics, Integrity and Policy
Volume 7, 1999 - Issue 2-4
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Original Articles

The ethics of conducting psychosis‐inducing experiments

Pages 137-167 | Published online: 11 Jun 2008

References

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  • Capron [See Ref. 27].
  • Davidson , M. , Keefe , R.S.E. Mohs , R.C. 1987 . “L‐Dopa challenge and relapse in schizophrenia,” . American Journal of Psychiatry , 144 : 934 – 938 .
  • Sharav , Hassner . 1994 . “What's ethical, what's not, where do you draw the line?” . L‐dopa consent form obtained under Freedom of Information is in author's file Concerns about this experiment were discussed previously: see, Lehrman and Sharav, 1997 [See Ref. 19];
  • Miller and Rosentstein, 1997, found it especially troubling ethically. [See Ref. 2].
  • The transcript was downloaded in June, 1997 from NBAC's website by an investigative reporter for the Boston Globe. When he attempted to retrieve a section that he had accidentally erased, the transcript was no longer available on NBAC's website. After public protests by Citizens for Responsible Care & Research, the transcript reappeared.
  • A Sept 2, 1998 letter from OPRR to Andrew Brownstein, a former research subject at NIMH, confirmed that: “OPRR has completed its evaluation of human subject protections,”; and “NIMH has taken the following corrective actions...”;: “ensuring that subjects sign only one copy of an informed consent document...”; “Provision of a reminder to NIMH investigators of their responsibilities in regard to documentation of informed consent and assessment of decisional capacity of research subjects.”;
  • 1999 . “Human Subject Protection Under Multiple Assurance (MPA) M‐1155, Research Projects Involving Human Subjects with Schizophrenia,” . January 18 U.S. DHHS, Office of Protection from Research Risks, Letter of Finding, Re: Citing the Code of Federal Regulations, OPRR's letter states: “OPRR finds that informed consent documents . . . . failed to include the following elements required by Department of Health and Human Services regulations at 45 CFR 46.116”;
  • “An explanation of the purposes of the research; a complete and accurate description of the procedures (i.e., . . . the plan for a 4‐week washout period prior to sinemet [L‐dopa] challenge; the plan to withhold neuroleptic medication for up to one year or until relapse);
  • An adequate description of all reasonably foreseeable risks and discomforts to the subject (i.e., the risk of schizophrenic relapse from either sinemet challenge or withdrawal of neuroleptic agents for up to one year, as well as the potential psychiatric, physical, social, and legal effects of such relapse; the psychological stress and anxiety. . . ; all the known major side effects of haldol, sinemet (L‐dopa) and selegiline, as well as possible adverse effects resulting from interactions of these medications”;
  • “A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject . . .”;
  • OPRR also found that “the MSSM IRB lacked sufficient information to make the determinations required for approval of research under HHS regulations”; and “failed to conduct continuing review"—as required under the Code of Federal Regulations.
  • OPRR's findings—at UCLA, Maryland Psychiatric Research Center, Mount Sinai Medical Center—demonstrate serious ethical violations‐including failure to disclose relevant risks, thereby invalidating the informed consent obtained. Despite such repeated findings, and despite widespread criticism in the press no investigator or institution has been held accountable, no actions or even a reprimand were issued. [See Katz, 1993, Ref. 2; Shamoo and Irving, 1993, Ref. 8; Hassner [Sharav], 1994, Lehrman and Sharav, 1997, Ref. 20; Victim Testimonies, 1997, Ref. 9].
  • Hilts , P. NY Times , Ref. 17;
  • Borr , J. 1998 . “Mental patients at risk in research,” . Baltimore Sun , June 7 front page
  • Wadman , M. 1998 . “Research Roulette: Are the Maryland Psychiatric Research Center's Schizophrenia Studies Harming Patients?” . CityPaper , July 1 cover story; St. Louis Post Dispatch, Editorial 1998;
  • Whitaker and Kong . 1998 . “Doing Harm: Research on the Mentally Ill,” . Boston Globe , Nov. 15–18 front page] [See also Ref. 46]
  • Dr. William Carpenter, Director, and Dr. Carol Tamminga, Deputy Director of MPRC were honored this year by the IOM. They, and James Childress, chairman of NBAC's human subjects sub‐committee, were inducted as new IOM members.
  • Bowdie , T.A. , Radant , A.D. , Cowley , D.S. , Kharasch , E.D. , Strassman , R.J. and Roy‐Byrne , P.P. 1998 . “Psychedelic effects of ketamine in healthy volunteers,” . Anesthesiology , 88 : 82 – 88 .
  • Cohen , S. 1960 . “Lysergic acid diethylamide: side effects and complications,” . Journal of Nervous Mental Diseases , 130 : 30 – 40 .
  • Kurland , A.A. , Yensen , R. and Dryer , D.A. “The relationship between peak experience and outcome in LSD assisted psychostherapy with substance abusers,” . a current project at the Orenda Institute, University of Maryland www.maps.org/ news
  • Prospectus, Heffter Research Institute, West Lafayette, Indiana, online at: www.well.com/user/dpd/heffter.html (www.well.com/user/dpd/heffter.html)
  • Geyer , M.A. 1998 . “Behavioral studies of hallucinogenic drugs in animals: implications for schizophrenia research,” . Pharmacopsychiatry , 2 ( Suppl. ) July 31 : 73 – 79 .
  • Krystal , J.H. , Petrakis , I.L. , Webb , E. , Cooney , N.L. , Karper , L.P. , Namanworth , S. , Stetson , P. , Trevisan , L.A. and Charney , D.S. 1998 . “Dose‐related ethanol‐like effects of the NMDA antagonist, ketamine, in recently detoxified alcoholics,” . Archives of General Psychiatry , 55 : 354 – 360 .
  • Schwartz , R.H. and Miller , N.S. 1997 . “MDMA (Ecstasy) and the Rave: A Review,” . Pediatrics , 100 : 705 – 708 .
  • Ricaurte , G.A. 1989 . “Studies of MDMA‐induced neurotoxicity in nonhuman primates: a basis for evaluating long‐term effects in humans,” . In Pharmacology and toxicology of amphetamines and related designer drugs , NIDA Res. Monogr. Edited by: Asghar , K. and DeSouza , E. Vol. 94 , 306 – 22 .
  • Ricaurte , G.A. and McCann , U.D. 1992 . “Neurotoxic amphetamine analogues: effects in monkeys and implications for humans,” . Annals of the NY Academy of Sciences , 648 : 371 – 382 .
  • McCann , U.D. , Szbo , Z. , Scheffel , U. , Dannals , R.F. and Ricaurte , G.A. 1998 . “Positron emission tomographic evidence of toxic effect of MDMA ("Ecstasy") on brain serotonin neurons in human beings,” . Lancet , 352 : 1433 – 1437 .
  • Morris and Kelly . 1998 . “Ecstasy users face consequences of neurotoxicity,” . Lancet , 352 Dec. 12 1913.
  • Editorial . 1996 . “Walking on the moon,” . Lancet , 347 : 207
  • Grob , C.S. , Poland , R.E. , Chang , L. and Ernst , T. 1996 . “Psychobiologic effects of 3,4‐methylenedioxymsethamphetamine in humans: methodological considerations and preliminary observations,” . Behavioral Brain Research 1996 , 73 : 103 – 107 . Updated information about this project is available on websites of the Hefter Institute and the Multidisciplinary Association of Psychedelic Studies, www.
  • Editorial . 1998 . St. Louis Post Dispatch , May
  • Editorial . 1998 . The Boston Globe , Nov. 18
  • Marshall , Elliot . 1999 . “NIMH to screen studies for science and human risks,” . Science , Jan. 22 : 464 – 165 .
  • Hilts , P. 1999 . “Federal Reviews Are Urged for Experiments on Mental Patients,” . The NY Times , Feb. 4 : A‐22

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