Ethical dilemmas in clinical research with human subjects: An investigator's perspective

Psychopharmacology Bulletin

Volumn 32, Issue 1, 1996, Pages 19-25

  Lieberman, Jeffrey A ^a  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

clinical research; ethics; human subjects; risk

Indexed keywords

AMPHETAMINE; ANTIANGINA PECTORIS AGENT; ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; ANTIHYPERTENSIVE AGENT; ANTIINFLAMMATORY AGENT; BRONCHODILATING AGENT; CHOLINESTERASE INHIBITOR; DOPAMINE RECEPTOR STIMULATING AGENT; EDROPHONIUM CHLORIDE; HALOPERIDOL; KETAMINE; METHYLPHENIDATE; N METHYL DEXTRO ASPARTIC ACID RECEPTOR BLOCKING AGENT; NEUROLEPTIC AGENT; VASODILATOR AGENT;

AFTERCARE; ARTHRITIS; BRONCHOSPASM; CLINICAL RESEARCH; CLINICAL TRIAL; COMPETENCE; CONFERENCE PAPER; CONFLICT; CORONARY ARTERY DISEASE; DIABETES MELLITUS; EXTRAPYRAMIDAL SYMPTOM; FOOD AND DRUG ADMINISTRATION; GLUCOSE TOLERANCE TEST; HEART ARRHYTHMIA; HUMAN; HYPERTENSION; INFECTION; INFORMED CONSENT; MEDICAL ETHICS; MENTAL PATIENT; MYASTHENIA GRAVIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROVOCATION TEST; PSYCHOSIS; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; SEIZURE; TARDIVE DYSKINESIA;

BIOMEDICAL AND BEHAVIORAL RESEARCH; MENTAL HEALTH THERAPIES;

ETHICS, MEDICAL; ETHICS, RESEARCH; EVALUATION STUDIES; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; MENTAL DISORDERS; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SCHIZOPHRENIA;

EID: 0029976648     PISSN: 00485764     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (26)

1. Code of Federal Regulations. 45 CFR Part 46 Subpart A (1991). Basic HHS Policy for Protection of Human Research Subjects.
2. Department of Health and Human Services. Protecting Research Subjects. Institutional Review Board Guidebook. Washington, DC: US Government Printing Office, 1993.
3. Fleiss, JL. The Design and Analysis of Clinical Experiments. New York: John Wiley & Sons, 1986.
4. Friedman, LM; Furberg, CD; and De Mets, DL. Fundamentals of Clinical Trials. 2nd ed. Boston: PSG Publishing Co., 1985.
5. Gilbert, PL; Harris, MJ; McAdams, LA; and Jeste, DV. Neuroleptic withdrawal in schizophrenic patients. A review of the literature. Arch. Gen. Psychiatry 52(3):173-188, 1995.
6. Gorman, JM; Fyer, MR; Liebowitz, MR; and Klein, DF. Pharmacologic provocation of panic attacks. In: Meltzer, HY, ed. Psychopharmacology: The Third Generation of Progress. New York: Raven Press, 1987. pp. 985-994.
7. Grisso, T, and Appelbaum, PS. Comparison of standards for assessing patients' capacities to make treatment decisions. Am. J. Psychiatry 152:1033-1037, 1995.
8. Hallstrom, AP; Verter, J; and Friedman, L. Randomizing responders. Controlled Clin. Trials. 12(4):486-505, 1991.
9. Hilts, PJ. Consensus ethics in research is elusive. New York Times 1/15/95. p. 24.
10. Kane, J. "The Need for Double-Blind and Placebo-Controlled Trials." Presented at Ethics in Neurobiological Research with Human Subjects meeting. Baltimore, MD, January 7-9, 1995.
11. Kane, JM, and Marder, SR. Psychopharmacologic treatment of schizophrenia. Schizophr. Bull. 19(2):113-128, 1993.
12. Kane, JM; Schooler, NR; Marder, SR, et al. Methods for clinical evaluation of pharmacologic treatments of schizophrenia. In: Prien, RF, and Robinson, DS, eds. Clinical Evaluation of Psychotropic Drugs. Principles and Guidelines New York: Raven Press, 1994.
13. Klein, D. "Ethical Considerations in Clinical Research." Presented at the 33rd Annual Meeting of the American College of Neuropsychopharmacology. San Juan, Puerto Rico, December 12-16, 1994.
14. Lieberman, J. "Ethical Dilemmas in Clinical Research: A Clinical Investigator's Perspective." Presented at the 35th Annual New Clinical Drug Evaluation Unit Meeting. Orlando, FL, May 31-June 3, 1995.
15. Lieberman, JA. Understanding the mechanism of atypical antipsychotic drugs: Review of compounds in use and development. Br. J Psychiatry 163(Suppl. 22):7-18, 1993.
16. Lieberman, JA; Kane, JM; and Alvir, J. Provocative tests with psychostimulant drugs in schizophrenia. Psychopharmacology 91:415-433, 1987.
17. Marder, SR, and Meibach, RC. Risperidone in the treatment of schizophrenia. Am. J. Psychiatry 1512:825-835, 1994.
18. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guidelines for the Protection of Subjects of Research. DHEW Pub. No. (OS) 78-0012. Washington, DC: DHEW, 1978.
19. Post, RM; Rubinow, DR; and Ballenger, JC. Conditioning and sensitization in the longitudinal course of affective illness. Br. J. Psychiatry 149:191-201, 1986.
20. Rosenberger, WF, and Lachin, JM. The use of response-adaptive designs in clinical trials. Controlled Clin. Trials 14(6):471-484, 1993.
21. Rothman, KJ, and Michels, KB. The continued unethical use of placebo controls. N. Engl. J. Med. 331:394-398, 1994.
22. Schneider, K. Secret nuclear research on people comes to life. New York Times 12/17/93. p. 1.
23. Uhde, TW; Gelenberg, AJ; Flynn, LM; Leber, PD; Lieberman, JA; and Frese, FJ. "Protecting Human Subjects in Clinical Research." Presented at the 1994 Annual Meeting of the American Psychiatric Association, Philadelphia, PA, May 21-26, 1994.
24. Wei, LJ, and Durham, S. The randomized play-the-winner rule in medical trials. J. Am. Stat. Assoc. 73:840-843, 1978.
25. World Medical Association. Declaration of Helsinki. Recommendations guiding medical doctors in biomedical research involving human subjects. In: Levine, RJ, ed. Ethics and Regulation of Clinical Research, 2nd ed. New Haven: Yale University Press, 1986.
26. Wyatt, RJ. Neuroleptics and the natural course of schizophrenia. Schizophr. Bull. 17(2):325-351, 1991.