College on problems of drug dependence policy on administering drugs with abuse potential in human research

IRB Ethics and Human Research

Volumn 18, Issue 5, 1996, Pages 5-10

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ADDICTION; ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COLLEGE ON PROBLEMS OF DRUG DEPENDENCE; FEE; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; METHODOLOGY; PATIENT SELECTION; PRACTICE GUIDELINE; RESEARCH SUBJECT; RISK; RISK ASSESSMENT;

BIOMEDICAL AND BEHAVIORAL RESEARCH; COLLEGE ON PROBLEMS OF DRUG DEPENDENCE;

FEES AND CHARGES; GUIDELINES; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; PATIENT SELECTION; PHARMACEUTICAL PREPARATIONS; RESEARCH DESIGN; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SUBSTANCE-RELATED DISORDERS;

EID: 0030231013     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564616     Document Type: Article

References (12)

1. Freedman, B: Equipoise and the ethics of clinical research. NEJM 1987; 317:141-45.
2. Freedman, B: Placebo controlled trials and the logic of clinical purpose. IRB 1990; 12(6):1-6.
3. Weijer, C et al: Monitoring clinical research: An obligation unfulfilled. Canadian Medical Association Journal 1995; 152:1973-80.
4. Elliott C, and Weijer, C: Cruel and unusual treatment. Saturday Night 1995; 110(10) (December): 31-34.
5. Blackwelder, WC: "Proving the null hypothesis" in clinical trials. Controlled Clinical Trials 1982; 3:345-53.
6. Makuch, R, and Johnson, M: Issues in planning and interpreting active control equivalence studies. Journal of Clinical Epidemiology 1989; 42:503-11.
7. Kane, JM: Schizophrenia. NEJM 1996; 334:34-41.
8. Henry, D, and Hill, S: Comparing treatments: Comparisons should be against active treatments rather than placebos. British Medical Journal 1995; 310:1279.
9. See also Weijer, C, and Elliott, C: Down with placebolatry. New Scientist 1996; 149 (March 2): 47.
10. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV). Washington, D.C.: APA, 1994.
11. Grisso, T, and Appelbaum, PS: The MacArthur Treatment Competence Study, III. Abilities of patients to consent to psychiatric and medical treatments. Law and Human Behavior 1995; 19:149-74.
12. Carpenter, WT, Schooler, NR, and Kane, JM: The rationale and ethics of medication-free research in schizophrenia. Archives of General Psychiatry (in press).