IRBs and randomized clinical trials

IRB Ethics and Human Research

Volumn 20, Issue 2-3, 1998, Pages 9-12

  Meinert, Curtis L ^a  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; ETHICS; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INJURY; MULTICENTER STUDY; PROFESSIONAL STANDARD; RANDOMIZATION; RESEARCH SUBJECT; RISK; RISK ASSESSMENT; SOCIAL CONTROL; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

DRUGS, INVESTIGATIONAL; ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FEDERAL GOVERNMENT; GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; MULTICENTER STUDIES; RANDOM ALLOCATION; REFERENCE STANDARDS; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SOCIAL CONTROL, FORMAL; UNITED STATES; WOUNDS AND INJURIES;

EID: 0032010051     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563556     Document Type: Article

References (11)

1. Freedman B: Equipoise and the ethics of clinical research. NEJM 1987; 317:141-5.
2. Meinert CL: Clinical trials and treatment effects monitoring. Controlled Clinical Trials (in press).
3. Meinert CL: Clinical Trials Dictionary: Terminology and Usage Recommendations. Baltimore, Maryland: The Johns Hopkins Center for Clinical Trials, 1996.
4. Meinert CL, Tonascia S: Clinical Trials: Design, Conduct, and Analysis. New York: Oxford University Press, 1986.
5. Gorden VM, Surgarman J, Kass N: Toward a more comprehensive approach to protecting human subjects: The interface of data safety monitoring boards and institutional review boards in randomized clinical trials. IRB 1998; 20(1):1-5.
6. Jones JH: Bad Blood: The Tuskegee Syphilis Experiment. New York: The Free Press, 1981.
7. Levine RJ: Ethics and Regulation of Clinical Research, 2nd ed. New Haven: Yale University Press, 1986.
8. Shuster E: Fifty years later: The significance of the Nuremberg Code. NEJM 1997; 337: 1436-40.
9. NIH Clinical Trials Committee (RS Gorden, chair): Clinical Activity. NIH Guide for Grants and Contracts, 5 June 1979; 8 29.
10. Meinert CL. Masked monitoring in trials: Blind stupidity? NEJM 1998; 338: 1381-2.
11. Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: World Health Organization, 1993.