IRB review of adverse events in investigational drug studies

IRB Ethics and Human Research

Volumn 19, Issue 6, 1997, Pages 1-4

  Prentice, Ernest D ^a   Gordon, Bruce ^b  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COST BENEFIT ANALYSIS; DRUG TOXICITY; ETHICS; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; GOVERNMENT REGULATION; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; MANDATORY REPORTING; OFFICE FOR PROTECTION FROM RESEARCH RISKS; PERSONNEL; PROFESSIONAL STANDARD; RESEARCH SUBJECT; RISK; RISK ASSESSMENT; SOCIAL CONTROL; UNITED STATES; UNIVERSITY OF NEBRASKA MEDICAL CENTER;

BIOMEDICAL AND BEHAVIORAL RESEARCH; OFFICE FOR PROTECTION FROM RESEARCH RISKS; UNIVERSITY OF NEBRASKA MEDICAL CENTER;

CONSENT FORMS; COST-BENEFIT ANALYSIS; DRUG TOXICITY; DRUGS, INVESTIGATIONAL; ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; FEDERAL GOVERNMENT; GOVERNMENT; GOVERNMENT REGULATION; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MANDATORY REPORTING; RESEARCH PERSONNEL; RESEARCH SUBJECTS; RISK; RISK ASSESSMENT; SOCIAL CONTROL, FORMAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031261128     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564433     Document Type: Review

References (4)

1. National Cancer Institute, Division of Cancer Treatment, Adverse Drug Reaction (ADR) Guidelines, October 1993.
2. Personal communication with T. Puglisi, Office of Protection From Research Risks (OPRR), 10 April 1996.
3. Newsome v. Breon Lab., Inc., 709 S.W. 2d 559,560 (1986).
4. Phillips DF: Institutional review boards under stress: Will they explode or change? JAMA 1996; 276:1623-26.