Continuing IRB review when research activity is limited to routine follow-up evaluations

IRB Ethics and Human Research

Volumn 19, Issue 1, 1997, Pages 7-8

  Amdur, Robert J ^a   Bankert, Elizabeth ^b  

^a DARTMOUTH MEDICAL SCHOOL   (United States)

^b DARTMOUTH COLLEGE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; ETHICS; EVALUATION; FOLLOW UP; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE ORGANIZATION; HUMAN EXPERIMENT; METHODOLOGY; ORGANIZATION AND MANAGEMENT; PROFESSIONAL STANDARD; RESOURCE ALLOCATION; SOCIAL CONTROL; TIME; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

ETHICAL REVIEW; ETHICS; ETHICS COMMITTEES; ETHICS COMMITTEES, RESEARCH; EVALUATION STUDIES; FEDERAL GOVERNMENT; FOLLOW-UP STUDIES; GOVERNMENT; GOVERNMENT REGULATION; HEALTH CARE RATIONING; HUMAN EXPERIMENTATION; ORGANIZATION AND ADMINISTRATION; RESEARCH DESIGN; RESOURCE ALLOCATION; SOCIAL CONTROL, FORMAL; TIME FACTORS; UNITED STATES;

EID: 0030667573     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3563884     Document Type: Review

References (10)

1. FDA Information Sheets for IRBs and Clinical Investigators Rev. 10/95 (p. 21).
2. 45 CFR 46.109(e).
3. National Institutes of Health, Office for Protection from Research Risks: Protecting Human Research Subjects: Institutional Review Board Guidebook. 1993 (pp. 3-47).
4. 45 CFR 46.116(a)(8)(b)(5).
5. Personal communication from Melody Lin, Deputy Director, Office for Protection from Research Risks (9 September 1996) and Paul Goebel, Director of the Division of Scientific Investigations, Food and Drug Administration (11 September 1996).
6. Personal communication from protocol managers from the Pediatric Oncology Group (Mary Klonowski, June 1996), Cancer and Leukemia Group B (Karen Sartell, 10 June 1996) and the Radiation Therapy and Oncology Group (Elain Pakuris, 3 September 1996).
7. Personal communication from Thomas Keens, IRB Chair, Childrens Hospital Los Angeles, 7 March 1996.
8. Personal communication from Ernest Prentice, IRB Chair, University of Nebraska Medical Center, Omaha, 26 November 1996.
9. For further discussion on this topic refer to Levine, RJ: Ethics and Regulation of Clinical Research, 2d ed. Baltimore, Md.: Urban and Schwarzenberg, 1986, p. 341ff.
10. Office for Protection from Research Risks 1993: H1.