Protecting human subjects in the NIH's Intramural Research Program: A draft instrument to evaluate convened meetings of its IRBs

IRB Ethics and Human Research

Volumn 28, Issue 3, 2006, Pages 7-10

  Wichman, Alison ^a   Kalyan, Dev N ^a,b,c   Abbott, Lura J ^a   Wesley, Robert ^a   Sandler, Alan L ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b The Earth Institute at Columbia University   (United States)

^c DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL PROTOCOL; EMPIRICAL APPROACH; ETHICS; EVALUATION; HEALTH CARE ORGANIZATION; HUMAN; HUMAN EXPERIMENT; INFORMATION PROCESSING; LEGAL ASPECT; MEDICAL RESEARCH; OBSERVATION; ORGANIZATION AND MANAGEMENT; PILOT STUDY; PROFESSIONAL STANDARD; PROGRAM DEVELOPMENT; QUESTIONNAIRE; STANDARD; UNITED STATES;

BIOMEDICAL AND BEHAVIORAL RESEARCH; EMPIRICAL APPROACH;

BIOMEDICAL RESEARCH; CLINICAL PROTOCOLS; ETHICAL REVIEW; ETHICS COMMITTEES, RESEARCH; EVALUATION STUDIES; HUMAN EXPERIMENTATION; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); OBSERVATION; PILOT PROJECTS; PROGRAM DEVELOPMENT; QUESTIONNAIRES; RECORDS; UNITED STATES;

EID: 33745163556     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (17)

1. 45 CFR 46. Protection of Human Subjects;
2. CFR 50. Protection of Human Subjects.
3. Bell J, Whiton J, Connelly S. Evaluation of NIH: Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects. Rockville, MD: Department of Health and Human Services, National Institutes of Health, 1998;
4. U.S. Department of Health and Human Services, Office of the Inspector General. Institutional Review Boards: A Time for Reform. Washington, DC: Government Printing Office, 1998.
5. Emanuel EJ, Wood A, Fleischman A, et al. Oversight of human participants research: Identifying problems to evaluate reform proposals. Annals of Internal Medicine 2004;141(4):282-291.
6. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Second Biennial Report. Implementing Human Research Regulations: The Adequacy and Uniformity of Federal Rules and their Implementation. Washington, DC: U.S. Government Printing Office, 1983.
7. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Appendix II. Washington, DC: Government Printing Office, 1975.
8. See ref. 1, 45 CFR 46.
9. See ref. 1, 21 CFR 50.
10. See ref. 4, President's Commission 1983.
11. Institute of Medicine Board on Health Sciences Policy. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy Press, 2002;
12. Institute of Medicine Board on Health Sciences Policy. Presenting Public Trust: Accreditation and Human Research Protection Programs. Washington, DC: National Academy Press, 2001.
13. See ref. 2, U.S. Department of Health and Human Services, Office of the Inspector General 1998.
14. Association for the Accreditation of Human Research Protection Programs Inc. (December 2004). http://www.aahrpp.org;
15. Partnership for Human Research Protection Inc., (December 2004). http://www.phrp.org. As of November 15, 2005, the PHRP discontinued providing accreditation services.
16. As of March 2006, evaluation teams had attended the eight IRB meetings. OHSR staff are analyzing evaluators' views, suggestions, and use of the instrument. The next phase will be to have evaluators use a modified instrument in two meetings of each of the NIH's 14 IRBs.
17. Barber B. Some perspectives on the role of assessment of risk/benefit criteria in the determination of the appropriateness of research involving human subjects. In: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Appendix II. Washington, DC: Government Printing Office, 1975.