Conflict of Interest and Institutional Review Boards

Journal of Investigative Medicine

Volumn 45, Issue 4, 1997, Pages 154-159

  Cho, Mildred K ^a   Billings, Paul ^b,c  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c VA PALO ALTO HEALTH CARE SYSTEM   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONFLICT OF INTEREST; HUMAN; LEGAL ASPECT; PROFESSIONAL STANDARD; REVIEW;

CONFLICT OF INTEREST; HUMANS; PROFESSIONAL STAFF COMMITTEES;

EID: 0031114801     PISSN: 17088267     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (44)

1. Food and Drug Administration. Code of Federal Regulations. 1981;title 21;CFR part 50.
2. Department of Health and Human Services. Code of federal regulations. 1983;title 45;CFR part 46.
3. Levine R. Ethics and regulation of clinical research. 2nd ed. New Haven: Yale University Press, 1986.
4. Rodwin M. Money, medicine and morals: physicians' conflicts of interest. New York: Oxford University Press, 1993.
5. McNeill P. The ethics and politics of human experimentation. Melbourne: Cambridge University Press, 1993.
6. Advisory Committee on Human Radiation Experiments. Final report of the Advisory Committee on Human Radiation Experiments. Washington DC: Human Radiation Interagency Working Group, 1995.
7. Rennie D. Breast cancer: how to handle misconduct. JAMA 1994;271:1205-7.
8. Hilts P. House panel told of more tests done without consent. The New York Times 1994 May 24:Sect A:13.
9. US General Accounting Office. Scientific research. Continued vigilance critical to protecting human subjects. Washington DC: GAO Health, Education and Human Services Division, 1996 March. Report No.: B259279.
10. Beauchamp T. Ethical issues in funding and monitoring university research. Business & Professional Ethics Journal 1992;11:5-16.
11. Thompson D. Understanding financial conflicts of interest. N Engl J Med 1993;329:573-6.
12. Morreim E. Conflict of interest. In: Reich W, ed. Encyclopedia of bioethics, vol 1. New York: Simon & Schuster MacMillan, 1995.
13. American College of Physicians Ethics Committee. American College of Physicians ethics manual. Ann Intern Med 1992;117:947-60.
14. American Federation for Clinical Research. American Federation for Clinical Research guidelines for avoiding conflict of interest. Clin Res 1990;38:239-40.
15. Association of American Medical Colleges. Guidelines for dealing with faculty conflicts of commitment and conflicts of interest in research. Acad Med 1990;65:489-96.
16. Porter R, Malone T. Vaughan C, eds. Biomedical research: collaboration and conflict of interest. Baltimore: Johns Hopkins University Press, 1992.
17. Jones J. Bad blood: the Tuskegee syphilis experiment. New York: Free Press, 1981.
18. Rothman D. Were Tuskegee and Willowbrook "studies in nature?" Hastings Center Report 1982;12:5-7.
19. Angell M. Editorial responsibility: protecting human rights by restricting publication of unethical research. In: Annas G, Grodin M, eds. The Nazi doctors and the Nuremberg Code. Human rights in human experimentation. New York: Oxford University Press, 1992:276-85.
20. Blumenthal D. Growing pains for new academic/industry relationships. Health Aff 1994;Summer:176-93.
21. Heath E. The IRB's monitoring function: four concepts of monitoring. IRB 1979;1:1-3, 12.
22. Caplan A. Random auditing - a modest proposal for reforming the regulation of research. Clin Res 1983;31:142-3.
23. Christakis N. Should IRBs monitor research more strictly? IRB 1988;10:8-10.
24. Barber B, Lally J, Makarushka J, Sullivan D. Research on human subjects: problems of social control in medical experimentation. New Brunswick: Transaction Books, 1973.
25. Gray B, Cooke R, Tannenbaum A. Research involving human subjects. Science 1978;201:1094-1101.
26. Sackoff-Lampert. Institutional review boards: a sociological inquiry - protection for whom? [doctoral thesis]. UCSF, 1984.
27. Veatch R. Human experimentation committees: professional or representative? Hastings Center Report 1975;5:31-40.
28. Williams P. Success in spite of failure: why IRBs falter in reviewing risks and benefits. IRB 1984;6:1-4.
29. World Medical Association. Declaration of Helsinki. In: Reich W, ed. Encyclopedia of bioethics, vol 5. New York: Simon & Shuster Macmillan, 1989:2765-7.
30. Gray B. An assessment of institutional review committees in human experimentation. Med Care 1975;13:318-28.
31. Annas G. Judging medicine. Clifton, NJ: Humana Press, 1988.
32. Katz J. Ethics and clinical research revisited: a tribute to Henry K Beecher. Hastings Center Report 1993;23:31-39.
33. Hayes G, Hayes S, Dykstra T. Characteristics of institutional review boards and their potential effects on decision making. American Public Health Association Annual Meeting. San Francisco, 1993.
34. Fox R, Swazey J. Spare Parts. Organ replacement in American Society. New York: Oxford University Press, 1992.
35. Sheldon R. The IRB's responsibility to itself. Hastings Center Report 1985;15:11-2.
36. Levine C, Caplan A. Beyond localism: a proposal for a national research review board. IRB 1986;8:7-9.
37. Sheretz R, Streed S. Medical devices: significant risk vs non-significant risk. JAMA 1994;272:955-6.
38. Meyers K. Is local review being circumvented? IRB 1982;4:6.
39. Food and Drug Administration. Warning letters Oct. 1993 Mar 1994.
40. Federal Register, Part II. Federal policy for the protection of human subjects; notices and rules, vol 56. Washington, DC: 1991:28002-32.
41. Holm S. How many lay members can you have in your IRB? An overview of the Danish system. IRB 1992;14:8-11.
42. Edgar H, Rothman D. The institutional review board and beyond: future challenges to the ethics of human experimentation. Milbank Q 1995;73:489-506.
43. Rodwin M. Physicians' conflicts of interest. The limitations of disclosure. New Engl J Med 1989;321:1405-7.
44. US Deptartment of Health and Human Services and National Science Foundation. Objectivity in research; investigatory financial disclosure policy; final rule and notice. Washington DC: Federal Register, 1995.