Disclosure of financial relationships to participants in clinical research

New England Journal of Medicine

Volumn 361, Issue 9, 2009, Pages 916-

  Weinfurt, Kevin P ^a,b   Hall, Mark A ^c,d   King, Nancy M P ^c,d   Friedman, Joëlle Y ^a   Schulman, Kevin A ^a,b   Sugarman, Jeremy ^e,f  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c WAKE FOREST UNIVERSITY   (United States)

^d WAKE FOREST SCHOOL OF MEDICINE   (United States)

^e JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL RESEARCH; CONFLICT OF INTEREST; INFORMED CONSENT; LEGAL LIABILITY; PATIENT RIGHT; PATIENT WELFARE; PRIORITY JOURNAL; REVIEW; TRUST; WELFARE;

EID: 69349102963     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsb0902598     Document Type: Article

References (43)

1. AAMC Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress II: principles and recommendations for oversight of an institution's financial interests in human subjects research. Acad Med 2003;78:237-245
2. Protecting patients, preserving integrity, advancing health: accelerating the implementation of COI policies in human subjects research. Washington, DC: Association of American Medical Colleges, 2008.
3. The Food and Drug Administration's oversight of clinical investigators' financial information. Washington, DC: Department of Health and Human Services, 2009. (DHHS publication no. OEI-05-07-00730.)
4. Morin K, Rakatansky H, Riddick FA Jr, et al. Managing conflicts of interest in the conduct of clinical trials. JAMA 2002;287:78-84. (Pubitemid 34251679)
5. Institute of Medicine. Conflict of interest in medical research, education, and practice. Washington, DC: National Academies Press, 2009.
6. Lavori PW, Sugarman J, Hays MT, Feussner JR. Improving informed consent in clinical trials: a duty to experiment. Control Clin Trials 1999;20:187-193 (Pubitemid 29164459)
7. Faden RR, Beauchamp TL. Decision-making and informed consent: a study of the impact of disclosed information. Soc Indic Res 1980;7:313-336
8. Beauchamp TL, Childress JF. Principles of biomedical ethics. 5th ed. Oxford, England: Oxford University Press, 2001.
9. Weinfurt KP, Friedman JY, Dinan MA, et al. Disclosing conflicts of interest in clinical research: views of institutional review boards, conflict of interest committees, and investigators. J Law Med Ethics 2006;34:581-591
10. Weinfurt KP, Dinan MA, Allsbrook JS, et al. Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Acad Med 2006;81:113-118 (Pubitemid 44356688)
11. Lipton S, Boyd EA, Bero LA. Conflicts of interest in academic research: policies, processes, and attitudes. Account Res 2004;11:83-102.
12. Weissman JS, Koski G, Vogeli C, Thiessen C, Campbell EG. Opinions of IRB members and chairs regarding investigators' relationships with industry. J Empir Res Hum Res Ethics 2008;3:3-13.
13. Boyd EA, Lipton S, Bero LA. Implementation of financial disclosure policies to manage conflicts of interest. Health Aff (Millwood) 2004;23(2):206-214 (Pubitemid 38471056)
14. Weinfurt KP, Friedman JY, Allsbrook JS, Dinan MA, Hall MA, Sugarman J. Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure. J Gen Intern Med 2006;21:901-906 (Pubitemid 44141756)
15. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 1982;5:319-329
16. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep 1987;17:20-24
17. Dresser R. The ubiquity and utility of the therapeutic misconception. Soc Philos Policy 2002;19:271-294
18. Friedman JY, Sugarman J, Dhillon JK, et al. Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants. Clin Trials 2007;4:272-278 (Pubitemid 47400538)
19. Weinfurt KP, Hall MA, Friedman JY, et al. Effects of disclosing financial interests on participation in medical research: a randomized vignette trial. Am Heart J 2008;156:689-697
20. Kim SY, Millard RW, Nisbet P, Cox C, Caine ED. Potential research participants' views regarding researcher and institutional conflicts of interest. J Med Ethics 2004;30:73-79
21. Hampson LA, Agrawal M, Joffe S, Gross CP, Verter J, Emanuel EJ. Patients' views on financial conflicts of interest in cancer research trials. N Engl J Med 2006;355:2330-2337 (Pubitemid 44837781)
22. Grady C, Horstmann E, Sussman JS, Hull SC. The limits of disclosure: what research subjects want to know about investigator financial interests. J Law Med Ethics 2006;34:592-599 (Pubitemid 44505519)
23. Weinfurt KP, Hall MA, Dinan MA, et al. Effects of disclosing financial interests on attitudes toward clinical research. J Gen Intern Med 2008;23:860-866
24. Faden RR, Beauchamp TL. A history and theory of informed consent. New York: Oxford University Press, 1986.
25. Hall MA, Bobinski MA, Orentlicher D. Health care law and ethics. 7th ed. New York: Aspen, 2007.
26. Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, the fragile foundation of contemporary biomedical research. Hastings Cent Rep 1996;26:25-29
27. Hall MA, Dugan E, Zheng B, Mishra AK. Trust in physicians and medical institutions: what is it, can it be measured, and does it matter? Milbank Q 2001;79:613-639
28. Hall MA, Dugan E, Balkrishnan R, Bradley D. How disclosing HMO physician incentives affects trust. Health Aff (Millwood) 2002;21(2):197-206.
29. Coleman CH. Duties to subjects in clinical research. Vanderbilt Law Rev 2005;58:387-420.
30. Resnik DB. Disclosing conflicts of interest to research subjects: an ethical and legal analysis. Account Res 2004;11:141-159
31. Morreim EH. The clinical investigator as fiduciary: discarding a misguided idea. J Law Med Ethics 2005;33:586-598
32. Sage WM. Some principles require principals: why banning conflicts of interest won't solve incentive problems in biomedical research. Tex Law Rev 2007;85:1113-1163
33. Wilson RF. Money, prestige, and conflicts of interests in human subjects research. New York: Aspen, 2009.
34. Hall MA, Berenson RA. Ethical practice in managed care: a dose of realism. Ann Intern Med 1998;128:395-402. (Pubitemid 28103109)
35. Dana J, Loewenstein G. A social science perspective on gifts to physicians from industry. JAMA 2003;290:252-255 (Pubitemid 37430065)
36. Cain DM, Loewenstein G, Moore DA. The dirt on coming clean: perverse effects of disclosing conflicts of interest. J Legal Stud 2005;34:1-25. (Pubitemid 40549835)
37. Capron AM. Informed consent in catastrophic disease research and treatment. Univ PA Law Rev 1974;123:340-438.
38. Report to the Congress: Medicare payment policy. Washington, DC: Medicare Payment Advisory Commission (MedPAC), March 2009. (Accessed August 6, 2009, at http://www.medpac. gov/documents/Mar09-EntireReport.pdf.)
39. Report to the Congress: reforming the delivery system. Washington, DC: Medicare Payment Advisory Commission (MedPAC), June 2008. (Accessed August 6, 2009, at http://www.medpac. gov/documents/Jun08-EntireReport.pdf.)
40. Ehringhaus SH, Weissman JS, Sears JL, Goold SD, Feibelmann S, Campbell EG. Responses of medical schools to institutional conflicts of interest. JAMA 2008;299:665-671 (Pubitemid 351252724)
41. Stossel TP. Regulating academic-industrial research relationships - solving problems or stifling progress? N Engl J Med 2005;353:1060-1065
42. Fisher MA. Medicine and industry: a necessary but conflicted relationship. Perspect Biol Med 2007;50:1-6.
43. Krimsky S. Introduction to special issue of Accountability in Research on conflict of interest in science. Account Res 2004;11:79-81.