Conflict over conflicts of interest: An analysis of the new NIH rules

Journal of Law, Medicine and Ethics

Volumn 34, Issue 1, 2006, Pages 105-110

  Gold, Jennifer L ^a,b,c  

^a YORK UNIVERSITY   (Canada)

^b BAYCREST CENTRE FOR GERIATRIC CARE   (Canada)

^c Canadian Research Institutions   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CONFLICT OF INTEREST; CONSULTATION; HEALTH CARE ORGANIZATION; HUMAN; LEGAL ASPECT; PERSONNEL; REVIEW; UNITED STATES;

CONFLICT OF INTEREST; CONSULTANTS; HUMANS; NATIONAL INSTITUTES OF HEALTH (U.S.); RESEARCH PERSONNEL; UNITED STATES;

EID: 33645146217     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2006.00013.x     Document Type: Review

References (39)

1. D. Willman, "Stealth Merger: Drug Companies and Government Medical Research," L.A. Times, December 7, 2003, at Al.
2. J. Abramson, Overdosed America: The Broken Promise of American Medicine (New York: Harper Collins, 2005).
3. S. S. Kohl, Rose and Podolsky Law Offices, Gelsinger v. Trustees of the University of Pennsylvania (Phila. Cnty. Ct. of C.P. filed September 18, 2000): 2000. A viral vector is viral DNA that has been modified to serve as a means of delivering the genetically engineered DNA to the patient.
4. F. H. Miller, "Trusting Doctors: Tricky Business when it comes to Clinical Research," Boston University Law Review 81 (2001): 423-443.
5. R. Steinbrook, "Financial Conflicts of Interest and the NIH," New England Journal of Medicine 350, no. 4 (2004): 327-30.
6. D. Labrador, "Damage Control," Scientific American 291, no. 5 (2004): 18-20, at 18.
7. J. Kaiser, "Conflict of Interest: NIH Proposes Temporary Ban on Paid Consulting," Science 306, no. 5693 (2004): at 27.
8. J. Kaiser, "Conflict of Interest: NIH Chief Clamps Down on Consulting and Stock Ownership," Science 307, no. 5711 (2005): 824-5.
9. Summary of NIH-Specific Provisions in Interim Final Rule, available at 〈www.nih.gov/about/ethics/020105COIsummary.pdf〉 (last visited January 13, 2006).
10. B. Wysocki, "Some Scientists Say New Ethics Rules May Damage NIH," Wall Street Journal, March 3, 2005, at B1.
11. M. Wadman, "NIH Workers see Red over Revised Rules for Conflicts of Interest," Nature 434, no. 7029 (2005): 3-4.
12. See Wadman, supra note 11.
13. J. Kaiser, "Conflict-of-interest Policy: NIH Rules Make Some Pack, Others Plead," Science 307, no. 5716 (2005): 1703.
14. M. S. Rosen wald and R. Weiss, "New Ethics Rules Cost NIH Another Top Researcher," Washington Post, April 2, 2005, at A1.
15. See Wadman, supra note 11.
16. R. Weiss, "NIH Clears Most Researchers in Conflict-of-interest Probe," Washington Post, February 23, 2005, at A1.
17. J. Kaiser, "NIH Ethics: Staff Scientists Protest Plan to Ban Outside Fees,"Science 306, no. 5700 (2004): 1276.
18. Administration News, "Some NII-I Scientists Hire Law Firm to Fight Against New Conflict of Interest Rules," Kaiser Daily Health Policy Report April 2, 2005, available at 〈http://www.kaisernetwork.org/ daily_reports/rep_index.cfm?hint=3&DR_ID=29506〉 (last visited January 13, 2006).
19. 5 U.S.C. 553(b)-(c).
20. Department of Health and Human Services, "Supplemental Standards of Ethical Conduct and Financial Disclosure Requirements for Employees of the Department of Health and Human Services," Federal Register 70, no. 22 (2005): 5543-5565. From the Federal Register, available at 〈http://a257.g. akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-2029. pdf〉 (last visited January 13, 2006).
21. S. P. Croley, "Symposium on the 50th Anniversary of the APA: The Administrative Procedures Act and Regulatory Reform: A Reconciliation," Administrative Law Journal, of American University 10 (1996): 35-49.
22. 415 U.S 199 (1974).
23. See supra note 22.
24. 486 F.2d 375 (D.C. Cir. 1973).
25. 568 F.2d 240 (2d Cir. 1977).
26. See Department of Health and Human Services, supra note 20.
27. See Weiss, supra note 16.
28. See Weiss, supra note 16.
29. J. B. Finkelstein, "Doctors Warned about October's HIPAA Deadline," American Medical News May 19, 2003, at 〈http://www.ama- assn.org/amednews/2003/05/19/Kvsa0519.htm〉 (last visited January 13, 2006).
30. See Wysocki, supra note 10.
31. L. Dornbrand, N. N. Dubler, "HIPAA and Patient Care: The Role for Professional Judgment," JAMA 293, no. 14 (2005): 1766-71.
32. National Institutes of Health, "Blue Ribbon Panel on Conflict of Interest Policies," June 22, 2004. Report of the Working Group of the Advisory Committee to the Director, National Institutes of Health, at 〈www.nih.gov/about/ethics_COI_panelreport.pdf〉 (last visited January 13, 2006).
33. See Weiss, supra note 16.
34. See Weiss, supra note 16.
35. Capitol Hill Watch, "Two Lawmakers Urge Zerhouni to Revise NIH Conflict-of-interest rules," Kaiser Daily Health Policy Report April 18, 2005, available at 〈http://www.kaisernetwork.org/daily_reports/rep_index. cfm?hint=3&DR_ID=29413〉(last visited January 13, 2006).
36. See National Institutes of Health, supra note 32.
37. A. Eisen and R. M. Barry, "The Absent Professor: Why we Don't Teach Research Ethics and What to do about it," American Journal. of Bioethics 2, no. 4 (2002): 38-49.
38. S. Brown and M. W. Kalichman, "Effects of Training in the Responsible Conduct of Research: A Survey of Graduate Students in Experimental Sciences," Science and Engineering Ethics 4, no. 4 (1998): 487-98.
39. M. J. Bebeau and S. J. Tohma, "The Impact of a Dental Ethics Curriculum on Moral Reasoning," Journal of Dental Education 58, no. 9 (1994): 684-92.