Currents in contemporary ethics: Improve privacy in research by eliminating informed consent? IOM report misses the mark

Journal of Law, Medicine and Ethics

Volumn 37, Issue 3, 2009, Pages 507-512

  Rothstein, Mark A ^a  

^a University of Louisville School of Medicine   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFIDENTIALITY; ETHICS; HUMAN; INFORMED CONSENT; LEGAL ASPECT; ORGANIZATION; RESEARCH ETHICS; STANDARD; UNITED STATES;

CONFIDENTIALITY; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; INSTITUTE OF MEDICINE (U.S.); REFERENCE STANDARDS; UNITED STATES;

EID: 69649107446     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2009.00411.x     Document Type: Article

References (44)

1. Institute of Medicine, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research (Washington, D.C. : The National Academies Press, 2009 hereinafter cited as IOM Report
2. -45 C.F.R. Part 46, Subpart A (2008).
3. -45 C.F.R. Parts 160, 164 (2008).
4. IOM Report, supra note 1, at Appendix A.
5. Id., at 33.
6. Id.
7. Id.
8. Id.
9. Id., at 34.
10. Id.
11. Id.
12. Id., at 35.
13. Id., at 209-214.
14. Id., at 214-220.
15. Id., at 35.
16. -45 C.F.R. § 46.102 (2008).
17. -45 C.F.R. § 164.514(a 2008).
18. M. A. Rothstein Research Privacy under HIPAA and the Common Rule Journal of Law, Medicine & Ethics 33, no. 1 (2005 154 159.
19. IOM Report, supra note 1, at 33.
20. T. L. Beauchamp and J. F. Childress, Principles of Biomedical Ethics, 6th ed. (New York : Oxford University Press, 2009 at 99.
21. Id., at 103.
22. C. C. Campbell Religion and the Body in Medical Research Kennedy Institute of Ethics Journal 8, no. 3 (1998 275 305
23. M. W. Foster and R. R. Sharp, "Genetic Research and Culturally Specific Risks: One Size Does Not Fit All," Trends in Genetics 16, no. 2 (2000): 93-95.
24. National Committee on Vital and Health Statistics, Report to the Secretary of Health and Human Services on Enhanced Protections for Uses of Health Data: A Stewardship Framework for "Secondary Uses" of Electronically Collected and Transmitted Health Data (2007 at 36, available at http://www.ncvhs.hhs.gov last visited July 6, 2009).
25. G. J. Annas and M. A. Grodin, eds., The Nazi Doctors and the Nuremberg Code (New York : Oxford University Press, 1995).
26. Nuremberg Code, Principle 1, available at http://ohsr.od.nih.gov/ guidelines/nuremberg.html last visited July 6, 2009).
27. World Medical Association, Declaration of Helsinki, as amended in 2008, available at http://www.wma.net/e/ethicsunit/helsinki.htm last visited July 6, 2009).
28. -45 C.F.R. § 46.116(d 2008).
29. The Privacy Rule provides for waiver of authorization for research under similar, but not identical, criteria. 45 C.F.R. § 164.512(1)(2)(ii 2008).
30. -45 C.F.R. § 46.116(a)(8 2008).
31. A. F. Westin, How the Public Views Privacy and Health Research (2007 at 17, available at http://www.iom.edu/CMS/3740/43729.aspx last visited July 6, 2009).
32. Id., at 18.
33. Id. at 19-20.
34. Id. at 21.
35. J. L. Pritts, The Importance and Value of Protecting the Privacy of Health Information: The Roles of the HIPAA Privacy Rule and the Common Rule in Health Research (2008 available at http://www.iom.edu/Object.File/Master/53/160/ Pritts%20Privacy%20Final%20Draft%20web.pdf last visited July 6, 2009).
36. Pub. L. 111-5, 111th Cong., 1st Sess. (2009).
37. American Recovery and Reinvestment Act of 2009, §§ 13400-13411.
38. Id. § 13404.
39. Id. § 13402.
40. Id. § 13405.
41. Id. § 13410.
42. Id. § 3002(b)(2)(B)(i).
43. National Committee on Vital and Health Statistics, Letter to Secretary of Health and Human Services Tommy G. Thompson, March 5, 2004, available at http://www.ncvhs.hhs.gov last visited July 6, 2009).
44. -45 C.F.R. § 160.103 (2008).