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Currents in Contemporary Ethics: Improve Privacy in Research by Eliminating Informed Consent? IOM Report Misses the Mark

Published online by Cambridge University Press:  01 January 2021

Mark A. Rothstein
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Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 37 , Issue 3 , Fall 2009 , pp. 507 - 512
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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].Google Scholar
45 C.F.R. Part 46, Subpart A (2008).Google Scholar
45 C.F.R. Parts 160, 164 (2008).Google Scholar
IOM Report, supra note 1, at Appendix A.Google Scholar
Id., at 33.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 34.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 35.Google Scholar
Id., at 209–214.Google Scholar
Id., at 214–220.Google Scholar
Id., at 35.Google Scholar
45 C.F.R. § 46.102 (2008).Google Scholar
45 C.F.R. § 164.514(a) (2008).CrossRefGoogle Scholar
Rothstein, M. A., “Research Privacy under HIPAA and the Common Rule”, Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.CrossRefGoogle Scholar
IOM Report, supra note 1, at 33.Google Scholar
Beauchamp, T. L. and Childress, J. F., Principles of Biomedical Ethics, 6th ed. (New York: Oxford University Press, 2009): at 99.Google Scholar
Id., at 103.Google Scholar
Campbell, C. C., “Religion and the Body in Medical Research”, Kennedy Institute of Ethics Journal 8, no. 3 (1998): 275–305; Foster, M. W. and Sharp, R. R., “Genetic Research and Culturally Specific Risks: One Size Does Not Fit All”, Trends in Genetics 16, no. 2 (2000): 93-95.CrossRefGoogle Scholar
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 <www.ncvhs.hhs.gov> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
Annas, G. J. and Grodin, M. A., eds., The Nazi Doctors and the Nuremberg Code (New York: Oxford University Press, 1995).Google Scholar
Nuremberg Code, Principle 1, available at <http://ohsr.od.nih.gov/guidelines/nuremberg.html> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
World Medical Association, Declaration of Helsinki, as amended in 2008, available at <www.wma.net/e/ethicsunit/helsinki.htm> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
45 C.F.R. § 46.116(d) (2008).CrossRefGoogle Scholar
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).Google Scholar
45 C.F.R. § 46.116(a)(8) (2008).CrossRefGoogle Scholar
Westin, A. F., How the Public Views Privacy and Health Research (2007): at 17, available at <www.iom.edu/CMS/3740/43729.aspx> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
Id., at 18.Google Scholar
Id. at 19–20.Google Scholar
Id. at 21.Google Scholar
Pritts, J. L., 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 <www.iom.edu/Object.File/Master/53/160/Pritts%20Privacy%20Final%20Draft%20web.pdf> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
Pub. L. 111–5, 111th Cong., 1st Sess. (2009).Google Scholar
American Recovery and Reinvestment Act of 2009, §§ 13400-13411.Google Scholar
Id. § 13404.Google Scholar
Id. § 13402.Google Scholar
Id. § 13405.Google Scholar
Id. § 13410.Google Scholar
Id. § 3002(b)(2)(B)(i).Google Scholar
National Committee on Vital and Health Statistics, Letter to Secretary of Health and Human Services Tommy G. Thompson, March 5, 2004, available at <www.ncvhs.hhs.gov> (last visited July 6, 2009).+(last+visited+July+6,+2009).>Google Scholar
45 C.F.R. § 160.103 (2008).Google Scholar