Hostname: page-component-586b7cd67f-vdxz6 Total loading time: 0 Render date: 2024-11-28T08:47:58.032Z Has data issue: false hasContentIssue false
  • English
  • Français

Biobanking Research and Privacy Laws in the United States

Published online by Cambridge University Press:  01 January 2021

Heather L. Harrell  and
Mark A. Rothstein
Get access Rights & Permissions [Opens in a new window]

Abstract

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 1: Part II: Harmonizing Privacy Laws to Enable International Biobank Research , Spring 2016 , pp. 106 - 127
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group, Part II: Tools for Investigators, IRBs and Repository Managers, March 2007 Report, at 1, available at <http://oprs.usc.edu/files/2013/01/Tissue-Banking-White-Paper-final-Part-II.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Henderson, G. E. et al., “Characterizing Biobank Organizations in the U.S.: Results from a National Survey,” Genome Medicine 5, no. 3 (2013): 1-12, at 1, available at <http://genomemedicine.biomedcentral.com/articles/10.1186/gm407> (last visited February 16, 2016).CrossRefGoogle Scholar
Id., at 4.Google Scholar
Pear, R., “U.S. to Collect Genetic Data to Hone Care,” New York Times, January 30, 2015, available at <http://www.nytimes.com/2015/01/31/us/obama-to-unveil-research-initiative-aiming-to-develop-tailored-medical-treatments.html?_r=0> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Office of Research & Development, Department of Veterans Affairs, “Million Veteran Program,” available at <http://www.research.va.gov/mvp/> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Henderson, et al., supra note 2, at 7.Google Scholar
Children’s Brain Tumor Tissue Consortium, “CBTTC Member Institutions,” available at <http://cbttc.org/sites.php> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Vanderbilt Research Institute for Clinical and Translational Research, “BioVU Description,” available at <https://victr.vanderbilt.edu/pub/biovu/?sid=194> (last visited February 16, 2016); Vanderbilt Research Institute for Clinical and Translational Research, “Multi-Institutional Collaborations,” available at <https://victr.vanderbilt.edu/pub/biovu/?sid=204> (last visited February 16, 2016).+(last+visited+February+16,+2016);+Vanderbilt+Research+Institute+for+Clinical+and+Translational+Research,+“Multi-Institutional+Collaborations,”+available+at++(last+visited+February+16,+2016).>Google Scholar
See Henderson, et al., supra note 2, at 10–11.Google Scholar
Eiseman, E. et al., Case Studies of Existing Human Tissue Repositories: Best Practices for a Biospecimen Resource for the Genomic and Proteomic Era, at 96, available at <http://www.rand.org/content/dam/rand/pubs/monographs/2004/RAND_MG120.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id., at 98.Google Scholar
See Henderson, et al., supra note 2, at 11.Google Scholar
Id.Google Scholar
Marshfield Clinic Research Foundation, “Wisconsin Genomics Initiative,” available at <http://www3.marshfieldclinic.org/mcrf/pages/default.aspx?page=research_collaborations_wgi_default> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, “caHUB Development,” available at <http://biospecimens.cancer.gov/programs/cahub/caHUB_development.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Henderson, et al., supra note 2, at 9.Google Scholar
Id.Google Scholar
Id., at 10; Henderson, G. E. et al., “Stewardship Practices of U.S. Biobanks,” Science Translational Medicine 5, no. 215 (2013), available at <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4185188/> (last visited February 16, 2016).Google Scholar
Id. (Henderson et al.).Google Scholar
Coriell Personalized Medicine Collaborative, available at <https://cpmc.coriell.org> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Coriell Personalized Medicine Collaborative, “Advisory Boards,” available at <https://cpmc.coriell.org/about-the-cpmc-study/advisory-boards> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Genetic Alliance, “About Us,” available at <http://www.geneticalliance.org/about> (last visited February 16, 2016); Genetic Alliance Registry & BioBank, available at <http://biobank.org> (last visited February 16, 2016).+(last+visited+February+16,+2016);+Genetic+Alliance+Registry+&+BioBank,+available+at++(last+visited+February+16,+2016).>Google Scholar
Genetic Alliance Registry & BioBank, Genetic Alliance Registry and BioBank Toolbox, “I am interested in Joining Genetic Alliance’s Biobank,” available at <http://biobank.org/toolbox/join_ga_biobank/faq> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
Id.Google Scholar
See Eiseman, et al., supra note 10, at xviii.Google Scholar
Cooperative Human Tissue Network, “Biospecimen Collection & Type,” available at <http://www.chtn.nci.nih.gov/biospecimen-type> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Henderson, et al., supra note 18, at 3.Google Scholar
Database of Genotypes and Phenotypes, available at <http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/about.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Simpson, C. L. et al., “Practical Barriers and Ethical Challenges in Genetic Data Sharing,” International Journal of Environmental Research and Public Health 11, no. 8 (2014): 8383–8398.Google Scholar
Id., at 8389.Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, Best Practices, “Technical and Operational Best Practices,” available at <http://biospecimens.cancer.gov/bestpractices/to> (last visited February 16, 2016); National Cancer Institute, Biorepositories and Biospecimen Research Branch, Best Practices, “Ethical, Legal, and Policy Best Practices,” available at <http://biospecimens.cancer.gov/bestpractices/elp> (last visited February 16, 2016).+(last+visited+February+16,+2016);+National+Cancer+Institute,+Biorepositories+and+Biospecimen+Research+Branch,+Best+Practices,+“Ethical,+Legal,+and+Policy+Best+Practices,”+available+at++(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, Best Practices, “Access to Biospecimens and Data, C.4.1.,” available at <http://biospecimens.cancer.gov/bestpractices/elp/abd.asp#c-4-1> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, Best Practices, “Privacy and Confidentiality Protections, C.3.2.3.,” available at <http://biospecimens.cancer.gov/bestpractices/elp/pp.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
NIH, “NIH Issues Finalized Policy on Genomic Data Sharing,” available at <http://www.nih.gov/news/health/aug2014/od-27.htm> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Moses, H. et al., “The Anatomy of Medical Research,” Journal of the American Medical Association 313, no. 2 (2014): 174-189, at 178; E. R. Dorsey et al., “Funding of US Biomedical Research 2003-2008,” Journal of the American Medical Association 303, no. 2 (2010): 137-143; H. Moses et al., “Financial Anatomy of Biomedical Research,” Journal of the American Medical Association 294, no. 11 (2005): 1333–1342.CrossRefGoogle Scholar
Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications and Awards, “Notice Number NOTOD-14-111,” available at <http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-111.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
NIH Genomic Data Sharing Policy, “Notice Number NOTOD-14-124,” available at <http://grants.nih.gov/grants/guide/notice-files/not-od-14-124.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Implementation of the NIH Genomic Data Sharing Policy for NIH Grant Applications and Awards, supra note 37.Google Scholar
Id.Google Scholar
See NIH Genomic Data Sharing Policy, supra note 38.Google Scholar
Simpson, et al., supra note 30, at 8390.Google Scholar
See National Cancer Institute, Cooperative Human Tissue Network, “Protection of Human Subjects,” available at <http://www.chtn.nci.nih.gov/human-subjects> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See NIH Genomic Data Sharing Policy, supra note 38.Google Scholar
Biorepositories and Biospecimen Research Branch, Best Practices, “Ethnical, Legal, and Policy Best Practices, Privacy and Confidentiality Protections, C.3.2.1,” available at <http://bio-specimens.cancer.gov/bestpractices/elp/pp.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Eiseman, et al., supra note 10, at 129.Google Scholar
Id., at 131.Google Scholar
The Cancer Human Biobank, Broad Consent Template, at 2, available at <http://biospecimens.cancer.gov/global/pdfs/caHUB_broad_consent_template-508.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Coriell Personalized Medicine Collaborative, “Data and Sample Security,” available at <https://cpmc.coriell.org/about-thecpmc-study/data-sample-security> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Singer, E., “Access to Research Data: Reconciling Risks and Benefits,” Journal of Law and Policy 14, no. 1 (2006): 85-114, at 105–106.Google Scholar
Wolf, L. E. et al., “Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice,” Minnesota Journal of Law, Science & Technology 14, no. 1 (2013): 11-88, at 20–21.Google Scholar
42 C.F.R. § 2a.7(a).Google Scholar
42 C.F.R. § 2a.7(c).Google Scholar
See NIH Genomic Data Sharing Policy, supra note 38.Google Scholar
See Wolf, et al., supra note 51, at 43–46.Google Scholar
Id., at 81.Google Scholar
Williams, B. A. and Wolf, L. E., “Biobanking, Consent, and Certificates of Confidentiality: Does the ANPRM Muddy the Water?” Journal of Law, Medicine & Ethics 41, no. 2 (2013): 440-453, at 441, at 447–448.Google Scholar
Personal Genome Project: Harvard, available at <http://www.personalgenomes.org/> (last visited February 16, 2016) and Personal Genome Project: Harvard, “Sign up for the PGP,” available at <http://www.personalgenomes.org/harvard/sign-up> (last visited February 16, 2016).+(last+visited+February+16,+2016)+and+Personal+Genome+Project:+Harvard,+“Sign+up+for+the+PGP,”+available+at++(last+visited+February+16,+2016).>Google Scholar
NCBI, “GenBank, GenBank Overview,” available at <http://www.ncbi.nlm.nih.gov/genbank> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See NIH Issues Finalized Policy on Genomic Data Sharing, supra note 37; NIH Genomic Data Sharing Policy, supra note 40. For a criticism of the assumptions underlying this policy, see Clayton, E. W., “Biospecimen Exceptionalism in the ANPRM,” in Cohen, I. G. and Lynch, H. F., eds., Human Subjects Research Regulation: Perspectives on the Future (Cambridge, MA: MIT Press, 2014): at 193–206.Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, The Cancer Human Biobank (caHUB), available at <http://biospecimens.cancer.gov/programs/cahub/default.asp> (last visited February 16, 2016); National Cancer Institute, Cooperative Human Tissue Network, available at <http://www.chtn.nci.nih.gov> (last visited February 16, 2016).+(last+visited+February+16,+2016);+National+Cancer+Institute,+Cooperative+Human+Tissue+Network,+available+at++(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Cooperative Human Tissue Network, Protection of Human Subjects, available at <http://www.chtn.nci.nih.gov/human-subjects> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, “Public Products: caHUB Development,” available at <http://biospecimens.cancer.gov/programs/cahub/public_products.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See International Cancer Genome Consortium, available at <https://icgc.org/icgc/goals-structure-policies-guidelines/e1-informed-consent-access-and-ethical-oversight> (last visited February 16, 2016) and International Human Epigenome Consortium, “Policies and Guidelines,” at 25.+(last+visited+February+16,+2016)+and+International+Human+Epigenome+Consortium,+“Policies+and+Guidelines,”+at+25.>Google Scholar
Vanderbilt Research, Institute for Clinical and Translational Research, “BioVU Research Form,” available at <https://victr.vanderbilt.edu/pub/biovu/?sid=220> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
National Cancer Institute, Biorepositories and Biospecimen Research Branch, “Informed Consent,” available at <http://biospecimens.cancer.gov/bestpractices/elp/ic.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
The Children’s Hospital of Philadelphia, Research Institute, Institutional Review Board (IRB), “Consent Templates,” available at <https://irb.research.chop.edu/consent-templates (last visited February 16, 2016).Google Scholar
See Personal Genome Project: Harvard, “Sign up for the PGP,” supra note 58.Google Scholar
Id.Google Scholar
See NCI Biorepository and Biospecimen Research Branch, Biospecimen Research Network, Best Practices, Ethical, Legal, and Policy Best Practices, “Privacy and Confidentiality Protections,” supra note 32.Google Scholar
Marshfield Clinic Research Foundation, Personalized Medicine Research Project (PMRP), “Frequently Asked Questions,” available at <http://marshfieldresearch.org/chg/pmrp/faqs> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Coriell Personalized Medicine Collaborative, “About the CPMC Study: Data and Sample Security,” available at <https://cpmc.coriell.org/about-the-cpmc-study/data-sample-security> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy, available at <http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=dbgap_2b_security_procedures.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Office of Research & Development, Department of Veterans Affairs, “Information for Veterans,” available at <http://www.research.va.gov/MVP/veterans.cfm> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Edwards, L. C., “Tissue Tug of War: A Comparison of International and U.S. Perspectives on the Regulation of Human Tissue Banks,” Vanderbilt Journal of Transnational Law 41, no. 2 (2008): 639-675, at 644.Google Scholar
45 C.F.R. § 46.101 (a).Google Scholar
Kapp, M. B., “A Legal Approach to the Use of Human Biological Materials for Research Purposes,” Rutgers Journal Law & Public Policy 10, no. 1 (2013): 1-29, at 5–6.Google Scholar
45 C.F.R. § 46.102(d).Google Scholar
HHS, Office for Human Research Protections, Policy and Guidance, OHRP - Guidance on Research Involving Coded Private Information or Biological Specimens, available at <http://www.hhs.gov/ohrp/policy/cdebiol.html> (last visited February 16, 2016) (stating “OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research.”).+(last+visited+February+16,+2016)+(stating+“OHRP+does+not+consider+the+act+of+solely+providing+coded+private+information+or+specimens+(for+example,+by+a+tissue+repository)+to+constitute+involvement+in+the+conduct+of+the+research.”).>Google Scholar
45 C.F.R. § 46.102(f).Google Scholar
Id.Google Scholar
See note 79 supra.Google Scholar
Id.Google Scholar
Id.Google Scholar
Pulley, J. et al., “Principles of Human Subjects Protections Applied in an Opt-Out, De-identified Biobank,” CTS Journal 3, no. 1 (2010): 42–48.Google Scholar
HHS, Office of the Assistant Secretary for Health, Office for Human Research Protections, Policy and Guidance, “Issues to Consider in the Research Use of Stored Data or Tissues,” available at <http://www.hhs.gov/ohrp/policy/reposit.html> (last visited February 16, 2016) (stating “Operation of the Repository and its data management center should be subject to oversight by an Institutional Review Board (IRB). The IRB should review and approve a protocol specifying the conditions under which data and specimens may be accepted and shared, and ensuring adequate provisions to protect the privacy of subjects and maintain the confidentiality of data. The IRB should also review and approve a sample collection protocol and informed consent document for distributions to tissue collectors and their local IRBs.”).+(last+visited+February+16,+2016)+(stating+“Operation+of+the+Repository+and+its+data+management+center+should+be+subject+to+oversight+by+an+Institutional+Review+Board+(IRB).+The+IRB+should+review+and+approve+a+protocol+specifying+the+conditions+under+which+data+and+specimens+may+be+accepted+and+shared,+and+ensuring+adequate+provisions+to+protect+the+privacy+of+subjects+and+maintain+the+confidentiality+of+data.+The+IRB+should+also+review+and+approve+a+sample+collection+protocol+and+informed+consent+document+for+distributions+to+tissue+collectors+and+their+local+IRBs.”).>Google Scholar
45 C.F.R. § 46.101(b)(4).Google Scholar
45 C.F.R. § 46.11.Google Scholar
Id.Google Scholar
45 C.F.R. § 46.116.Google Scholar
45 C.F.R. § 46. 117(c).Google Scholar
45 C.F.R. § 46. 116(d).Google Scholar
Dep’t of Homeland Security et al., “Federal Policy for Protection of Human Subjects Proposed Rule,” Federal Register 80 (2015): 53,933, at 54,049.Google Scholar
Id., at 53,944.Google Scholar
Id., at 53,953.Google Scholar
Id., at 53,952.Google Scholar
Id., at 53,961.Google Scholar
Id., at 53,965–66.Google Scholar
Id., at 53,973.Google Scholar
Id.Google Scholar
Id., at 53,972.Google Scholar
Id., at 53,987.Google Scholar
Id., at 53,983.Google Scholar
21 C.F.R. § 50.1; 21 U.S.C. § 355, available at <http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapV-partA-sec355.pdf> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
The Secretary’s Advisory Committee on Human Research Protections (SACHRP), “FAQ’s, Terms and Recommendations on Informed Consent and Research Use of Biospeci-mens,” July 20, 2011 (quoting 21 C.F.R. § 812.3(p).Google Scholar
Evans, B. J., “The Limits of FDA’s Authority to Regulate Clinical Research Involving High-Throughput DNA Sequencing,” Food and Drug Law Journal 70, no. 2 (2014): 259-287, at 266–267.Google Scholar
FDA, “Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable,” 2006, at 7, available at <http://www.fda.gov/RegulatoryInformation/Guidances/ucm078384.htm> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id., at 8.Google Scholar
Id., at 10.Google Scholar
42 C.F.R. § 493.2.Google Scholar
42 U.S.C. § 263a(a).Google Scholar
42 C.F.R. § 493.1231.Google Scholar
42 C.F.R. § 493.1232.Google Scholar
42 C.F.R. § 493.1291(f).Google Scholar
42 C.F.R. § 493.2.Google Scholar
Javitt, G. H. and Carner, K. S., “Regulation of Next Generation Sequencing,” Journal of Law, Medicine, & Ethics 42, no. 3, Supp. (2014): 9-21, at 11–12.Google Scholar
42 C.F.R. § 493.3.Google Scholar
Evans, B. J., “The First Amendment Right to Speak About the Human Genome,” University of Pennsylvania Journal of Constitutional Law 16, no. 3 (2014): 549-636, at 564–565.Google Scholar
American Society for Clinical Pathology, Policy Statement, Direct Access Testing (Policy Number 01-02), at 3, available at <https://www.ascp.org/pdf/DirectAccessTesting.aspx> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See 45 C.F.R. § 164.524.Google Scholar
79 Fed. Reg. at 7289, 7292.Google Scholar
429 U.S. 589 (1977). See National Aeronautics & Space Admin. v. Nelson, 562 U.S. 134, 138 (2011) (stating “We assume, without deciding, that the Constitution protects a privacy right of the sort mentioned in Whalen ….”).Google Scholar
See Wyatt v. Fletcher, 718 F.3d 496, 505 (5th Cir. 2013).Google Scholar
See Nunes v. Mass. Dep’t of Corr., 766 F.3d 136, 144 (1st Cir. 2014).Google Scholar
Matson v. Board of Educ., 631 F.3d 57, 64 (2d Cir 2011) (quoting Powell v Schriver, 175 F.3d 107, 111 (2d Cir. 1999)). See Rothstein, M. A., “Constitutional Right to Informational Health Privacy in Critical Condition,” Journal of Law, Medicine & Ethics 39, no. 2 (2011): 280–284.Google ScholarPubMed
Summe v. Kenton County Clerk’s Office, 604 F.3d 257, 270 (6th Cir. 2010).Google Scholar
Lee v. City of Columbus, 636 F.3d 245, 261 (6th Cir. 2011).Google Scholar
See Summe v. Kenton County Clerk’s Office, 604 F.3d 257 (6th Cir. 2010).Google Scholar
Whalen v. Roe, 429 U.S. 589, 605 (1977).Google Scholar
U.S. Department of Justice, Office of Privacy and Civil Liberties, available at <http://www.justice.gov/opcl/privacy-act-1974> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
5 U.S.C. § 552a(a)(5).Google Scholar
U.S. Department of Justice, Office of Privacy and Civil Liberties, Privacy Act of 1974, Overview of the Privacy Act of 1974, available at <http://www.justice.gov/opcl/policy-objectives> (last visited February 16, 2016) and 5 U.S.C. § 552a(e)(9) (2011).+(last+visited+February+16,+2016)+and+5+U.S.C.+§+552a(e)(9)+(2011).>Google Scholar
5 U.S.C. § 552a(b)(5); 5 U.S.C. § 552a(b)(1).Google Scholar
5 U.S.C. § 552a(b)(3); 5 U.S.C. § 552a(a)(7).Google Scholar
5 U.S.C. § 552a(e)(1).Google Scholar
5 U.S.C. § 552a(e)(4); 5 USC 552a(e)(8).Google Scholar
5 U.S.C. § 552a (e)(9).Google Scholar
5 U.S.C. § 552a(e)(9).Google Scholar
HHS, Office for Civil Rights, Health Information Privacy, “Covered Entities and Business Associates,” available at <http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities> (last visited August 5, 2015) and 45 C.F.R. § 160.102.+(last+visited+August+5,+2015)+and+45+C.F.R.+§+160.102.>Google Scholar
42 U.S.C. § 1395x(r), (s), and (u).Google Scholar
45 C.F.R. § 160.103.Google Scholar
Id.Google Scholar
78 Federal Register at 5566, 5573.Google Scholar
U.S. Department of Health and Human Services, National Institutes of Health, Research “Repositories, Databases, and the HIPAA Privacy Rule,” at 5, available at <http://privacyruleandresearch.nih.gov/research_repositories.asp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
45 C.F.R. § 164.302.Google Scholar
See generally 45 C.F.R. Parts 160, 164.Google Scholar
45 C.F.R. § 164.302.Google Scholar
45 C.F.R. § 164.514(a).Google Scholar
45 C.F.R. § 164.514(b).Google Scholar
45 C.F.R. § 160.103 (definition adopted from GINA § 201(4)).Google Scholar
Department of Health and Human Services, Health Information Privacy, “Does the HIPAA Privacy Rule Protect Genetic Information?” available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/privacy_rule_general_topics/354.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
U.S. Department of Health and Human Services, Office for Human Research Protections, “Guidance on Research Involving Coded Private Information or Biological Specimens,” 2004, available at <www.hhs.gov/ohrp/humansubjects/guidance/cdebid.pdf> (last visited June 22, 2015).+(last+visited+June+22,+2015).>Google Scholar
Id.Google Scholar
See Rothstein, M. A., “Research Privacy Under HIPAA and the Common Rule,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.Google Scholar
See Dep’t. of Homeland Security et al., supra note 93, at 53,953.Google Scholar
Id., at 53,944.Google Scholar
45 C.F.R. § 164.514(a).Google Scholar
45 C.F.R. § 164.514(e)(4).Google Scholar
45 C.F.R. § 164.514(e)(ii)(A).Google Scholar
45 C.F.R. § 164.514(e)(4)(ii)(C)(4).Google Scholar
HHS, Office for Civil Rights, Health Information Privacy, Understanding HIPAA Privacy, “Summary of the HIPPA Privacy Rule,” available at <http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
45 C.F.R. § 164.512(i)(2)(ii). See also Fatehi, L. and Hall, R. F., “Enforcing the Rights of Human Sources to Informed Consent and Disclosures of Incidental Findings from Biobanks and Researchers: State Mechanisms in Light of Broad Regulatory Failure,” Minnesota Journal of Law, Science & Technology 13, no. 2 (2012): 575-654, at 580.Google Scholar
45 C.F.R. § 164.508(b)(3)(i).Google Scholar
45 C.F.R. § 164.508(c)(v).Google Scholar
45 C.F.R. § 164.502(a)(5).Google Scholar
Tessmer, A., “Pharmacogenomics and the Genetic Information Nondiscrimination Act of 2008: Legislation Limitations and its Impact on PGx Research and Clinical Opportunity,” Saint Louis University Journal Health Law & Policy 3, no. 1 (2009): 153–182.Google Scholar
Slaughter, L., “Policy Essay: Genetic Information Non-Discrimination Act,” Harvard Journal on Legislation 50, no. 1 (2013): 41–66.Google Scholar
Roberts, J., “Preempting Discrimination: Lessons from the Genetic Information Nondiscrimination Act,” Vanderbilt Law Review 63, no. 2 (2010): 439–490.Google Scholar
Price, A. E. R. and Berkman, B. E., “When Does an Illness Begin: Genetic Discrimination and Disease Manifestation,” Journal of Law Medicine & Ethics 40, no. 3 (2012): 655-664, at 656.Google Scholar
GINA § 201(4).Google Scholar
29 C.F.R. § 1635.3(a)).Google Scholar
26 U.S.C. § 9832(8)(A).Google Scholar
26 U.S.C. § 9832(8)(B) (ii).Google Scholar
Rothstein, M. A., “GINA, the ADA, and Genetic Discrimination in Employment,” Journal of Law, Medicine & Ethics 36, no. 4 (2008): 837–840.Google Scholar
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, § 1201, available at <www.hhs.gov/healthcare/rights/pre-existing-conditions.html> (last visited September 2, 2015).+(last+visited+September+2,+2015).>Google Scholar
See Rothstein, M. A., “GINA’s Beauty Is Only Skin Deep,” Gene Watch 22, no. 2 (2009): 9–12.Google Scholar
42 U.S.C. §§ 17931, 17932, 17934, 17937.Google Scholar
Bowton, E. et al., “Biobanks and Electronic Medical Records: Enabling Cost-Effective Research,” Science Translational Medicine 6, no. 234 (2014): 234.Google Scholar
42 U.S.C. § 3006–17.Google Scholar
Bearder v. State, 806 N.W.2d 766, 769 (Minn. 2011).Google Scholar
Suter, S. M., “Did You Give the Government Your Baby’s DNA? Rethinking Consent in Newborn Screening,” Minnesota Journal of Law, Science & Technology 15, no. 2 (2014): 729-790, at 733.Google Scholar
Waldo, A., “The Texas Newborn Bloodspot Saga Has Reached a Sad – and Preventable – Conclusion,” Genomics Law Report, March 16, 2010, available at <http://www.genomicslawreport.com/index.php/2010/03/16/the-texas-newborn-bloodspot-saga-has-reached-a-sad-and-preventable-conclusion> (last visited February 16, 2016); Drabiak-Syed, K., “Legal Regulation of Banking Newborn Blood Spots for Research: How Bearder and Beleno Resolved the Question of Consent,” Houston Journal of Health Law & Policy 11, no. 1 (2011): 1–45.Google Scholar
See 42 U.S.C. § 263a(p)(2).Google Scholar
For a comprehensive listing of state laws, see National Human Genome Research Institute, “Table of State Statutes Related to Genomics,” available at <http://www.genome.gov/27552194> (last visited February 16, 2016). On genetic exceptionalism, see M. A. Rothstein, “Genetic Exceptionalism and Legislative Pragmatism,” Hastings Center Report 35, no. 4 (2005): 27–33.+(last+visited+February+16,+2016).+On+genetic+exceptionalism,+see+M.+A.+Rothstein,+“Genetic+Exceptionalism+and+Legislative+Pragmatism,”+Hastings+Center+Report+35,+no.+4+(2005):+27–33.>Google Scholar
Del. Code § 1203.Google Scholar
Nev. Rev. Stat. § 629.161.Google Scholar
Miss. Code. Ann. § 41-119–13.Google Scholar
Or. Laws Ch. 680 (1995).Google Scholar
Or. Laws Ch. 780 (1997).Google Scholar
Or. Laws Ch. 588 (2001).Google Scholar
See Colo. Rev. Stat. Ann. § 10-3-1104.6.Google Scholar
Fla. Stat. Ann. § 760.40; Georgia and Louisiana also have property laws with regards to ownership of genetic information.Google Scholar
Washington Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007); Moore v. Regents of Univ. of Cal., 793 P.2d 479 (Cal. 1990).Google Scholar
Ariz. Rev. Stat. Ann. § 12–2803.Google Scholar
See, e.g., Nev. Rev. Stat. Ann. § 629.151; N.M. Stat. Ann. § 24-21–3.Google Scholar
N.M. Stat. Ann. § 24-21-3C(8).Google Scholar
Ky. Rev. Stat. § 61.932(1)(a).Google Scholar
See, e.g., Ky. Rev. Stat. § 61.933.Google Scholar
Me. Rev. Stat. Ann. tit. 22, § 1711-C.Google Scholar
Cal. Health & Safety Code § 24175.Google Scholar
Md. Code Ann., Health-Gen. § 13–2002.Google Scholar
N.Y. Pub. Health §§ 2442, 2444.Google Scholar
Va. Code Ann. §§ 32.1-162.16 to 32.1-162.20.Google Scholar
410 Ill. Comp. Stat. § 50/3.1(a).Google Scholar
N.J. Stat. Ann. § 26:14–4.Google Scholar
Ark. Code § 20-35-103; Colo. Rev. Stat. §10-3-1104.6(4); Ga. Rev. Code §§ 33-54-3; Ga. Rev. Code §§ 33-54-6; Me. Rev. Stat. Ann. tit. 22, § 1711-C; N.M. Stat. Ann. § 24-21–3.Google Scholar
See Eiseman, et al., supra note 10, at 132.Google Scholar
NIH, National Human Genome Research Institute, Education, All About the Human Genome Project, available at <http://www.genome.gov/10001772> (last visited August 5, 2015)+(last+visited+August+5,+2015)>Google Scholar
Contreras, J. L., “Bermuda Legacy: Policy, Patents, and the Design of the Genome Commons,” Minnesota Journal of Law Science & Technology 12, no.1 (2011): 61-125, at 82–86.Google Scholar
Id., at 87, 91; Contreras, J. L., “Data Sharing, Latency Variables, and Science Commons,” Berkeley Technology Law Journal 25, no. 1 (2010): 1601-1671, at 1650–1651.Google Scholar
NCBI, GenBank, “GenBank Overview,” available at <http://www.ncbi.nlm.nih.gov/genbank> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
International HapMap Project, “Groups Participating in the International HapMap Project,” available at <http://hapmap.ncbi.nlm.nih.gov/groups.html> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
International HapMap Project, available at <http://hapmap.ncbi.nlm.nih.gov> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
International Cancer Genome Consortium, International Cancer Genome Consortium (ICGC) Goals, Structure, Policies, and Guidelines, “C. Background to the Consortium,” available at <https://icgc.org/icgc/goals-structure-policies-guidelines/c-background-consortium> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
International Cancer Genome Consortium, Cancer Genome Projects, available at <https://icgc.org/icgc/cgp> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Global Alliance for Genomics & Health, “About the Global Alliance: History,” available at <http://genomicsandhealth.org/about-global-alliance/history> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
International Human Epigenome Consortium, “About: IHEC Countries,” available at <http://ihec-epigenomes.org/about/ihec-countries> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
Official Journal of the European Communities, Commission Decision of 26 July 2000 Pursuant to Directive 95/46/EC of the European Parliament and of the Council on the Adequacy of the Protection Provided by the Safe Harbour Privacy Principles and Related Frequently Asked Questions Issued by the US Department of Commerce (notified under document number C(2000) 2441), at “whereas,” available at <http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32000D0520&from=en> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
Id., at “whereas (7).”Google Scholar
Id., at 215/10.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at 215/7Google Scholar
Id.Google Scholar
Id.; U.S. Dep’t of Commerce, “U.S.–E.U. Safe Harbor List,” available at <https://safeharbor.export.gov/list.aspx> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.; Communication from the Commission to the European Parliament and the Council on the Functioning of the Safe Harbour from the Perspective of EU Citizens and Companies Established in the EU/*COM/2013/0847 final*/, available at <http://eurlex.europa.eu/resource.html?uri=cellar:551c0723-784a-11e3-b889-01aa75ed71a1.0001.01/DOC_1&format=PDF> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
See Commission Decision, supra note 219, at Annex II, FAQ 6.Google Scholar
Id., at Annex II, FAQ7.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id., at Annex II, FAQ14.Google Scholar
Id.Google Scholar
Maximillian Schrems v. Data Protection Commissioner, Case C-362/14, October 6, 2015, available at <http://curia.europa.eu/juris/fiche.jsf?id=C%3B362%3B14%3BRP%3B1%3BP%3B1%3BC2014%2F0362%2FJ&pro=&lgrec=en&nat=or&oqp=&dates=&lg=&language=en&jur=C%2CT%2CF&cit=none%252CC%252CCJ%252CR%252C2008E%252C%252C%252C%252C%252C%252C%252C%252C%252C%252Ctrue%252Cfalse%252Cfalse&num=C-362&td=%3BALL&pcs=Oor&avg=&mat=or&jge=&for=&cid=173827> (last visited February 16, 2016).+(last+visited+February+16,+2016).>Google Scholar
Id.Google Scholar
U.S. Dep’t of Commerce, “Eligibility for Self-Certification,” available at <http://www.export.gov/safeharbor> (last visited October 25, 2015).+(last+visited+October+25,+2015).>Google Scholar
Id.Google Scholar
See Rothstein, M. A., “International Health Research after Schrems v. Data Protection Commissioner,” Hastings Center Report 46, no. 2 (in press, forthcoming 2016).Google Scholar
See generally, Presidential Commission for the Study of Bioethical Issues, Privacy and Progress in Whole Genome Sequencing (October 2012).Google Scholar
See Rothstein, M. A, “Research Privacy under HIPAA and the Common Rule,” Journal of Law, Medicine & Ethics 33, no. 1 (2005): 154–159.Google Scholar
See HHS, Office for Human Research Protections, Policy and Guidance, supra note 86.Google Scholar
See Hudson, K. L. and Collins, F. S., “Bringing the Common Rule into the 21st Century,” New England Journal of Medicine 373, no. 24 (2105): 2293-2296, at 2294.CrossRefGoogle Scholar
42 U.S.C. §§ 3006–3017.Google Scholar
H.R. 6, 114th Cong., 1st Sess. (2015).Google Scholar
Compare Koenig, B. A., “Have We Asked Too Much of Informed Consent?” Hastings Center Report 44, no. 4 (2014): 33-34 and G. Henderson, “Is Informed Consent Broken?” American Journal of Medical Sciences 342, no. 4 (2011): 267-272 (questioning continued adherence to informed consent) with A. M. Capron, “Subjects, Participants and Partners: What Are the Implications for Research as the Role of Informed Consent Evolves?” in I. G. Cohen and H. F. Lynch, supra note 60 and M. A. Rothstein, “Ethical Issues in Big Data Health Research,” Journal of Law, Medicine & Ethics 43, no. 2 (2015): 425-429 (indicating continued support for informed consent despite recent criticisms).CrossRefGoogle Scholar