“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Fed. Reg. 44512 (July 26, 2011) [hereinafter ANPRM] (to be codified at 45 C.F.R. pts. 46, 160, and 164 and 21 C.F.R. pts. 50 and 56).Google Scholar

The Common Rule is codified at 45 C.F.R. pt. 46, subpart A. Promulgated by HHS, the Rule applies to research conducted by the Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Department of Commerce, Consumer Product Safety Commission, International Development Cooperation Agency, Agency for International Development, Department of Housing and Urban Development, Department of Justice, Department of Defense, Department of Education, Department of Veterans Affairs, Environmental Protection Agency, National Science Foundation, Department of Transportation, and the Central Intelligence Agency. While the Food and Drug Administration has concurred with the Federal Policy, it has not adopted the policy in its entirety and maintains changes from the policy in its IRB and informed consent regulations. See “Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations,” 56 Fed. Reg. 28025 (June 18, 1991) (to be codified at 21 C.F.R. pts. 50 and 56).Google Scholar

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See McGuire, A. L., “Identifiability of DNA Data: The Need for Consistent Federal Policy,” American Journal of Bioethics 8, no. 10 (2008): 75–76; Wolf, L. E., “Advancing Research on Stored Biological Materials, Reconciling Law, Ethics, and Practice,” Minnesota Journal of Law, Science & Technology 11, no. 1 (2010): 99–156.Google Scholar

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See ANPRM, supra note 1, at 44519–44520. The ANPRM suggests use of check boxes to allow participants to say no to a limited number of types of research that may be objectionable. Id.Google Scholar

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Potential research participants have identified that their greatest concern, and thereby their main reason for nonparticipation in biospecimen research, relates to the confidentiality of their health-related and genetic information. Goddard, K. A. B. et al., “Biobank Recruitment: Motivations for Nonparticipation,” Biopreservation & Biobanking 7, no. 2 (2009): 119–121, at 120 (reporting the most frequent concerns were security and confidentiality of health information (73%) and genetic information (61%)). Further, the enactment of HIPAA demonstrates the heightened concerns surrounding the need to protect health information, including data collected for research purposes. See, generally, Currie, P. M., “Balancing Privacy Protections with Efficient Research: Institutional Review Boards and the Use of Certificates of Confidentiality,” IRB Ethics & Human Research 27, no. 5 (2005): 7–12.CrossRefGoogle Scholar

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See infra discussion of History and Purpose of Certificates of Confidentiality.Google Scholar

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45 C.F.R. § 46.101 (2012).CrossRefGoogle Scholar

45 C.F.R. § 46.111 (2012) (requiring informed consent from research participants).Google Scholar

45 C.F.R. § 46.116 (2012). Although not typically applicable to biospecimen research, the Common Rule also requires “[f]or research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.” Id., at 46.116(a)(6).Google Scholar

Office for Human Research Protections (OHRP), Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens, available at <http://www.hhs.gov/ohrp/policy/cdebiol.html> (last visited April 17, 2013). OHRP further explains that “[o]btaining identifiable private information or identifiable specimens includes, but is not limited to: (1) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that have been provided to investigators from any source; and (2) using, studying, or analyzing for research purposes identifiable private information or identifiable specimens that were already in the possession of the investigator.”.+(last+visited+April+17,+2013).+OHRP+further+explains+that+“[o]btaining+identifiable+private+information+or+identifiable+specimens+includes,+but+is+not+limited+to:+(1)+using,+studying,+or+analyzing+for+research+purposes+identifiable+private+information+or+identifiable+specimens+that+have+been+provided+to+investigators+from+any+source;+and+(2)+using,+studying,+or+analyzing+for+research+purposes+identifiable+private+information+or+identifiable+specimens+that+were+already+in+the+possession+of+the+investigator.”.>Google Scholar

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The OHRP Guidance considers information or specimens “coded” when “(1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.” See OHRP, supra, note 51.Google Scholar

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42 U.S.C. § 241(d) (2012). The authorizing statute does not use the phrase “Certificate of Confidentiality.” The term may come from the regulations, which refer to a “Confidentiality Certificate.” 42 C.F.R. § 2a. In any event, the protections afforded by 42 U.S.C. § 241(d) are commonly referred to as a “Certificate of Confidentiality” by NIH and other issuers, IRBs, and the researchers who use them.Google Scholar

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32 N.Y.2d 379 (1973). Because such cases involve discovery disputes that rarely give rise to final orders, there are only a few reported cases involving Certificates. In addition to Newman, they are: People v. Still, 369 N.Y.S.2d 759 (App. Div. 1975) (holding that methadone clinic had to produce clinic documents when the individual to whom the information pertained requested their disclosure to defend against criminal charges) and North Carolina v. Bradley, 634 S.E.2d 258 (N.C. Ct. App. 2006) (holding that defendant was not entitled to research records as immaterial to the case, although the records were produced under a protective order for purposes of the appeal). For a further discussion of cases involving Certificates, see Wolf, L. E. et al., “Certificates of Confidentiality: Protecting Human Subjects Research Data in Law and Practice,” Minnesota Journal of Law, Science & Technology 14, no. 1 (2013): 11–87.Google Scholar

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Federal agencies other than NIH issue Certificates. These include the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration, which issues Certificates only for research they fund. The Food and Drug Administration, like the NIH, issues Certificates regardless of federal funding. National Institutes of Health, “Frequently Asked Questions: Certificates of Confidentiality,” June 20, 2011, available at <http://grants.nih.gov/grants/policy/coc/faqs.htm#133> (last visited April 17, 2013). However, we focus on the NIH because most researchers look to the NIH and the NIH has taken a leading role of educating researchers about Certificates through its “kiosk” website.+(last+visited+April+17,+2013).+However,+we+focus+on+the+NIH+because+most+researchers+look+to+the+NIH+and+the+NIH+has+taken+a+leading+role+of+educating+researchers+about+Certificates+through+its+“kiosk”+website.>Google Scholar

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Id., at 44524. Further, some individuals may object to at least some uses of their biological materials without consent. These objections can be seen in the several lawsuits that have been brought by patients objecting to use of their biological materials for research purposes. See Moore v. Regents of the Univ. of Cal., 793 P.2d 479 (Cal. 1990); Greenberg v. Miami Children's Hosp. Research Inst., Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003); Wash. Univ. v. Catalona, 490 F.3d 667 (8th Cir. 2007); Havasupai Tribe v. Ariz. Bd. of Regents, 204 P.3d 1063 (Ariz. Ct. App. 2008). For further discussion and analysis of these cases, see Wolf, , supra note 3, at 103.Google Scholar

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