This phrase is taken from Big Brother and the Holding Company, Piece of My Heart, on Cheap Thrills (Columbia Records 1968).Google Scholar

There is no single codified definition of “personalized medicine.” However, it has been described as “[a] model for taking into account a patient's particular genetic, genomic, or proteomic constitution, together with environmental and other factors, to deliver treatments that are as safe and as effective for patients as possible.” See Težak, Z. Kondratovich, M. Mansfield, E., “US FDA and Personalized Medicine: In Vitro Diagnostic Regulatory Perspective,” Personalized Medicine 7, no. 5 (2010): 517–530, at 517.CrossRefGoogle Scholar

See infra notes accompanying Section II.B.Google Scholar

Greenberg, 264 F. Supp. 2d at 1066–67, and Catalona, (Catalona II), 490 F.3d 667 (8th Cir. 2007), aff’g 437 F. Supp. 2d 985 (E.D. Mo. 2006) (Catalona I).Google Scholar

LabAutopedia, Biobank Information and Sites, available at <http://labautopedia.com/mw/index.php/Biobank_information_sites#A_compliation_of_external_resources_on_biobanks> (last visited April 22, 2013) (highlighting that a biobank can also include tissues from other animals, cell and bacterial cultures, and even environmental samples).+(last+visited+April+22,+2013)+(highlighting+that+a+biobank+can+also+include+tissues+from+other+animals,+cell+and+bacterial+cultures,+and+even+environmental+samples).>Google Scholar

Id.Google Scholar

O’Brien, S. J., “Stewardship of Human Biospecimens, DNA, Genotype, and Clinical Data in the GWAS Era,” Annual Review of Genomics and Human Genetics 10 (2009): 193–209, at 193, 194.CrossRefGoogle Scholar

See Genetics and Public Policy Center, Issue Brief, “Using Genomic Databases to Study Complex Diseases,” revised March 28, 2008, available at <http://www.dnapolicy.org/images/issuebriefpdfs/Genes%20and%20Environment%20Issue%20Brief.pdf> (last visited April 22, 2013). For example, diabetes is known to run in families, and researchers have identified some genetic variants that increase an individual's risk of developing the disease. However, not all individuals who have the variants develop diabetes, and many people with diabetes do not have the variants. This suggests that there may be more variants that affect the risk of developing the disease, such as diet and exercise. The collection of large numbers of samples in biobanks could assist researchers in studying both genetic and environmental factors influencing many common diseases, including diabetes, cancer, and heart disease, which could “hold tremendous promise” for understanding how those diseases develop.+(last+visited+April+22,+2013).+For+example,+diabetes+is+known+to+run+in+families,+and+researchers+have+identified+some+genetic+variants+that+increase+an+individual's+risk+of+developing+the+disease.+However,+not+all+individuals+who+have+the+variants+develop+diabetes,+and+many+people+with+diabetes+do+not+have+the+variants.+This+suggests+that+there+may+be+more+variants+that+affect+the+risk+of+developing+the+disease,+such+as+diet+and+exercise.+The+collection+of+large+numbers+of+samples+in+biobanks+could+assist+researchers+in+studying+both+genetic+and+environmental+factors+influencing+many+common+diseases,+including+diabetes,+cancer,+and+heart+disease,+which+could+“hold+tremendous+promise”+for+understanding+how+those+diseases+develop.>Google Scholar

See Eiseman, E. Haga, S. B., Handbook of Human Tissue Sources: A National Resource of Human Tissue Samples (Santa Monica, CA: Rand Publishing, 1999): At xvii.Google Scholar

Moreover, consensus does not exist regarding what should be considered a “biobank,” i.e., whether it includes all collections of human specimens, regardless of their source, or is limited to only specimens collected under particular circumstances. There are different mechanisms by which samples become available for research, including from patients (leftover samples) and from subjects who are actively recruited. Part of the challenge in crafting legal rules in this context is the heterogeneity, and lack of consensus, about the scope of what constitutes a biobank. See Gibbons, S. M. C., “Regulating Biobanks: A Twelve-Point Typological Tool,” Medical Law Review 17, no. 3 (2009): 313–346.CrossRefGoogle Scholar

See “Trials of War Criminals before the Nuremberg Military Tribunals Under Control Council Law No. 10,” vol. 2 (Washington D.C.: U.S. Government Printing Office 1949): At 181–182. Among other principles, the Code states that the “voluntary consent of the human subject is absolutely essential,” and specifies the components of such consent. The Code also specifies the limits of the risks that subjects should be asked to assume as part of research and articulates the duties that researchers owe to research participants.Google Scholar

Office for Human Research Protections, Department of Health and Human Services, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 44 Fed. Reg. 23,192, 23,192–197 (April 18, 1979), available at <http://www.hhs.gov/ohrp/archive/documents/19790418.pdf> (last visited April 22, 2013).+(last+visited+April+22,+2013).>Google Scholar

Jones, J. H., Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1981): At passim.Google Scholar

Protection of Human Subjects, 45 C.F.R. 46 (2009).Google Scholar

See Advisory Committee on Human Radiation Experiments, U.S. Department of Energy, Final Report (Washington D.C.: U.S. Government Printing Office, 1995): At pt. 2, ch. 9, available at <http://www.hss.energy.gov/healthsafety/ohre/road-map/achre/report.html> (last visited April 22, 2013).+(last+visited+April+22,+2013).>Google Scholar

Id., at ch. 7.Google Scholar

Id., at ch. 5.Google Scholar

Id.Google Scholar

The Common Rule includes non-interventional research if “(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.” 45 C.F.R. 46.101(b)(2) (2009).Google Scholar

Nearly every newborn in the United States has a small quantity of blood removed and tested for certain genetic disorders. The blood is collected on “Guthrie cards,” which are named for the individual who developed them. See McEwen, J. E. Reilly, P. R., “Stored Guthrie Cards as DNA ‘Banks,’” American Journal of Human Genetics 55, no. 1 (1994): 196–200, at 196. The cards may be stored indefinitely, and there are no uniform policies regarding their destruction or use in research. Guthrie cards have the potential to be immensely useful in research because they can be linked with the individual's medical record, and a researcher can obtain follow-up information to track the individual longitudinally. Guthrie cards are also useful even if they are “anonymized.” Their use in research, however, is controversial because they were obtained for a health-related purpose and are being re-directed for research without the consent of the parents or the child.Google Scholar

45 C.F.R. 46.101(a) (2009).Google Scholar

See Office for Human Research Protections, Department of Health and Human Services, Guidance on Research Involving Coded Private Information or Biological Specimens (2008), available at <http://www.hhs.gov/ohrp/policy/cdebiol.html> [hereinafter OHRP Guidance].+[hereinafter+OHRP+Guidance].>Google Scholar

45 C.F.R. 46.116 (2009). The basic elements of informed consent include: (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) A description of any reasonably foreseeable risks or discomforts to the subject; (3) A description of any benefits to the subjects or to others which may reasonably be expected from the research; (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) For 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; (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of a research-related injury to the subject; and (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.Google Scholar

See id. § 46.101(a) (2009). “Research” is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” See id. § 46.102(d). The term “human subject” is defined as “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.” See id. § 46.102(f). “Private information” is defined as “information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).” Id. The regulation provides, further: “Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.” Id.Google Scholar

This is confirmed by the guidance document issued by the Office of Human Research Protections (OHRP) of the NIH, which provides that, for the purpose of the definition of human subject under 45 C.F.R. 6.102(f), obtaining identifiable private information or identifiable specimens includes: “(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.” See OHRP Guidance, supra note 22. The guidance provides that OHRP considers specimens to be “individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems.” Id.Google Scholar

45 C.F.R 46.101(b)(4) (2009) (emphasis added).Google Scholar

See OHRP Guidance, supra note 22. The OHRP Guidance uses the term “coded” to signify that human specimens contain “identifying information (such as name or social security number). … [that] has been replaced with a number, letter, symbol, or combination thereof (i.e., the code);. … and a key to decipher the code exists, enabling linkage of the identifying information to the. … specimens.” Id. The OHRP Guidance clarifies the circumstances under which OHRP does not consider research involving coded specimens to involve human subjects. Id.Google Scholar

In contrast, the Food and Drug Administration (FDA) does appear to consider research involving deidentified human specimens to be human subject research, but the agency has stated that it will exercise enforcement discretion and exempt such research from informed consent requirements if certain conditions are met. See Food and Drug Administration, OMB Control No. 0910–0582, Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff”, Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable (April 25, 2006), available at <http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071265.pdf> (last visited April 22, 2013) [hereinafter Leftover Specimens Guidance].+(last+visited+April+22,+2013)+[hereinafter+Leftover+Specimens+Guidance].>Google Scholar

45 C.F.R. 46.116 (2009) (listing the requirements for informed consent under the rule).Google Scholar

See generally id.Google Scholar

76 Fed. Reg. 44,512 (July 26, 2011).Google Scholar

Id., at 44,513–44,514.Google Scholar

Id., at 44,515.Google Scholar

Id., at 44,520.Google Scholar

See Office of Human Research Protections, Food and Drug Administration, UCM187772, Draft Guidance on Exculpatory Language in Informed Consent (August 19, 2011), available at <http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM271036.pdf> (last visited April 22, 2013) [hereinafter Exculpatory Language Draft Guidance].+(last+visited+April+22,+2013)+[hereinafter+Exculpatory+Language+Draft+Guidance].>Google Scholar

45 C.F.R. 46.116 (2009); 21 C.F.R. 50.20 (2009).CrossRefGoogle Scholar

See Exculpatory Language Draft Guidance, supra note 36, at 2 (emphasis added).Google Scholar

Id.Google Scholar

Samples already in biorepositories whose owners are now unknown are in many cases deceased. This paper should not be construed to recommend a categorical prohibition on the use of specimens already contained in biorepositories whose contributors are unknown. However, the failure prospectively to develop rules to govern the use of specimens has caused significant practical problems for researchers, as well as for manufacturers, who rely on such samples to develop new medical products. See, e.g., Leftover Specimens Guidance, supra note 28 (discussing the difficulties associated with finding the source of a leftover specimen and obtaining his or her consent, but noting that human subject protection still must be ensured).Google Scholar

793 P.2d 479 (Cal. 1990).Google Scholar

Id., at 481.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id., at 481–482.Google Scholar

Id.Google Scholar

Id., at 482.Google Scholar

Id.Google Scholar

Id., at 487.Google Scholar

Id., at 488.Google Scholar

Id., at 492–493. First, the court rejected the argument that a person has an absolute right to the unique products of their body on the basis that Moore's cells were “no more unique to Moore than the number of vertebrae in the spine or the chemical formula for hemoglobin.” Id., at 490. Furthermore, the court reviewed California statutes dealing with various types of tissues and concluded that these laws did not treat tissues as property, but rather as “objects sui generis,” and that different types of tissues were subject to different legal requirements based on the policy objective sought to be achieved. See Id., at 489.Google Scholar

Id., at 493.Google Scholar

Id., at 493–496.Google Scholar

Id., at 495–496.Google Scholar

Id., at 496.Google Scholar

Id.Google Scholar

Id., at 496–497.Google Scholar

Id., at 496, n. 41.Google Scholar

Id., at 496–497.Google Scholar

Id., at 486, 497.Google Scholar

Id., at 484–485.Google Scholar

Id., at 484.Google Scholar

According to the California Supreme Court, Moore alleged in his complaint that before Dr. Golde recommended to Moore that his spleen be removed, Golde was “aware that ‘certain blood products and blood components were of great value in a number of commercial and scientific efforts’ and that access to a patient whose blood contained these substances would provide ‘competitive, commercial, and scientific advantages.’” Id., at 481.Google Scholar

The majority did acknowledge that requiring disclosure could undermine a patient's judgment, but nevertheless viewed such disclosure as necessary. See Id., at 484–485 (“To require disclosure of research and economic interests may corrupt the patient's own judgment by distracting him from the requirements of his health. But California law does not grant physicians unlimited discretion to decide what to disclose. Instead, it is the prerogative of the patient, not the physician, to determine for himself the direction in which he believes his interests lie. Unlimited discretion in the physician is irreconcilable with the basic right of the patient to make the ultimate informed decision.”) (Internal quotation marks, citation, omission and footnote omitted).Google Scholar

264 F. Supp. 2d 1064 (S.D. Fla. 2003).Google Scholar

Moore, 793 P.2d at 499 (Broussard, J., concurring and dissenting).Google Scholar

Id., at 501.Google Scholar

Id., at 515–516 (Mosk, J., dissenting).Google Scholar

Id., at 516 (footnote omitted).Google Scholar

Greenberg, 264 F. Supp. 2d at 1066–1067.Google Scholar

Id., at 1067.Google Scholar

Id.Google Scholar

Id., at 1068.Google Scholar

The plaintiffs had alleged that Miami Children's Hospital was being unjustly enriched by collecting license fees under the patent. Id., at 1072. Under Florida law, the elements of a claim for unjust enrichment are (1) the plaintiff conferred a benefit on the defendant, who had knowledge of the benefit; (2) the defendant voluntarily accepted and retained the benefit; and (3) under the circumstances it would be inequitable for the defendant to retain the benefit without paying for it. Id. The parties agreed that the plaintiffs conferred a benefit on the defendants, but the defendants contended that the plaintiffs had not suffered any detriment, nor had any plaintiff been denied access to testing for Canavan disease. Id. The court held that the complaint alleged “more than just a donor-donee relationship,” in that the “facts paint a picture of a continuing research collaboration that involved Plaintiffs also investing significant resources in the race to isolate the Canavan gene.” Id., at 1072–1073. Under those facts as alleged, the court concluded that the plaintiffs had “sufficiently pled the requisite elements of an unjust enrichment claim” and denied the defendants’ motion to dismiss that claim. Id., at 1073. The parties ultimately entered into a sealed, nonpublic settlement in 2003 that apparently allowed for nonexclusive licensing. See Colaianni, A. Chandrasekharan, S. Cook-Deegan, R., “Impact of Gene Patents and Licensing Practices on Access to Genetic Testing and Carrier Screening for Tay-Sachs and Canavan Disease,” Genetics in Medicine: Official Journal of the American College of Medical Genetics 12, no. 4, Supp. (2010): S5–S14.CrossRefGoogle Scholar

Greenberg, 264 F. Supp. 2d, at 1077–78.Google Scholar

See id., at 1070.Google Scholar

Id., at 1070–1071.Google Scholar

Id., at 1071.Google Scholar

See id., at 1070.Google Scholar

Because donations are considered gifts and are given without consideration, an agreement to donate is considered an imperfect contract that is void for want of consideration under common law legal systems. Williston, S. Lord, R. A., A Treatise on the Law of Contracts, 4th ed. (Eagan, Minn.: West, 2008): At 7:11 (discussing a lack of consideration in a common law system). The doctrine of promissory estoppel, which applies where enforcement of promises unsupported by consideration is necessary to avoid injustice, has been used to enforce promises based on donations or gifts. Id., at 8:8 (discussing the use of the doctrine of promissory estoppel to enforce “purely donative gratuitous promises”). Although an agreement to donate is not enforceable, when a donation is made it acquires the legal status as a transfer of property. Restatement (Third) of Property: Wills and Other Donative Transfers § 6.1 cmt. a (2003).Google Scholar

Greenberg, 264 F. Supp. 2d at 1069.Google Scholar

Id., at 1071.Google Scholar

Catalona II, 490 F.3d 667 (8th Cir. 2007), aff’g 437 F. Supp. 2d 985 (E.D. Mo. 2006) (Catalona I).Google Scholar

Id., at 670.Google Scholar

Id.Google Scholar

Id., at 671.Google Scholar

Id.Google Scholar

Id., at 672.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id., at 673, 677.Google Scholar

Id., at 673.Google Scholar

Id., at 673–674.Google Scholar

Id., at 674–675.Google Scholar

Id., at 675 (“The attachment of a condition to a charitable donation of property does not negate or void an otherwise valid inter vivos gift.”).Google Scholar

Id., at 671.Google Scholar

Id., at 674.Google Scholar

Id., at 671 (alterations in original).Google Scholar

45 C.F.R. 46.116 (2009). OHRP has issued a guidance document distinguishing between unacceptable exculpatory language and acceptable language, which demonstrates the fine line separating the two. See Office for Human Research Protections, Department of Health and Human Services, “‘Exculpatory Language’ in Informed Consent,” November 15, 1996, available at <http://www.hhs.gov/ohrp/policy/exculp.html> (last visited April 22, 2013) [hereinafter OHRP Informed Consent]. For example, according to the guidance, it is impermissible to use the following language: “I voluntarily and freely donate any and all blood, urine, and tissue samples to the U.S. Government and hereby relinquish all right, title, and interest to said items.” Id. However, it is permissible to include the following statement in an informed consent document: “Tissue obtained from you in this research may be used to establish a cell line that could be patented and licensed. There are no plans to provide financial compensation to you should this occur.” Id.+(last+visited+April+22,+2013)+[hereinafter+OHRP+Informed+Consent].+For+example,+according+to+the+guidance,+it+is+impermissible+to+use+the+following+language:+“I+voluntarily+and+freely+donate+any+and+all+blood,+urine,+and+tissue+samples+to+the+U.S.+Government+and+hereby+relinquish+all+right,+title,+and+interest+to+said+items.”+Id.+However,+it+is+permissible+to+include+the+following+statement+in+an+informed+consent+document:+“Tissue+obtained+from+you+in+this+research+may+be+used+to+establish+a+cell+line+that+could+be+patented+and+licensed.+There+are+no+plans+to+provide+financial+compensation+to+you+should+this+occur.”+Id.>Google Scholar

Catalona II, 490 F.3d at 675 n.7. The court also gave short shrift to another central tenet of the Common Rule, which is that participants may “discontinue participation at any time.” See 45 C.F.R. 46.116(a)(8). The consent form signed by participants stated that their participation was voluntary and that they could withdraw their consent “‘at any time.’” Catalona I, 437 F. Supp. 2d at 990. Some of the consent forms indicated that participants “could request destruction of their biological materials if they changed their minds about participating in the study” while others did not. Catalona II, 490 F.3d at 671. Washington University took the position that it could satisfy participants’ request to withdraw by anonymizing the samples while continuing to use them for research. Catalona I, 437 F. Supp. 2d at 992. The district court appears to have accepted as valid Washington University's assertion and the issue was not reviewed on appeal. However, there is certainly room for argument that this after-the-fact anonymization does not satisfy the letter or spirit of the federal human subjects regulations. See Wolf, L., “Advancing Research on Stored Biological Materials: Reconciling Law, Ethics, and Practice,” Minnesota Journal of Law, Science, & Technology 11, no. 1 (2010): 99–156. Nevertheless, accepting Washington University's interpretation was consonant with the court's conclusion that the participants did not retain proprietary interests in their tissues.Google Scholar

See Doerr, A., “Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples,” Genomics Law Report (February 2, 2010), available at <http://www.genomicslawreport.com/index.php/2010/02/02/newborn-blood-spot-litigation-70-days-to-destroy-5-million-samples> (last visited April 23, 2013). Drabiak-Syed, K., “Newborn Blood Spot Litigation Continues in Minnesota and Texas,” PredictER News (November 20, 2009), available at <http://predicter.blogspot.com/2009/11/newborn-blood-spot-litigation-continues.html> (last visited April 23, 2013) (describing the Minnesota and Texas litigation).+(last+visited+April+23,+2013).+Drabiak-Syed,+K.,+“Newborn+Blood+Spot+Litigation+Continues+in+Minnesota+and+Texas,”+PredictER+News+(November+20,+2009),+available+at++(last+visited+April+23,+2013)+(describing+the+Minnesota+and+Texas+litigation).>Google Scholar

Id. (Doerr).Google Scholar

Tex. Health & Safety Code 33.0021 (Note: This section refers to sickle cell trait), 33.0111, 33.0112, 33.017 (2009).Google Scholar

Id.Google Scholar

Bearder v. State 806, N.W.2d 766 (Minn. Nov. 16, 2011).Google Scholar

Drabiak-Syed, K., “Minnesota Judge's Dismissal of Newborn Blood Spot Case Misses the Mark,” PredictER News (December 14, 2009), available at <http://predicter.blogspot.com/2009/12/minnesota-judges-dismissal-of-newborn.html> (last visited April 23, 2013). (last visited April 23, 2013).' href=https://scholar.google.com/scholar?q=Drabiak-Syed,+K.,+“Minnesota+Judge's+Dismissal+of+Newborn+Blood+Spot+Case+Misses+the+Mark,”+PredictER+News+(December+14,+2009),+available+at++(last+visited+April+23,+2013).>Google Scholar

Minnesota Department of Health, Minnesota Department of Health to Begin Destroying Newborn Blood Spots in Order to Comply with Recent Minnesota Supreme Court Ruling, Press Release, January 31, 2012, available at <http://www.health.state.mn.us/news/pressrel/2012/newborn013112.html> (last visited April 23, 2013) [hereinafter Press Release].+(last+visited+April+23,+2013)+[hereinafter+Press+Release].>Google Scholar

Id.Google Scholar

See, e.g., Melas, P. A. et al., “Examining the Public Refusal to Consent to DNA Biobanking: Empirical Data from a Swedish Population-Based Study,” Journal of Medical Ethics 36, no. 2 (2010): 93–98, at passim; Tupasela, A. et al., “Attitudes towards Biomedical Use of Tissue Sample Collections, Consent, and Biobanks among Finns,” Scandinavian Journal of Public Health 38, no. 1 (2010): 46–52 at passim; Hoeyer, K., “Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity?” Public Health Genomics, 13, no. 6 (2010): 345–352, available at <http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ArtikelNr=262329&Ausgabe=0&ProduktNr=224224> (last visited April 23, 2013); Thornton, H., “The UK Biobank Project: Trust and Altruism Are Alive and Well: A Model for Achieving Public Support for Research Using Personal Data,” International Journal of Surgery 7, no. 6 (2009): 501–502, at passim; Treweek, S. Doney, A. Leiman, D., “Public Attitudes to the Storage of Blood Left Over from Routine General Practice Tests and Its Use in Research,” Journal of Health Services Research and Policy 14, no. 1 (2009): 13–19, at passim.Google Scholar

See generally Bishop, G. F., The Illusion of Public Opinion: Fact and Artifact in American Public Opinion Polls (Lanham, Md.: Rowan and Littlefield Publishers, 2005): At passim.Google Scholar

See Williams, S. et al., Genetics and Public Policy Center, Johns Hopkins University, The Genetic Town Hall: Public Opinion about Research on Genes, Environment, and Health (2008), available at <http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/Reports/Genetics_and_Public_Policy/2009PCPTownHalls.pdf> (last visited April 23, 2013); Kaufman, D. et al., “Veterans' Attitudes Regarding a Database for Genomic Research,” Genetics in Medicine 11, no. 5 (2009): 329–337 [hereinafter Kaufman et al., Veterans’ Attitudes].Google Scholar

Id. (Williams, et al.); Kaufman, D. et al., “Public Opinion about the Importance of Privacy in Biobank Research,” American Journal of Human Genetics 85, no. 5 (2009): 643–654, at passim [hereinafter Kaufman et al., Public Opinion]; see id. (Kaufman, et al.); see also Lemke, A. A. et al., “Biobank Participation and Returning Research Results: Perspectives from a Deliberative Engagement in South Side Chicago,” American Journal of Medical Genetics 158A, no. 5 (2011): 1029–1037, at 1032.Google Scholar

See Williams, et al., supra note 111, at 8.Google Scholar

Id., at 9; see Lemke, et al., supra note 112, at 1033; Kaufman, et al., supra note 111, at 334; Murphy, J. et al., “Public Expectations for Return of Results from Large-Cohort Genetic Research,” American Journal of Bioethics 8, no. 11 (2008): 36–43, at 36–41 [hereinafter Murphy et al., Public Expectations].Google Scholar

Results from this study were reported in a number of publications: Kaufman, et al., Public Opinion, supra note 112; Murphy, J. et al., “Public Perspectives on Informed Consent for Biobanking,” American Journal of Public Health 99, no. 12 (2009): 2128–2134, at passim [hereinafter Murphy et al., Informed Perspectives]; Murphy, et al., Public Expectations, supra note 114, at 36–41.Google Scholar

See Murphy, et al., Informed Perspectives, supra note 115, at 2129.Google Scholar

Id.Google Scholar

Id., at 2131; see also Kaufman, et al., Public Opinion, supra note 112, at 645.Google Scholar

See Murphy, et al., Informed Perspectives, supra note 115, at 2131; Kaufman, et al., Public Opinion, supra note 112, at 645.Google Scholar

See Kaufman, et al., Public Opinion, supra note 112, at 645.Google Scholar

See Murphy, et al., Informed Perspectives, supra note 115, at 2131.Google Scholar

Id.Google Scholar

Id.Google Scholar

See Murphy, et al., Public Expectations, supra note 114, at 40.Google Scholar

Id., at 39.Google Scholar

See Williams, et al., supra note 111, at 9.Google Scholar

See Murphy, et al., Public Expectations, supra note 114, at 40.Google Scholar

See Williams, et al., supra note 111, at 9.Google Scholar

See Murphy, et al., Informed Perspectives, supra note 115, at 2131.Google Scholar

Id., at 2132.Google Scholar

Id.Google Scholar

Id.Google Scholar

Id., at 2133.Google Scholar

Id.Google Scholar

See Murphy, et al., Public Expectations, supra note 114, at 41.Google Scholar

Beskow, L. M. Dean, E., “Informed Consent for Biorepositories: Assessing Prospective Participants’ Understanding and Opinions,” Cancer Epidemiology, Biomarkers and Prevention 17, no. 6 (2008): 1440–1451, at 1440.CrossRefGoogle Scholar

Rao, R., “Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?” Journal of Law, Medicine & Ethics 35, no. 3 (2007): 371–382, at 371.CrossRefGoogle Scholar

Alta Charo, R., “Body of Research – Ownership and Use of Human Tissue,” New England Journal of Medicine 355, no. 15 (2006): 1517–1519, at 1519.CrossRefGoogle Scholar

Id., at 1519.Google Scholar

See Moore, 793 P.2d at 489.Google Scholar

Id., at 489, 491–92.Google Scholar

See Williams, et al., supra note 111, at 8.Google Scholar

See Rao, , supra note 136, at 379.Google Scholar

Id.Google Scholar

See Harmon, A., “Indian Tribe Wins Fight to Limit Research of Its DNA,” New York Times, April 21, 2010, at A1, available at <http://www.nytimes.com/2010/04/22/us/22dna.html?ref=us> (last visited April 23, 2013) (stating that to the Havasupai tribe, “blood has deep spiritual meaning”).+(last+visited+April+23,+2013)+(stating+that+to+the+Havasupai+tribe,+“blood+has+deep+spiritual+meaning”).>Google Scholar

See, e.g., Vermeulen, E. et al., “A Trial of Consent Procedures for Future Research with Clinically Derived Biological Samples,” British Journal of Cancer 101, no. 9 (2009): 1505–1512, at 1505; see also Saunders, B., “Normative Consent and Opt-Out Organ Donation,” Journal of Medical Ethics 36, no. 2 (2010): 84–87, at 84.CrossRefGoogle Scholar

See, e.g., Press Release, supra note 107 (statement by Minnesota Health Commissioner that “destroying newborn screening blood spots. … will compromise our ability to assure the quality and accuracy of the newborn screening program).Google Scholar

With respect to archived samples, it may in practice be difficult to locate and gain consent from the contributors of the tissue, particularly if the collection occurred many years prior. This paper does not advocate the automatic destruction of archived samples when approval for their research use cannot be obtained; such cases should be considered on a case-by-case basis. However, the paper does advocate for the development of uniform rules that are applied prospectively that appropriately characterize the role and consider the preferences of human specimen contributors.Google Scholar

See Terry, S. F., “Learning Genetics,” Health Affairs 22, no. 5 (2003): 166–171.CrossRefGoogle Scholar

See Saha, K. Hurlbut, J. B., “Research Ethics: Treat Donors as Partners in Biobank Research,” Nature 478, no. 7369 (2011): 312–313.CrossRefGoogle Scholar

See, e.g., Maschke, K. J., “Wanted: Human Biospecimens,” Hastings Center Report 40, no. 5 (2010): 21–23, at 22 (noting that “the traditional concept of consent as an agreement to participate in research after being informed about the purpose of a specific study – how long it will last, how many people will participate, and the potential risks and benefits of participation – isn’t a good fit for research with bodily materials and data stored for multiple future purposes, some unforeseeable.”).CrossRefGoogle Scholar

See 45 C.F.R. 46.116 (2009); 21 C.F.R. 50.20 (2009).CrossRefGoogle Scholar

See Exculpatory Language Draft Guidance, supra note 36, at 2.Google Scholar

See Shalala v. Guernsey Memorial Hospital, 514 U.S. 87, 100 (1995) (holding that APA rulemaking would be required if the Medicare Provider Reimbursement Manual § 233 issued by HHS adopted a new position inconsistent with any of the Secretary's existing regulations); Nat’l Family Planning & Reproductive Health Ass’n v. Sullivan, 979 F. 2d, 227, 235 (D.C. Cir. 1992) (quoting as a “maxim of administrative law” the principle that, “if a second rule repudiates or is irreconcilable with a [prior legislative rule], the second rule must be an amendment of the first; and of course an amendment to a legislative rule must itself be legislative”).Google Scholar

For research not covered by the Common Rule or other federal human subject regulations, researchers or institutions should nevertheless be required to provide a donation agreement to prospective contributors of tissue.Google Scholar

The HIPAA authorization, however, focuses on privacy, whereas contributors of biospecimens may have a broader interest in their specimens than simply the protection of their personal privacy.Google Scholar