Human Specimen Collection, Biobanking and Genetic Research: PredictER Law and Policy Update

BACKGROUND*

Biobanks collect, store, process, and distribute biological specimens and associated patient data to allow researchers to study the connection between molecular information and patients' clinical responses. Collection and use of human biological specimens is considered human subjects research when tissue is collected for through an interaction with the subject for an identified research project or the donor's private information is readily identifiable by the researcher.  Federal law governing this area remains ambiguous and potentially confusing to both researchers and specimen donors because it raises several issues related to ownership of specimens, informed consent, genetic privacy, and retention of DNA specimens and associated information. Courts have partially addressed questions related to tissue ownership, and some states have legislation clarifying uncertainties in the federal framework.

Three sections of federal law primarily govern human subjects research and associated patient data. Federal regulatory law referred to as the Common Rule requires that researchers obtain informed consent from donors prior to collecting, storing and using their tissue for research. An exception applies if an IRB determines that (1) the research involves no more than minimal risk to the subjects; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation. The FDA has a separate system designed to protect the rights of human subjects for FDA-regulated clinical investigations. Unlike the Common Rule, the FDA’s classification of whether these regulations apply is not contingent upon whether human tissues are directly identifiable and the FDA does not allow an IRB to waive its requirements. Lastly, the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) governs research use of protected health information (PHI) such as names, social security numbers, and medical record information that is associated with specimens. An entity bound by the Privacy Rule cannot disclose an individual’s PHI without obtaining an authorization from unless the entity has de-identified the data by removing most of the personal information or uses a limited data set that has been stripped of direct identifiers. In addition to these three areas of federal law, the Genetic Information and Nondiscrimination Act is designed to protect individuals from genetic discrimination (See “GINA” topic for more information).

Although members of the public may believe they “own” their tissues samples and genetic specimens, courts have held that once a physician or researcher excises tissues, they are no longer the property of the donor but instead become property of the research institution. (Moore v. Regents of the Univ. of California, 793 P.2d 479 (Cal. 1990); Greenberg v. Miami Children's Hosp. Res. Inst., 264 F.Supp.2d 1064, 1074-75 (S.D. Fla. 2003)). Because the individual no longer “owns” his specimens, he cannot redirect or transfer his specimen unless the institution plans on destroying a large database, and in most instances he cannot withdraw his specimen once it is already being used in a research protocol. (Washington Univ. v. Catalona, 490 F.3d 667, 675 (8th Cir. 2007); Cornyn v. Fifty-Two Members of the Schoppa Family, 70 S.W.3d 895 (Tx. Ct. App. 2001)). Some states have enacted legislation to supplement federal law in this area, although very few states have developed a comprehensive framework. Existing state law generally addresses some or all of the following issues: personal access to DNA results, informed consent and exemptions, retention and destruction of DNA samples and genetic information, disclosure of results, property interests, and liability for noncompliance. States have structured their laws differently to reflect whether they intend to award more protection to donors or attempt to increase research efficiency.

* This section (above) is an excerpt from: Jennifer Girod & Katherine Drabiak, “A Proposal for Comprehensive Biobank Research Laws to Promote Translational Medicine in Indiana,” 5 Indiana Health Law Review 217 (2008). Available from: http://hdl.handle.net/1805/1843

ISSUES

Federal Law

• Should the application of the Common Rule be contingent upon whether or not specimens are directly identifiable to the researcher?
• The purpose of an IRB is to protect the rights and interests of human subjects. Should an IRB be allowed to waive application of the Common Rule for biobanking research because individuals may not be aware their specimens are being used for research or does this conflict with the IRB’s function?
• A PHI may contain an individual’s race, ethnicity, or socioeconomic status and could be connected to individual’s genetic information. This information is considered legally de-identified under HIPAA’s Privacy Rule and researchers do not need to obtain authorization to use each individual’s PHI. Does this adequately protect individuals’ PHI?

Ethical Concerns

• Can (or should) an individual provide “blanket consent” giving permission to an institution and its research partners the ability to use one’s specimen for future unspecified use or does this undermine the purpose of informed consent?
• Does respecting an individual’s autonomy give one the ability to limit how one’s specimen is used (such as authorizing use for a particular study only and not for other studies)?
• How (if at all) should biobanks address the principle of benefit sharing with donors?

Policy Considerations

• The current assumption of current jurisprudence is that an individual no longer owns one’s tissues once they have been excised from one’s body by consent or waiver. Is this desireable?
• Does an individual have a right to prevent one’s specimen from being used in for-profit research intended to develop commercial products such as gene patents or genetic diagnostic tests?
• How should we balance the goals of advancing medicine and improving health (requiring broad collection of specimens and information) while recognizing and protecting individuals’ rights not to donate specimens?
• How should we address the potential for information leaks in genome wide association studies? Does this change when research falls under the Common Rule and Privacy rule because the donor can be identifiable?

CASE LAW

Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990)

Summary

John Moore, a patient who underwent treatment for leukemia at UCLA Medical Center filed an action against his physician Dr. Golde and others, because they used cells extracted from him in lucrative medical research which eventually yielded a patented cell line without his permission. Moore alleged thirteen claims, including a breach of physician’s duty to disclose competing interests that may affect medical judgment, lack of informed consent, and conversion. The court held that a physician who is seeking a patient's consent for a medical procedure must, in order to satisfy his fiduciary duty and to obtain the patient's informed consent, disclose personal interests unrelated to the patient's health that may affect his medical judgment. The court ruled Moore had no cause of action for conversion because once the cells were extracted from Moore’s body; he no longer had any claims of ownership over them.

Moore and Research with Human Subjects:

• Moore recognizes the possibility of the dual nature of physicians who conduct research in the same area as they practice, holding that even when physicians act within their research capacity with their patients, they are required to obtain informed consent. Moore, 793 P.2d 479, 485-486. Given the potential of conflicting loyalties between research advancement and patient care, the Moore court emphasizes the importance of obtaining full informed consent from the subject. Within the information, the researcher must disclose any personal interests unrelated to the patient’s health, including both research and economic interests.
• Due to the ongoing physician-to-researcher relationship between Moore and Golde, the Moore court specifically addressed the issue of timing. Even if the researchers were not aware or had not formed the requisite intent at the beginning of medical treatment to extract Moore’s cells, a research interest which developed during the ongoing physician-patient relationship would require Golde to disclose these interests prior to extracting more tissue. Id. at 486. Even if the removal of tissue during Moore’s splenectomy had a therapeutic purpose, Golde still had a duty to disclose any additional research and economic purposes which were possible motivations unrelated to the patient’s health which would be material to the patient’s decision. Id. at 486.
• Regents, Quan, Genetics Institute, and Sandoz were not physicians and thus had no duty to obtain informed consent for the medical procedures performed on Moore (here, the court implicitly defines all extraction and collections as constituting medical procedures.) Id. at 486.

Moore and Institutional Ownership

• Moore addresses ownership by holding he had no cause of action for conversion because Moore failed to satisfy the essential element of establishing actual interference in his ownership or right to possession. Moore, 793 P.2d 479, 488. The court held that Moore did not expect nor have a right to possession, which is consistent with California’s Health & Safety Code regulations outlining the proper disposal of tissue. Id. at 489. After human tissues have been used, the Health & Safety Code requires their disposal or destruction. Id. at 491. Moore notes this would eliminate many of the rights ordinarily connected to other forms of property while also limiting the patient’s control over excised cells. Id. at 492.
• In a footnote, the court likens Moore’s tissues to other gifts provided per the Uniform Anatomical Gift Act whereby a competent adult may gift “all or part of his body” for certain designated purposes, including research or the advancement of medical science. Id. at 489. Although the cells may be transferred through gift, the court held they do not constitute tangible personal property capable of being converted because Moore did not own them. Id. at 490.

Cornyn v. Fifty-Two Members of the Schoppa Family, 70 S.W.3d 895 (Tx. Ct. App. 2001)

Summary

Participants donated DNA samples, brains of family members, and or medical records to researchers at Texas Tech University for a study on Alzheimer’s disease. The participants signed written consent forms for a researcher to conduct the research. The university officials took over the project and restricted the researcher's access to materials obtained. When consent forms were discovered missing the university sought to destroy collected materials for which there was no consent form. The participants sought to enjoin the destruction of samples, have the research continue, or have the samples returned under the theory that the research project constituted a charitable trust. The court found that the plaintiffs had standing to sue because a termination of the research would constitute a termination of the trust and create a reversionary interest of the samples to the plaintiffs. The case was remanded to the district court, a mandate issued in April 2002, and the case was permanently retained in October 2002.

Schoppa and Institutional Ownership and Donor Ownership

Schoppa focused on the intent of the donors and the reason for participation in research. The court held that they (the trustors) provided samples (the property) to university (the trustee) for the purpose of engaging in Alzheimer’s research (the intent) which created a charitable trust. If the university was no longer willing or able to fulfill the intent of the trust and continue research, the donors could potentially find a new trustee and transfer the samples. The court distinguished that the donors were not attempting to direct or control the research, but rather make productive use of the samples.

Greenberg v. Miami Children's Hospital Research Institute, 264 F.Supp.2d 1064 (S.D. Fla. 2003)

Summary

Parents of children who donated samples for Canavan disease and non-profit organizations filed a suit against Miami Children’s Hospital Research Institute, a hospital that was conducting research on the samples. The researchers used the samples to develop a patented commercial product (a screening test) for Canavan disease. The plaintiffs claimed breach of informed consent, breach of fiduciary duty, unjust enrichment, fraudulent concealment, conversion, and misappropriation of trade secrets. The court held that informed consent did not require disclosing potential economic interests to donors because they were classified as donors rather than human subjects. The court also declined to find a property interest for the samples because they were voluntarily given to the hospital, so the conversion claim failed. It also rejected the claims for misappropriation of fraudulent concealment and trade secrets. The court did find that plaintiffs may have a claim for unjust enrichment because the institution was collecting licensing fees from its patent for the screening test. Following the district court’s ruling dismissing all claims except unjust enrichment, the parties settled out of court on the issue of unjust enrichment.

Greenberg and Research with Human Subjects

• Unlike other courts which continue to utilize the informed consent requirements, the Greenberg court recognizes a distinction between medical research and human experimentation. Unlike instances where subjects are personally tested, the mere donation of genetic material does not constitute human experimentation and thus there is no duty to obtain informed consent from the donors under federal law. Greenberg, 264 F.Supp.2d 1064, 1069. Florida state law, however, does require obtaining a person’s informed consent when genetic analysis is taken on his or her tissue. Id. Greenberg notes that this consent to obtain genetic analysis does not extend to research results and thus the researchers were not required to obtain consent for the genetic tests conducted subsequent to its donation. Id.
• Greenberg rejected the donors’ claims that informed consent regulations required the duty of informed consent to cover a researcher’s economic interests. Id. at 1070. In a footnote, the court cited (without addressing) the American Medical Association’s Code of Ethics guidelines for physicians and researchers. These guidelines explicitly require disclosing potential commercial applications to a patient before the realization of profit and that “human tissue and its products may not be used for commercial purposes with the informed consent of the patient who provided the original cellular material.” Id. at 1071. As in Catalona, the Greenberg court focused on the practical implications of imposing this duty on researchers. Requiring this element would be unworkable according to the court as it would chill research by mandating researchers’ constant evaluation of their work. Id. at 1070. In addition, Greenberg raises the same concern that Catalona later cites, predicting that control vesting in the donors would allow them to dictate the progression of scientific advancements. Id.

Greenberg and Institutional Ownership and Donor Ownership

The court held that plaintiffs have no cognizable property interest in body tissue and genetic matter donated for research under a theory of conversion. Id. at 1074. It followed the Moore precedent, holding that a donor has no property interest in bodily materials once they have been excised. The Court also recognized that the patented result of research is both factually and legally distinct from excised material used in the research and the product of the specimen is too attenuated to be considered for a conversion claim. Id. Allowing recognition for a donor’s continuing right to his specimen would unduly hinder medical research; thus, a donor who provides specimens for research has no contemporaneous expectation of return. Id.

Tilousi v. Arizona State University Board of Regents, Havasupai Tribe v. Arizona State University Board of Regents, 204 P.3d 1063 (9th Cir. 2008)

[Review granted, review denied by Havasupai Tribe v. Arizona State University Board of Regents, 2009 Ariz. Lexis 82. In March 2010, consolidated parties entered into a settlement agreement.]

Summary

Members of the Havasupai tribe donated blood samples to researchers at Arizona State University for research on diabetes and the researchers used the specimens and donors’ medical information for additional unauthorized research on schizophrenia, inbreeding, and population migration. Plaintiffs contend had they known the purposes for which their samples would have been used, they would not have consented to provide any samples. Plaintiffs averred several claims including breach of fiduciary duty/lack of informed consent, fraud and misrepresentation, conversion, several claims of negligence, and several tort claims relating to privacy. In March of 2005, the Arizona district court heard Tilousi v. Arizona State University Board of Regents (ABOR) and dismissed plaintiffs’ claims relating to breach of fiduciary duty/lack of informed consent, fraud and misrepresentation, conversion, a portion of plaintiffs’ allegation of negligence, and the tort claims related to privacy. In November of 2008, the Arizona Court of Appeals heard the consolidated cases but only addressed the procedural issue of whether the plaintiffs’ notice of claims were sufficient and found the district court erred in granting summary judgment to the defendants. In March 2010, consolidated parties filed a settlement agreement with the court. This settlement contained several provisions including details for ABOR's performance obligations such as: (1) ABOR must pay the plaintiffs a sum of $700,000; (2) ABOR must return all blood samples in its possession; and (3) ABOR must return documents such as lab books and genealogy materials containing research derived from the blood samples, direct IRBs at the universities involved in the suit not to approve ongoing or new research using the samples, and provide the tribe a list of entities to which it previously transferred the samples.  It also set forth a creative collaborative five year agreement between ABOR and the tribe designed to address the tribe's needs in the areas of education, health and nutrition, economic development, architecture, engineering, and legal governance.

Washington University v. Catalona, 490 F.3d 667, 675 (8th Cir. 2007)

Summary

Dr. Catalona was a physician and researcher at Washington University who collected samples for prostate cancer research and helped the university establish a repository to store the samples. The university sought a declaratory judgment to establish it as the owner of the samples and prevent Catalona or the individual donors from transferring the samples to Catalona at a different research institution. The court used the framework of an inter vivos gift, and found that the donors intended to make a gift to the university, delivered the gift to the university when they donated their samples, and the university accepted their gift of samples. The donors did not retain the right to revoke, repossess, or redirect their samples once the gift was made; thus, the university retained ownership of the samples.

Catalona and Research with Human Subjects

In the court’s discussion of the Common Rule requirements for informed consent, the court acknowledges that the forms cannot waive the subject’s legal rights and the subject must have the option to discontinue participation. Yet Catalona distinguishes these two requirements from a right to possession, holding that they do not encompass the right of ownership. In interpreting 45 C.F.R. § 46.116(b)(4) the court held that the right to discontinue participation or withdraw does not translate to a right to physically possess the samples upon termination or a right to direct sample transfer. Catalona, 490 F.3d 667, 674-675.

The appellate court affirmed the district court decision, but did not discuss several of the following pertinent issues developed in the district court opinion:

• Although Catalona continues to classify the donors within the research subject framework, the district court declined to extend a private right of action to enforce the terms of international law per the Declaration of Helsinki or the Nuremberg Code. 437 F. Supp.2d 985 at 1000. The district court also held that because neither Catalona nor the donors were parties to the university’s agreement relating to the Belmont Report nor third party beneficiaries, they could not bring a private cause of action for the university’s breach of contract with the government requiring compliance with the Belmont Report. Id.
• The district court also discusses possible policy considerations of abandoning the inherent constraints within human subjects regulations initially raised on Greenberg. Current regulations provide a “check and balance” system to monitor the research in addition to the safety and welfare of the subjects involved. Id. at 1002. The court warns that erasing the human subject framework would open the disposition of biological materials to the whims of the donors, who could exploit the market value rather than promoting the public good. Id.

Catalona and Institutional Ownership

The appellate court affirmed the district court decision, but did not discuss several of the following pertinent issues developed in the district court opinion:

• When deciding ownership of the patients’ donated tissue, the Catalona court examined several issues related to the storage and handling of the tissue samples. Catalona cited Missouri law which holds that exclusive possession and control over personal property constitutes prima facie evidence of ownership and any other claimants bear the burden of proof. Catalona, F.Supp.2d 985, 995. The court found that the university did satisfy the element of exclusive possession, finding that the university had exclusive possession of the tissue because the biorepository storage facility was physically housed in buildings owned by Washington University, administered by Washington University employees, and operated and maintained by mainly by funding provided by Washington University. Although employees and Catalona had access to the samples, this was achieved by virtue of their employment and compliance with IRB protocol. Id. at 994.
• While much of the research relating to the samples was conducted within the university’s biorepository, the university did transfer some samples to other research institutions. These transfers were made pursuant to a “Material Transfer Agreement” and were signed by Catalona acknowledging Washington University as the owner of the biological samples.
• The Catalona court also sought guidance from Washington University’s intellectual property policy for research, which stated that tangible research property, including biological materials, belonged to the university if significant university resources were used or such property was obtained pursuant to a research project funded by an external sponsor administered by the university. Id. at 995. The university defined the donated tissue within the definition of tangible research. While the researchers retained custody of the tangible research property while at the university, the court clarified that all tangible research property, thus the donated tissue, is owned by the university. Id.
• To further distinguish the issue of ownership, Catalona used the language and format of the informed consent forms. The court noted that many donors signed forms which listed other physicians than Catalona as the principal investigator. The forms were also printed on paper which bore the Washington University logo and were only valid with a stamp of approval by the university’s human studies committee, which provided evidence that the donors were donating their tissues to the university, not a specific researcher. Id. at 997.

Catalona and Donor Ownership

Catalona held that the donors contributed their tissue samples in the form of an inter vivos gift as ruled by Missouri law satisfying the following three elements: (1) present intention of the donor to make gift, (2) delivery of property by the donor to the donee, (3) acceptance by donee whose ownership takes effect immediately and absolutely. Catalona, 490 F.3d 667, 674.

The appellate court affirmed the district court decision, but did not discuss several of the following pertinent issues developed in the district court opinion:

• When determining the intent of the donors’ actions, the court looked to the language used on the informed consent forms signed prior to the donation process. The donors signed forms which specifically stated that by signing, each donor “makes a free and generous gift of your blood, tissue, or DNA to research that may benefit others.” Id. at 990. In addition to the consent form, the court looked to the information provided to the tissue donors in the information brochure. This brochure addressed the circumstance where a donor may change his or her mind and no longer wanted the tissue samples used. The brochures offered identification and destruction of tissue but cautioned that research results already obtained could not be destroyed or recalled.
• Catalona noted the absence of any specific language regarding withdrawal of tissue or tissue transfer and held that the right to discontinue participation did not amount to a right to control the disposition and use of the excised materials but rather was a requirement for compliance for federal regulations. Id. at 999. This right to discontinue participation did not mean control over disposition of the tissue, but only a right to not provide any more tissue samples and make any more inter vivos gifts to the university. Id. at 999. By signing the informed consent form, the court found that the donors demonstrated the present intent to donate their samples to the university. Id. Although the informed consent form provided sufficient evidence to the donor’s intent, it was not necessary to establish the elements of an inter vivos gift. Id. at 998.
• The court only briefly addresses delivery, stating that the university took delivery and acceptance of the tissue samples which immediately and absolutely effectuated the university’s ownership in the samples. Id. The absence of discussion in this area suggests that the informed consent form and surrounding circumstances relating to collection and storage in the repository are sufficient to satisfy the delivery and acceptance requirements. Once the donors and university completed the gift transaction, the tissue cannot be revoked. Id. at 999.

RECENT DEVELOPMENTS

Federal Law

HIPAA Amendments

In February 17, 2009, Title XIII the Health Information Technology for Economic and Clinical Health (HITECH) Act passed as part of the American Recovery and Reinvestment Act of 2009. Under the old law, HIPAA only applied to covered entities and did not apply to business associates of these entities but could be indirectly and partially imposed with Business Associate Agreements. For example, a research hospital that collected PHI from patients for a study was directly covered but if the hospital shared this PHI and research with a corporation, this corporation was not required to comply with HIPAA and the corporation would not be directly liable for any privacy breach. Now, HIPAA applies directly to business associates who are required to comply with the Security Rule which outlines specific standards to safeguard PHI. This law also outlines both the responsibilities of a covered entity and business associates in the event of a privacy breach, redefines the meaning of “minimum necessary disclosures,” and expands potential liability to include criminal penalties. If the business associate is noncompliant, then it will also be directly subject to civil and or criminal penalties for noncompliance.

Health Information Technology for Economic and Clinical Health (HITECH) Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111–5). Available from: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_public_laws&docid=f:publ005.111

HIPAA Security Rule, 45 C.F.R. §164.308 (2003). Available from: http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=45&PART=164&SECTION=308&TYPE=PDF

Administrative Law and Guidance Documents

Genome Wide Association Studies: NIH Points to Consider for IRBs and Institutions

This document provides additional guidance about the requirements set forth in the Common Rule pertaining to genome wide association studies. The NIH will only accept GWAS data into the NIH GWAS data repository after receiving appropriate certification, which requires an IRB to review and ensure that the study’s research protocol follows these guidelines pertaining to informed consent documents, de-identifying data, and considers risk of the research on the individuals or groups referenced by the study.

Office of Extramural Research, NIH. NIH points to consider for IRBs and institutions in their review of data submission plans for institutional certification under the NIH’s policy for sharing of data obtained in NIH supported or conducted Genome Wide Association Studies (GWAS). November 2007. Available from: http://grants.nih.gov/grants/gwas/gwas_ptc.pdf

NIH Modifications to Genome-Wide Association Studies (GWAS) Data Access

In August of 2008, the NIH swiftly removed aggregate genotype data for GWAS from public access after learning of the possibility of data attack in genome wide association studies. The NIH stated it is studying how to effectively create a method of data sharing that would minimize potential attacks.

Office of Extramural Research, NIH. NIH modifications to Genome-Wide Association Studies (GWAS) data access. August 28, 2008. Available from: http://grants.nih.gov/grants/gwas/data_sharing_policy_modifications_20080828.pdf

NIH Research Policies and Practices: Hearing before the Subcommittee on Oversight and Investigations and Committee on Energy and Commerce

This testimony was spurred by an investigation into allegations that Dr. Trey Sunderland of the National Institute of Mental Health was shipping specimens related to Alzheimer’s research to Pfizer, who used the samples for research and compensated Sunderland without the NIH’s permission or knowledge. In addition to the inquiry of Sunderland’s actions, the testimony discussed methods to improve informed consent documents and data sharing agreements.

Human tissue samples: NIH research policies and practices. Hearings before the subcommittee on oversight and investigations of the committee on energy and commerce. House of Representatives, One Hundred Ninth Congress. Second Session. June 13 and June 14, 2006. Serial No. 109-119. U.S. Government Printing Office. Available from: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_house_hearings&docid=f:30412.pdf

Institute of Medicine. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research

This summary report released in February 2009 addresses how HIPAA has been ineffective in protecting privacy of PHI in biobanking research and argues it has impeded important research. It proposes several recommendations to clarify the meaning of HIPAA’s requirements, revise several requirements, and change the applicability by eliminating the need for an individual’s authorization/consent for biobanks and other information based research.

Institute of Medicine (U.S.). Committee on Health Research and the Privacy of Health Information, the HIPAA Privacy Rule. Beyond the HIPAA privacy rule: enhancing privacy, improving health through research. Washington, D.C.: National Academies Press; 2009. Available from: http://books.nap.edu/openbook.php?record_id=12458

International Law

International Compilation of Human Research Protections

This document provides a table of approximately 1,100 laws, regulations, and guidelines that govern human subjects research in 92 countries, as well as standards from a number of international and regional organizations. It covers research involving human biological materials, genetic research, privacy laws, and well as other topics such as drug trials and stem cell research.

Office for Human Research Protections. International compilation of human research protections, 2009 Edition. U.S. Department of Health and Human Services. Available from: http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

News and Other Resources

Erika Check Hayden. Major biobank launches in America. Nature News. December 17, 2008. Accessed from: http://www.nature.com/news/2008/081217/full/news.2008.1315.html (subscription required)

Elie Dolgin. Child DNA donors should have their say. Nature News. August 13, 2009. Accessed from: http://www.nature.com/news/2009/090813/full/news.2009.819.html (subscription required)

Gurwitz D, Fortier I, Lunshof JE, Knoppers BM. Research ethics. Children and population biobanks. Science. 2009 Aug 14;325(5942):818-9. Accessed from: http://www.sciencemag.org/cgi/content/short/325/5942/818 (subscription required)

The Institute for Science, Law & Technology (ISLAT). The Sunderland case: federal researcher appropriates thousands of tissue samples. Who Owns Your Body. Illinois Institute of Technology, 2007. Available from: http://www.whoownsyourbody.org/sunderland.html

Katherine Drabiak-Syed. Human specimen collection, biobanking, and genetic research. PredictER Law and Policy Update. Indiana University Center for Bioethics. May 14, 2010. | PDF - 98 KB

Predictive Health Ethics Research (PredictER), a multidisciplinary research, policy and public education program at the Indiana University Center for Bioethics is supported by a grant from the Richard M. Fairbanks Foundation.