To the Editor: Biobanks are a crucial resource for the advancementof genomic discoveries into clinical care. A charitable-trustmodel for biobanks, proposed by Winickoff and Winickoff (Sept.18 issue),1 has merit. However, the premise that this modelis the most effective way to protect patients' interests isuntested. For-profit organizations can be structured with identicalsafeguards; Ardais and other corporations have these as wellas additional safeguards. Although a charitable-trust modelmay be interesting conceptually, we believe it would face substantialchallenges in overcoming the financial and organizational difficultiesinvolved in effectively managing a biobank to protect patients'interests and promote society's interests in research, as wellas substantial challenges in managing potential conflict-of-interestand privacy issues.2,3 For-profit models can be altruistic whilereceiving due compensation for the considerable investment andeffort required to run an ethical, efficient biobank.
The structures and procedures of Ardais4 start from the NationalBioethics Advisory Commission's recommendations5; result fromnumerous consultations with scientific, community, medical,government, and academic leaders, as well as patient groups,clergy, and bioethicists; and put the patient or donor first.Institutional review boards approve all Ardais-sponsored collectionactivities, proposed research, sponsors, and principal investigators,and a bioethics advisory board reports to the board of directorsto ensure independence. Most important, the medical center–Ardaiscollaboration protects patients through detailed, auditabledata-access protocols; an informed-consent process carried outby dedicated nurses using full-disclosure forms; procedureswhereby all identified materials and information are handledsolely by members of the medical-center staff; and de-identificationof data. In summary, our "chain of trust" model ensures privacy,confidentiality, and information at each step, from patientto doctor, to medical center, to Ardais, and to researcher.The recent literature and the experience of Ardais confirm thatthis model protects patients' interests and wishes as we seekbetter health care for all.6
Jeffrey Otten, M.A., M.B.A. Heidi R. Wyle, Ph.D. Gregory D. Phelps, M.B.A. Ardais Lexington, MA 02421
References
Winickoff DE, Winickoff RN. The charitable trust as a model for genomic biobanks. N Engl J Med 2003;349:1180-1184. [Free Full Text]
Alpert S. Privacy and the analysis of stored tissue. In: Research involving human biological materials: ethical issues and policy guidance. Vol. 2. Commissioned papers. Rockville, Md.: National Bioethics Advisory Commission, January 2000:A31.
Merz J, Sankar P, Taube S, Livolski V. Use of human tissues in research: clarifying clinician and researcher roles and information flows. J Investig Med 1997;45:252-257. [Web of Science][Medline]
Donors & institutions. How Ardais standards are applied. Lexington, Mass.: Ardais, 2003. (Accessed December 8, 2003, at http://www.ardais.com.)
Research involving human biological materials: ethical issues and policy guidance. Vol. 1. Report and recommendations of the National Bioethics Advisory Commission. Rockville, Md.: National Bioethics Advisory Commission, August 1999.
Rothstein MA. Bioethical and regulatory issues from a US perspective. Presented at the 11th North American ISSX Meeting, Symposium 1, Human Genome: Legal, Ethics and Regulatory Issues, Orlando, Fla., October 27–31, 2002.
The authors reply: Though we applaud the desire of Ardais toimplement strong privacy protections in its biobanking model,the problems of autonomy, entitlement, and governance outlinedin our article remain troublesome. For example, the structuredescribed by Otten and colleagues contains no mechanism forinforming donors or the hospital's institutional review boardabout the specific uses of samples and contains no mechanismfor group consent when, for example, ethnic groups are studied,even though both of these mechanisms have been recommended bythe National Bioethics Advisory Commission.1 The structure theydescribe also denies the donors rights to any new treatmentdeveloped from their donations, even when they cannot affordsuch treatment, and it does not always adequately representthe medical and financial value of donated tissue and recordson the consent form.2 Can this sort of process really be saidto "put the patient or donor first"?
Academic medical centers face difficult choices in decidinghow to handle the new market value of donated tissue and medicalinformation. We argue that a collaborative model, embodied ina charitable-trust structure, is economically feasible, sociallypreferable, and scientifically advantageous. As the FraminghamStudy amply demonstrates, people and their good will —not just their samples or health records — are the realresource.3 We are cognizant that our proposal goes against thegrain of privatization in the medical-research arena, but ourproposal does not work against market logic — it onlyallows the donor community to maximize the altruistic valueof its gift.
David E. Winickoff, J.D. Harvard University Cambridge, MA 02138
Richard N. Winickoff, M.D. Massachusetts General Hospital Boston, MA 02114
References
Research involving human biological materials: ethical issues and policy guidance. Vol. 1. Report and recommendations of the National Bioethics Advisory Commission. Rockville, Md.: National Bioethics Advisory Commission, August 1999.
Winickoff DE. Governing population genomics: law, bioethics, and biopolitics in three case studies. Jurimetrics 2003;43:187-228. [Medline]
Voelker R. Two generations of data aid Framingham's focus on genes. JAMA 1998;279:1245-1246. [Free Full Text]
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