Correspondence

The Charitable Trust as a Model for Genomic Biobanks

N Engl J Med 2004; 350:85-86January 1, 2004

Article

To the Editor:

Biobanks are a crucial resource for the advancement of genomic discoveries into clinical care. A charitable-trust model for biobanks, proposed by Winickoff and Winickoff (Sept. 18 issue),1 has merit. However, the premise that this model is the most effective way to protect patients' interests is untested. For-profit organizations can be structured with identical safeguards; Ardais and other corporations have these as well as additional safeguards. Although a charitable-trust model may be interesting conceptually, we believe it would face substantial challenges in overcoming the financial and organizational difficulties involved in effectively managing a biobank to protect patients' interests and promote society's interests in research, as well as substantial challenges in managing potential conflict-of-interest and privacy issues.2,3 For-profit models can be altruistic while receiving due compensation for the considerable investment and effort required to run an ethical, efficient biobank.

The structures and procedures of Ardais4 start from the National Bioethics Advisory Commission's recommendations5; result from numerous 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 collection activities, proposed research, sponsors, and principal investigators, and a bioethics advisory board reports to the board of directors to ensure independence. Most important, the medical center–Ardais collaboration protects patients through detailed, auditable data-access protocols; an informed-consent process carried out by dedicated nurses using full-disclosure forms; procedures whereby all identified materials and information are handled solely by members of the medical-center staff; and de-identification of data. In summary, our “chain of trust” model ensures privacy, confidentiality, and information at each step, from patient to doctor, to medical center, to Ardais, and to researcher. The recent literature and the experience of Ardais confirm that this model protects patients' interests and wishes as we seek better 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

6 References

1. 1

   Winickoff DE, Winickoff RN. The charitable trust as a model for genomic biobanks. N Engl J Med 2003;349:1180-1184
   Full Text | Web of Science | Medline

2. 2

   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.
   

3. 3

   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

4. 4

   Donors & institutions. How Ardais standards are applied. Lexington, Mass.: Ardais, 2003. (Accessed December 8, 2003, at http://www.ardais.com.)
   

5. 5

   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.
   

6. 6

   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.
   

Author/Editor Response

Though we applaud the desire of Ardais to implement strong privacy protections in its biobanking model, the problems of autonomy, entitlement, and governance outlined in our article remain troublesome. For example, the structure described by Otten and colleagues contains no mechanism for informing donors or the hospital's institutional review board about the specific uses of samples and contains no mechanism for group consent when, for example, ethnic groups are studied, even though both of these mechanisms have been recommended by the National Bioethics Advisory Commission.1 The structure they describe also denies the donors rights to any new treatment developed from their donations, even when they cannot afford such treatment, and it does not always adequately represent the medical and financial value of donated tissue and records on the consent form.2 Can this sort of process really be said to “put the patient or donor first”?

Academic medical centers face difficult choices in deciding how to handle the new market value of donated tissue and medical information. We argue that a collaborative model, embodied in a charitable-trust structure, is economically feasible, socially preferable, and scientifically advantageous. As the Framingham Study amply demonstrates, people and their good will — not just their samples or health records — are the real resource.3 We are cognizant that our proposal goes against the grain of privatization in the medical-research arena, but our proposal does not work against market logic — it only allows the donor community to maximize the altruistic value of its gift.

David E. Winickoff, J.D.
Harvard University, Cambridge, MA 02138

Richard N. Winickoff, M.D.
Massachusetts General Hospital, Boston, MA 02114

3 References

1. 1

   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.
   

2. 2

   Winickoff DE. Governing population genomics: law, bioethics, and biopolitics in three case studies. Jurimetrics 2003;43:187-228
   Medline

3. 3

   Voelker R. Two generations of data aid Framingham's focus on genes. JAMA 1998;279:1245-1246
   CrossRef | Web of Science | Medline

Citing Articles (1)

Citing Articles

1. 1

   Anne Scott, Hazel Phillips, Andrew Moore, Rosemary Du Plessis. (2005) Ethics in practice: Conversations about biobanks. Critical Public Health 15:4, 359-368
   CrossRef