Genomic Biobanks Charitable Trusts
The charitable trust is being proposed as a system to manage genomic biobanks (tissue and health data), as David E. Winickoff and Richard N. Winickoff describe in the New England Journal of Medicine.
The national context of the article pertains to the U.S.A.
"As academic medical centers decide how to approach the difficult questions involved in the collection and storage of human tissue and blood, they should resist the temptation to assume the role of broker to private-sector biobanks. The charitable trust is an alternative that has clear ethical, legal, and scientific advantages. It can accommodate and foster the altruism, good governance, and benefit to the public that are necessary for the success of such a project over the long term. In addition, the tissue trust can comply with increasingly stringent rules about privacy and informed consent without losing its value as an information-rich genomic resource." (http://content.nejm.org/cgi/content/full/349/12/1180 )
"When a person agrees to donate tissue, the recipient has a responsibility to serve as a trustee, or steward, of the tissue in order to ensure protection of the contribution.23,28 The National Research Council has suggested that for a worldwide collection of DNA, "a more sophisticated and complicated approach would be to form an international organization to serve as a trustee and fund-holder for all the sampled populations."26 The charitable trust is a promising legal structure for handling such a set of obligations, for promoting donor participation in research governance, and for stimulating research that will benefit the public.7,29
Under a trust agreement, the tissue donor, or settlor, formally expresses a wish to transfer his or her property interest in the tissue to the trust. The permission form could be used for this purpose. The settlor appoints a trustee of the property, who has legal fiduciary duties to keep or use the property for the benefit of a specified party, the beneficiary.30 In a charitable trust, the general public acts as the beneficiary.30
A charitable trust is an elegant and flexible legal model that has a number of advantages over private biobanks. First, charitable trusts accord well with the altruism that characterizes gifts of tissue.21 If altruistic donations are solicited by hospitals for research, then the hospitals should act as stewards rather than as brokers. Second, the architect of the trust can provide the donor group with an advisory role in the governance of the trust.30 We believe that the patient population of a medical center, with appropriate leadership from the institution, would have the necessary sense of community to make the advisory role meaningful. Finally, private biobanks may be forced to sell off their inventory in the event of bankruptcy, but charitable trusts have the advantage of longevity. This feature is important not only for donors but also for researchers who perform longitudinal studies." (http://content.nejm.org/cgi/content/full/349/12/1180 )
Structuring the Trust
"Structuring a charitable trust requires careful thought about recruitment, permission, protection of donors' privacy and autonomy, and benefits to the community. To maximize its value, a biobank could contain tissue removed during surgery, as well as blood and serum collected from volunteers. Recruitment could take place in clinics and through outreach programs, but must be undertaken with caution. Surgical candidates for tissue donation should be recruited outside the context of clinical care, in order to avoid the misperception that care is contingent on consent. Mailings to community members and Web sites could be used to attract volunteers.
The permission form should contain the safeguards that Greely has proposed4 — including review by the IRB of any subsequent research, absolute right of withdrawal, and full disclosure of commercial arrangements — which are unlikely to reduce the rate of participation substantially.31 However, before patients or volunteers are presented with a permission form, they should be shown an explanatory videotape and have an opportunity to ask questions.13
In terms of safeguarding privacy, the trust would encrypt the identifying information on the tissue or blood sample before sending it to researchers, thus obviating the need for additional authorization by the donor under the new privacy regulations.32 However, the trust would retain the key to the encryption, enabling it to update information.
Maintaining the biobank as a charitable trust governed by a board of trustees would allow the donor group to participate in the governance of the trust.30 Forms of participation might include membership on the trust's IRB, membership on a donor committee that has veto power over particular projects, and election of a donor to serve on the board of trustees. Research applications could be evaluated by the trustees according to a set of criteria that would ensure public benefit — by addressing public health failures, for example.
Donors would be asked to give permission for future research projects, but two features of the trust would safeguard their autonomy. First, the trust would keep donors informed about all research projects through a Web site and would specify a period of time during which donors could opt out of the research. This would encourage open-ended participation but would also allow donors to withdraw from a project. Second, the trust would require consultation with and consent by the community for studies that involve particular populations, such as members of an ethnic group. This would help protect group autonomy in genetic research.33
A cooperative model could have scientific advantages over private biobanks, whose customers are cut off from the donors. Since many common diseases in humans arise from a complex interaction between genes and the environment, the most useful biobanks for genomic research will contain information about a donor's phenotype, environmental exposures, and nutrition.34 With a charitable trust, the ongoing acquisition of such data would be possible. If carefully constructed, the trust would allow donors to feel comfortable with the submission to the data bank of new medical data from their hospital visits and with being contacted if additional samples or specific information were needed. Donors could indicate on the initial permission form their willingness to be contacted." (http://content.nejm.org/cgi/content/full/349/12/1180 )
Funding the Trusts
"A clear advantage of private biobanks is that they can quickly attract large amounts of venture capital. Raising the necessary funds for proper administration of a charitable trust would be a great but surmountable challenge.
Biobanks can attract the funding necessary to make them work with public benefit, not profit, as the organizing principle. For instance, the Marshfield Clinic, in Wisconsin, has developed what it calls the "personalized medicine research project," a nonprofit biobank that holds blood samples and medical information, as well as demographic and family information, from volunteers who are patients in the clinic's health network.2 This biobank has received grants from Congress and the State of Wisconsin in support of its mission to construct a national resource. The National Health Service in the United Kingdom has also begun to develop a biobank, and there are nascent plans to start one on the national level in the United States.2
We believe that academic medical centers are qualified to take a leadership role in initiating and governing tissue trusts, for several reasons. First, academic medical centers have a unique relationship with tissue and blood donors and have access to medical and environmental data. Second, they have the means and experience to attract public grants and funding from private foundations. Third, they and the public would benefit from the development of good governance structures that would help educate and motivate potential donors. Also, such an endeavor accords well with the mission of teaching hospitals.
We are not rejecting market-based solutions for funding: indeed, biotechnology and pharmaceutical companies that want tissue or data from a hospital could be partners with the tissue bank in order to help fund it.23 However, trustees that have been advised by donors should use funding models that seek research partnerships instead of tissue buyers. For instance, PXE International — a rare-disease group that has established a nonprofit blood and tissue bank — has generated funding by negotiating intellectual-property arrangements with commercial researchers.35 The nonprofit model will facilitate research by maintaining open access and encouraging such partnerships." (http://content.nejm.org/cgi/content/full/349/12/1180 )
See the entry on Trusts