Collaborating with Commercial Tissue Repositories: An ethics guide for IRBs, researchers and policymakers
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Mission of medical center

Medical centers are united in the goal of patient care. However, medical centers vary in the degree to which they also support and conduct medical research. For medical centers with small research agendas, collaborations with repositories offer a direct way to contribute to research efforts by tissue collection if not also by giving local researchers access to a large scale high quality tissue inventory.

The key issue with repository collaborations in regard to the medical center mission is their commercial nature. This issue is larger than whether or not donors consent to tissue donation. It is a matter of whether tissue collection for commercial repositories, with, of course, donor consent, is an appropriate practice for a medical center to engage in. Is it in conflict with the mission of a medical center to negotiate with private companies about patients' extra surgical tissue for research purposes?

The issue would be a simple one if the tissue repository were a locally-controlled public bank. Many would be willing to put their otherwise discarded tissue to good use by donating it to a research repository at the medical center where their surgery was performed or a nearby affiliated institution. However, local control and public ownership do not necessarily provide more protections for tissue donors. Nor is a local repository always the best use of stored tissue and information. For instance, local repositories can vary in the quality of tissue that is banked, and have limited collections, users, and research projects. Most donors would prefer that their tissue be distributed to those conducting the most promising not the nearest research.

Large commercial repositories can meet the needs of researchers but not without also raising issues about commercial interests in research. A key concern for medical centers considering collaborating with a commercial tissue repository has to do with the commercialization of body parts. Some refuse collaborations because they believe that a business in patient surgical tissue, even if for research, is in direct conflict with their primary mission: patient care.

The issue of commercialization of body parts through commercial banking of research tissue is complex. For instance, are repositories actually selling tissue? In the U.S. it is legally permissible to recover fees for preparing and distributing human biological materials for research. Human tissue itself cannot be bought and sold. The costs for access to human tissue (and organs) need to be commensurate with the costs of collection, preparation, storage, and related tissue processes. Repositories vary in how they describe their services in this regard. Many sell licenses to access their tissue inventory or sell the results of research conducted on repository tissue by repository researchers. Does the commercial nature of a repository take advantage of the donor? Medical centers need to examine the financial incentives offered to them by repositories and assess any conflicts of interest. (See: D. Conflicts of Interest).

Even if collaboration affords no financial advantages to the medical center, there can still remain a perception that the medical center exploits patients by marketing their extra tissue to commercial businesses. Does the profit motive for commercial repositories corrupt these forms of tissue collection? Or does the end goal of research make the tissue collection process an honorable one? Is there an inherent moral difference between for-profit and non-profit repositories? Discussion of this point is timely as new for-profit repositories emerge. Key to this discussion is whether a profit motive trumps ethical considerations and what is required for a business to be ethically sound and socially responsible.

Institutional Integrity Issues