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Are there unique ethical issues when the repository is commercial?

Issues common to collaborations with profit and non-profit repositories:

• informed consent procedures for donors
• protecting donor privacy with samples and information
• ensuring that tissue donation and collection do not compromise patient care
• potential conflicts of interest
• ethical policies and procedures in tissue collection, preparation, storage, and distribution to end-users.

Issues unique to collaborations with for-profit repositories:

• disclosures in informed consent procedures of the commercial nature of the repository and general description of any profits back to the medical center
• disclosure that donors will not profit from tissue donation even if commercial products are developed
• evaluating financial conflicts of interest (e.g. the handling of any profits or other financial incentives)
• assessing community interest and perception of a collaboration with a commercial company
• protecting the integrity of the medical center by evaluating:
  • the ethical policies and procedures of the commercial repository
  • the conditions under which tissue and information will be released to end-user;
  • the review, if any, of appropriate end-users
  • the procedures for managing competition between medical center end-users and others for tissue collected at the medical center
  • the conditions under which the repository may transfer tissue and information to another company (i.e., if its objectives change, if it closes, or if it declares bankruptcy)