Home Medical Centers as Suppliers Risks

Are there risks?

While donating excised tissue to repositories has no medical risks to donors, there are other possible harms to consider.

Donors can be harmed by breaches of privacy of their medical information. Since human tissue contains genetic information, it can be a storehouse of information about individual tissue donors. Moreover, since the tissue is being banked, presumably it will yield more information about genetic probabilities for disease in the future when knowledge of genetics expands. In addition, some tissue is linked with associated clinical information including sensitive personal and family history information (e.g., alcoholism, mental illness, reproductive choices, etc.). Inappropriate release of medical information can harm individuals. Donors can also be harmed if the process of tissue collection compromises patient care.

Medical centers may be concerned that tissue collection itself and/or for a commercial company may erode public trust in their institutionby selling tissue or commercializing body parts or result in other negative perceptions. Commercial repositories tend to license access to their tissue inventories (and related services). Critics may consider the distinction between selling tissue and licensing access to tissue a distinction without a difference. How medical centers use any funds provided by collaborations may also negatively affect the public perceptions of the medical center. In addition, medical centers must collect tissue in compliance with federal and state regulations for human subject research, the federal Privacy Rule and state genetic privacy and other laws. Medical centers could suffer fines or other actions from non-compliance. In addition, there are liability issues that might arise affecting stewardship of donor tissue/information in collaborations with repositories.

Research can be hindered if tissue collection is conducted in a manner that erodes public trust in research and diminishes people’s willingness to be tissue donors or subjects in clinical trials.