Ramifications of selling unused autologous blood

A California blood banker reports that her transfusion service has been approached by a physician who wishes to purchase expired autologous whole blood units to be used for "research". The physician promises that donor confidentiality will be maintained per HIPPA requirements. The inquiring colleague has concerns regarding the legal ramifications of this practice. She asks if a consent should be obtained from the donor that spells out that their autologous blood might be sold for research purposes. She wonders if anyone has a policy or procedure that they would be willing to share that addresses this situation.

The following comments have been received.

ADDENDA Dec. 20, 2004

1. A colleague in Los Angeles worries that if autologous units are untested, they may be infectious. This could present risk and liability to all concerned. She thinks that it would therefore be important to obtain informed consent from the donor, and to use a medical release that has been signed by the donor and the individual or company purchasing the product. In addition, she cautions that since blood banks are responsible for the disposition of each blood product (untested or not) from 'cradle to grave', she does not think it should be given or sold to the physician for research, unless there is an absolute guarantee in terms of what he/she will do with it, and how the product can be traced, if the need to recall the product should arise. Finally, she wonders if such use should be reviewed and approved by an Institutional Review Board.

Please submit comments to the e-Network Forum.

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator