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Are individuals who donate tissue patients, donors, or human subjects?

Throughout this guide, individuals who consent to the banking of their excised tissue for research purposes are referred to as "donors". However, this form of tissue donation should not be confused with the donation of tissue or organs for therapeutic purposes. Those who agree to bank their leftover surgical specimens for future research are patients first and foremost with regard to their disease, and derive no clinical benefit from banking their tissue. Therefore they are not patients from the perspective of the tissue repository process. They are also not human research subjects, since the tissue collection and clinical database process is not research in and of itself, and since the downstream research is not conducted on the donor, but on their excised tissue. There is some confusion over the use of these terms ("donor", "patient", "subject") in this field. In order to clarify the distinction between clinical trials or other therapeutic endeavors and the act of consenting to allow research to be performed on leftover surgically resected tissue, the term donor is used here rather than patient or subject.