Home Ethical Issues Informed Consent Anonymous Tissue

Is informed consent always required for tissue collection?

While informed consent is required when collecting human tissue with personal identifiers attached to the tissue, is it required if no personal identifiers are attached to the tissue?

The literature on consent for research use of anonymous tissue is divided on this matter. It has not been routine to seek consent since there is no way individuals from whom the tissue was removed could be harmed by what is learned from or done with the tissue. In fact, it is a philosophical question whether anonymous tissue "belongs" to anyone. Certainly it came from a particular individual, but if the excised tissue contains no identifying information, is it still the individual's tissue?

Past practice in using anonymous tissue for research (or medical education) was largely uncontroversial. Still critics might suggest that this is because the vast majority of patients are not aware that discarded (anonymous) surgical tissue is being used for educational and research purposes. They believe instead that extra surgical tissue not needed for diagnostic purposes is discarded, as is commonly the case with most extra tissue. Some, who learned about such practices after the fact, might feel that their autonomy, which includes the right to control use of their excised tissue and organs, has been compromised. Doesn't their personal autonomy grant them the right to direct the use of their tissue, even if anonymous, after its removal?

Ethical practice requires that patients be informed of the possibility that their extra tissue may be used as anonymous tissue for research or education (rather than discarded). Medical centers might consider going beyond mere notification and actually allow patients to opt out of the research or educational use of their anonymous tissue.