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Withdrawing consent

Just as federal regulations and good ethical practice require that human subjects have the opportunity to end their participation in a research study (usually at any time during the study), ethical practice requires that tissue donors also have the opportunity to withdraw their tissue and associated clinical information from a repository.

In order for a tissue donor to withdraw his/her tissue, he/she must contact the medical center and make such a request. This should be clearly spelled out in the consent process and consent form. Tissue donors may not be able to withdraw their tissue if the repository has already distributed all of it to researchers or if the repository has no way of identifying the tissue. If the tissue has not yet been sent to the repository and is still identifiable at the medical center, the donor's request can be fulfilled.

The same is true for donors who wish to withdraw associated clinical information. If the repository that stores and distributes the donor's tissue has collected it as unlinked and therefore untraceable to an individual, the donor's request cannot be fulfilled. If the donor has agreed to linking the tissue to his/her medical record (e.g., for prospective studies), then a donor's request to withdraw consent may be fulfilled. This requires that the entity holding the code (e.g. a coding agent at the medical center/collection site, a third party escrow agent that handles codes for repository, etc.) destroys the link.

Tissue donors have several options for withdrawing. They may choose to withdraw tissue, and/or associated information, or leave their tissue in the repository but have it unlinked to prevent continued access to their medical records. These options should be clearly spelled out in the consent process and form. A contact person associated with tissue collection should be identified so donors know where and with whom to make their request.