Executive Summary

Beginning in 1993, the Ethics Committee (the Committee) developed a series of white papers that are available through the OPTN website. In 2014, the Committee began a systematic review of these white papers to evaluate if each of the white papers were accurate and relevant, and therefore valuable resources for the transplant community. The original white paper addressing presumed consent was produced in 1993, and was written in response proposed presumed consent legislation under consideration in Maryland and Pennsylvania with the following features:

• The potential donor is presumed to have wished to donate if he or she had not expressed an objection during the individual's lifetime;

• If the potential donor had not expressed a preference for organ donation, the objection of the next of kin is sufficient to preclude donation, even though the potential donor's consent is presumed;

• The recorded preference of a potential donor for organ donation overrides the objection of that individual's next of kin;

• All reasonable efforts are to be made to contact the potential donor's next of kin.

Of note, this white paper was written at a time when there was limited access to personal computers and soon after the advent of the World Wide Web (1990). The original white paper proposed using mail to object to presumed consent, and cited Gallop surveys from 1985 and research from 1976.

The Committee determined that this white paper was neither accurate nor relevant. Over the past year, the Committee completed a line-by-line review and a substantive revision of the white paper. The white paper received a new title, contains new content addressing current issues with presumed consent which is supported by citations to current research and literature.

This project was completed before the OPTN/UNOS Board determined that all types of guidance documents would require public comment (June 2016). The Committee elected to follow the new process even though the requirement was not in effect at the time work on the project was completed.

Read the full proposal. (PDF - 208 K)