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Changes Approved to Consent-related Standards

AATB News Release

April 13, 2011

The Board of Governors has approved a detailed set of recommendations from the Standards Committee that update all consent-related standards in AATB's Standards for Tissue Banking (Standards).

Changes were originally developed by a multi-organizational Consent/Authorization Task Force organized by the AATB and chaired by Christina W. Strong, Esq. These final recommendations are the product of the Task Force members who work at eye banks, organ procurement organizations, tissue banks, and non-anatomical donation organizations.

Valuable input was also provided by participants during the open consultation period when draft revisions were issued for public comment. The AATB Standards provide the most comprehensive guidance published anywhere for consent and authorization practices.

The following bullets generally describe the changes made, which create a baseline for behavior and documentation when obtaining informed consent or handling an authorization:

  • A variety of new terms with definitions are included: Adequate Information, Authorization, Authorizing Person, Document of Authorization, Document of Gift, Donation Coordinator, Donor Registry, Notification, Record, Sign (Signed, Signature), and Witness;
  • Key elements from the "Model Elements of Informed Consent" were incorporated into the new standards in Section D, and this section was re-organized;
  • Concepts from the Revised Uniform Anatomical Gift Act are harmonized with Authorization;
  • Post-mortem anatomical gifts are now subject to a donation/ authorization process, while living donors require informed consent;
  • Core Elements are described when either obtaining Authorization or when obtaining Informed Consent;
  • Clarifies that those who sign a Document of Gift (donor designation, first person consent, registered donors) do not need to demonstrate knowledge of Core Elements;
  • Distinguishes, where necessary, between documentation of gift made by the Donor of his or her own body, and documentation of authorization of a gift made by a third-party after the death of the Donor;
  • Distinguishes between Authorization, which is the process by which post-mortem gifts are made, and Informed Consent, which involves gifts made that are recovered during the life of the Donor; and
  • Specifically defines the role of a witness and methods for obtaining and documenting Authorization and Informed Consent.

A decision regarding an implementation date is forthcoming and will be announced.

All comments and responses from the open consultation period.

Contact Scott Brubaker (brubakers@aatb.org) if you have any questions.