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The NCBC Submits Comments to OPTN/UNOS Concerning Revisions to its Organ Procurement and Transplant Network Policies, and Invites Others to Provide Comment

The National Catholic Bioethics Center (NCBC) has submitted a response to the request for public comment from the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) as OPTN/UNOS seeks to amend the OPTN Organ Procurement and Transplant Network Policies.

The NCBC has grave concerns pertaining to the integrity of the process to assure proper consideration of public comments.  In 2011 a notice for comment was posted by OPTN/UNOS concerning the plan to Update and Clarify Language in the DCD [Donation after Cardiac/Circulatory Death] Model Elements. The original call for comment was to end on June 10, 2011; but due to inadequate notice to assure true public awareness, a second call for comment was issued, with a deadline to receive comments of June 15, 2012. On June 22, 2012, long before any meaningful consideration or vote pertaining to comments already received could occur either by the OPTN/UNOS Board of Directors (which did not meet until June 25–26, 2012) or the OPTN Organ Procurement Committee (OPO Committee) or the OPTN Ethics Committee, yet another call for comment was announced concerning a proposed “OPTN Policy Plain Language Rewrite” (Policies Rewrite). The notice for this call for comment states that the Policies Rewrite did “not make any substantive changes to the content of . . . current policies.”  A review of the current DCD Model Elements and the proposed Polices Rewrite draws into question the accuracy of this statement.  The NCBC has raised significant concerns about policies pertaining to Donation after Cardiac/Circulatory Death (DCD) concerning donor selection,  informed consent, and the Dead Donor Rule.

Currently the Policies Rewrite,  presented as not containing substantive changes, does contain un-adopted proposed changes to the DCD Model Elements. The NCBC is requesting of the OPTN/UNOS, to correct any procedural errors in soliciting public comment concerning the proposed Policies Rewrite, that the OPTN/UNOS should immediately withdraw the proposal  from public review until the portions relating to the DCD Model Elements are revised to reflect current policy accurately. 

Please e-mail OPTN/UNOS by August 31, 2012 requesting that “OPTN/UNOS  correct any procedural errors in soliciting public comment concerning the proposed Policies Rewrite and that OPTN/UNOS immediately withdraw the proposal from public review until the portions relating to the DCD Model Elements are revised to reflect current policy accurately.” 

It is imperative that all of us are engaged in these important regulatory matters.