Matching organs. Saving lives.

System notice

Kidney and liver transplant programs seeking HOPE Act IRB approval

Audience:

OPO staff

Staff at living donor programs

At a Glance:

OPTN policy changes related to the HOPE Act are in effect as of November 21, 2015.

These changes will make it possible for HIV positive livers and kidneys to be transplanted into HIV positive candidates. Related functional changes to WaitlistSM and DonorNet® that will allow OPOs to run liver and kidney matches for HIV positive donors were implemented November 19.

Only transplant centers that have received IRB approval to participate in a HOPE Act research study and submitted a request to UNOS to join the open variance will be able to participate. We will explain specifically how you will inform UNOS of your IRB approval as those details become available.

Important: Although the new functionality is operational in UNet, OPOs MUST NOT run HIV positive matches and transplant centers must not accept or transplant HIV positive livers and kidneys until all requirements of the HOPE Act are in place.

What changed in UNet?

  • We added three new donor HIV fields on the match criteria page in DonorNet. These are required fields in order to run matches for all organ types.
  • We added candidate HIV screening for liver and kidney in Waitlist.
  • We updated the donor snapshot and print match results pages in DonorNet to reflect the addition of the three new HIV fields to the match criteria page.
  • We updated the View Candidate Information section of the match results page to reflect the addition of the new HIV screening fields in Waitlist.

What this means for transplant centers:

  • Once the Secretary of Health and Human Services has published the final research criteria under subsection (a) of section 377E of the Public Health Service Act, your program can begin the IRB approval process based on the requirements outlined in the regulations. Once you have received HOPE Act IRB approval, you must notify UNOS that you have met all the requirements in the research criteria (Details about how to notify UNOS coming soon).
  • Once you have HOPE Act IRB approval and have notified UNOS of this approval, you will be able to indicate in Waitlist whether your candidate is willing to accept an HIV positive kidney or liver. (see Policy 15.6)
  • Living donor transplant hospitals must meet all the requirements outlined in Policy 15.6: Open Variance for the Recovery and Transplantation of Organs from HIV Positive Donors and the research criteria as referenced in §121.6(b)(ii)(A). The research criteria being developed by the NIH under the authority of the Secretary of HHS will contain additional requirements for living donors participating in a HOPE Act research study.

What this means for OPOs:

  • The changes to DonorNet will allow you to run HIV positive matches (liver and kidney only). Only HIV-positive candidates from centers that have HOPE Act IRB approval and whose HIV status has been verified will appear on HIV + match runs.

Questions?

If you have any questions related to the HOPE Act or subsequent changes to UNet, contact your regional administrator at 804-782-4800. View resources.

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