This proposal includes changes to the OPTN/UNOS Bylaws intended to improve the OPTN/UNOS policy development process and provide the OPTN/UNOS Board of Directors (the Board) and committees more flexibility in addressing different types of problems identified by the transplant community. The proposal includes the creation of two new policy development tracks designed to allow the OPTN/UNOS Board to address emergency and non-controversial issues in a more efficient and expedient manner, while continuing to maintain the OPTN’s cornerstone principles of transparency and community consensus in the process. Specifically, the proposal includes the following:

• Clarifies the process the Board will follow to address ‘emergency actions’ that fall into one of the three below categories:
1. A proposal necessitated by a pending statutory or regulatory change.
2. A proposal required due to an emergent public health issue or patient safety factors.
3. A proposal necessitated by a new medical device or technology that affects organ allocation.
• This proposed Bylaws change would clarify that the Board can take action on a policy change in these limited instances, but requires the Board to specify a sunset date that is no more than 12 months beyond the policy’s effective date and distribute the policy for public comment no more than 6 months after approval.
• Creates the following new process for non-controversial and routine policy changes:
1. The sponsoring Committee distributes a public comment proposal (following the normal policy development process) for a new or existing policy and specifies in the policy language areas that will be eligible for future expedited updates.
2. The Board approves the proposal, including policy language specifying that the particular policy section is eligible for expedited updates.
3. At a later date, the sponsoring Committee develops a proposal for expedited action.
4. The proposal is distributed for public comment. This public comment period can be shorter than the normal public comment period but must be at least 30 days.
5. The sponsoring committee considers public comments and recommends final adoption of the proposal.
6. If an objection to the use of the expedited action is received during the public comment period by five members of the public, another OPTN committee, or four members of the Board of Directors, then the sponsoring Committee will notify the Executive Committee of the objections and the proposal will follow the normal OPTN policy development process.
7. If the specified number of objections in #6 above are not received during the public comment period, then the process will proceed as follows:
1. If no objections were raised during the public comment period, the proposal will become effective upon notice to the OPTN membership unless a different date is specified.
2. If one or more objections were raised, then the sponsoring Committee will submit the proposal for final action according to 11.2 Submitting Policy Proposals to the Board of Directors. This will require a review by the Board or Executive Committee before the proposal is adopted.

Read the full proposal