OPTN Comment due 12/23/11: #8: Living Donor Informed Consent

[Clark]

All comment solicited:
http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/proposals.asp

This proposal:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSub_293.pdf

Exhibit:
http://optn.transplant.hrsa.gov/PublicComment/pubcommentPropSurveyExhibit_36.pdf

Precis:
Living Donor Committee: Proposal to Establish Requirements for the Informed Consent of Living Kidney Donors 
This proposal would establish policy requirements for the informed consent of living kidney donors. This proposal is in response to a directive from the Health Resources and Services Administration (HRSA) and based on recommendations from a Joint Societies Steering Committee composed of representatives of the American Society of Transplantation (AST); the American Society of Transplant Surgeons (ASTS); and the North American Transplant Coordinators Organization (NATCO) to the OTPN/UNOS Living Donor Committee.


Please read the two pdf files and discuss them in this thread.  If you are moved to formally submit your comments at http://optn.transplant.hrsa.gov/policiesAndBylaws/publicComment/submitYourComment.asp?PropID=317 , please consider providing a copy here.  Thanks!

[Clark]

http://communication.unos.org/2011/08/fall-2011-regional-business-meetings-schedule/

Fall 2011 Regional Business Meetings Schedule

Here’s the schedule of upcoming fall 2011 regional business meetings, where transplant professionals can participate in discussions and learn about regional business, committee activity, and policy and bylaw proposals that are out for public comment. All UNOS members are welcome. There is no registration fee and no need to pre-register.

• Region 6 Business Meeting: September 23, 2011 in Honolulu, HI
• Region 1 Business Meeting: September 26, 2011 in Worcester, MA
• Region 10 Business Meeting: September 30, 2011 in Dayton, OH
• Region 9 Business Meeting: October 12, 2011 in Albany, NY
• Region 7 Business Meeting: October 14, 2011 in Chicago, IL
• Region 3 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 11 Business Meeting: October 14, 2011 in Atlanta, GA
• Region 2 Business Meeting: October 28, 2011 in Philadelphia, PA
• Region 4 Business Meeting: December 2, 2011 in Houston, TX
• Region 8 Business Meeting: December 2, 2011 in Kansas City, MO
• Region 5 Business Meeting: December 15, 2011 in Las Vegas, NV

Visit the UNOS Calendar on www.unos.org  for more information or contact the UNOS administrator responsible for your region.

• Regions 1,4,9: Shannon Edwards – Shannon.Edwards@unos.org
• Regions 2, 6, 8: Betsy L. Gans – Betsy.Gans@unos.org
• Regions 5, 7, 10: Chrystal Graybill – Chrystal.Graybill@unos.org
• Regions 3, 11: Clifton McClenney – Clifton.McClenney@unos.org

FYI, here's a link to the regional map for those who don't know which one they're in.  Do try to attend, and identify yourself to the Regional Counselor, who will chair the meeting.  http://optn.transplant.hrsa.gov/latestData/stateData.asp?type=region

[Clark]

FYI, I plan to attend Monday's Region 1 meeting.  See you there?

[Clark]

This passed without dissent at Today's Region 1 meeting.  A comment which the region will be forwarding is a suggestion/request that a template acceptable informed consent document be provided.

[Clark]

I've received some informal feedback about the public comment received to date and it can be summarized in two words: sparse and negative.  Don't let this be all that the committee and the board sees!  Get your comments in, attend the regional meetings, be a visible witness!  There's time to get your comments in, but the regional meetings are upon us.

[Clark]

Complete? Correct?  Enough?  Too much?  If you, too, think this is desirable and important, please try to attend a regional or national meeting and make your presence known!  Please let us know what you learn.  Thanks!

[WilliamLFreeman]

Clark,

Thanks very much for reminding us to think about and respond to this Proposed Policy, too.  I assume you and other LDOers will send comments to UNOS as public comments.  I & other members of the Living Donor Committee who are faithful readers [and sometimes posters] of LDO will bring all comments posted on LDO to our meeting as well.

Anyone with comments or observations?

Bill

[Clark]

Please let us know what you learned at a meeting, or what you've submitted as public comment.  Thanks!

[Clark]

Just about a month left to concentrate your thoughts and get your public comments in!

[Donna Luebke]

Clark

Maybe a section of LDO can be dedicated to share our public comment. One issue I have is that 'public commnent' is not readily available for the public to read.  Appreciate your reminders and invitation to get more to comment/be involved.  I am not confident any of this current work will lead to policy.  Can read OPTN committee meeting minutes from the last 15-20 years and the last 10 years of ACOT meeting minutes which again, have not lead to policy, safeguards, or protections for donors.  The OPTN has had 5 years to develop even one living donor policy which impacts donor care and there are none.  Plus, if this proposal does develop into policy says nothing will be implemented until 2014.  Too much bureaucracy and too many meetings with few results. 

One thing that has changed is that HRSA is using tougher language calling this work a 'directive' and that they will not accept recommendations.  Time for policy.  I need to reread these proposals and past work of the OPTN Living Donor Committee--have heard from other donors that these proposals have watered down previous work.  Why?  Rationale for this?  If was to at least get something passed, this is not acceptable. 

[Michael]

Maybe a section of LDO can be dedicated to share our public comment. One issue I have is that 'public commnent' is not readily available for the public to read.

We can do that. Moreover, there may be suggestions we collectively support that don't make it into any final policies (assuming OPTN actually passes something), and it would be helpful to have a record so we can continue to petition OPTN for improvements in the policy in the future.

I'm writing up my comments on the informed consent proposal today.

[Michael]

Here is a link to my comments on Proposal 8: https://livingdonorsonline.org/UNOSProposals/Murphy_Proposal_8.pdf

Email me any comments you submitted to UNOS/OPTN, and I'll post them here, too. Thanks!

[Clark]

Due Friday!

[Michael]

Comments on the three living donor proposals by Cristy Wright: http://www.sirencristy.blogspot.com/

[Michael]

Comments from Donna Luebke: https://livingdonorsonline.org/UNOSProposals/DLuebke-InformedConsentDec2011.pdf