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Proposal to Modify Requirements for Informed Consent of Living Donors

This proposal aims to establish consistent requirements for informed consent of living liver, lung, pancreas, and intestine donors. The goal is to improve the informed consent process for future living donors in these programs.

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Proposal to Modify Requirements for Informed Consent of Living Donors

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  1. Proposal to Modify Existing or Establish New Requirements for the Informed Consent of Living Donors(Resolution 18)Living Donor CommitteeMary Amanda Dew, PhD

  2. The Problem • OPTN policy has inconsistent requirements for living donor informed consent • Kidney donor recovery hospitals must follow OPTN policies • Liver donor recovery hospitals must develop and follow center-specific protocols • Hospitals performing living lung, pancreas or intestine donor recovery are not required to follow OPTN policy or develop and follow center-specific protocols

  3. StrategicPlan

  4. Goal of the Proposal • Establish informed consent requirements for living liver, lung, pancreas, and intestine donors that mirror existing requirements for informed consent of living kidney donors • Improve informed consent process for future living liver, lung, pancreas and intestine donors

  5. How the Proposal will Achieve its Goal • Extend standardization of the informed consent process to living donor liver, lung, pancreas and intestine programs

  6. Background • Proposed requirements are based on recommendations from a Joint Societies Steering Committee and early comment from 5 OPTN Committees • Joint Societies representation from: • American Society of Transplantation (AST); • American Society of Transplant Surgeons (ASTS); • North American Transplant Coordinators Organization (NATCO)

  7. Overall Project Impact

  8. Public Comment Results (3/13/14 – 6/13/14)

  9. Post Public Comment Considerations • June 2014 – Board approved VCA policies • Early September – Living Donor Committee leadership asked to extend proposed policy to include living VCA donors • September 8, 2014 – Committee heard presentation from VCA Committee Chair. Committee discussed and did not support extending proposed policy to VCA donors

  10. Post Public Comment Considerations Reasons for Committee decision: SUMMARY • VCA not considered in policy development/public comment • Elements of policy are inaccurate/false for living VCA donors • Different types of living donor VCA will require different consent elements, none of which have received deliberation • It took years to implement consent policies for kidney donors despite large donation volume; no clear emergent problem for VCA requiring action without deliberation • Delaying passage of policy for liver, lung, pancreas and intestine donors in order to deliberate about VCA donors will not promote safety of these non-VCA donors

  11. Resolution 18 RESOLVED, that the following new or modified Policies 14.2.A (ILDA Requirements for Kidney Recovery Hospitals), 14.2.B (Protocols for Kidney Recovery Hospitals), 14.3 (Informed Consent Requirements), as set forth below are effective February 1, 2015. *Page 61 of Board book

  12. Additional Background • Proposed requirements are based on recommendations from a Joint Societies Steering Committee and early comment from 5 OPTN Committees • Joint Societies representation from: • American Society of Transplantation (AST); • American Society of Transplant Surgeons (ASTS); • North American Transplant Coordinators Organization (NATCO)

  13. Proposal Summary • Living donor recovery programs would be required to provide an ILDA and develop center specific ILDA protocols • Majority of existing (living kidney donor) informed consent requirements are extended to living liver, lung, pancreas, and intestine donors • Remaining informed consent requirements specific to living kidney donors are retained

  14. Proposal Summary Includes new informed consent disclosure requirements specific to risks of living liver donation: • Acute liver failure • Transient liver dysfunction • Biliary complications • Need for blood products • Liver donation-related surgical complications • Abnormal post-donation lab results which could lead to additional testing with associated risks

  15. Public Comment Results • Regions 3 and 11 (joint meeting) did not support the proposal because it would not require living donor programs to disclose the number of living donor deaths that had occurred at their program. • Committee response: • Policy is based on JSWG recommendations: center-specific risk data, including risk of death, should not be required within policy because most centers’ volume is too small to yield reliable estimates of risk of specific events, particularly when events are rare (as is the case with donor deaths)

  16. Public Comment Results • ASTS supported the proposal as written • NATCO supported the proposal as written • AST supported the proposal and submitted comments about requirements for kidney donor consent which the Committee considered when preparing final proposed policy language

  17. Public Comment Results: Individual Two organizations responded with concerns: • National Catholic Bioethics Center • National Catholic Partnership on Disability The Committee leadership prepared a detailed written response to address their concerns, met with group their representatives by conference call, received an additional letter from the groups, and sent written follow-up response.

  18. Public Comment Results: Individual Primary concerns of Catholic organizations included: • Use of term “all,” as short-hand reference to kidney, liver, lung, pancreas, intestine donation, opens the door to donation of all tissues, not just those listed, and no matter how great the potential for donor harm, mutilation, and permanent disfigurement • Incomplete monitoring plan for living donor recovery hospitals

  19. Post Public Comment Considerations • June 2014 – The Board approved VCA policies which allow for living VCA donation • Early September – Living Donor Committee leadership was asked to consider extending this informed consent policy to include living VCA donors • September 8, 2014 – VCA Committee Chair and Vice Chair presented the VCA policies and proposals during a full Living Donor Committee meeting, and responded to questions

  20. Timeline 1/14 Committee completes work on proposal (inception 8/12) 3/13/14 – 6/13/14 Public comment Late 6/14 Board approves VCA policies Late 8/14 Committee receives clarification that VCA policies include living donors Early 9/14 Committee Leadership is asked to extend proposal to include VCA donors 9/8/14 Committee hears presentation from VCA Committee Chair and finalizes proposal

  21. Post Public Comment Considerations • Request by the VCA Committee Chair to Living Donor Committee to extend this informed consent policy proposal to include living VCA donors to prevent “unregulated vacuum and to protect public safety and preserve the public trust.” • The Committee did not support extending this proposal to include living VCA donation for multiple reasons.

  22. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: • The Committee had specifically referred only to kidney, liver, pancreas, intestine, and lung donors in policy drafts and background supporting information • Informed consent requirements for living VCA donors were not considered • by the JSWG during development of their policy recommendations, • by the Committee during policy development, or • during public comment

  23. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: • The policy contains elements that would be inaccurate or false when applied to living VCA donors. • Consider, for example, hand or limb donation. The following elements of policy would be false: • Informing donor of a “potential” change to the donor’s lifestyle from donation • Informing donor of a “potential” negative impact on ability to obtain/maintain disability insurance

  24. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: • The policy does not contain elements essential for full informed consent of living VCA donors. • Different categories of living VCA donation will require separate informed consent considerations, namely 1) limb and face, 2) multi-visceral as a composite (e.g., uterus+ovaries), and 3) other non-visceral organs. .

  25. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: • VCA transplantation is a life-enhancing, not life-saving procedure that could create a permanent disability in the living donor. This changes the ratio of donor risks relative to potential recipient benefits. The proposed policy is not adequate to address this ratio or to address the implications of permanent donor disability • It has taken years to develop, gain approval and implement informed consent policies for living kidney donation, which has the longest history and greatest volume. Absence of informed consent policies should not be considered an emergent problem.

  26. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: • Developing informed consent policy for living VCA donation needs careful consideration due to unique issues. • In the meantime, there is no clear rationale for delaying the policy approval process for informed consent policies for liver, lung, pancreas and intestine donors.

  27. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: SUMMARY • No consideration of VCA during policy development/public comment • Elements of policy are inaccurate and/or false for living VCA donors • Different types of living donor VCA will require different informed consent elements, none of which have received any deliberation

  28. Post Public Comment Considerations • Reasons for lack of Committee support for including living VCA donation: SUMMARY • It took years to implement informed consent policies for living kidney donors despite large volume of donations; no clear emergent problem for VCA requiring action without deliberation • Delaying passage of policy to cover liver, lung, pancreas and intestine donors in order to deliberate about VCA donors will not promote safety of these non-VCA donors

  29. Resolution 18 RESOLVED, that the following new or modified Policies 14.2.A (ILDA Requirements for Kidney Recovery Hospitals), 14.2.B (Protocols for Kidney Recovery Hospitals), 14.3 (Informed Consent Requirements), excluding lines 13, 109 and 110, as set forth below are effective February 1, 2015. *Page 61 of Board book

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