proposal to modify existing or establish new requirements for the informed consent of living donors...
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Proposal to Modify Existing or Establish New Requirements for the Informed Consent of Living Donors
(Resolution 18)
Living Donor CommitteeMary Amanda Dew, PhD
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
The Problem
Strategic Plan
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
Goal of the Proposal
Extend standardization of the informed consent process to living donor liver, lung, pancreas and intestine programs
How the Proposal will Achieve its Goal
• 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)
Background
Overall Project Impact
Type Total Support Support as
Amended
Opposed No vote/ No
comment/Did not
considerCommittee 19 7 0 0 12
Regional 11 9 (81.8%)
2 (18.2%)
0 0
Individual 31 23 (74.2%)
0 2 (6.4%)
6 (19.4%)
Public Comment Results (3/13/14 – 6/13/14)
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
Post Public Comment Considerations
Post Public Comment ConsiderationsReasons for Committee decision: SUMMARY1. VCA not considered in policy development/public comment
2. Elements of policy are inaccurate/false for living VCA donors
3. Different types of living donor VCA will require different consent elements, none of which have received deliberation
4. It took years to implement consent policies for kidney donors despite large donation volume; no clear emergent problem for VCA requiring action without deliberation
5. 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
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
Resolution 18
• 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)
Additional Background
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
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
Proposal Summary
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)
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
Public Comment Results
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.
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
Public Comment Results: Individual
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
Post Public Comment Considerations
Timeline
3/13/14 – 6/13/14 Public comment
9/8/14 Committee hears presentation from VCA Committee Chair and finalizes proposal
Late 8/14 Committee receives clarification that VCA policies include living donors
1/14 Committee completes work on proposal (inception 8/12)
Late 6/14 Board approves VCA policies
Early 9/14 Committee Leadership is asked to extend proposal to include VCA donors
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.
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
a) by the JSWG during development of their policy recommendations,
b) by the Committee during policy development, or c) during public comment
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
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. .
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.
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.
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
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
Post Public Comment Considerations
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
Resolution 18