Transcript informed consent

Proposal to Modify Existing or
Establish New Requirements for the
Informed Consent of Living Donors
(Resolution 18)
Living Donor Committee
Mary Amanda Dew, PhD
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
Strategic Plan
#5- Promote Living
Donor Safety
• Ensure that all living
organ donors consent
freely
• Maintain effective
standards for the
consent of living
donors
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
How the Proposal will Achieve its Goal

Extend standardization of the informed
consent process to living donor liver, lung,
pancreas and intestine programs
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)
Overall Project Impact
Product
Policy
Target
Population
Impact:
Living Donors
Total IT
Implementation
Hours
0/10,680
Total Overall
Implementation
Hours
20/17,885
Public Comment Results (3/13/14 – 6/13/14)
Type
Total
Support
Support Opposed No vote/
as
No
Amended
comment/
Did not
consider
0
0
12
Committee
19
7
Regional
11
9
(81.8%)
2
(18.2%)
0
0
Individual
31
23
(74.2%)
0
2
(6.4%)
6
(19.4%)
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
Post Public Comment Considerations
Reasons for Committee decision: SUMMARY
1. 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
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
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)
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
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
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: centerspecific 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: 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.
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
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
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
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.
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) multivisceral 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
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