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Ethical guidelines for organ transplantation from deceased donors submission

Submission ID: 
10
This submission reflects the views of
Organisation Name: 
General Ethical Issues S-C of Alfred Hospital EC
Please identify the best term to describe the Organisation: 
HREC
Personal Details
Submission - Option 1. Online submission
Specific Comments: 
INTRODUCTION
  • The reason for developing these Guidelines is somewhat unclear in the Introduction.  Presumably the current Consensus statement on eligibility criteria and allocation protocols (the Consensus Statement) is clinically focussed and does not provide any, or clear, ethical guidance to inform decision-making and/or does not contain ethics-based reasons to support the existing criteria and protocols…?
  • The section ‘Scope of the Ethical Guidelines’ makes it clear that these Guidelines do not apply to the management of potential organ donors, but rather the selection and management of organ recipients.  The title of the document could make this clearer (e.g. Ethical guidelines for the allocation and transplantation of organs from deceased donors).
  • Mention could be made of how these Guidelines fit with those relating to the potential donor.
1.3 How are organs allocated?

Under the sub-heading ‘Urgent situations’, pancreas and lungs are excluded from urgent listings.  Although this may be reasonable in the case of pancreas transplants where potential recipients can usually be supported for some time with other therapies, there is no rationale or ethical reason to exclude lungs from the urgent listing process. Indeed this statement implies that there are different ethical principles applicable for each organ. A more generic statement should be used such as “Urgent listing should be available for any potential organ recipient who is otherwise suitable for transplantation but expected to die within a short time frame (e.g. 24-48 hours). A coordinated urgent listing process for national prioritisation of organ allocation exists for potential liver recipients. Similar processes should be used by other transplant groups.”

1.4 How is the process monitored?

[The following points are also relevant to Section 2.2.6 ‘The organisation and implementation of transplantation activities, as well as their clinical results, must be transparent and open to scrutiny, while ensuring that the personal anonymity of donors and recipients are always protected.’ And Section 3.2.2 ‘Organ allocation’, last sentence: “A process of audit and peer review of clinical decisions must therefore be in place.”]

  • There is considerable variability between sites with respect to donor organ referral practices, organ acceptance and utilisation rates. There is no standardised bench-marking process to measure these rates and how the efficiency of the organ donation and transplantation process and patient outcomes may be affected.  This should be included.
  • In addition the current monitoring and reporting processes should be expanded to include a national and regional review of organs not allocated.
3.1 Discussing transplantation
  • The first paragraph should include a statement about consent being able to be revoked at any stage if the potential recipient changes their mind.
  • Discussions about transplantation between a potential recipient (on the waiting list) and members of multi-disciplinary team should include discussion of wishes for end-of-life care if an organ doesn’t become available, and advance care planning should be offered to all patients being placed on the organ donation waiting list.  This should include consideration of which treatments should be offered as a bridge to transplantation.
  • Under the sub-heading: ‘Decision-making by potential recipients’, first sentence. The process of decision-making should ideally be conducted in consultation with the potential recipient/representative and the potential recipient’s partner, family and/or carer. This should be left up to the potential recipient and should not be mandated. However, the point could be made that the success of a transplant is greatly dependent on the recipient’s support network afterwards and it is therefore advisable for family etc. to be involved in the consent process.
3.2.2 Organ allocation
  • The last dot point in the list of criteria to be taken into account when considering potential recipients for a particular organ (‘the likelihood that the potential recipient will be able to adhere to the necessary ongoing treatment and health advice after transplantation’) should not be included in this list as it is not material to the allocation of a particular organ; it is relevant to who can be eligible for transplantation.  That is to say that once a potential recipient has been determined to meet the criteria for transplantation, including their capacity to adhere to post-transplantation treatment regimens, they should be considered for organ allocation on an equal footing to all others who have been deemed eligible for transplantation.
  • There could be more transparency around organ allocation decision-making than there currently is.  Decisions need to be conveyed in a way that the general public can understand. 
General Comments: 

Overall, the draft Guidelines do not substantially conflict with the current approach to organ transplantation decision making, or with what is generally considered good practice.  The Guidelines are not too specific, enabling broad principles to be applied.  Feedback from physicians involved in the field is that it is helpful to articulate the broad ethical principles in this way, that an ethical framework is particularly helpful for the time-critical decision-making process of organ allocation; and that the case examples are useful and illustrative.

Page reviewed: 8 April, 2016