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Ethical guidelines for organ transplantation from deceased donors submission

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Submission - Option 1. Online submission
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This draft document appears to be a framework encompassing the ethical principles around decision making for a) the listing of patients for deceased donor organs and b) the allocation of deceased donor organs as well as vascularised composite tissue allografts. Hence there is an emphasis throughout the document on the ethics pertaining to transplantation in the absence as stated apriori of the ethics pertaining to deceased donor organ donation.

It appears that the target audience is anyone with an interest and/or involvement with the transplantation of solid organs and/or composite vascularised tissue in the health care sector as the content of the guidelines seem to be pitched at professionals and not to members of the community. If these guidelines are intended for a community audience then it is unlikely that anyone who has not attained at least a level of high school English will be able to comprehend them. This is a health literacy issue as per the Australian Commission on Safety and Quality in Healthcare report-http://www.safetyandquality.gov.au/wp-content/uploads/2014/08/Health-Literacy-Taking-action-to-improve-safety-and-quality.pdf As it is not stipulated within the ethical guidelines document as to what levels of the health service are actually being targeted by these guidelines, the question then arises ‘Is it the members of the transplant teams’?


The concept of higher risk organs is introduced (page 7) although it is noted that there is little in the way of specific information on what higher risk donor organs actually represents.  This includes for example of no specific mention being made of organs from donation after circulatory death (DCD) donors within this section (although DCD is mentioned in Section 1.4). In addition there are no supporting references from the recent scientific literature or recently published guidelines as evidence of a systematic review having been undertaken for this topic. Additional references would provide support for the information contained in this particular section of the document. If the supporting scientific evidence is to be subsequently addressed in the new TSANZ Clinical Protocols then perhaps this needs to be made clearer.

When it comes to Section 1.4 ‘How is the process monitored?’ ( page 8), it is noted that there is a heavy emphasis on both data collection and data reporting but that there is no mention of any of the other governance processes or of the governance framework that are currently in place. This includes the various oversight mechanisms which contribute to the governance system for both organ donation and transplantation in Australia. At the very least this information or links to this particular information needs to be placed in the Appendices.


When it comes to the clinical cases that are used to illustrate the principles of Ethical decision-making in the context of transplantation in Section 3.2, it is noted that there are some other possible clinical scenarios which could also be mentioned. The use of bridging technology e.g. Left ventricular assistance devices for heart failure is one example, along with the at times the critical size matching issue which may need to occur between donor and recipient.

On page 19 in the first paragraph of the section under the title ‘Use of higher risk criteria organs’ the introductory statement is made that ‘Decisions about the suitability of organs for transplantation should be based on established criteria’ In an ideal world this is of course what should always happen in practice. However there will be times where there is clinical uncertainty pertaining to the use of organs for e.g. from donors with either confirmed or possible genetic disorders, where the limited time frames that are available for the consideration of the organ offers will not allow for an exhaustive review of international experience (if it is able to be sourced at all), and hence judgements will and often need to be made. Perhaps there should be a statement about judgements needing to be made within the limited time frames often with limited information that pertain to deceased donor organ donation.

When it comes to Section 3.3’Ethical decision-making in innovative transplantation practice and research’ it is noted that the statements that have been made are not supported by any references to the relevant recent evidence when in fact they could be or more to the point ?must be. At the very least it would be expected that there should be some evidence of a systematic review of published references and guidelines to the ethics pertaining to novel and innovative therapies. For e.g. http://www.ncbi.nlm.nih.gov/pubmed/20420628 http://onlinelibrary.wiley.com/doi/10.1111/ajt.12939/abstract  http://www.ncbi.nlm.nih.gov/pubmed/21511086

There is the possibility that bionic type technology may in the not too distant future become an alternative pathway for some patients being considered for organ or vascularised composite tissue allograft transplantation for e.g. the bionic pancreas or the bionic hand http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61776-1/abstract

In addition pertaining to Section 3.3 there no mention of the other governance and oversight mechanisms in place pertaining to novel therapies that exist at the different levels in the healthcare system. For completeness some mention needs to again be made of this even if it is predominantly via referencing to information contained in the appendices.




Page reviewed: 8 April, 2016