‘Research on donors or donor organs and tissues'
Introduction
Research in transplantation offers the potential to increase knowledge and further improve present standards and outcomes. Investigational procedures may require treatment of the donor prior to organ or tissue removal or can involve the treatment of organs or tissues after removal from the donor, either before or after implantation. This statement deals with research on the donor before organ or tissue removal and on the donated organ or tissue prior to and after implantation, but excludes research involving DNA or gametes, which are subject to separate statutory regulation by the HFEA.
Planning research
Any research protocol must have prior approval from the appropriate Research Ethics Committee.
There are three parties whose consent may be material to the conduct of the research: The donor in life, the donor family where the donor is deceased, and the recipient. The interests of all these parties, where appropriate, must be respected.
Where research is carried out after implantation into the recipient, the consent process need not involve the donor or donor family. Organs that are donated for transplantation are given unconditionally and once transplanted they become, in effect, part of the recipient. Hence consent for research after implantation is for the recipient alone to provide. The recognition of the interests of the donor in such research is vested in the REC scrutinising the research proposal.
Research before implantation
Living donor
Whether the research is carried out on the donor before organ or tissue removal, or on the donor tissue or organ after removal, consent must be sought from both the donor and recipient. Consent is necessary because the donor/donor tissue may be the subject of an investigational procedure whose benefit is unknown. Refusal to consent to take part in the research should not affect the donation, which may proceed as usual.
Deceased donor
True informed consent is not possible, though the donor may have indicated in life that research may be undertaken.
With research carried out on the donor before organ or tissue removal, assent must be sought from the donor family at the same time as seeking assent for organ donation itself, to establish lack of objection from the relatives. Assent is necessary because the donor may be the subject of an investigational procedure whose benefit is unknown. Refusal to give assent for the research should not affect the donation, which may proceed in the normal way. It is possible, however, that the request for assent to carry out research may affect the decision of the person being asked to assent to donation. This is a consequence that should be considered on an individual basis in the wider interests of advancing knowledge of transplantation.
With research on donor tissues or organs after removal but before implantation, it may not be practicable to obtain specific assent. For example, if research is taking place at another centre, but the allocation of the tissue or organ to this centre is as yet unknown. In this case, it is justifiable to rely on generic consent for research obtained with the usual assent for donation. Since it is always possible that a receiving centre will be undertaking research, generic assent should be sought as a matter of routine.
Research after implantation
The recipient has an interest in research carried out on any organ or tissue he or she is about to receive. Departments carrying out research in donors or donor tissues should give potential recipients as much notice as possible about the research, as would be expected for other clinical research activity. This may involve a generic statement for potential recipients, indicating that they may be invited to take part in the research and explaining their rights. It is advisable that such generic or specific information for patients about research has approval from the appropriate Research Ethics Committee.
True informed consent should also be sought where possible from the intended recipient where the donor organ or tissue is part of a research protocol. This raises a potential conflict, since on occasion the nature of the investigational procedure will be such that refusal of consent to take part in the research effectively means no transplant on that occasion, as the organ or tissue on offer will already be part of the research. This could be considered coercive, although the recipient still may choose whether or not to accept the transplant. Once again, this is an unintended consequence that should be considered in the wider context of advancing the knowledge of transplantation.
The practicalities may prevent each individual recipient giving true informed consent for each individual research project and this is acceptable in the light of the potential overall benefit of research. It is realised that because a potential recipient may not have been identified before the investigational procedure is carried out that they may not be able to object and hence be placed in the coercive position of agreeing the research or not receiving the transplant. It is therefore important that the research has been properly scrutinised by the relevant Research Ethics Committee
Conclusion
It is difficult to make provision for every possibility, and therefore the relevant Research Ethics Committee should consider the merits of each proposal. It is recommended that the relevant REC should seek advice from the appropriate transplant specialty, in particular to verify the evidence base for the proposed research and possible unwanted effects of the research procedure.
With these provisos, the Society supports properly conducted research on organ or tissue donors to improve transplantation outcomes, where appropriate consent or assent as outlined above has been obtained.
