The following guidance has been produced to bring clarity to the issues surrounding consent under the Human Tissue Act 2004 for research relating to transplantation where donors are deceased. It applies in England, Wales and Northern Ireland, and is not affected by the Human Transplantation (Wales) Act 2013.
The guidance does not cover the licensing requirements of the relevant legislation, which are also considerations for those contemplating research using material from deceased donors. Licensing requirements are covered on our website and those needing clarification are encouraged to contact us.
Where any relevant material, which includes organs, is to be removed from deceased donors for the primary purpose of research within the scope of the Human Tissue Act 2004, appropriate consent for the removal, use and storage of the material for research is a legal requirement. ‘Appropriate consent’ means either the consent of the person concerned, their ‘nominated representative’ or (in the absence of either of these) that of a person in a qualifying relationship to them immediately before they died. Appropriate consent for research must also be in place where an organ, intended for transplantation but which cannot be subsequently used for transplantation, is used for research purposes. This requirement for appropriate consent is also true for other tissue, including that which is surplus to other, ‘non-research’ purposes, such as diagnosis.
Appropriate consent, as described above, is also required where organs are to be removed from the deceased for transplantation. Consent for this is typically given by the person while they are alive (via the NHS Organ Donation Register) or by a suitable relative after the person has died.
As part of the transplant process, transplant professionals might wish to evaluate new approaches which could improve the chances of a transplant being successful or improve the quality of the lives of the recipients of transplanted material. This might include doing something with or to an organ before it is implanted or involve the recipient before and /or after the organ has been implanted. These types of interventions, occurring in conjunction with clinical treatment, will always be subject to approvals within the NHS, including review by a Research Ethics Committee. The consent of the recipient, to participate in the research, must also be obtained. Consent for these research interventions, occurring as part of clinical treatment, are outside the scope of the Human Tissue Act 2004.
In some cases, the identity of the recipient may not be known at the time a pre-implantation intervention is made. If so, consent to the transplantation and any intervention occurring in conjunction with the clinical treatment may be obtained from the recipient after the initial intervention but ahead of implantation. As set out in existing guidelines, consent to participate in research occurring in conjunction with the therapeutic process of transplantation can first be sought from a potential recipient at the time they are accepted to the National Transplant List. The guidelines also recommend that consent is re-affirmed at least every 12 months where possible and immediately prior to the transplantation. If consent is not obtained from the recipient for a pre-implantation intervention, the organ which has been subject to an intervention cannot be transplanted into that recipient. The guidelines also recommend that giving information about possible research projects and seeking consent for participation in approved studies is done only after consent for transplantation has been sought so that there is no potential for the recipient to feel any degree of coercion to consent to participation in research.
The donor’s consent to the research is not required where approved research interventions occur in conjunction with the transplant process, even if those interventions occur prior to the removal of the organ. Appropriate consent has already been obtained from the donor (or suitable representative) for the removal of organs for transplantation, the purpose for which their organ will be removed and used. To ensure fully informed consent, the HTA advises that consent for transplantation is sought on the understanding that, as in other areas of clinical care, health professionals might be involved in undertaking approved research to improve the outcome of the transplantation.
As set out in the paragraph under ‘Research’, where organs removed for transplantation cannot subsequently be implanted, they can be instead be used for research provided that appropriate consent is in place for that research.