Disclosure or discourse? A critical examination of consent in research using surplus clinical tissue

Abstract

Patient tissue samples are a valuable resource for medical research, and can therefore be used to contribute to the well-being of people in the future. It is common when using tissue for research to seek the consent of the person it came from. Conventionally, this requires that they are given a description of the proposed research project so that they can make an informed decision about whether to consent to this use. However, advances in technology mean it is feasible to store tissue samples in good condition for long periods. Alongside this, research techniques are continually being developed, and research results are revealing new areas for investigation. Because of these factors, a sample collected today could conceivably be used throughout the next several decades, for multiple experiments, none of which might have been thought of when the patient's consent was first sought. If full disclosure of the proposed research is necessary to support this consent, then uncertainty over future use makes this difficult to achieve when the sample is first collected. I have described and evaluated the most prominent approaches to working around this difficulty with disclosure. Each of these approaches presents its own moral and practical difficulties, from undermining donor autonomy to placing excessive administrative burdens upon researchers. Nonetheless, the statutory requirements for consent to future unspecified use of surplus clinical tissue range across this spectrum of approaches to consent, potentially complicating international research collaborations. Publication of results, sharing research material, establishment of further collaborations, and funding of follow-up work could all be adversely affected if there are varying consent requirements in each of the jurisdictions where the work is being conducted. A more consistent approach to the ethics of research using human tissue is required. In order to develop such an approach, I have identified and discussed the ethical values that are most prominent when considering the use of surplus clinical tissue for future unspecified research. These values include support for the autonomy and dignity of individual donors, protection of their privacy, and respect for the concerns of minority groups within the wider community. I have also discussed the public good that can arise from this type of research, whether patients have a duty to contribute their tissue to research, and the role of consent in supporting these values. I conclude that it is possible to support the values that I have identified, and that the key to this support is communication between those who plan and conduct research, and the community as a whole. By using a discourse between the parties concerned to identify points of concern, a standard approach to using tissue for research can be negotiated. Individual patients should still be asked for a broad consent to use of their tissue in research, which will be supported by a disclosure of how projects will be approved and how their interests will be supported. They can then make an informed decision as to whether they wish to opt in to this system.