Authors: Maria Stuifbergen, Lars Ursin
Paper: The Ethics of dead participants: policy recommendations for biobank research
Have you ever been operated at a hospital, donated blood, or participated in a health survey? Then you might have agreed to let health information and tissue samples from you be stored in a research biobank. You gave your consent for researchers to use your material now and in the future: but what was the expiry date of your consent? Is it a lifelong commitment, or maybe eternal?
Health information and stored tissue samples in biobanks are extremely valuable for research into causes of illness and, ultimately, death. The usual conditions for valid consent in medical research include adequate information regarding the aims, methods, benefits and harms. Participation in research is voluntary, and consent can be withdrawn at any time.
Biobanks are in general a resource for unknown future research projects. Consequently, to provide full disclosure of the aims, methods and possible consequences of these projects is impossible. Biobanks therefore often operate with a so-called “broad consent”. Biobank participants typically consent broadly to take part in future research without knowing exactly what this research will consist in and entail.
An important part of the biobank consent contract is that procedural standards will be followed, such as approval of future research projects by data access and research ethics committees. The biobank should also provide the participants with updates on the projects using the biobank resource. This on-going audit and information legitimize the contract between the biobank institution and the participants.
When the use of the biobank resource is significantly altered, beyond what is deemed to be within the scope of the original consent, participants should renew their consent. This might for instance happen with the introduction of new research methods like genetic analyses, or changes in the access to the biobank resource, such as data sharing with institutions abroad or commercial companies.
Now, as participants age, so do biobanks. However, as participants die, biobanks most often just live on. As there usually is no expiry date for the validity of the consent, dead participants will still very much continue to be research participants. Is this a problem? In The ethics of dead participants, we discuss this question, and suggest how biobank policies should deal with the situation.
In our paper, we identify and discuss two problematic aspects of the continued participation of the dead: Firstly, when participants die, continued information to the participant as part of the conditions of broad consent can no longer be given. Secondly, it is no longer possible for the participant to withdraw from the biobank.
A way to solve this problem with ease is to say that this is unproblematic, as the point of consent is to shield participants from harm, and after death, no one can be harmed anymore. In our paper, we discuss complications of this easy solution. We argue that death does not seem to put an end to our continued interests as research participants. Therefore, it matters how we treat deceased participants’ materials, and whether that is in line with their consent.
In the course of time, and with changing research scopes and methods, continued use of deceased participants’ biobank materials may go against the interests of dead biobank participant. This has to be acknowledged and accommodated for in biobank policies. On the other hand, these policies have to balance the interests of dead participants against the considerable scientific potential of health information and tissue samples from and about the deceased.
Based on our discussion in the paper, our policy recommendation for biobanks is that the interests of participants in biobank research are best served by asking at enrolment if and how the biobank material may be used after death. We argue that the default option should be that the use of biobank material from deceased participants should be delimited both by their consent and by the prevailing broad consent choices of living participants.
We further state that biobanks need to inform participants at enrolment about the duration of storage of biobank material, or at minimum have procedures for deciding how long material will be stored for and for which purpose. For older collections, in the absence of such information or consent options, relevant authorities should decide. In this way, even eternal participation can be eternally justified.
Maria Stuifbergen, HUNT Research Centre, Department of Public Health and Nursing, NTNU, Trondheim, Norway
Lars Ursin, Department of Public Health and Nursing, Department of Philosophy and Religious Studies, NTNU