Beyond competence: advance directives in dementia research

Monash Bioeth. Rev. (2015) 33:167–180 DOI 10.1007/s40592-015-0034-y ORIGINAL ARTICLE Beyond competence: advance directives in dementia research Karin Rolanda Jongsma1 • Suzanne van de Vathorst1 Published online: 12 October 2015 Ó The Author(s) 2015. This article is published with open access at Springerlink.com Abstract Dementia is highly prevalent and incurable. The participation of dementia patients in clinical research is indispensable if we want to find an effective treatment for dementia. However, one of the primary challenges in dementia research is the patients’ gradual loss of the capacity to consent. Patients with dementia are characterized by the fact that, at an earlier stage of their life, they were able to give their consent to participation in research. Therefore, the phase when patients are still competent to decide offers a valuable opportunity to authorize research, by using an advance research directive (ARD). Yet, the use of ARDs as an authorization for research participation remains controversial. In this paper we discuss the role of autonomous decision-making and the protection of incompetent research subjects. We will show why ARDs are a morally defensible basis for the inclusion of this population in biomedical research and that the use of ARDs is compatible with the protection of incompetent research subjects. Keywords Dementia
Informed consent
Advance directives
Research ethics & Karin Rolanda Jongsma Suzanne van de Vathorst 1 Department of Medical Ethics and Philosophy of Medicine, Erasmus University Medical Centre Rotterdam, Office NA 21.17, PO box 2040, 3000 CA Rotterdam, The Netherlands 123 168 K. R. Jongsma, S. van de Vathorst 1 Introduction Imagine this typical, and unfortunately prevalent, case: Mr. Jansen has been suffering from dementia1 for the past 4 years. At the moment there is no cure for dementia and he will lose more and more of his mental capacities. While previously in his life he was able to make his own decisions, he is now at the point where he has lost the capacities needed to competently make decisions. His wife will now have to make decisions for him. One of the decisions she is facing is whether he will participate in a research trial that aims to develop new treatments for the cognitive decline due to dementia. The participation in clinical research of dementia patients like Mr. Jansen is essential for the development of more effective diagnostic instruments and therapeutic interventions for this condition (Downs 1997; Warner and Nomani 2008; Selkoe 1992). Even though the inclusion of dementia patients in research is necessary, it is also important that their participation is based on appropriate consent regimes. Patients with dementia face an increased risk of becoming incompetent to provide informed consent. In most countries, the legal possibilities for doing research with incapacitated research subjects are limited2 and require the consent of a legal representative (European Clinical Trials Directive 2001; Biomedicine Convention 1997). These measures also have clear downsides: they restrict the possibilities of doing research with dementia patients, are not based upon autonomous authorization of the research participant and decisions made by legal representatives do not necessarily conform to what the patients choose whilst still competent (e.g. Stocking et al. 2006). Consent by a legal representative has therefore been criticized for failing to represent the patient’s wishes (Shalowitz et al. 2006). Given the often slowly progressive nature of dementia, and the possibility of anticipating future incompetence, we suggest allowing dementia patients to anticipate future research participation by signing an advance research directive (ARD). In an ARD the dementia patient could describe his preferences concerning future research participation. ARDs are not yet commonly used in practice. In the United States, even though it is not a legal standard, the NIH allows dementia patients to use ARDs, but these seem to have a low rate of completion (Muthappan et al. 2005). In Europe, ARDs are not yet used in the context of research,3 but for many health-care decisions, such as organ 1 We have not specified due to which disease Mr. Jansen is suffering from dementia, because we aim to describe situations concerning cognitive decline, regardless of the underlying neurodegenerative disease. Dementia is a collective term, but is not a disease itself. When we write a dementia patient, we mean a person suffering from the symptoms of dementia due to an underlying illness, such as Alzheimer’s disease. 2 In Europe, most guidelines and legislation set additional protective rules for the inclusion of participants unable to consent, as consent of a legal representative is a necessary, but not sufficient condition. Additional requirements include a direct benefit to the research subject, or if that is not likely the study should not convey more than a minimal risk. These requirements are formulated to protect the vulnerable research participant. 3 Switzerland is a noteworthy exception, with Art. 24, para. 1 of the domestic law stipulating that ‘‘[r]esearch projects involving persons unable to consent which offers prospects of direct benefit to participants can be conducted if the following conditions are met: 1. the subjects have given their consent when they were still competent and the consent is evidenced by a document;.’’ in the law. 123 Beyond competence: advance directives in dementia research 169 donation and end-of-life decisions, advance directives are accepted and widely used. The use of advance directives in research remains, nevertheless, controversial, it is argued for example that legal representatives should make decisions based on the concept of ‘‘best-interest’’ and that an anticipated decision is neither free nor informed (Dresser 2001, 2014; Fagerlin and Schneider 2004). In this paper we address the following questions: (1) do ARDs provide a morally defensible basis for including incapacitated dementia patients in research trials, (2) are ARDs a better alternative to research authorization than consent by a legal representative? and (3) what are the problems raised by the use of ARDs in dementia research? We will argue that ARDs are a valuable authorization tool, provide a morally defensible basis for the inclusion of dementia patients in research, and are the better alternative to consent by a legal representative. Furthermore we will show that the remaining issues all have to do with protection during the trial and with withdrawal. Therefore we will start by discussing the moral aims of informed consent as the gold standard for research authorization, and then we explain the problems concerning the current practice of consent by a legal representative and describe why ARDs are a reasonable option for research authorization. Finally, we will discuss controversies for using ARDs, and investiga (...truncated)