Many healthy volunteers choose to take part in Alzheimer’s disease (AD) prevention studies because they want to know whether they will develop dementia—and what they can do to reduce their risk—and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD biomarkers, claiming that research participants will be able to use AD biomarker information for personal purposes, such as planning ahead or making important life decisions. In this paper, the claim that AD biomarkers have personal utility for asymptomatic individuals is critically assessed. It demonstrates that in the absence of clinical validity, AD biomarkers cannot have personal utility and do not serve research participants’ autonomy. Over the next few years, many research groups will be confronted with participants’ preferences to learn the results of AD biomarker tests. When researchers choose to make results available upon explicit request, they should ensure adequate information provision and education, notably on the uncertain clinical significance of AD biomarker information. Routine disclosure of AD biomarkers to cognitively unimpaired individuals in research settings cannot be justified with an appeal to the personal utility of AD biomarker information.
- clinical trials
- research ethics
- genetic screening/testing
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Contributors EMB and MHNS had originally developed the ideas underlying this paper. RM and ER contributed to the further development of these ideas. EMB drafted the manuscript. MHNS, RM and ER critically revised previous versions of the manuscript.
Funding This work was funded through the Ethical Legal and Social Implications work package of the European Prevention of Alzheimer’s Dementia (EPAD) study and the project ‘Early diagnosis of Alzheimer’s disease: conceptual considerations and ethical guidance’ which was funded through the Netherlands Organisation for Health Research and Development (ZonMw, project number 731010012). EPAD receives support from the Innovative Medicines Initiative Joint Undertaking under grant agreement number 115736, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies' in-kind contribution.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.