Ethical Frameworks for Disclosure of Alzheimer Disease Biomarkers to Research Participants: Conflicting Norms and a Nuanced Policy

Eline M. Bunnik, Marthe Smedinga, Richard Milne, Jean Georges, Edo Richard, Maartje H.N. Schermer

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

More and more frequently, clinical trials for Alzheimer disease (AD) are targeting cognitively unimpaired individuals who are at increased risk of developing the disease. It is not always clear whether AD biomarker information should be disclosed to research participants: on the one hand, research participants may be interested in learning this information because of its perceived utility, but on the other hand, learning this information may be harmful, as there are very few effective preventive or therapeutic options available for AD. In this article, we bring together three separate sets of ethical guidance literature: on the return of individual research results, on an individual's right to access personal data, and on transparent enrollment into clinical trials. Based on these literatures, we suggest policies for the disclosure of AD biomarker test results in longitudinal observational cohort studies, clinical trials, and hybrid research projects, such as the European Prevention of Alzheimer's Dementia (EPAD) project, in which we served as an ethics team. We also present and critically discuss recommendations for disclosure of AD biomarkers in practice. We underscore that, as long as the clinical validity of AD biomarkers remains limited, there are good reasons to avoid actively disclosing them to cognitively unimpaired research participants.

Original languageEnglish
Pages (from-to)2-13
Number of pages12
JournalEthics & human research
Volume44
Issue number6
DOIs
Publication statusPublished - Nov 2022

Bibliographical note

Funding Information:
In recent years, several large research projects have been set up to enroll and monitor cognitively unimpaired research participants who are at risk of developing AD. These projects include observational studies and registries, clinical trials, and hybrid projects, such as the Global Alzheimer's Platform (GAP) and the European Prevention of Alzheimer's Disease (EPAD) project. The GAP is a patientcentric network of over 90 clinical sites involved in AD research across Northern America aimed at reducing the time investment and costs of AD clinical trials, inter alia by “pre‐recruiting” research participants. Its aim is to gather a “trial‐ready” cohort of research participants who can be easily enrolled in preclinical or prodromal AD clinical trials. The EPAD project ran from 2016 to 2020 and was funded by the Innovative Medicines Initiative, and we were involved in this project as an ethics team, conducting qualitative and conceptual research and offering ethical guidance throughout the project. The EPAD project combined a longitudinal observational study with a planned platform for clinical trials aimed at accelerating drug development for the prevention of AD. In the past, AD clinical trials had faced several methodological and practical hurdles, including high screening‐failure rates and study lengths hindering recruitment and retention of research participants, as well as problems in relation to generalizability of study results. To address these issues, the EPAD project set up a multinational longitudinal cohort study spanning several European countries for the purposes of disease modelling and clinical trial recruitment. Participants with low and high risk of developing AD were recruited from existing population‐based and clinical cohorts across Europe and included 2 3 4 5 6 7

Funding Information:
This work was supported by the European Union‐European Federation of Pharmaceutical Industries and Associations Innovative Medicines Initiatives Joint Undertaking EPAD (115736) and AMYPAD (115952) projects. Milne's contribution was also supported by Wellcome Trust grant number 108413/A/15/D. This publication represents the views of the authors and not necessarily those of the entire consortium. We, the authors, would like to thank Craig Ritchie, Dianne Gove, Shirlene Badger, Jason Karlawish, and Carol Brayne for their contributions to our discussions on the ethics of disclosure.

Funding Information:
This work was supported by the European Union-European Federation of Pharmaceutical Industries and Associations Innovative Medicines Initiatives Joint Undertaking EPAD (115736) and AMYPAD (115952) projects. Milne's contribution was also supported by Wellcome Trust grant number 108413/A/15/D. This publication represents the views of the authors and not necessarily those of the entire consortium. We, the authors, would like to thank Craig Ritchie, Dianne Gove, Shirlene Badger, Jason Karlawish, and Carol Brayne for their contributions to our discussions on the ethics of disclosure.

Publisher Copyright:
© 2022 by The Hastings Center. All rights reserved.

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