{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T06:39:52Z","timestamp":1791614392383,"version":"4.3.4"},"reference-count":78,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2022,10,31]],"date-time":"2022-10-31T00:00:00Z","timestamp":1667174400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"publisher","award":["108413\/A\/15\/D"],"award-info":[{"award-number":["108413\/A\/15\/D"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Ethics &amp; Human Research"],"published-print":{"date-parts":[[2022,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1002\/eahr.500146","type":"journal-article","created":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T01:25:35Z","timestamp":1667265935000},"page":"2-13","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Ethical Frameworks for Disclosure of Alzheimer Disease Biomarkers to Research Participants: Conflicting Norms and a Nuanced Policy"],"prefix":"10.1002","volume":"44","author":[{"given":"Eline M.","family":"Bunnik","sequence":"first","affiliation":[{"name":"Associate professor at the Erasmus University Medical Center in the Department of Medical Ethics, Philosophy and History of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marthe","family":"Smedinga","sequence":"additional","affiliation":[{"name":"Scientific secretary for the subcommittee on ethics and societal aspects at the Netherlands Commission on Genetic Modification"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Milne","sequence":"additional","affiliation":[{"name":"Sociologist of science, technology, and medicine, the head of research and dialogue at Wellcome Connecting Science, and the deputy director of the Kavli Centre for Ethics, Science, and the Public at the University of Cambridge"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Georges","sequence":"additional","affiliation":[{"name":"Executive director of Alzheimer Europe"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edo","family":"Richard","sequence":"additional","affiliation":[{"name":"Professor of neurology at Amsterdam University Medical Centre and a neurologist at the Department of Neurology at the Donders Institute for Brain, Cognition and Behaviour at Radboud University Medical Centre"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maartje H. N.","family":"Schermer","sequence":"additional","affiliation":[{"name":"Professor of philosophy of medicine at the Erasmus University Medical Center in the Department of Ethics, Philosophy and History of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,10,31]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-016-0481-z"},{"issue":"2","key":"e_1_2_6_3_1","first-page":"68","article-title":"Registries and Cohorts to Accelerate Early Phase Alzheimer's Trials. A Report from the E.U.\/U.S. Clinical Trials in Alzheimer's Disease Task Force","volume":"3","author":"Aisen P.","year":"2016","journal-title":"Journal of Prevention of Alzheimer's Disease"},{"issue":"4","key":"e_1_2_6_4_1","first-page":"185","article-title":"Global Alzheimer's Platform Trial Ready Cohorts for the Prevention of Alzheimer's Dementia","volume":"3","author":"Sperling R.","year":"2016","journal-title":"Journal of Prevention of Alzheimer's Disease"},{"issue":"12","key":"e_1_2_6_5_1","doi-asserted-by":"crossref","first-page":"e021017","DOI":"10.1136\/bmjopen-2017-021017","article-title":"European Prevention of Alzheimer's Dementia Longitudinal Cohort Study (EPAD LCS): Study Protocol","volume":"8","author":"Solomon A.","year":"2019","journal-title":"BMJ 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Adults\u2019 Reactions.\u201d"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2014.05.016"},{"key":"e_1_2_6_22_1","unstructured":"Declaration of Helsinki World Medical Association October2000 https:\/\/www.wma.net\/policies-post\/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects\/."},{"key":"e_1_2_6_23_1","volume-title":"Returning Individual Research Results to Participants: Guidance for a New Research Paradigm","author":"National Academies of Sciences, Engineering, and Medicine","year":"2018"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.tig.2010.11.004"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-genom-091212-153506"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41431-018-0311-3"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrg3960"},{"key":"e_1_2_6_28_1","unstructured":"Lewczuk P. et al. \u201cCerebrospinal Fluid and Blood Biomarkers for Neurodegenerative Dementias: An Update of the Consensus of the Task Force on Biological Markers in Psychiatry of the World Federation of Societies of Biological Psychiatry \u201dWorld Journal of Biological Psychiatry?19 no. 4 (2018): 244-328 at 277."},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1093\/geront\/gnaa113"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2012.09.014"},{"key":"e_1_2_6_31_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-016-0212-z"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1002\/dad2.12150"},{"key":"e_1_2_6_33_1","unstructured":"Largentet al. \u201cCognitively Unimpaired Adults\u2019 Reactions.\u201d"},{"key":"e_1_2_6_34_1","doi-asserted-by":"publisher","DOI":"10.1111\/1467-9566.12731"},{"key":"e_1_2_6_35_1","unstructured":"Lewczuket al. \u201cCerebrospinal Fluid and Blood 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L.","year":"2008"},{"key":"e_1_2_6_44_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12910-020-0446-y"},{"key":"e_1_2_6_45_1","unstructured":"Council of Europe \u201cConvention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine \u201d ETS No. 164. article 10.2 1997 https:\/\/www.coe.int\/en\/web\/conventions\/full-list?module=treaty-detail&treatynum=164."},{"key":"e_1_2_6_46_1","volume-title":"European Union","author":"General Data Protection Regulation (GDPR)","year":"2018"},{"key":"e_1_2_6_47_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40246-018-0139-5"},{"key":"e_1_2_6_48_1","unstructured":"Schickhardt Fleischer andWinkler \u201cDo Patients and Research Subjects Have a Right to Receive Their Genomic Raw Data?\u201d"},{"key":"e_1_2_6_49_1","unstructured":"National Academies of Sciences Engineering and Medicine Returning Individual Research Results to Participants."},{"key":"e_1_2_6_50_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-190589"},{"key":"e_1_2_6_51_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-190725"},{"key":"e_1_2_6_52_1","unstructured":"Ericksonet al. \u201cDisclosure of Preclinical Alzheimer's Disease Biomarker Results.\u201d"},{"key":"e_1_2_6_53_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13073-021-00928-5"},{"key":"e_1_2_6_54_1","doi-asserted-by":"publisher","DOI":"10.1089\/bio.2015.0115"},{"key":"e_1_2_6_55_1","unstructured":"National Academies of Sciences Engineering and Medicine Returning Individual Research Results to Participants 73\u201374."},{"key":"e_1_2_6_56_1","unstructured":"Milneet al. \u201cPerspectives on Communicating Biomarker\u2010Based Assessments.\u201d"},{"key":"e_1_2_6_57_1","volume-title":"The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research","author":"National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research","year":"1979"},{"key":"e_1_2_6_58_1","unstructured":"Ibid. 5."},{"key":"e_1_2_6_59_1","unstructured":"Ibid. 11."},{"key":"e_1_2_6_60_1","doi-asserted-by":"publisher","DOI":"10.56759\/rgxl7405"},{"key":"e_1_2_6_61_1","unstructured":"Lewczuket al. \u201cCerebrospinal Fluid and Blood Biomarkers.\u201d"},{"key":"e_1_2_6_62_1","doi-asserted-by":"publisher","DOI":"10.2217\/nmt.13.25"},{"key":"e_1_2_6_63_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001451"},{"key":"e_1_2_6_64_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jalz.2016.01.009"},{"key":"e_1_2_6_65_1","unstructured":"Ibid."},{"key":"e_1_2_6_66_1","unstructured":"Ibid."},{"key":"e_1_2_6_67_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-015-0112-7"},{"key":"e_1_2_6_68_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.trci.2018.04.002"},{"key":"e_1_2_6_69_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2017.2954"},{"key":"e_1_2_6_70_1","unstructured":"Mozerskyet al. \u201cComprehension of an Elevated Amyloid Positron Emission Tomography Biomarker.\u201d"},{"key":"e_1_2_6_71_1","unstructured":"Harkinset al. \u201cDevelopment of a Process to Disclose Amyloid Imaging Results.\u201d"},{"key":"e_1_2_6_72_1","unstructured":"Ibid."},{"key":"e_1_2_6_73_1","unstructured":"Milneet al. \u201cPerspectives on Communicating Biomarker\u2010Based Assessments.\u201d"},{"key":"e_1_2_6_74_1","unstructured":"Harkinset al. \u201cDevelopment of a Process to Disclose Amyloid Imaging Results.\u201d"},{"key":"e_1_2_6_75_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0809578"},{"key":"e_1_2_6_76_1","unstructured":"Harkinset al. \u201cDevelopment of a Process to Disclose Amyloid Imaging Results.\u201d"},{"key":"e_1_2_6_77_1","unstructured":"Milneet al. \u201cPerspectives on Communicating Biomarker\u2010Based Assessments.\u201d"},{"key":"e_1_2_6_78_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.052297"},{"key":"e_1_2_6_79_1","unstructured":"Ericksonet al. \u201cDisclosure of Preclinical Alzheimer's Disease Biomarker Results.\u201d"}],"container-title":["Ethics &amp; 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