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Neurology. 2014 Feb 25;82(8):725-9. doi: 10.1212/WNL.0000000000000153. Epub 2014 Jan 29.

Confidentiality in preclinical Alzheimer disease studies: when research and medical records meet.

Author information

1
From the Cleveland Clinic (J.J.A.), Center for Ethics, Humanities, and Spiritual Care, Department of Bioethics, Cleveland, OH; and University of Pennsylvania (J.K.), Perelman School of Medicine, Departments of Medicine and Medical Ethics and Health Policy, Alzheimer's Disease Core Center, Penn Neurodegenerative Disease Ethics and Policy Program, Philadelphia, PA.

Abstract

Clinical trials to advance the diagnosis and treatment of Alzheimer disease (AD) may expose research subjects to discrimination risks. An individual enrolled in a research study that uses positive test results from amyloid PET imaging or CSF measures of β-amyloid 42 as inclusion criteria has biomarkers indicative of AD pathology. If insurers and employers learn this information, it could expose subjects to discrimination. Unfortunately, current legal and regulatory mechanisms are not sufficient to protect against harms that have significant consequences for subjects. Existing law that prohibits employment and insurance discrimination based on genetic status does not apply to amyloid biomarkers or any other biomarkers for neurodegenerative diseases. Gaps in legal protections fail to protect research subjects from discrimination by long-term care and disability insurers. This risk is particularly concerning because individuals with AD dementia ultimately need long-term care services. To maximize subject protections and advance valuable research, policymakers, investigators, and research institutions must address shortcomings in the design of the electronic medical record, revise laws to limit discrimination, and develop practices that inform research participants of risks associated with loss of confidentiality.

PMID:
24477112
PMCID:
PMC3945659
DOI:
10.1212/WNL.0000000000000153
[Indexed for MEDLINE]
Free PMC Article

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