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[P4–331]: ARE MEMBERS OF UNDERREPRESENTED GROUPS REALLY LESS LIKELY TO PARTICIPATE IN BIOMARKER STUDIES REQUESTING BLOOD OR CSF ?
Author(s) -
Edwards Dorothy Farrar,
Dykema Jennifer
Publication year - 2017
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2017.06.2201
Subject(s) - ethnic group , medicine , demography , biomarker , gerontology , psychology , biology , biochemistry , sociology , anthropology
Background: The disclosure of results from genetic (e.g., APOE) and non-genetic (e.g., amyloid or tau) biomarker testing for Alzheimer’s disease (AD) raise similar concerns regarding discrimination and stigmatization. Legal and ethical models to guide the attainment and disclosure of such AD biomarker information are needed to inform best practices in both research and clinical settings.Methods:Data on legal standards were collected and analyzed in all 50 states and the District of Columbia using empirical legal methods proposed by Tremper et al. These methods implement a four-step process of gathering, organizing, interpreting, and applying legal sources to a research question: Do current legal standards provide protections against discrimination based on genetic or non-genetic biomarker status? Additionally, Federal legislation, regulations, and case law data were collected and analyzed to evaluate whether Federal standards would provide privacy or antidiscrimination protections. Results:Data collected in all 50 states reflect privacy or anti-discrimination protections specific to individuals who learn of genetic information. An analysis of this data, state by state, consistently revealed that genetic policies designed to provide privacy or anti-discrimination protections did so by applying a definition of genetic information. Amyloid and tau biomarkers are not, by definition, genetic information and not protected by genetic information policies. An additional analysis of state and federal law found that current legal standards do not provide protections to individuals who learn their non-biomarker information, with the potential exception of “preexisting condition” protections for health insurance within the Affordable Care Act (ACA). However, a review of recent proposals to repeal the ACAwould challenge these results. Conclusions:Legal and ethical issues that arise in disclosing non-genetic and genetic biomarkers must be evaluated separately. Current legal standards limit protections to individuals who learn of their genetic risk for conditions like AD. These protections do not extend to non-genetic biomarkers of disease, and this distinction should be clearly explaining to individuals who are contemplating the pursuit of biomarker testing for AD. Additionally, the potential repeal of the ACA may have dramatic consequences for disclosure of biomarker information, whether genetic or non-genetic in nature.