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. 2021 Oct 14;7(1):e12213.
doi: 10.1002/trc2.12213. eCollection 2021.

Disclosure of individual research results at federally funded Alzheimer's Disease Research Centers

J Scott Roberts  1 , Rebecca Ferber  1 , Deborah Blacker  2   3 , Malia Rumbaugh  4 , Joshua D Grill  5   6   7 ; Advisory Group on Risk Evidence Education for Dementia (AGREED)
Affiliations

Disclosure of individual research results at federally funded Alzheimer's Disease Research Centers

J Scott Roberts et al. Alzheimers Dement (N Y). .

Abstract

Introduction: This study describes practices for disclosing individual research results to participants in Alzheimer's disease research.

Methods: An online survey of clinical core leaders at National Institutes of Health-funded Alzheimer's Disease Research Centers in the United States (response rate: 30/31, 97%) examined return of results practices across nine different types of research results.

Results: Most centers had returned consensus research diagnoses (83%) and neuropsychological test results (73%), with fewer having shared amyloid positron emission tomography (43%), tau imaging (10%), or apolipoprotein E (APOE) genotype (7%) results. Centers reported having disclosed a mean of 3.1 types of results (standard deviation = 2.1; range 0-8). The most commonly cited reason for disclosure was to inform participants' medical decision-making (88%). Disclosure involved multiple professionals and modalities, with neurologists (87%) and in-person visits (85%) most commonplace.

Discussion: Centers varied widely as to whether and how they disclosed research results. Diagnostic and cognitive test results were more commonly returned than genetic or biomarker results.

Keywords: biomarkers; genetic testing; research ethics; return of research results; risk communication.

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Conflict of interest statement

The authors report no financial conflicts of interest. Dr. Roberts has served as a paid advisory board member for the national Alzheimer's Clinical Trials Consortium and NIH‐funded research projects based at Indiana University (U01 AG057195), Washington University (R01AG065234), and Children's National Medical Center (R01 HD095068). He also serves in an unpaid role as co‐chair of the Michigan Dementia Coalition. Dr. Blacker and Ms. Rumbaugh serve in unpaid roles as co‐chairs of the Asymptomatic Subcommittee of the Advisory Group on Risk Evidence Education for Dementia. Dr. Grill has served in an unpaid role on an advisory board convened by the National Institute on Aging. Ms. Ferber reports no relevant disclosures. Dr. Blacker has received consulting fees for legal consultation from Saul Ewing Arnstein & Lehr, LLP, and the estate of Barbara Bartle; and for epidemiology forecasting from Biogen (2015‐18). Dr. Grill has received consulting fees from SiteRx, Flint Rehab, and Cogniciti. Dr. Roberts has received payment from the National Institutes of Health for scientific review activities.

Figures

FIGURE 1
FIGURE 1
Number of types of results disclosed by Alzheimer's Disease Research Centers (N = 30)
See this image and copyright information in PMC

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