Reconciling recommendations for ethical sharing of biomarker results with Alzheimer's disease research participants: A systematic review and qualitative synthesis

Abstract

Background

The shift toward a biological definition of Alzheimer's disease (AD) has led to increased use of biomarkers (e.g., amyloid, tau, APOE genotype) in research settings. As return of biomarker results becomes more common in AD research, understanding how participants perceive and make decisions about receiving individual research results is essential for ethical trial design and informed consent practices.

Objective

(1) To map and appraise the landscape of qualitative and mixed-methods research focused on perspectives of AD research community members related to biomarker result sharing in AD research settings; and (2) to synthesize findings on decisional needs of research participants considering whether to receive individual biomarker or genetic risk information.

Methods

We searched PubMed and EMBASE for qualitative and mixed-methods studies published between January 2012 and January 2025. Eligibility criteria included empirical studies reporting qualitative data on experiences, attitudes, or decision-making processes related to receiving AD biomarker or genetic results in research contexts.

Results

Of 3269 records screened, 42 records were assessed for eligibility and 8 met inclusion criteria and were included in our final analysis. Participants emphasized empowerment through research participation and desire for knowledge related to research results. Across studies, decisional needs, characterized as “aspects of decision-making” clustered around four domains: (1) clarity of biomarker meaning and limitations, (2) emotional readiness and support, (3) social consequences of disclosure, and (4) alignment with personal values and future planning.

Conclusions

Findings can inform the development of ethically grounded protocols for returning individual research results in preclinical AD trials.