# Returning Research Results that Indicate Risk of Alzheimer Disease to Healthy Participants in Longitudinal Studies

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2020 · $711,131

## Abstract

Project Summary
This project will determine the impact of returning research results that indicate 5-year risk of developing
Alzheimer Disease (AD) to healthy older adults enrolled in a longitudinal cohort of aging. Returning research
results that indicate risk of AD is controversial for ethical and scientific reasons. Ethical concerns relate to the
potential harms of informing individuals their risk of a highly feared untreatable disease. Scientific concerns
relate to the potential change in cognitive test results due to knowing one’s risk of AD, potentially
compromising the scientific integrity of research studies that follow cognitive outcomes. However, participants
in longitudinal studies of AD increasingly ask for their research results to understand their AD risk. Returning
research results to those who wish to receive them respects autonomy and recognizes participant contributions
to research. Evidence is needed to determine the impact of returning research results on psychosocial and
cognitive outcomes to responsibly design future studies in AD.
A randomized delayed-start clinical trial will evaluate the impact of returning research results to participants in
longitudinal studies of aging. All participants of a longitudinal cohort of aging will be offered the option to
receive research results from a recent PET amyloid scan, MRI, and APOE genotype, presented as a
synthesized 5-year risk of developing AD. All consenting participants will be randomized to either receiving
their research results within 2 weeks or after 1 year. Those who choose to receive results will be followed for
up to 24 months to determine the impact of receiving results on cognitive and psychosocial outcomes. Aim 1
will quantitatively and qualitatively explore the decision to receive results and reasons for declining or choosing
to receive results. Aim 2 will use quantitative and qualitative analyses to determine the effect of returning
research results on 1-year cognitive and psychosocial outcomes. Aim 3 will assess feasibility, acceptability,
and resource requirements of the return of results process and develop educational materials and a training
module for future implementation.
Laying the foundation for widespread return of research results, this is the first systematic and comprehensive
approach to returning research results in cognitively normal persons engaged in biomarker studies of AD.

## Key facts

- **NIH application ID:** 9860711
- **Project number:** 1R01AG065234-01
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Sarah Hartz
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $711,131
- **Award type:** 1
- **Project period:** 2020-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9860711

## Citation

> US National Institutes of Health, RePORTER application 9860711, Returning Research Results that Indicate Risk of Alzheimer Disease to Healthy Participants in Longitudinal Studies (1R01AG065234-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9860711. Licensed CC0.

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