# Meaningful Outcomes and Multi-Site Readiness for Clinical Trials in Juvenile Neuronal Ceroid Lipofuscinosis

> **NIH NIH U01** · UNIVERSITY OF ROCHESTER · 2020 · $153,983

## Abstract

PROJECT SUMMARY
Sharing research findings with research participants has long been considered an ethical imperative, in part as
a reflection of respect for persons. Results are typically shared in aggregate, in the form of a published
manuscript, lay summary, or letter from investigators. Increasingly, the research community has turned its
attention to return of individual-level research results (‘individual results’) – a specific research participant’s
own research data, not merely aggregate results.
The overarching objective of this supplement project is to identify preferences, perceived risks and benefits,
challenges, and obstacles related to returning individual results among multiple stakeholder groups including:
caregivers, clinical researchers, clinicians, and sponsors. We will: 1) ascertain stakeholder perspectives on
return of individual results through qualitative interviews and 2) evaluate and expand our understanding of
themes identified in Aim 1, using surveys in independent samples representative of the identified stakeholder
groups. The proposed research activities complement the activities of the parent award and will enable
preparation for future return of individual results in the parent study.

## Key facts

- **NIH application ID:** 10154499
- **Project number:** 3U01NS101946-02S1
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Erika Augustine
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $153,983
- **Award type:** 3
- **Project period:** 2020-07-01 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10154499

## Citation

> US National Institutes of Health, RePORTER application 10154499, Meaningful Outcomes and Multi-Site Readiness for Clinical Trials in Juvenile Neuronal Ceroid Lipofuscinosis (3U01NS101946-02S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10154499. Licensed CC0.

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