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

NIH RePORTER · NIH · U01 · $153,983 · view on reporter.nih.gov ↗

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
UNIVERSITY OF ROCHESTER
Principal Investigator
Erika Augustine
Activity code
U01
Funding institute
NIH
Fiscal year
2020
Award amount
$153,983
Award type
3
Project period
2020-07-01 → 2021-06-30