# HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics Supplement

> **NIH NIH U24** · DUKE UNIVERSITY · 2021 · $191,152

## Abstract

PROJECT SUMMARY/ABSTRACT
Numerous arguments have been advanced for the broad sharing of deidentified, participant-
level clinical trial data. However, data sharing in the context of pragmatic clinical trials (PCTs)
presents particular challenges. For example, prior debates about data sharing have largely
focused on risks for individual research participants, yet sharing data from PCTs can also carry
risks for health systems and for the clinicians within them—clinicians who may not have made a
proactive decision to participate in the PCT, and who, in some cases, may be research subjects
themselves. Furthermore, many PCTs are conducted with a waiver or alteration of informed
consent, limiting the ability to align sharing decisions with the values and preferences of those
individuals about whom information will be shared.
Funders of PCTs, including the NIH HCS Collaboratory, NIH HEAL Initiative and the Patient-
Centered Outcomes Research Institute, have recently developed policies and related
resources to encourage data sharing.Yet how such policies are being implemented within
individual PCTs, and the implications of these policies for the likelihood that PCT data will, in
fact, be reused, remains poorly understood.
The proposed research will develop empirically grounded evidence to support the responsible
sharing of PCT data. In Aim 1, we will develop a conceptual model of the specific features of the
PCT context that may influence the risk-benefit calculus for data sharing. This model will inform
our Aim 2 work, which will explore the trade-offs presenting by data sharing in PCTs, as
understood by those responsible for the oversight, creation, and future use of PCT data. In Aim
3, we will use a virtual conference with an expert advisory panel to evaluate the extent to which
existing and proposed policies to promote data sharing are responsive to PCT-specific
considerations. The contribution of this research will be significant because it will lay the
essential groundwork for effective guidance regarding sharing of PCT data. This groundwork will
advance the NIH Health Care Systems Research Collaboratory’s commitment to developing
best practices for PCTs so as to maximize the National Institute of Health’s investments in
embedded health research, and, ultimately to accelerate the pace of learning throughout the
nation’s healthcare system.

## Key facts

- **NIH application ID:** 10364578
- **Project number:** 3U24AT010961-01S1
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** LESLEY H CURTIS
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $191,152
- **Award type:** 3
- **Project period:** 2019-09-28 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10364578

## Citation

> US National Institutes of Health, RePORTER application 10364578, HEAL Collaboratory Resource Coordinating Center (PRISM) (U24): Bioethics Supplement (3U24AT010961-01S1). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/10364578. Licensed CC0.

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