PCORI Open Science Pilot Project: Facilitating Data Sharing through - - PowerPoint PPT Presentation

ANNUAL MEETING

• OCT. 31-NOV. 2, 2017

ARLINGTON, VA

#PCORI2017

PCORI Open Science Pilot Project: Facilitating Data Sharing through Harmonized Governance Tools

Rebecca Li, Ph.D.

Senior Advisor, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Executive Director, Vivli November 1, 2017

ANNUAL MEETING | #PCORI2017

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Rebecca Li, Ph.D.

• Has nothing to disclose.

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• r png file)

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ANNUAL MEETING | #PCORI2017

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Objectives

• Summarize MRCT Center’s efforts and commitments to

data sharing and data transparency

• Outline MRCT Center’s involvement in PCORI Open Science

Pilot Project

• Role: to define and address key governance issues related to data

deposition in repositories and data sharing

• Review the 3 governance tools that MRCT Center will

develop as part of the PCORI Open Science Pilot Project

• Data Contributor Agreement Template (DCA)
• Data Use Agreement Template (DUA)
• Data Sharing Section of Informed Consent Form (ICF)

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ANNUAL MEETING | #PCORI2017

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MRCT Center Overview

• We engage diverse stakeholders to define emerging issues

in global clinical trials and to create and implement ethical, actionable, and practical solutions.

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Non profits Industry Patients and Patient Org Academia Gov’t Journal editors

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Our Focus Areas

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Global Regulatory Ethical Frameworks Data Transparency Training

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MRCT’s 3-Tiered Commitment to Data Transparency

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MRCT’s Past Data Sharing Efforts

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MRCT’s Role in Open Science Pilot Project

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• To deliver three harmonized governance tools (DUA,

DCA, ICF) that will be made publicly available for all PCORI grantees

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• To lower the barriers to data sharing while preserving

participant privacy and autonomy

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• To respect interests of data generators, data users,

funders, and patients/ participants through multi- stakeholder engagement

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Harmonized Governance Tools: High-Level Development Plan

RADCOMP team DCA, DUA, ICF CODA team DCA, DUA, ICF Other Pilot Project teams’ DCA, DUA, ICF MRCT DCA, DUA, ICF Template DCA Template DUA Template ICF Final DCA, DUA, and ICF Templates

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PCORI- assigned teams

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Harmonized Governance Tools: Communication and Iterative Development

• MRCT Center hosts bi-weekly calls with our assigned

Open Science Pilot Project teams (RADCOMP and CODA) to discuss considerations for the harmonized governance tools

• MRCT Center circulates finalized documents to larger

Open Science Pilot Project group for feedback as part

• f iterative review process

ANNUAL MEETING | #PCORI2017

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Progress to Date

• Governance Tools working group launched on September

11, 2017; regularly meets every 2 weeks

• Drafted and circulated considerations document for DCA, DUA, ICF
• Drafted and circulated Data Use Agreement v.1.0
• Initiated discussion toward DUA version 1.1
• Data Contributor Agreement v.1.0 in progress
• Initiated contact with patient advocacy representatives re: plain

language data sharing section of ICF

• Examples of governance considerations discussed to date:
• Whether requesters or institutions should be signee of DUA
• Publication, citation, and summary results requirements
• Commercial and litigious use of requested datasets
• Intellectual property, licensing, and ownership of datasets and

secondary analyses

• Obligations and responsibilities of data contributors, repositories, and

data requesters

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Considerations for DCA

• Agreement to deposition of data package elements to

repository

• Description of data deposition requirements
• PCORI-defined requirements, data format requirements, dataset

size/ number of records

• Description of repository’s hosting services and

responsibilities

• Description of data contributor responsibilities
• Anonymization/ de-identification requirements
• Statement re: data ownership
• Permission to host data for intended re-use; permission to

disseminate data for approved purposes

ANNUAL MEETING | #PCORI2017

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Considerations for DUA

• Definition of terms, parties, and relationship between parties
• Description of repository’s hosting services and responsibilities
• Description of requester’s responsibilities
• Use of dataset for proposed research only
• Commitment to not attempt to re-identify participants
• Agreement to not re-distribute to data to unapproved 3rd parties
• Expectations for data citation, publication, submission of

secondary analyses, and registration on ClinicalTrials.gov

• Communication plans
• Breach notification responsibilities and processes
• Liability provisions
• Duration of agreement and procedures for violation

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Considerations for ICF

• Aim to enable secondary use of collected data for open

science

• Explain “your” data, coded data, de-identified data, and

anonymized data

• Provisions to respect participant autonomy and privacy
• Minimal but non-zero risk of re-identification
• Minimal but non-zero risk of privacy breach
• Information that will be obtained/ is required by PCORI
• Opt-out provision for secondary use of collected data

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Questions?

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Learn more about MRCT Center’s Data Sharing efforts at

www.mrctcenter.org

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Thank You!

Rebecca Li, Ph.D.

Senior Advisor, the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard Executive Director, Vivli November 1, 2017