PCORI Methodology Standards: Academic Curriculum Patient-Centered Outcomes Research Institute. All Rights Reserved.

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1 PCORI Methodology Standards: Academic Curriculum 2016 Patient-Centered Outcomes Research Institute. All Rights Reserved.

2 Module 7: Governance Category 7: Data Networks as Research-Facilitating Structures Prepared by Hadi Kharrazi, MD, PhD Dan Ford, MD, MPH Presented by Hadi Kharrazi, MD, PhD

3 Data Network Methodology Standards Mapping With Content DN-1 (requirements for the design and features of data networks) is discussed in Modules 3, 4, 5, 6, and 7 A. Data Integration Strategy Module 4 B. Risk Assessment Strategy Module 6 C. Identity Management and Authentication of Individual Researchers Module 6 D. Intellectual Property Policies Module 7 E. Standardized Terminology Encoding of Data Content Module 4 F. Metadata Annotation of Data Content Module 4 G. Common Data Model Module 5 DN-2 (selection and use of data networks) is discussed in Modules 8 and 9 4

4 Terms and Concepts Secondary use use of patient or participant data for research purposes Collaborative/distributed data networks multiple institutions sharing research data or using research data located in different systems or locations Governance artifacts policies, structure, best practices, or guidelines about governance, data stewardship, or decision making. 4

5 Governance Models/Structures: Data Sharing Data including raw data and metadata from publicly funded research should be made available to other researchers at the time the paper is published. Such data should be made available consistent with the applicable law and the other data governance policies described in these guidelines. Different distributed data networks have different guidelines and best practices about raw data sharing. For some, it is a requirement, while for others data ultimately resides at the local level Data sharing contributes to patient-centeredness by reducing respondent burden by allowing re-use of data to conduct important research. More at: Accessed August 27,

6 Governance Models/Structures: Agreements Specific consent for data sharing with informed consent for research: Consent for data sharing involving identifiable or potentially identifiable personal health information, including genomic data, should be obtained in compliance with state and federal law and IRB requirements. Network, trust, business associate agreements: A network agreement should be developed in order to clearly state expectations and commitments of member institutions and streamline the contracting process so that n-squared bilateral agreements are avoided. Data use agreement (DUA): specify the use of datasets that contain identifiable health information or qualify as a HIPAA-defined limited data set should be signed by all user organizations. Accessed August 27,

7 Governance Models/Structures: Organization and Committees Governing body: A legal entity with a governing body should be designated or established so that there is a clear authority to enforce contracts/agreements and make ethical decisions. This entity should be separate from the research institutions and core operations of the network so that there is a system of checks and balances. Data access committees: should be created to manage access to and uses of all data contributed to a research network and the members. The bylaws should be publicly available. Stakeholder engagement: Stakeholders, including the public, communities, researchers, network organizations, commercial and corporate organizations, academic, and government institutions, should be included in decision making regarding relevant aspects of the network or consortium. Accessed August 27,

8 Governance Models/Structures: Organization and Committees Centralized coordinating center: A centralized coordinating center provides the administrative infrastructure to operate the research network. A coordinating center is not a replacement for a governing body. Other committees and workgroups for operational performance: The need for committees and workgroups will vary depending on the research network purpose and stakeholders. While retaining flexibility, networks should ensure committees and workgroups are created for critical functions to ensure inclusion of input and collaboration among network participants and stakeholders. These committees and workgroups should not be considered a replacement for governing board or coordinating center. Accessed August 27,

9 Governance Models/Structures: Organization and Committees Examples: SCANNER's workgroups are organized to develop requirements for the network and implement the functions: architecture, policy, and comparative effectiveness research. emerge consists of four main working groups, which focus on different network goals: (1) Genomics, (2) Informatics, (3) Consent & Community Consultation Working Group, and (4) Return of Results Oversight Committee. Mini-Sentinel uses Cores (workgroups) to develop guidelines for Data, Methods, and Protocol. DARTNet has four core work groups that execute the day-to-day operations of the network: Administrative Core, Technical Core, Research Core, and Practice Network Core. Accessed August 27,

10 Intellectual Property Policy A research network should develop policies for handling and dissemination of intellectual property (IP) Networks should also have an ongoing process for reviewing and refreshing those policies. IP can include data, research databases, papers, reports, patents, or products resulting from research using the network. Guidelines should balance (1) minimizing impediments to innovation in research processes, and (2) making the research widely accessible, particularly to the people who need them the most. IP policies dictate who owns what data or biosamples, as well as who owns the research based on these samples. Policies can contribute to patient centeredness by ensuring that innovative research results are shared accountably with those in need, as well as with those originally intended to be beneficiaries of the research results. Accessed August 27,