Contents

• Acknowledgments
• Executive Summary
• Chapter 1. Introduction
  • 1. Background
  • 2. How This Toolkit Was Developed
  • 3. How To Use This Toolkit
• Chapter 2. Preparing To Share Data
  • 1. Rights to the Data
  • 2. Informed Consent
  • 3. Impact of HIPAA Rules
  • 4. Other Ethical Considerations
  • 5. Setting Up for Success
• Chapter 3. Governance
  • 1. Key Governance Tasks
  • 2. Governance Structure
  • 3. Governance Procedures
• Chapter 4. Procedures for Reviewing and Responding to Data Requests
  • 1. What Data Are Available?
  • 2. Who Can Access the Data?
  • 3. Developing a Form for Data Access Requests
  • 4. Reviewing and Responding to Data Access Requests
  • 5. Data Use Agreements
  • 6. Providing Data Access
• Chapter 5. Resources and References
• Appendixes
  • Appendix A. Questions To Consider When Sharing Data With External Parties
  • Appendix B. Sample Data Use Agreement

Suggested citation:

Friedler HS, Leavy MB, Bickelman E, Casanova B, Clarke D, Cooke D, DeMayo A, Egan B, Gibson D, Hajjar S, Gliklich R. Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression: Data Use and Governance Toolkit. Research White Paper. (Prepared by OM1, Inc. and its subcontractors the American Board of Family Medicine and the American Psychiatric Association under Contract No. 75Q80119C00005.) AHRQ Publication No. 21(22)-EHC031. Rockville, MD: Agency for Healthcare Research and Quality; October 2021. DOI: 10.23970/AHRQEPCWHITEPAPERDEPRESSIONTOOLKIT. Posted final reports are located on the Effective Health Care Program search page.

This report is based on research conducted by OM1, Inc. with subcontractors the American Board of Family Medicine and American Psychiatric Association under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 75Q80119C00005). This work is supported by the Office of the Secretary Patient-Centered Outcomes Research Trust Fund under Interagency Agreement 18-596R-18. The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the United States (U.S.) Department of Health and Human Services.

None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.

The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.

This report is made available to the public under the terms of a licensing agreement between the author and AHRQ. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.

AHRQ appreciates appropriate acknowledgment and citation of its work. Suggested language for acknowledgment: This work was based on a Research White Paper, Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression: Data Use and Governance Toolkit, by OM1, Inc., with subcontractors the American Board of Family Medicine and American Psychiatric Association through the Agency for Healthcare Research and Quality (AHRQ).

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Co-Lead Authors