Introduction

CHAPTER SECTIONS

Privacy Considerations


Section 1

Introduction

Contributors

Pragmatic clinical trials embedded in healthcare systems integrate research into routine clinical care. Therefore, data are typically collected from the electronic health record (EHR), from claims data sources, and via patient-reported outcomes. Because these data are often collected for the primary purpose of patient care and billing, and may include sensitive information, there can be privacy considerations for studies that use these data.

In this chapter, we examine privacy considerations in embedded pragmatic clinical trials by reviewing the relevant regulatory frameworks and by discussing studies that use real-word data for research. We explore privacy considerations from patient, clinician, and healthcare system perspectives.

Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Current Federal Regulatory Framework: Common Rule, FDA, and HIPAA
  3. Additional Protections: Certificates of Confidentiality
  4. Individual Privacy
  5. Clinician and Institutional Privacy Considerations

Resources

Post-Trial Responsibilities in Pragmatic Clinical Trials: Fulfilling the Promise of Research to Drive Real-World Change
Article from the Ethics and Regulatory Core

Ethical Considerations for Sharing Aggregate Results From Pragmatic Clinical Trials
Article from the Ethics and Regulatory Core


Version History

July 3, 2025: Added the Resources sidebar and made nonsubstantive changes to the text as part of the regular content review (changes made by D. Seils).

Published September 27, 2022

current section :

Introduction

  1. Introduction
  2. Current Federal Regulatory Framework: Common Rule, FDA, and HIPAA
  3. Additional Protections: Certificates of Confidentiality
  4. Individual Privacy
  5. Clinician and Institutional Privacy Considerations

Citation:

Morain S, Carrithers J, Ali J, et al. Privacy Considerations: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/ethics-and-regulatory/special-privacy-considerations/introduction/. Updated December 3, 2025. DOI: 10.28929/170.