The NIH Pragmatic Trials Collaboratory announced the addition of a new collection in the Living Textbook of Pragmatic Clinical Trials focused on ethical and regulatory aspects of pragmatic trials.

“The Living Textbook is a dynamic, evolving collection of knowledge gained from 10 years of conducting pragmatic clinical trials within the NIH Collaboratory,” said Dr. Kevin Weinfurt, co–principal investigator of the NIH Collaboratory Coordinating Center and editor-in-chief of the Living Textbook. “Our new offering of content focuses on ethics and regulatory issues and will further expand researchers’ ability and capacity to conduct these innovative studies,” he said.

The collection launches with 4 new chapters contributed by members of the NIH Collaboratory’s Ethics and Regulatory Core:

• Privacy Considerations: Real-world data sources like electronic health records, insurance claims, and patient-reported outcomes are generated for purposes other than research. This chapter examines the privacy considerations for use of real-world data in pragmatic trials from patient, clinician, and healthcare system perspectives by reviewing current regulatory frameworks and highlighting experiences from studies that used real-word data for research.
• Identifying Those Engaged in Research: Clinical research routinely involves 2 distinct roles: researchers and research participants. But pragmatic trials, as well as other clinical research, can be more complex and may require consideration of additional roles. This chapter describes, in addition to the standard roles of researchers and research participants, the roles of service providers and those affected by the research. Appropriate mechanisms of oversight for each of these groups is summarized.
• Consent, Waiver of Consent, and Notification: Informed consent, which is one means of upholding the fundamental ethical principle of respect for persons, is codified in human subjects protection regulations. However, the regulations acknowledge that it may be ethically and practically inappropriate to obtain informed consent for some research. This is particularly relevant for pragmatic trials. This chapter reviews regulatory requirements for informed consent, discusses waivers and alterations of consent, and examines mechanisms for notification, with a focus on special considerations for pragmatic trials.
• Collateral Findings: Collateral findings in pragmatic trials are findings that emerge during the course of the trial that are unrelated to the primary research question but may have implications for the individual patients, clinicians, or healthcare systems from whom or within which research data are collected. This chapter examines the ethical considerations related to the identification and management of collateral findings by describing these findings and how they differ from findings that emerge in other contexts.

Additional content that is in development for the Ethics & Regulatory collection will provide more information about these important aspects of pragmatic research.

Navigate the new collection by using the “Ethics & Regulatory” drop-down menu on any page of the Living Textbook at rethinkingclinicaltrials.org. The drop-down menu appears alongside the menus for the existing collections of “Design,” “Data, Tools & Conduct,” and “Dissemination.”