A new chapter of the Living Textbook of Pragmatic Clinical Trials describes regulatory requirements for informed consent, waivers and alterations of consent, mechanisms for notification, and research participants’ perspectives on a variety of approaches to consent and notification—all with a focus on special considerations for pragmatic clinical trials.
For a variety of reasons, the application of ethical principles and regulations regarding informed consent can be complex for pragmatic clinical trials. For example, pragmatic trials often use novel study designs, including cluster randomization, in which the unit of randomization may be a clinic, hospital, or healthcare system rather than the individual. Some pragmatic trials also use stepped-wedge designs, in which the study intervention is introduced to sites at different times.
The new chapter has 5 sections:
- Section 1 discusses reasons why the application of ethical principles and regulations regarding informed consent can be complex for pragmatic trials.
- Section 2 describes the regulatory requirements for informed consent.
- Section 3 focuses on waivers and alterations of the informed consent process.
- Section 4 provides examples of mechanisms for notifying participants about the trial when consent is not required.
- Section 5 presents findings on research partners’ preferences regarding various approaches to research and consent.
The chapter was developed by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core.