Engaging Patients and the Public to Improve Future Research Conducted with Waivers of Informed Consent

There is growing interest in using embedded research methods, particularly pragmatic clinical trials (PCTs). Reviews of PCTs published between 2014 and 2019 found that nearly 10% were conducted with waivers of informed consent for research (“waivers”), and this number is increasing with time. Waivers are ethically justifiable and permitted under the Common Rule when certain conditions are met. However, their use presents ethical challenges. This panel will use empirical, normative, and case-based lenses to inform the ethical conduct of PCTs conducted with a waiver of consent.

Panelist One will provide background on PCTs, explain why waivers have become an increasingly prominent feature of them, and provide empirical data on patients’ and the public’s views on waivers. Panelist One will then argue that a fundamental ethical challenge arising when waivers are used is how to both demonstrate respect for participants, and to satisfy certain functions of consent in the absence of traditional consent processes. Building on this, Panelists Two and Three will discuss two potential means for resolving this challenge: community consultation and participant notification. Panelist Two will argue for the ethical importance of consulting with community representatives during the design-phase of PCTs and present a recent example of successful engagement with people living with dementia and caregivers on the topic of waivers. Panelist Three will discuss the ethical importance of participant notification when research is conducted with a waiver, which investigators often underestimate, outlining the goals and potential means of notification. There will be time for Q&A and discussion.