Patient notification about pragmatic clinical trials conducted with a waiver of consent: A qualitative study.

Abstract

Background: Some scholars have proposed that investigators and health systems should notify patients about their enrollment in pragmatic clinical trials conducted with a waiver of consent. However, others argue that decision-making about notification requires judgment, and reports suggest considerable heterogeneity about whether, when, and how individuals enrolled in pragmatic clinical trials with a waiver of consent are notified about that enrollment. Empirical data can inform this decision-making.

Methods: We conducted semi-structured interviews with knowledgeable stakeholders involved in conducting and/or overseeing pragmatic clinical trials conducted with waivers of consent, including investigators, those charged with the oversight of human subjects research, and operational leadership. Interviews were conducted via video conference from September to December 2024 and were audio-recorded and professionally transcribed. Data were qualitatively analyzed using an integrated approach, including both a priori codes drawn from the interview guide and emergent, inductive codes.

Results: Twenty-three of 28 experts invited to participate completed interviews. Respondents described rationales both for and against notification. Rationales for notification included both appeals to moral values (respect for persons, respect for autonomy, and transparency), as well as instrumental goals (promoting understanding of and/or support for research, avoiding downstream surprise, and supporting buy-in). Rationales against notification included preserving scientific validity, perceiving notification to lack value, and concerns that notification might be burdensome for patient-subjects or undermine trust and/or clinical or public health goals. Decision-making about notification was context-specific and reflected features related to the study design, the health system setting, the patient population, the clinical condition, and the intervention(s) being evaluated. While some factors were consistently described as weighing against notification, including scientific validity or decisions for which a patient would not be offered a choice outside the research context, other factors resulted in divergent decisions across different pragmatic clinical trials (or even across different sites for the same trial).

Conclusions: While several rationales support notification about enrollment in pragmatic clinical trials conducted with waivers of consent, the relative value and practicability of notification is context-dependent. Some features, such as the need to preserve scientific validity, may appropriately weigh in favor of forgoing notification. However, evidence of divergent decision-making for similar trials suggests the need for a framework to guide future notification decisions. These data can be an important input to inform future framework development.