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 operation

SUBMITTER: Morain SR 

PROVIDER: S-EPMC12614351 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature