Who is willing to participate in low-risk pragmatic clinical trials without consent?

ABSTRACT:

Purpose

General notification offers a possible alternative to written informed consent for pragmatic randomized controlled trials (pRCTs). It involves patients being informed through brochures, posters, and letters that research is being conducted simultaneously to providing clinical care and that patients will be enrolled in pRCTs without study-specific consent. A previous survey found that a substantial minority of respondents endorsed general notification. We aimed to know who is willing to enroll in this type of trials using general notification rather than written consent.

Methods

The previous study was a cross-sectional, probability-based survey, with a 2 × 2 factorial design. Two scenarios were assessed: two low-risk pRCTs in hypertension, one comparing two drugs with

SUBMITTER: Dal-Re R 

PROVIDER: S-EPMC5684310 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature