Public preferences on written informed consent for low-risk pragmatic clinical trials in Spain.

ABSTRACT:

Aims

Pragmatic randomized clinical trials (pRCTs) collect data that have the potential to improve medical care significantly. However, these trials may be undermined by the requirement to obtain written informed consent, which can decrease accrual and increase selection bias. Recent data suggest that the majority of the US public endorses written consent for low-risk pRCTs. The present study was designed to assess whether this view is specific to the US.

Methods

The study took the form of a cross-sectional, probability-based survey, with a 2 × 2 factorial design, assessing support for written informed consent vs. verbal consent or general notification for two low-risk pRCTs in hypertension, one comparing two drugs with similar risk/benefit profiles and the other comparing th

SUBMITTER: Dal-Re R 

PROVIDER: S-EPMC5582372 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature