Randomized comparison of two interventions to enhance understanding during the informed consent process for research.

ABSTRACT:

Background/aims

Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies).

Methods

In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the i

SUBMITTER: Taylor HA 

PROVIDER: S-EPMC10173028 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature