Reported consent processes and demographics: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.

ABSTRACT:

Objectives

Efforts are needed to improve informed consent of participants in research. The Strategic Timing of AntiRetroviral Therapy (START) study provides a unique opportunity to study the effect of length and complexity of informed consent documents on understanding and satisfaction among geographically diverse participants.

Methods

Interested START sites were randomized to use either the standard consent form or the concise consent form for all of the site's participants.

Results

A total of 4473 HIV-positive participants at 154 sites world-wide took part in the Informed Consent Substudy, with consent given in 11 primary languages. Most sites sent written information to potential participants in advance of clinic visits, usually including the consent form. At about

SUBMITTER: Denning E 

PROVIDER: S-EPMC4341940 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature