Format

Send to

Choose Destination
HIV Med. 2015 Apr;16 Suppl 1:24-9. doi: 10.1111/hiv.12230.

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

Author information

1
Coordinating Centers for Biometric Research, Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.

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 half the sites, staff reported spending less than an hour per participant in the consent process. The vast majority of sites assessed participant understanding using informal nonspecific questions or clinical judgment.

CONCLUSIONS:

These data reflect the interest of START research staff in evaluating the consent process and improving informed consent. The START Informed Consent Substudy is by far the largest study of informed consent intervention ever conducted. Its results have the potential to impact how consent forms are written around the world.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00867048.

KEYWORDS:

START trial; informed consent

PMID:
25711320
PMCID:
PMC4341940
DOI:
10.1111/hiv.12230
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center