Informed Consent Formats by Information Preference and Priority

Summary

This study will test whether different formats of medical informed consent documents can help improve understanding and confidence in decision-making for clinical trials. The study will be primarily run through an online survey.

Conditions

• Consent Forms
• Asthma

Interventions

BEHAVIORAL

Original consent form

Participants will review the full-length, original consent form for the clinical trial.

BEHAVIORAL

Shortened consent form

Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.

BEHAVIORAL

Reordered, shortened consent form

Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).

BEHAVIORAL

Shortened consent form with a highlights box

Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.

BEHAVIORAL

Interactive, shortened consent form

Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.

Sponsors & Collaborators

• ICON plc

  collaborator INDUSTRY

• Carnegie Mellon University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-11-27

Primary Completion

2017-12-31

Completion

2017-12-31

Countries

• United States

Study Locations