A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension

The medium-length informed consent form, written at a sixth-grade reading level, with shorter words and sentences, tables, and enhanced formatting, produced significantly better comprehension than longer or shorter informed consent forms. The short informed consent form produced the same level of comprehension as a long informed consent form used in approved clinical trials. Researchers, pharmaceutical companies, and institutional review boards should adopt these informed consent form modifications to increase participant comprehension and satisfaction.

Authors

Institutions

Publication Details

Journal
Clinical Trials
Published
2026-03-28
DOI
https://doi.org/10.1177/17407745261429936
Primary Topic
Ethics in Clinical Research
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension

Eli Silvert, Merjan Lijerón Ozisik, Ezekiel J Emanuel, Samantha Lopez-Rico
Clinical Trials
Ethics in Clinical Research
article

A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension

Eli Silvert, Merjan Lijerón Ozisik, Ezekiel J Emanuel, Samantha Lopez-Rico
article en

Abstract

The medium-length informed consent form, written at a sixth-grade reading level, with shorter words and sentences, tables, and enhanced formatting, produced significantly better comprehension than longer or shorter informed consent forms. The short informed consent form produced the same level of comprehension as a long informed consent form used in approved clinical trials. Researchers, pharmaceutical companies, and institutional review boards should adopt these informed consent form modifications to increase participant comprehension and satisfaction.

Clinical Trials
University of Pennsylvania (US)
Quality Education
Openalex Percentile: Top 5%
Ethics in Clinical Research
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.