Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Study informed consent forms (ICFs) based on template used
| Template used | Template description | Number of ICFs assessed | Mean readability | Standard deviation | Analysis of variance P-value (vs NT) |
|---|---|---|---|---|---|
| NT | NT: No plain language ICF template used | 139 | 11.33 | 1.36 | Not applicable |
| T1 | T1: Original plain language ICF template used | 43 | 8.28 | 0.89 | <0.0001 |
| T2 | T2: Updated plain language ICF template used (inclusive of revised common rule requirements) | 41 | 8.54 | 0.81 | <0.0001 |
