Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov.

ABSTRACT:

Introduction

Recent revisions to the US Federal Common Rule governing human studies funded or conducted by the federal government require the provision of a "concise and focused" key information (KI) section in informed consent forms (ICFs). We performed a systematic study to characterize KI sections of ICFs for federally funded trials available on ClinicalTrials.gov.

Methods

We downloaded ICFs posted on ClinicalTrials.gov for treatment trials initiated on or after the revised Common Rule effective date. Trial records (n = 102) were assessed by intervention type, study phase, recruitment status, and enrollment size. The ICFs and their KI sections, if present, were characterized by page length, word count, readability, topic, and formatting elements.

Results

Of

SUBMITTER: Gelinas L 

PROVIDER: S-EPMC10514692 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature