This is a tool I developed for use at the NIH Clinical Center. It is a web-based tool for authoring informed consent documents. The system has built-in readability analysis, language templates for standard descriptions of procedures, and can have customized document templates.

1. Beta Version – Pilot phase

2. The goals
Enforce a standardized consent template with some
flexibility.
Allow insertion of language from NIH ProtoMechanics,
IRBs, and individuals.
Provide real-time reading level, reading difficulty, and
suggestions for improving difficult language.

3. The workflow

4. Web-based
application

5. Document dashboard
Manage your consent
documents through
the dashboard
interface.
Consent title
Protocol
Title

6. Consent editor
Edit your consent
documents
on-line

7. Consent format
Add content to sections
of the consent by
clicking on
“answer question”

8. Format flexibility
Omit sections that do
not pertain to your
study.

9. Rich-text editor
Edit your documents
with a
“MS Word – like”
editor

10. Insert standard language
Pre-approved
IRB/Inst. language can
be inserted into a
consent document.

11. Readability analysis
The integrated
readability tool
identifies grade
level and difficult
words.
Highlighted text is
considered difficult
to read.

12. Word suggestions
Difficult words and the
suggested
replacements are
provided. Replacement
is left to the author.

13. Readability review
Readability is
assessed on a
per-section basis.

14. Print. Download. Done.
Print or download your
consent document to
your computer once
you are finished.

15. For more info…
Contact Brian Chamberlain at:
b-chamberlain@northwestern.edu
The system is still in development
so feel free to send
comments, suggestions, and/or feedback.