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NIH Informed Consent Authoring tool


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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.

Published in: Health & Medicine, Technology
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NIH Informed Consent Authoring tool

  1. 1. Beta Version – Pilot phase
  2. 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. 3. The workflow
  4. 4. Web-based application
  5. 5. Document dashboard Manage your consent documents through the dashboard interface. Consent title Protocol Title
  6. 6. Consent editor Edit your consent documents on-line
  7. 7. Consent format Add content to sections of the consent by clicking on “answer question”
  8. 8. Format flexibility Omit sections that do not pertain to your study.
  9. 9. Rich-text editor Edit your documents with a “MS Word – like” editor
  10. 10. Insert standard language Pre-approved IRB/Inst. language can be inserted into a consent document.
  11. 11. Readability analysis The integrated readability tool identifies grade level and difficult words. Highlighted text is considered difficult to read.
  12. 12. Word suggestions Difficult words and the suggested replacements are provided. Replacement is left to the author.
  13. 13. Readability review Readability is assessed on a per-section basis.
  14. 14. Print. Download. Done. Print or download your consent document to your computer once you are finished.
  15. 15. For more info… Contact Brian Chamberlain at: The system is still in development so feel free to send comments, suggestions, and/or feedback.