Creating a Consent Document - Instructions



After completion of this module, you will have a consent document in a format acceptable to the Institutional Review Board (IRB). This document is submitted with your application to the IRB for approval before beginning any research.

When you are creating your document, the screen will automatically divide into two frames. These can be resized by dragging the center horizontal bar that separates the frames. For information on how to change your display size, consult your operating system manual.

The document section headings will appear on the screen. Fill in these areas with the information for the study you are conducting. If a field or section does not apply to your research, you may skip it. Information you enter will be saved only when you click the "Save this Section" button.

Headings and sentences with a red label will be inserted automatically into the document. Otherwise, if you want to use the suggested phrase or wording, you must retype or cut and paste it. You may complete the document in any order.

The following buttons link you to information that can help you complete the document.

Key Points provides a clarification of the elements that should appear in this section of the consent document.
Pitfalls provides a list of common mistakes to avoid when creating this section of the consent document.
Examples provides exerpts of consent documents as samples for this section.
Simple Wording provides a list of alternative wording.this text is an invisible placeholder
View provides a working view of the current document. The Update button will display the most recent version as you add or change information.
Options will take you to a page where you can make the following selections:
  • start a new document,
  • work on an existing document,
  • send a document to your e-mail address,
  • permanently delete a document, or
  • review these instructions.

When you have finished constructing your document, you e-mail it to yourself. You may need to reformat it before printing. Remember to check it with your word processor for spelling and eighth-grade readability.

The Back button will return you to the previous page.

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