The document outlines the procedure for submitting an informed consent letter, emphasizing the importance of adhering to the due date and clarity in the content. It specifies that the letter should be written in lay language and include relevant risks and benefits. Additionally, it mentions addressing assent if applicable and provides an example related to an IRB application.

1. Informed Consent Form
By the due date assigned, submit the Informed Consent Letter to
the
Submissions Area
(please note that this is only an example and no data may be
collected).
Informed Consent Letter
Procedure section is clear, described in detail, specific, and all
inclusive. Written in lay language (as documented by reading
level score). Includes risks and benefits relevant to study.
Address assent (if applicable).
Informed Consent Letter Example
IRB Application