Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.

The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed ... in the form of a letter signed by the sponsor(s) with the same ...

Informed consent documents explain to potential participants ... and what rights they have as research subjects. The consent form is one part of the dialogue that investigators have with each subject.

Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that the form is written ... and condition. This sample is intended to help you ...

Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form template (pdf) for more help and sample language. 1. Title of the Study 2. Names and Affiliations ...