The IRB determines, for each protocol it reviews, which of the following elements and disclosures must be included in the informed consent process. Investigators can avoid delay in the review process ...

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 ...

In general, it should briefly explain in basic terms: For children between the ages of 12 and 14, investigators should use their judgment in deciding which of the required elements of informed consent ...