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.

In these cases, an Assent Form is prepared and the procedure is very similar to that of obtaining consent with an adult. The Investigator provides the form to the child and, depending on the child’s ...

Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...