Informed consent is more than just a form; it is a process that actively involves the participant ... Child Assent forms should be written to match the reading and comprehension level of your ...

The consent form must be written in language that is easy for the participant to understand. Avoid technical terms and complex sentences, regardless of your intended audience. When there are different ...

Potential subjects or the parents of children who are subjects are presented (either verbally or in writing) with the same information required in a written consent document, but documentation of the ...

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.

A waiver of the need for subjects to sign a consent form can be granted if any one of the following ... and involves no procedures for which written consent is normally required outside of the ...

Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that the form is written for the parents so it will reference “your child” instead ...

include a summary of relevant pieces of information that are explained in greater detail later in the consent form. It should be written in everyday language and could be similar to what you’d say to ...