and what rights they have as research subjects. The consent form is one part of the dialogue that investigators have with each subject. It is recommended that forms for adult subjects be written at a ...

The information and sample documents in the compliance form section are provided to help researchers develop consent and assent documents customized to the design of the individual research project.

See the informed consent form template (pdf) for more help and sample language. 1. Title of the Study 2 ... and their probability as a direct result of participation in the research and/or from breach ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s) with the same wording given in the consent form ... may result from participation in the ...

Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that ... benefit to the research subjects, and the child’s age, maturity, status, ...

A waiver of the need for subjects to sign a consent form can be granted if any one of the following three conditions are met: The only record linking the subject and the research would be the consent ...