Consent Process

Informed consent is an educational process, not just a form to sign!

The procedures used to obtain informed consent should be designed to educate the subject population and ensure they fully understand the study and the voluntariness of their participation.

1. Informed consent must be prospectively obtained from subjects or their legally authorized representatives (guardian, parent, proxy).
2. Subjects should fully understand the study and their role as participants.
3. Subjects must be given sufficient opportunity to consider whether they want to participate.
4. Consent must be given without coercion, manipulation or undue influence.
5. Subjects do not give up any of their legal rights or be given the impression that they are being asked to do so.
6. The consent document is to be used as a guide for the verbal explanation of the study.
7. The consent document should be the basis for a meaningful exchange between the researcher and the participant.
8. Each element of the consent form should be read to the subject for studies that have face-to-face interactions and require a signature to confirm subject understanding and voluntary participation.
9. The subject’s signature and the investigator’s signature (or person obtaining consent) provides documentation of mutual understanding and the subject’s agreement to participate in a study, but is only one part of the consent process.
10. The consent document must not serve as a substitute for discussion.
11. A copy of the consent document must be provided to subjects.
12. Contact information – including the PI’s and HPA’s contact information – should be provided.  If someone is obtaining consent other than the PI, their contact information should also be given to the subject in the event they need to clarify elements of the study, especially when a trusting relationship has been established.