Consent/Assent Process and Forms

Since subjects retain the right to withdraw from a study, consent is an ongoing process. It starts well before any forms are signed and continues until the subject's participation is complete.

The informed consent process is different from the consent form. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation. The consent form formalizes the agreement to participate and should be designed to document the process. Obtaining consent is not just giving a prospective subject a consent form and getting it signed.

If consent is to be informed, the subjects must genuinely understand the study. Researchers should convey information to subject, not merely disclose it to them. Subjects should be able to demonstrate their understanding of the study procedures, risks, and benefits in which they are agreeing to participate.

Download: Templates and Standard Statements

Guidelines for Developing an Informed Consent

Telephone Consent Guidance

Re-consent Requirements

Non-English Speaking Subjects

Waiver of Documentation

Waiver of Consent

Using Track Changes in Microsoft Word for Informed Consent Form Revisions

NO LINKS YET:

Emergency Research Consent Exception

Assent Guidelines

Children in Clinical Research