Frequently Asked Questions

Is getting the subject to sign a consent document all that is required by the regulations?

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Guidelines & Standards
Clinical Trials
Clinical: Biopharma
Clinical: MedTech

No. The consent document is a written summary of the information that should be provided to the subject. Many clinical investigators use the consent document as a guide for the verbal explanation of the study. The subject's signature provides documentation of agreement to participate in a study but is only one part of the consent process. The entire informed consent process involves giving a subject adequate information concerning the study, providing adequate opportunity for the subject to consider all options, responding to the subject's questions, ensuring that the subject has comprehended this information, obtaining the subject's voluntary agreement to participate and, continuing to provide information as the subject or situation requires. To be effective, the process should provide ample opportunity for the investigator and the subject to exchange information and ask questions.