Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

subject, and the approximate number of subjects in the study.
(21 CFR 50.25(b))
In short, the clinical investigator must tell the human
subjects important information about the study and its
potential consequences, so that the person can decide whether
to be in the experiment. The entire informed consent process
involves giving the subject all the information concerning the
study that he or she would reasonably want to know; ensuring
that the subject has comprehended this information; and
finally, obtaining the subject's consent to participate. The
process, to be meaningful, should involve an opportunity for
both parties, the investigator and the subject, to exchange
information and ask questions. It is up to the clinical
researcher to make certain that, as best as possible, the
person understands the information. To acknowledge that the
person has received the information and has consented to the
research, FDA also requires the clinical investigator to
document in writing that consent was obtained. We recognize
that the documentation of informed consent represents only one
part of the entire consent process. The consent form itself is
an aid to help ensure that a required minimum amount of
information is provided to the subject and that the subject
consents.

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