Informed consent is more than just a signature on a form; it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions,and measures of subject understanding. Institutional Review Boards (IRBs), clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate. Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject.

The clinical investigator is responsible for ensuring that informed consent is obtained from each research subject before that subject participates in the research study. While FDA does not require the investigator to personally conduct the consent interview, the investigator remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual knowledgeable about the research.

In addition to signing the consent, the subject/representative should enter the date of signature on the consent document, to permit verification that consent was actually obtained before the subject began participation in the study. If consent is obtained the same day that the subject's involvement in the study begins, the subject's medical records/case report form should document that consent was obtained prior to participation in the research. A copy of the consent document must be provided to the subject and the original signed consent document should be retained in the study records. Note that the FDA regulations do not require the subject's copy to be a signed copy, although a photocopy with signature(s) is preferred.

The IRB should be aware of who will conduct the consent interview. The IRB should also be informed of such matters as the timing of obtaining informed consent and of any waiting period (between informing the subject and obtaining the consent) that will be observed.

The consent process begins when a potential research subject is initially contacted. Although an investigator may not recruit subjects to participate in a research study before the IRB reviews and approves the study, an investigator may query potential subjects to determine if an adequate number of potentially eligible subjects is available.

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