Section 5.19 of the SOP for Obtaining and Documenting Informed Consent addresses the requirements for documentation of informed consent. Please note that it is important to make thorough notes regarding the consent process. Be sure to include all relevant information. Some examples of relevant information are: whether the subject received a copy of the informed consent statement; whether the subject took the consent home to review and sign; and who participated in the consent process (i.e., the PI, a study nurse, other appropriate study staff, a friend/relative of the subject, etc.). It is best to be as detailed as possible with the documentation. That way, if there are questions about what happened, or if the study is audited, the documentation can provide the appropriate answers.
In addition, the informed consent process should be detailed in section XIII of the summary safeguard statement. If processes change from what is included in the summary safeguard statement, an amendment should be submitted to the IRB for review and approval of the new processes.
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