The federal regulations require that informed consent be documented; documentation involves the use of a written consent form containing all the information to be disclosed which is signed by the subject or their representative. A copy of the consent form is given to each participant.
Documenting informed consent can be accomplished in one of two ways:
- A written consent document that contains all of the elements required by the Federal Guidelines Basic Elements of a Consent Form. The form may be read to or with the subject or their representative, but in any case the subject or the representative must have time to read the form and ask questions before it is signed, OR
- A short form written consent document; this document states that the elements of informed consent required by the Federal Guidelines have been orally presented to the subject or their representative. There must be a witness to the oral presentation and the IRB must review and approve a written summary of what was said to the subject or representative. The subject or representative signs the short form and the witness signs both the short form and a copy of the summary, and the person obtaining informed consent (usually the Investigator) signs a copy of the summary. Copies of the summary and short form are given to the subject.
There are two situations where the IRB may waive the regulatory requirement for written documentation of consent:
- The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research (e.g., studies on sensitive topics such as drug abuse or sexual deviance); and (2) the consent document is the only record linking the subject with the research, OR
- The research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting
In cases in which the documentation requirement is waived, the IRB will require the investigator to provide subjects with a written statement regarding the research.