How should informed consent be documented?

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Except as provided in 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent. A copy shall be given to the person signing the form.

The consent form may be either of the following:

  • A written consent document that may be read to the subject or the subject's legally authorized representative, but, in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed.
  • A short form written consent document that has been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative in addition to a copy of the short form.

When a short form consent document is to be used, the IRB should review and approve the written summary of the full information to be presented orally to the subjects. A witness is required to attest to the adequacy of the consent process and to the subject's voluntary consent. Therefore, the witness must be present during the entire consent interview, not just for signing the documents. The subject or the subject's legally authorized representative must sign and date the short form. The witness must sign both the short form and a copy of the summary, and the person obtaining the consent must sign a copy of the summary. The subject or the representative must be given a copy of the summary as well as a copy of the short form. While the regulations do not prohibit the use of multiple consent documents, FDA suggests that they be used with caution. Multiple consent documents may be confusing to a research subject and if, inadvertently, one document is not presented, critical information may not be relayed to the research subject. For some studies, however, the use of multiple documents may improve subject understanding by "staging" information in the consent process. This process may be useful for studies with separate and distinct, but linked, phases through which the subject may proceed. If this technique is used, the initial document should explain that subjects will be asked to participate in the additional phases. It should be clear whether the phases are steps in one study or separate but interrelated studies. For certain types of studies, the Agency encourages the process of renewing the consent of subjects.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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