Witness Line on the Informed Consent Document

Many informed consent documents provide a signature line for a Witness Signature, but when is a witness actually required to sign?

FDA's Information Sheets state that "a person who can understand and comprehend spoken English, but is physically unable to talk or write, can be entered into a study if they are competent and able to indicate approval or disapproval by other means. The consent form should document the method used for communication with the prospective subject and the specific means by which the prospective subject communicated agreement to participate in the study. An impartial third party should witness the entire consent process and sign the consent document." A witness signature is also required when using the "short form" written consent document. [21 CFR 50.27 and 45 CFR 46.117]

So, what exactly is the role of the witness?  "The witness is required to attest to the adequacy of the informed 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."

GCP Guidance (ICH E6 4.6.9) also provides guidance regarding  requirements for a witness' signature:

• By signing the consent form, the witness attests that the information in the consent form and any other written information was accurately explained to, and apparently understood by, the subject or the subject's legally authorized representative.
• The witness must be impartial.
• The witness dates his/her signature.

In this instance, the witness must have some knowledge about what is being presented to the subject and able to determine if the subject understands the information.

NOTE:  In addition to federal regulations for obtaining witness signatures for consent forms, it is imporatnt to also check with state and local laws prior to obtaining consent from witnesses for prospective participants.

FDA Revises Informed Consent Form Requirements

The FDA has updated regulations that require additional language to informed consent form (ICF) documentation.  21 CFR 50.25(c) was updated on January 4, 2012 requiring that the informed consent document disclose the sponsor’s posting of clinical trial information on www.clinicaltrials.gov.  The deadline for this change will take place for applicable studies that are initiated on or before March 7, 2012.

The FDA clearly stated that this requirement will not be applied retroactively to those studies that were initiated prior to March 7, 2012 and defined which studies were required to contain the new language.  The following statement must be reproduced word-for-word in informed consent documents:

“A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law[1].  This Website will not include information that can identify you.  At most, the Web site will include a summary of the results.  You can search this Web site at anytime.”

For more information about the FDA’s ICF deadline or a list of clinical trials that apply to this regulation, please visit (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf).

 For an updated Informed Consent Form checklist including the new regulation, you can contact Christina Billias at cbillias@harrisonirb.com .

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[1] For more information about the U.S. Law, please refer to Section 801 of FDAAA.