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.

Central Independent Review Boards and Community Attitudes

The Food and Drug Administration (FDA) requires an Independent Review Board (IRB) to consider "community attitudes" during its review of research.  So what is the FDA's definition of "community attitude" and how can a central IRB have knowledge of a location's attitudes towards research when it reviews submissions from other cities, states or countries? 

The FDA addresses community attitudes in the Non-Local IRB Review section of the FDA Information Sheets.  "The non-local IRB should have adequate knowledge of community attitudes, information on conditions surrounding the conduct of the research, and the continuing status of the research to assure fulfilling the requirements of 21 CFR 56.107, 56.111(a)(3), (a)(7) and (b) for each study site.  The non-local IRB needs to ensure these requirements are met for each location for which it has assumed IRB oversight responsibility.  IRBs need to be knowledgeable about the community from which the participants are drawn to ensure that subject rights will be protected and that the consent process is appropriate for the subject population involved.  The IRB should be sensitive to community laws because state and local laws, as well as community attitudes pertaining to research, may be more restrictive than federal regulations or the prevailing standards of the community where the IRB is located.