The role and use of Impartial Witnesses in the informed consent process

By Patience Stevens,  MD, MPH, CIP
Board Vice Chair Person

Patience StevensFederal regulations for the protection of human subjects assign the principal investigator with the ultimate responsibility for ensuring the safety, rights and welfare of research subjects. Chief among those responsibilities is the obligation to ensure that the regulatory and ethical requirements relating to obtaining informed consent are met.

Investigators are sometimes confronted with different situations regarding the need for other persons to be part of the informed consent process. This may necessitate additional signature lines on the Informed Consent Document (ICD), in addition to the one containing the subject’s name. One situation frequently encountered is the addition of “Impartial Witness” signature lines.

Use of an Impartial Witness is necessary when either the subject or the subject’s legally authorized representative (LAR) speaks and understands English, but cannot read and write or is visually impaired. Persons who cannot read and write are considered illiterate. Visual impairments include blindness and other visual defects in which changes to the consent document, such as increased font size, are insufficient to allow the subject (or LAR) to read it. It is important to emphasize that use of an Impartial Witness is limited to situations in which the subject (or the subject’s LAR) comprehends spoken English and is able to communicate.

What is an Impartial Witness?

ICH Good Clinical Practice (GCP) defines an Impartial Witness as “a person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.” This definition contains four parts, all of which must be met. Here they are presented separately for emphasis and analysis:

  • “Who is independent of the trial:” This could be a person who is a family member. It would not be a member of the site staff involved with the study.
  • “Who cannot be unfairly influenced by people involved with the trial:” This would be a person free from potential coercion or undue influence or conflicted interest.
  • “Who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read:” This emphasizes the participation of the witness throughout the consent process, not just when the subject signs. A robust informed consent process will likely result, on the part of the person obtaining consent.
  • “Who reads the informed consent form and any other written information supplied to the subject:” This responsibility has the witness confirming the subject was presented sufficient information to assure truly informed consent of the subject.

Why the Impartial Witness signature?

The purpose of the Impartial Witness signature is to attest to the fulfillment of the regulatory requirements as stated in 21 CFR 50.20 – General requirements for informed consent. This includes affirming that the prospective subject was provided sufficient opportunity to consider whether or not to participate, that the possibility of coercion or undue influence was minimized, and that the information given to the subject was in language understandable to the subject or the representative. The witness can further attest that the informed consent, whether oral or written, did not include any exculpatory language through which the subject was made to waive or appear to waive any of his/her legal rights, or release or appear to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

ICH GCP further adds: “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 acceptable representative, and that informed consent was freely given by the subject or the subject’s legally acceptable representative.

The Impartial Witness should sign and personally date the consent form after all of the following occur:

  • The written informed consent document and any other written information  provided to subjects is read and explained to the subject (or the subject’s LAR)
  • The subject (or the subject’s LAR) has orally consented to the subject’s participation in the trial
  • And, when capable of doing so, the subject (or the subject’s LAR) has signed (or made his/her “mark”) and personally dated the informed consent form (when capable).

Cases of physical compromise

According to the FDA information sheets, the use of an Impartial Witness may also be required when a potential subject is physically compromised.

“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. If (1) the person retains the ability to understand the concepts of the study and evaluate the risk and benefit of being in the study when it is explained verbally (still competent) and (2) is able to indicate approval or disapproval to study entry, they may be entered into the study. 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 video tape recording of the consent interview is recommended.”

If the subject or LAR can read and write, an Impartial Witness does not need to be part of the consent process unless there is state law requiring an Impartial Witness, or if a site’s and/or institution’s Standard Operating Procedures (SOP) require this addition to the consent process and ICD.

Pre-determined policy recommended

Having a pre-determined written definition or policy of who may serve as an Impartial Witness is recommended as a useful SOP for all sites that conduct informed consent on a regular basis as a way to ensure regulatory compliance. This allows for potential witnesses to be educated in this role, and will help minimize hasty choices or study-related site personnel being pulled in unprepared, or inappropriately, to serve as an Impartial Witness.

The IRB may guide this choice, but it is good practice for the site to be able to identify and define who can serve in this Impartial Witness role within its walls. Staff involved with the study should not serve as Impartial Witnesses. This, by extension, leaves non-study staff (“employees of the institution who are not engaged in the conduct of the research”) and “relatives” to serve as Impartial Witnesses. The decision to choose a family member or non-study staff member can be flexible or situational. For example, if a potential subject arrives without a family member but requires an Impartial Witness, the burden on a subject to return with a family member is negated by ability of a non-study staff member serve as the Impartial Witness.

Impact on short-form written ICDs

Finally, though infrequently utilized in the routine clinical study setting, it is important to note the mandated use of an Impartial Witness when the IRB authorizes the use of a “short-form written ICD.” Here is the second of the two descriptions of the “written consent document” presented under “Documentation of informed consent,” in the regulations at  § 46.117 and §  50.27.

(2) A short form written consent document stating that the elements of informed consent required by § 46.116  //  § 50.25 have 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 actually 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.

In this description, “witness to the oral presentation” reinforces the concept of the participation of the witness throughout the consent process, not just when the subject signs. In the circumstances where use of the short form is appropriate, the witness can also bring a further element of impartiality to the decisions.

Placement of the Impartial Witness signature line

It is effective to place the Impartial Witness’ signature lines after the subject’s line(s), and after the lines of the person obtaining consent. When the study allows subjects for whom an Impartial Witness may be necessary, having the Impartial Witness lines qualified as “if applicable” presents these lines consistently across all consent forms, avoids the need for an updated ICD and mitigates the temptation to make unapproved modifications to the ICD.

When an Impartial Witness is required, he/she plays a key role in the informed consent process. Proactively identifying who can serve in that role can help ensure a smooth consent process, with maximal return and minimal obstacles. Since correctly documented signatures are part of an appropriate consent process, the investigator has the responsibility to follow the regulations and to ensure that documentation is correctly managed.