What Is the Role of a Legally Authorized Representative in Informed Consent?

The informed consent process in clinical research generally involves a potential participant and the person conducting the consent discussion, but sometimes, other individuals are involved in the process. The different terms for these individuals and the roles they play in the informed consent process are discussed. 

While the topic of Legally Authorized Representatives (LARs) and their role in consent is complex and multifaceted, for the purposes of this discussion, an LAR is an individual who provides consent on behalf of an adult who lacks the mental capacity to make decisions for themselves. In other words, an LAR is only necessary when an adult’s mental capacity is impaired, rendering them unable to provide informed consent.

This is different from a parent or guardian, who provides permission for a child to participate in research. WCG makes a clear distinction between an LAR and a parent or guardian to highlight the differences between a child who cannot consent due to their age, versus an adult who lacks mental capacity. In some cases, a parent or guardian may also serve as an LAR for an adult, but this would be documented as an LAR, rather than a parent or guardian.

A witness is very different. They are an impartial person not related to the research study who is brought in to observe the consent process with the consent document. They are not an LAR, not a parent, and are not signing for anyone else. They are someone completely independent of the research. An example of an impartial individual who can undertake this role is a nurse who is not part of the research team and has no other involvement with the investigator. In contrast, a study coordinator working on the same study, even if they are not directly responsible for obtaining consent, would not be considered impartial and thus not an appropriate witness.

Per regulation, a witness is needed when you unexpectedly encounter a person who can’t read the consent form, or in some very rare cases, physically can’t document consent. The “short form” consent process is used in this case. In this process, a witness observes the verbal discussion and reviews the short form and long form documents. The witness then signs both the short and long form documents, attesting to what they observed. Meanwhile, the participant signs the short form, and the person obtaining consent signs the long form to formally document the consent. It’s essential to note that this process, including the requirement for a witness, is distinct and separate from the involvement of an LAR.

For the short form process, a person who speaks and understands English, but does not read and write, can be enrolled in a study by “making their mark” on the consent document, when consistent with applicable state law.

While a person not being able to read the consent form is the baseline for when a witness is required by regulations, WCG IRB has the following policy regarding the use of a short form consent process to enroll participants. This policy, which may be more restrictive than federal requirements, limits the use to the situation when both of the following are true:

1. A full-length version of the consent form in language understandable to the participant is not available or is not appropriate for the participant. Situations that generally meet this condition include:
   1. Unexpected translations
   2. Low literacy
   3. Visual impairment
2. It is in the participant’s best medical interest to be enrolled in the research, and for unexpected translations, before a translated consent form can be obtained.

In both circumstances — the participant cannot consent or cannot read — the key component is consent. Consent involves understanding what the research is about and agreeing to participate. A consideration often conflated with consent in total is the documentation of consent. For example, an adult able to consent who has a broken arm might have a different way of documenting their consent, such as a larger or non-dominant hand signature. If someone has the capacity to consent but has physical impediments to signing a form, there’s almost always a way to have them make a mark to legally document their consent. This can include with assistance of another person who doesn’t have to be an LAR or witness but someone who is helping them do every other activity of daily living, such as helping a person with spasticity make a thumbprint. For a very rare case, such as complete paralysis, the witness process would be used, with additional documentation like a note to file. This would include the specifics of why this process was used, how agreement was indicated by the participant, and related details. 

In circumstances where you need a signature, but one does not exist on the IRB-approved consent form, there are two very different cases.

1. If you need a witness and you don’t have a signature line on your form, you can use one of the pre-approved templates from WCG’s IRB & IBC Resource Center, under the Template Consents tab in the IRB Forms section. Access the form here.
2. If you are planning on consenting a person who needs an LAR or parent/guardian, but there are no signature lines on the consent form for an LAR or parent/guardian to sign, then stop and talk to your IRB.

Do you have questions about your informed consent form?

Consult WCG’s experts by completing the form below.