Can Someone Give Valid Consent if They Cannot Read the Consent Form?

Does informed consent require the participant to read the form?

A prospective participant tells you that they cannot read the consent form. Perhaps they never learned to read, have very limited literacy, have a visual impairment, or cannot independently access the written document in its current format.

It is easy to make one of two mistakes. The first is to assume that the person cannot participate because they cannot read the document. The second is to read the form aloud, obtain a signature or mark, and assume the problem has been solved.

Neither approach gets to the central ethical question. Informed consent depends on whether the person can receive and understand the relevant information, ask questions, make a voluntary decision, and communicate that decision. Reading is one way of receiving information. It is not the definition of informed consent.

A person does not have to be able to read to make an informed decision

Separate the ability to read from the ability to consent

Reading ability and decision-making capacity are different questions

A person may be unable to read a page of text yet readily understand an oral explanation, compare the advantages and disadvantages of participation, ask sophisticated questions, and make a voluntary choice. Conversely, the ability to read and sign a form does not prove that someone understands it.

This is why researchers should not use literacy as a shortcut for assessing a participant's capacity to give informed consent. A genuine concern about decision-making capacity requires its own assessment. An inability to read requires an accessible way of communicating the information.

The information can be communicated orally

Major research-ethics frameworks recognize that consent information can be communicated through more than independent reading. CIOMS describes informed consent as a two-way communicative process and recognizes oral presentation and appropriate audiovisual aids as ways of supplementing written information.

For someone who cannot read, the researcher can explain the relevant information orally using understandable language, with sufficient time for discussion and questions. The participant should receive the same substantive information needed by someone who reads the consent materials independently. Oral consent procedures are not an ethical shortcut that permits important information to disappear.

The person obtaining consent should also check understanding. Asking the participant to explain important aspects of the study in their own words can reveal misunderstandings that would remain invisible if the process ended with "Do you understand?"

Reading the form aloud is not necessarily the same as explaining it

Imagine a consent form containing terms such as randomization, placebo, coded biospecimen, incidental finding, or foreseeable risk. Reading every sentence aloud does not automatically make those concepts understandable.

An effective oral process may require researchers to pause, explain unfamiliar terms, answer questions, use examples, and revisit information that the participant has misunderstood. The goal is comprehension rather than successful completion of a recital.

If inability to read reflects broader limitations in using written information, the entire consent process may need to be adapted rather than simply converting written words into spoken words.

An impartial witness may be required

Witness requirements depend on the regulatory and ethical framework governing the study. They should therefore be checked rather than assumed.

ICH E6(R3), which applies to clinical trials within its scope, defines an impartial witness as a person independent of the trial who cannot be unfairly influenced by people involved in the trial. When the participant or the participant's legally acceptable representative cannot read, the impartial witness attends the informed consent process and reads the informed consent form and other documented information supplied or read to the participant or representative.

Under the U.S. Common Rule short-form procedure, a witness is required when the elements of informed consent are presented orally using the short-form documentation process. The participant or legally authorized representative signs the short form, the witness signs both the short form and the approved summary, and the person obtaining consent signs the summary.

A witness does not consent for the participant

The witness and the participant have fundamentally different roles. The participant makes the decision. The witness observes or attests to the consent process as required by the applicable procedure.

That distinction becomes particularly important when a relative accompanies the participant. A relative's presence should not quietly transform the participant's own decision into family permission. Questions about whether a family member can serve as an interpreter or appropriately perform another role should be addressed separately.

Unable to read and unable to sign are not the same thing

Researchers sometimes collapse these into one problem, but they are distinct. A participant might be unable to read yet able to sign their name. Another participant might understand written or orally presented information but be physically unable to produce a conventional signature.

The applicable framework may permit another method of documenting consent. FDA guidance, for example, has recognized that a person who cannot write may make a mark where consistent with applicable law. An alternative method should not be invented during the consent encounter simply because it seems practical. It should be consistent with the approved protocol and applicable requirements.

Documentation is not the same as consent itself

A useful distinction is between obtaining informed consent and documenting that it occurred. OHRP describes informed consent as a process involving adequate information, comprehension, and voluntary choice. Documentation records that process in the manner required by the relevant framework.

This explains why a signature, thumbprint, mark, witness signature, or electronic record cannot independently establish that consent was genuinely informed. Documentation matters, sometimes as a legal or regulatory requirement, but the ethical substance lies in the decision that preceded it.

Do not appoint a substitute decision-maker merely because the person cannot read

A participant who cannot read does not automatically need someone else to make the participation decision. Whether another person can consent on behalf of a research participant depends on questions such as decision-making capacity, applicable law, and the research framework.

Replacing a capable participant's decision with someone else's because the participant cannot read would confuse accessibility with incapacity. The first response should ordinarily be to make the information accessible to the participant.

How consent might work when a participant cannot read

The participant's inability to read did not transfer the decision to the witness. It changed how information was communicated and how the consent process was documented.

Common mistakes when participants cannot read the form

Plan for non-readers before recruitment begins

If people who cannot read may reasonably be recruited, describe the proposed consent procedure in the protocol and ethics submission. Determine in advance how information will be presented, how comprehension will be assessed, whether a witness is required, who qualifies as an appropriate witness, and how consent will be documented.

The practical rule is straightforward even though the documentation rules can be less so: preserve the participant's own decision whenever they are capable of making it, remove unnecessary communication barriers, and follow the specific procedure approved for the study.

Before obtaining consent from someone who cannot read

Questions about consent when a participant cannot read

Reading the form is not what makes consent informed

How to Cite This Guide

This guide is intended to be read, shared, and used in research, teaching, and academic work. If you draw on its ideas, explanations, or other content, please acknowledge the source by citing the guide. Doing so gives appropriate credit and helps your readers locate the original resource.