Consent that a participant signs but did not understand is not informed. This guide covers how to write, present and check consent for people with low literacy or accessibility needs, what IRBs expect, and, plainly, which parts Capture eConsent supports and which it does not.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Study
DEMO-OBS-02
Population
Adults, mixed literacy
Signature path
On-screen + witness
What to take from this guide
The problem
Consent documents grow because every stakeholder adds a paragraph: the sponsor adds risk language, the institution adds its template, the IRB adds a required sentence. By the time it reaches a participant it can run to many pages of dense legal text. Adults with limited reading skills, people reading in their second language, people with low vision or dyslexia, and anyone who is simply anxious in a clinic room will struggle with it. They often sign anyway, because signing is what is expected.
US and international rules on informed consent share a simple idea: the information must be given in language the participant can understand, with enough time to consider and the chance to ask questions. The revised US Common Rule also asks that consent begin with a concise summary of key information. Exact citations and local rules vary, so check with your IRB, but the direction is clear and it applies to paper and electronic consent alike.
A useful way to think about it is to separate three things: the text (what it says and how), the delivery (how the participant meets it, with whom, with what support) and the record (how agreement is captured and proven). Software mostly touches the record and part of the delivery. Most of the gain is in the text and the conversation, which is why the first sections of this guide are about writing, not tools.
The text
Run each section of the consent through these checks before it goes to the IRB. A coordinator who has never seen the protocol is a good reviewer: if they cannot explain a paragraph back, rewrite it.
Open with a short summary: why the study is being done, what you will be asked to do, the main risks, the main benefits, and that taking part is voluntary.
Aim for one idea per sentence. Replace "randomized" with "chosen by chance, like flipping a coin" and "adverse event" with "a health problem".
Write "You will visit the clinic four times" rather than "Participants will be required to attend four visits".
If "placebo" or "biopsy" must appear, explain it in the same sentence and keep the term consistent afterwards.
Say "about 45 minutes" and "one tablespoon of blood" instead of unexplained units or ranges.
Descriptive headings, short paragraphs, bullet lists for steps, and generous spacing. Avoid long all-caps blocks.
Say clearly that the person can say no or stop at any time and that their usual care does not change.
Use the free consent readability checker to see where sentences are long. Many IRBs ask for text around the 6th to 8th grade level; check what yours expects.
The delivery
Good consent is a conversation with a document attached. The strongest low-tech technique is teach-back: after explaining a topic, ask the participant to tell you in their own words what they will do or what the main risk is. If the answer is wrong, the explanation, not the participant, needs another try. Prepare four to six teach-back questions in advance and note in the consent record that the discussion took place.
Give people time. Offering the document ahead of the visit, with a way to ask questions before they arrive, helps participants who read slowly or want to talk it over with family. Capture's remote consent flow supports sending the consent to the participant to read on a phone or computer, but the conversation with the investigator or coordinator should still happen, in person, by phone or by video, outside Capture.
Think about the environment as well. A quiet room, a chair, large print available on request, the option of a support person, and a coordinator who is not rushing change what participants take in. For participants with vision, hearing, motor or cognitive differences, ask them what helps, and record the accommodation.
Many regulatory frameworks allow consent for a person who cannot read through an impartial witness who attends the whole discussion, confirms that the information was accurately explained and that the participant appeared to understand, and signs the form. The exact conditions differ by region and IRB. In Capture, an optional witness co-signature is supported; see impartial witness eConsent.
Where the law allows a legally authorized representative to consent on someone's behalf, the participant's own assent and dignity still matter. Capture supports an optional LAR signature; see legally authorized representative consent. Who qualifies as an LAR is set by law and your IRB, not by the software.
Be specific
Procurement and IRB reviewers ask direct questions about accessibility. Here are direct answers, limited to what is verified.
| Need | Capture eConsent | How to cover it |
|---|---|---|
| On-screen signature | Yes: participant signs on-screen, must acknowledge the legal-binding statement | Used as is |
| Identity confirmation | Yes: mandatory email OTP confirmation | Participant needs access to email |
| Witness for non-readers | Yes: optional witness co-signature | Define who may witness in your protocol and IRB documents |
| LAR consent | Yes: optional LAR signature | IRB-approved process for capacity and eligibility of the LAR |
| Staff countersignature | Yes: password re-authentication and a legal meaning statement; fully executed only after countersignature | Used as is |
| Proof of what was signed | Yes: signature hash-linked to the document content; signed PDF with timestamps and audit trail | Used as is |
| Read-aloud or audio narration | Not available | Coordinator reads aloud, or a separate audio file approved by the IRB |
| Video explanation | Not available | Separate IRB-approved video, referenced in the consent text |
| Translation | Not available (do not rely on it) | IRB-approved translated documents handled outside Capture; confirm status with us first |
| Reading-level scoring | Not in the consent flow | Use the separate readability checker before you upload text |
Screen reader and keyboard accessibility of the participant pages has not been separately certified in the materials this page relies on. If that matters for your population, test the sandbox with your own tools and ask us.
Paste your rewritten consent into a free sandbox, send it to a colleague on a phone and see how it reads. Free, every feature, no credit card.
The record
Once the text and conversation are right, the record should be simple to produce and hard to dispute. Capture's eConsent keeps the sequence short and puts each step on the audit trail.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Putting it together
Apply the checklist above, then run the text through a readability check and a coordinator read-through.
Describe large print, a support person, the witness process and the LAR process in the submission. Use the IRB submission checklist to make sure the pieces are there.
Write four to six, and decide how the coordinator records that the discussion took place.
Standard, witnessed or LAR. Build the eConsent in the sandbox and rehearse each path. See how to write an eConsent form.
If many participants need repeat explanations of the same section, revise that section and amend the consent through your IRB.
No. There is no audio narration or video in the consent flow. A coordinator can read the consent aloud, or you can use a separate IRB-approved audio or video file.
No. Do not rely on built-in translation. IRB-approved translated documents have to be prepared and handled by your team; ask us about the current status of multilingual support before you plan around it.
Capture supports an optional witness co-signature. Whether and how a witness is acceptable is set by your regulations and IRB. See the impartial witness eConsent page.
Many IRBs ask for roughly the 6th to 8th grade level, but requirements differ. Check yours, and test the real text with the readability checker and a coordinator.
Neither by itself. Screens can add clarity if the text is plain and a person still explains it, or add friction if participants are not comfortable with devices. Offer a paper or in-person option when your population needs it.
No. It is practical design guidance. Your IRB or ethics committee and your regulatory adviser decide what is required.
Keep exploring
Informed consent readability checker
Find the hard sentences.
How to write an eConsent form
Elements and screens.
Impartial witness eConsent
Witness co-signature.
LAR consent software
Consent through a representative.
Remote patient consent
Consent away from the clinic.
Pediatric assent template
Age-appropriate assent.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.