An electronic consent form still has to contain every required element, but it is read on a phone, often without a researcher in the room. That changes how you write it. Here is a practical way to go from protocol to approved eConsent.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Key information
One screen, before the detail
Why is this study being done?
What will happen if I take part?
Risks and discomforts
Benefits and alternatives
Your data and privacy
Signatures
The short version
Step by step
Make a checklist from the regulations and your ethics committee's template: purpose, procedures, duration, risks, benefits, alternatives, confidentiality, compensation for injury, contacts and voluntariness, plus any additional elements that apply.
In a few short paragraphs: what the study is, why someone might or might not want to take part, the main risks, and that participation is voluntary.
Use headings such as "What will happen if I take part?" and answer them in plain language, with procedures in the order the participant will experience them.
Run a readability check, then ask people like your participants to read it and explain it back. Fix what they misunderstand.
Check that every section reads well on a small screen, and that signature steps are clear.
Submit the text and the electronic presentation, for example screenshots or a PDF of the screens, with the signature process described.
Writing
Consent forms often fail because they are written to protect the institution rather than to inform the person. Plain language does not mean leaving things out. It means choosing everyday words ("medicine" rather than "investigational product" after first definition), active sentences ("We will take a blood sample") and one term for one thing throughout. Numbers help: "about 1 in 10 people" is clearer than "common".
Risks deserve particular care. Group them by how likely and how serious they are, say what will be done to reduce and manage them, and avoid long lists of rare events without context. The DCT consent template shows how to explain remote procedures and data flows, and the wearable data consent template covers device data.
Studies involving children need a parent permission form and an age-appropriate assent form, often two or more versions for different ages. Studies involving adults who cannot consent need a representative process. See the pediatric assent template.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Checklist
| Element | Plain-language heading |
|---|---|
| Research purpose and duration | Why is this study being done, and how long will I be in it? |
| Procedures, including experimental ones | What will happen if I take part? |
| Foreseeable risks and discomforts | What are the risks? |
| Benefits | Could this study help me or others? |
| Alternatives | What are my other choices? |
| Confidentiality | Who will see my information? |
| Compensation and treatment for injury | What happens if I am harmed? |
| Contacts | Who can I talk to? |
| Voluntary participation and withdrawal | Do I have to take part, and can I stop? |
Check the full list of required and additional elements for the regulations and ethics committee that apply to your study.
In Capture
Build the consent from a template, preview it on a phone, and send it to participants for remote signing or use it in clinic. Participants confirm a one-time email code and acknowledge the legal statement before signing; the investigator countersigns with password re-authentication. Witness and representative signatures are available, and the signed PDF exports with timestamps and 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
••••••••••
Build it in the free sandbox and sign a test copy.
After approval
Put a version number and date on every consent document and keep a record of which version each participant signed. When the protocol changes in a way that affects what participants were told, the ethics committee will decide whether participants need to be informed or asked to sign an updated version. Plan how you will identify affected participants and document their decision.
Keep the approved text, the approved electronic presentation and the signed records together in the site file. Monitors will compare them. See the IRB submission checklist for what ethics committees usually ask for.
Before submission
Against the regulations and ethics template that apply.
Concise summary before the detail.
Readability check and reader testing.
Short sections with question headings.
Participant, investigator, witness and representative as needed.
Version and date on every document; signed version recorded.
Required elements include the purpose, procedures, duration, risks, benefits, alternatives, confidentiality, compensation for injury, contacts and voluntary participation. Check the full list for the regulations that apply.
A concise summary at the start of the consent that explains the most important reasons someone might or might not want to take part. The revised US Common Rule requires it.
Many ethics committees expect a reading level around that of a 12 to 14 year old. Test with readers as well as readability formulas.
Ethics committees usually review the content and the electronic presentation, including how signatures are obtained.
Yes. In Capture, optional witness and legally authorised representative signatures are supported.
Yes, in the free sandbox, starting from a consent template.
Start from a template in the free sandbox.