Informed consent is the process in which a person is told what a research study involves, understands it, and voluntarily agrees to take part. It is usually documented on a consent form that the person signs and dates.
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Informed consent
noun · clinical research
A process through which a prospective participant voluntarily confirms willingness to take part in a study after being informed of everything relevant to the decision, documented by a signed and dated consent form.
Related terms
In short
Explained
Three ideas sit inside the term. The person is informed: they receive an explanation of the study in language they understand. They understand it: they have time and opportunity to ask questions, and the person obtaining consent checks understanding rather than assuming it. And they agree voluntarily, free from coercion or undue influence, including from a treating clinician they depend on.
In the United States, FDA regulations on consent for FDA-regulated research set out the elements that must be provided. The list in 21 CFR 50.25 begins with a statement that the study involves research, an explanation of its purposes and expected duration, a description of the procedures and which are experimental, a description of reasonably foreseeable risks or discomforts, a description of benefits, and a disclosure of appropriate alternatives. It continues with further required elements, including those on confidentiality, contact information and voluntary participation. Research funded by US federal agencies also falls under the Common Rule (45 CFR 46), which has its own consent requirements, including a concise presentation of key information at the start; check the current text of both. Outside the US the same ground is covered by ICH GCP and by national and regional law.
The consent form is the written record. Under 21 CFR 50.27, consent is generally documented on a written form approved by the IRB and signed and dated by the participant or their legally authorized representative, and a copy goes to the person signing. The investigator must give the person enough opportunity to read it before signing, even if it is read aloud. Strong practice also records the discussion: who explained the study, when, and that questions were answered.
Adults with capacity consent for themselves. Where a person cannot, local law may allow a legally authorized representative to consent on their behalf. Children typically take part with parental permission and, where appropriate for their age, their own assent. Some people need an impartial witness, for example when a participant cannot read; see impartial witness eConsent.
A consent document nobody can follow is not informed consent. Plain language, short sentences and a clear structure matter, and you can test draft text with a readability checker. For participants with literacy or accessibility needs, see accessible low-literacy consent.
The process
The consent form and participant information are reviewed and approved before use. See IRB.
The participant gets the approved information, with enough time to read it and talk it over with others if they wish.
A qualified member of the study team explains the study and checks understanding.
The participant (or representative) signs and dates the form, and the person obtaining consent signs too. A copy is given to the participant.
If new information could affect willingness to continue, such as a protocol amendment, participants are told, and the documents are updated as the IRB requires.
Start from a consent template in the free sandbox, sign as a test participant and look at the signed PDF and audit trail. No credit card.
Electronic consent
Electronic consent (eConsent) puts the participant information and signature on a screen. It does not change the principle: the same information, time and voluntariness apply. What changes is the record. An eConsent system can store which version was signed, when, by whom, and link the signature to the exact document content, which paper cannot do on its own. Read the electronic informed consent regulations guide for what regulators expect, and HIPAA authorization versus informed consent if you work in the US, because the two are different documents.
If you are starting from scratch, the basic clinical trial consent template and our guide to writing an eConsent form give a structure to adapt. Your IRB or ethics committee must approve whatever you finally use.
Participant reads approved consent
Version 2.0
Participant signs on screen
Email code confirmed
Investigator countersigns
Password re-entered
Fully executed PDF exported
With audit trail
In Capture
Capture eConsent has the participant sign on screen with email one-time-code confirmation after acknowledging the legal-binding statement. Authorised site staff countersign with password re-authentication, and the document is fully executed only after countersignature. Optional witness and legally authorized representative signatures are supported. Each signature is cryptographically linked to the exact document content at signing, and the signed consent exports as a PDF with signature data, timestamps and the audit trail. Templates cover common study types, including pediatric assent.
Pre-launch readiness
1 site activated
1 form not yet approved
The process by which a person is told about a study, understands it and voluntarily agrees to take part, usually documented on an IRB-approved form they sign and date before any study procedure.
No. The form is the record of the process. Informed consent also includes the explanation, the chance to ask questions and the freedom to decline or withdraw.
Yes. Participation is voluntary, and a person may withdraw at any time without penalty or loss of benefits they are otherwise entitled to.
In US FDA-regulated research, 21 CFR 50.25 lists the elements, including the purpose and procedures, risks, benefits, alternatives, confidentiality, contacts and the voluntary nature of participation. Your IRB can require more. Check the current text.
Regulators accept electronic consent when the same information and process are provided and the system supports reliable signatures and records. Requirements vary by jurisdiction, so confirm with your ethics committee or IRB.
Consent is the agreement of someone legally able to give it. Assent is the agreement of a child or other person who cannot legally consent but can understand the study to an appropriate degree; a parent or guardian usually also gives permission.
Keep exploring
eConsent software
How Capture handles consent.
Electronic consent regulations guide
What regulators expect.
Basic consent template
Starting structure.
Institutional review board (IRB)
Who approves the form.
HIPAA authorization vs consent
Two different documents.
Consent readability checker
Test plain language.
Build, sign and countersign a test consent in the free sandbox. No credit card.