When a participant cannot give consent themselves, someone with legal authority signs for them. Capture supports a Legally Authorized Representative (LAR) signature in the same eConsent workflow, with email one-time code verification, investigator countersignature and an exportable signed PDF.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Consent form sent to the LAR
Secure link by email
LAR signs on screen
Name and relationship to participant recorded
Email one-time code confirmed
Two-step verification
Investigator countersigns
Password re-entered, meaning statement shown
Fully Executed
Signed PDF with audit trail
LAR consent in brief
LAR
signature supported in the eConsent workflow
2-step
signature verification with email one-time code
Hashed
signature linked to the exact document text
Free
sandbox to test the full signing flow, no time limit
The concept
Informed consent belongs to the participant. Some prospective participants cannot give it: adults who lack decision-making capacity because of dementia, stroke, severe mental illness or critical illness, and children below the age of consent. The regulations let someone else consent for them, provided the law gives that person the authority. US FDA rules call this person a legally authorized representative, defined in general terms as an individual or body authorised under applicable law to consent on behalf of a prospective subject. ICH E6 says legally acceptable representative. The EU Clinical Trials Regulation, Regulation (EU) 536/2014, says legally designated representative and deals with incapacitated adults in Article 31 and minors in Article 32.
The consequence is that the list of eligible people is not universal. In the United States state law decides, and many states have a hierarchy such as a court-appointed guardian, a health care agent, a spouse, an adult child, then a parent or sibling. In EU member states national law decides, and Article 29 of the Regulation leaves room for national rules that go further. A multi-country study therefore needs a country-specific description of who may sign, written into the protocol or the site’s consent SOP and approved by the relevant ethics committee. Software cannot know which family member qualifies, so it should not pretend to.
What software can do is make the result unambiguous. A reviewer opening the file years later should see who signed, in what capacity, for which participant, on which version of the document, and who countersigned. That is exactly what paper consent forms often leave unclear when the “relationship” box is blank or the signature is illegible. The electronic signatures page explains the controls behind each signature, and the eConsent overview shows the full workflow.
In Capture
The consent document is sent by secure link. The LAR reads it in a browser on a phone, tablet or computer, with no app to install. They sign on screen, acknowledge the legal-binding statement for electronic signatures and confirm with a one-time code sent by email. The signature record carries the LAR’s name and relationship to the participant.
Participant
Cannot consent: LAR signs
LAR signature
Name, relationship, time, one-time code verified
Witness co-signature
Optional, if the process requires one
Investigator countersignature
Pending
Audit trail and document hash
Responsibilities
The signature is the last step of a longer process. This table separates the parts that need human judgement from the parts a system can make traceable.
| Step | Who is responsible | Where it lives |
|---|---|---|
| Decide the participant lacks capacity or is a minor | Investigator or delegate, per protocol and law | Medical record or source note |
| Identify the person who may legally consent | Site, using the country or state hierarchy approved by the ethics committee | Source note, optionally a field on the enrolment eCRF |
| Explain the study to the LAR and to the participant as far as possible | Person conducting the discussion | Consent discussion note |
| Sign the consent form as LAR | LAR | Capture eConsent signature record |
| Co-sign if a witness was needed | Witness | Capture eConsent, optional co-signature |
| Countersign | Investigator or authorised site staff | Capture eConsent, password re-authentication |
| Seek the participant’s own consent if capacity returns | Investigator | A new consent signed by the participant, per local process |
Capture does not currently provide a dedicated re-consent workflow, so a participant who regains capacity signs a fresh consent through the normal eConsent flow, as the site’s SOP directs.
Create a consent form, run the signing flow including countersignature, and inspect the audit trail in the free sandbox. No credit card, no time limit.
Setting it up
State when a LAR may consent, who qualifies in each country or state, and what the ethics committee has approved. Link it to your informed consent form so the wording matches.
Start from a consent template, such as the basic clinical trial consent template, and write the LAR-facing language: the LAR is being asked to decide what the participant would want, not only what they themselves prefer.
The investigator documents the assessment in the medical record. Optionally add an enrolment eCRF field for “consent given by” (participant or LAR) so it exports with the data.
The LAR signs and verifies by email code; a witness co-signs if needed; the investigator countersigns after review. Pending countersignatures are visible in the consent status view.
Export the signed PDF with its embedded signature data and audit trail for the investigator site file, and give the LAR a copy as the regulations require.
Be clear about the limits
Capture does not decide who is a valid LAR, does not check identity documents, and does not assess capacity. Those are clinical and legal judgements, and a form field that appeared to settle them would be false assurance. Video consent, multilingual consent documents and a dedicated re-consent push are also not available today, so studies that need them should plan the process outside the tool.
If the LAR is not present at the site, remote signing by secure link works with the email one-time code, but ethics committees differ on how the discussion with a remote surrogate must be documented. Agree it in advance and describe it in the consent SOP. For the general model of signing away from the site, see remote patient consent, and for the cohort-level view see eConsent software for clinical trials.
Audit readiness
Capacity or age documented in source before the consent was taken.
Name and relationship recorded in the signature record; supporting evidence of authority held per site SOP.
Document hash ties the signature to the exact consent text and version.
Consent signed before any study procedure; timestamps in the audit trail show it.
Investigator countersignature with a meaning statement; status shown as Fully Executed.
Signed PDF provided and the hand-over noted in source.
Yes. eConsent supports a Legally Authorized Representative signature for participants who cannot consent for themselves. The LAR name and relationship to the participant are recorded as part of the signature record.
They describe the same idea under different regimes. US FDA rules say legally authorized representative, ICH E6 says legally acceptable representative, and the EU Clinical Trials Regulation says legally designated representative. Who qualifies depends on state or national law.
No. The site decides who may legally consent, following the protocol, the law and the ethics committee approval. Capture records who signed and in what capacity, and the signature is verified with an email one-time code.
Yes. Witness co-signature is optional in the same workflow, for example where the LAR cannot read the form and the process requires an impartial witness.
Signers acknowledge the legal-binding statement for electronic signatures before signing, and the signature is verified, hashed to the document and countersigned. Whether an electronic consent is acceptable for your study is decided by the protocol, the regulator and the ethics committee.
The investigator follows the consent SOP and seeks the participant’s own consent. In Capture that is a new consent signed by the participant through the normal flow. There is no dedicated re-consent workflow today.
Yes. The LAR receives a secure link by email and signs in a browser, then confirms with a one-time code. Confirm with your ethics committee how a remote discussion with a surrogate must be documented.
Yes. The free sandbox includes eConsent with the full signing workflow, including countersignature and the audit trail. There is no credit card and no time limit.
Build the consent form, run the LAR signing flow and review the audit trail in the free sandbox. No credit card; you pay only when you go live with real participants.