Research informed consent

How do we present the IRB-approved consent version to a prospective research participant, log their questions, capture the signatures and the witness, and send the record to the research office?

Run the consent discussion as a versioned, witnessed, logged event. When a patient is approached for a study, Callvu classifies the study and the participant (the protocol, the IRB-approved consent version and language, the participant's capacity and age, whether a legally authorized representative, a witness, an interpreter or a short form is required, the HIPAA research authorization), presents exactly that version on a secure screen with the required elements in plain language, logs the participant's questions and the answers from the study team, chases the signatures of the participant or representative, the person obtaining consent, the witness and the interpreter, checks the consent for completeness and version, and writes the signed record to the research office's system and the EHR with the date, the version and who obtained it.

In scopeComplex: multi-party handoffsCallvu moves: classify, chase and verify, write back

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Last updated November 7, 2026.

The problem today

The monitor found participants consented on a version the IRB had retired three weeks earlier, and the sponsor stopped enrollment.

Today, without Callvu

Research consent is a conversation that must be documented as a legal record: the right approved version, every required element, a signature from the participant or their representative, from the person obtaining consent, from a witness where required, from an interpreter where used, the date, and a copy to the participant. Paper versions proliferate across sites; a retired version is used by mistake; a signature line is missed; the monitor's finding becomes a protocol deviation and the sponsor's audit.

The Common Rule sets the elements of informed consent and the documentation requirements, the FDA adds its own for regulated studies, HIPAA requires a research authorization for the use of protected health information, and the IRB controls the approved version. Each is a check the consent process can enforce: the version from the IRB system, the elements from the approved form, the signers from the protocol, the record to the research office.

A consent captured on the approved version with every signature is a record the monitor accepts.

How it runs

From the requestto the system of record.

A study team member approaches an eligible patient for a study (in clinic, by phone with a link, or remotely). Callvu classifies the study and the participant and opens the consent.

Participant or legally authorized representative: Reads the consent, asks questions, and signs on a secure screen; receives a copy.
Study team member obtaining consent: Conducts the discussion, answers questions, and signs.
Witness and interpreter: Sign where the protocol, the regulation or the short form requires.
Research office and IRB: Hold the approved versions and receive the signed record.
Callvu: Classifies, presents the approved version, logs questions, chases signatures, checks and writes.

Classify the study and the participant
The protocol and its IRB status, the currently approved consent version and the languages available, the participant's age, capacity and language, whether a legally authorized representative, assent, a witness, an interpreter or a short form is required, whether the study is FDA regulated, and the HIPAA research authorization (combined or separate) classify the consent and the signers; a protocol without a current approval or a version that is not the approved one stops here.
Present and log
The approved version is presented on a secure screen with the required elements (the purpose, the procedures, the risks, the benefits, the alternatives, confidentiality, compensation and injury terms, the voluntary nature and the right to withdraw, the contacts, and the additional elements where applicable), the participant's questions and the study team's answers are logged with time, and the discussion is documented as the regulation requires.
Chase and verify the signatures
The participant or representative, the person obtaining consent, and the witness and interpreter where required sign on their own devices or the same secure screen with identity recorded; a missing signature is chased from the right person; the consent is checked for the version, every element and every signer, and a copy is delivered to the participant; a capacity question, an assent requirement or an emergency research situation goes to the principal investigator or the IRB office in the Decision Desk with only the allowed outcomes.
Write back
The signed consent with the version, the date, the signers and the question log is written to the research office's system and to the EHR as the regulation and the policy require, the HIPAA authorization is recorded for the privacy office, and the participant is enrolled on the study with the consent date so the re-consent process can find them when the version changes.

Where it ends: Each participant was consented on the IRB-approved version with every element, every signature and the questions logged, and the research office and the EHR hold the record the monitor will ask for. The Decision Trace shows the classification, the version and any decision; the Audit Trace shows the presentation, the questions and each signature with time.

Runtime enforcement

What is enforcedwhile the work runs.

The regulations preloaded in Callvu Studio and the bank's own policies, applied as steps that run, not lines in a binder. A step that breaks a rule does not run, so a completed run was compliant.

Regulations

Common Rule (45 CFR 46): Informed consent must be sought under circumstances that give the prospective participant sufficient opportunity to consider, in understandable language, with the basic and additional elements in 45 CFR 46.116 (including the key information summary at the start), documented by a written consent form approved by the IRB and signed by the participant or the legally authorized representative under 46.117 (with a short form and a witness where used), with a copy given to the signer; the IRB approves each version and the consent must be obtained on the current one.
HIPAA research authorization (45 CFR 164.508 and 164.512(i)): The use and disclosure of protected health information for research requires an authorization with the required elements (or an IRB waiver), which may be combined with the consent; the authorization is recorded for the privacy office and governs the data use.
FDA informed consent regulations (21 CFR 50) and ICH good clinical practice (E6) for regulated studies: FDA regulated studies require the elements in 21 CFR 50.25, documentation under 50.27 with the participant's dated signature, and under ICH E6 the signature of the person who conducted the discussion and the impartial witness where applicable; electronic consent is acceptable under the FDA's guidance with the identity and the audit trail.

Company policies

Only the IRB-approved current version can be presented; a retired version cannot be opened.
Every required signer signs, and the record is checked for the version, the elements and the signers before it is filed.
Questions and answers are logged as part of the consent discussion.
The research office's system is the system of record for the consent, with the EHR holding the clinical copy.

Controls

Study, version and participant classification.
Approved version presentation with the elements.
Question and answer logging.
Signature chases by signer with identity.
Completeness and version checks with Decision Desk for capacity and assent.
Research office and EHR write with the copy to the participant.

Clocks and deadlines

Before any study procedure: The signed consent must be on file before enrollment and any research procedure.
Version currency: The IRB's approval dates; a version change triggers the re-consent process.

Documents and checks

The classification with the approved version
The consent as presented and the question log
The signatures with identity and time
Any decision
The research office record, the EHR copy and the participant's copy

In the Decision Trace

The classification and the version.
The signers required and obtained.
Any decision and the person.

In the Audit Trace

The presentation with time.
Each question and answer with time.
Each signature with time and device, and the write.

The handoff

Between the front doorand the back office.

The front door

A secure screen in clinic or a link to the participant's phone for remote consent, with the study team on the call.

The back office

The research office receives a checked record; the IRB's version control is enforced at presentation.

The Decision Desk

A capacity question, an assent requirement, a representative's authority or an emergency research situation goes to the principal investigator or the IRB office in the Decision Desk with only the allowed outcomes.

Proof

In scope.Proof at scale, not one process at a time.

The kind of process Callvu runs in production for customers in this industry. Ask for a reference on this exact process. The results below are the industry's published proof; each claim code links to its record on agents.callvu.com.

23 hospitals in the Ministry of Health network run on Callvu.

Across Callvu customers

More than 1,000 processes are live across Callvu customers.

Across Callvu customers

Questions

What buyers ask next,answered plainly.

How is the right version guaranteed?

The IRB-approved current version is the only one the process can present; a retired or unapproved version cannot be opened.

Who has to sign?

The participant or their legally authorized representative, the person obtaining consent, and a witness and interpreter where the protocol, the short form or the regulation requires; each is chased until the record is complete.

Can consent be obtained remotely?

Yes, on the participant's phone with the study team on the call, with identity recorded and the audit trail the FDA's electronic consent guidance expects.

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