Research re-consent on protocol amendment

How do we re-consent every active participant on a new IRB-approved consent version after a protocol amendment, and track it until the last one is done?

Treat the amendment as a cohort with a deadline. When the IRB approves a new consent version, Callvu classifies the change (what changed, whether re-consent is required for all active participants or a subset, whether a notification suffices for some, the IRB's deadline, the languages), builds the list of active participants from the study's enrollment, sends each the new version on their phone or schedules it for their next visit with a plain summary of what changed, chases each until the re-consent is signed with the required signers, routes a participant who cannot be reached, declines or has lost capacity to the principal investigator in the Decision Desk, writes each re-consent to the research office's system and the EHR, and reports the cohort's progress until it is complete.

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 amendment changed the risks; forty participants were re-consented at their next visit, and the twelve who were between visits were found by the monitor six months later.

Today, without Callvu

A protocol amendment that changes the risks, the procedures or the alternatives requires the IRB to approve a new consent version and the site to re-consent active participants, usually by a deadline. The site's coordinator keeps a spreadsheet and catches participants at visits; those between visits, those who moved, those with a representative are missed; the study's continuing review reports the gap as deviations.

The Common Rule requires that participants be told of significant new findings and that consent be obtained on the approved version; the IRB sets whether re-consent, an addendum or a notification is required and by when; the sponsor's monitor checks every participant against the version in force at each visit. The cohort is a list, each participant is a chase, and the completion is a report.

A cohort chased on its deadline is a cohort with no deviations.

How it runs

From the requestto the system of record.

The IRB approves a new consent version for an active study. Callvu classifies the change and opens the re-consent cohort.

Active participants or their representatives: Read the summary of what changed and the new version, ask questions, and sign on their phone or at a visit.
Study team: Conducts the discussions, signs, and resolves exceptions.
Principal investigator and IRB office: Decide unreachable, declining or incapacitated participants in the Decision Desk.
Callvu: Classifies the change, builds the cohort, sends and chases, checks, writes and reports.

Classify the change and the cohort
The amendment's content, the IRB's determination (full re-consent, an addendum, a notification letter, or re-consent only for a subset such as participants still in treatment), the deadline, the languages and any assent or representative requirements classify the cohort; the active participants are listed from the study's enrollment with their status, their next visit and their consent version.
Send and chase
Each participant receives the new version with a plain summary of what changed, on their phone where remote re-consent is approved or scheduled at their next visit with the study team, and is chased on the IRB's deadline with the cohort showing who is outstanding; the discussion and the questions are logged as in the original consent.
Chase and verify the signatures
Each re-consent is checked for the version, the elements and the required signers (the participant or representative, the person obtaining consent, a witness or interpreter where required), and a copy is delivered; a participant who cannot be reached by the deadline, declines the new version, or has lost capacity since the original consent goes to the principal investigator or the IRB office in the Decision Desk with only the allowed outcomes (withdraw from the study, continue under the IRB's determination, document the attempts, or obtain a representative's consent).
Write back and report
Each re-consent is written to the research office's system and the EHR with the version and the date, the participant's version of record is updated so the monitor sees it at each visit, and the cohort report shows the amendment's progress to the research office and the IRB until the last participant is complete or decided.

Where it ends: Every active participant was re-consented on the new version or decided by the investigator before the deadline, each record is in the research office's system with the version, and the cohort report shows the amendment closed. The Decision Trace shows the classification, each re-consent's checks and any decision; the Audit Trace shows each send, chase and 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): Under 45 CFR 46.116(c)(5), where appropriate participants must be told that significant new findings that may relate to their willingness to continue will be provided; the IRB reviews amendments under 46.108 and 46.109 and determines whether the change requires a new consent version and re-consent of enrolled participants, by what means and by when; the documentation requirements of 46.117 apply to the re-consent as to the original.
FDA regulations (21 CFR 50 and 56) and ICH E6 for regulated studies: Changes in research require IRB approval before implementation except to eliminate immediate hazards, the revised consent form must be approved before use, and ICH E6 requires that participants be informed in a timely manner of new information and that the revised consent be signed and dated by the participant and the person conducting the discussion; the monitor verifies the version at each visit.
HIPAA research authorization (45 CFR 164.508) where the data use changed: An amendment that changes the use or disclosure of protected health information requires a new or revised authorization, captured with the re-consent.

Company policies

The cohort is built from the enrollment the day the version is approved; no participant is found by chance at a visit.
Each participant is chased on the IRB's deadline, with the cohort showing who is outstanding.
Unreachable, declining or incapacitated participants are decided by the investigator and documented before the deadline.
The research office's system is the system of record for the version of record per participant.

Controls

Change and cohort classification from the IRB determination.
Participant list from enrollment with status and next visit.
Sends and chases on the deadline.
Version, element and signer checks.
Decision Desk for exceptions.
Research office and EHR writes with the cohort report.

Clocks and deadlines

IRB deadline: The date the IRB set for re-consent, on every participant's chase.
Next visit: A participant due before the deadline is re-consented at the visit; one not due is reached remotely.

Documents and checks

The IRB approval and the classification
The cohort list with status
Each re-consent with version, signers and date
Any investigator decision
The research office record and the cohort report

In the Decision Trace

The classification and the IRB's determination.
Each re-consent's checks.
Any decision and the person.

In the Audit Trace

Each send and chase with time.
Each signature with time and device.
The writes and the report.

The handoff

Between the front doorand the back office.

The front door

The participant's phone where remote re-consent is approved, or the next visit with the study team.

The back office

The research office and the IRB see the cohort's progress; the monitor finds the version of record per participant.

The Decision Desk

A participant who cannot be reached, declines or has lost capacity goes to the principal investigator or the IRB office in the Decision Desk with only withdraw, continue under the IRB's determination, document the attempts, or obtain a representative's consent.

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.

Who needs to be re-consented?

The active participants the IRB's determination covers (all, or a subset such as those still in treatment), listed from the enrollment the day the version is approved.

What if a participant cannot be reached?

The attempts are documented and the principal investigator decides in the Decision Desk before the deadline, under the IRB's determination.

How does the monitor see it?

Each participant's version of record is updated in the research office's system with the date, and the cohort report shows the amendment's completion.

Related processes

Research informed consent HIPAA authorizations Substance use disorder records consent Try it in the sandbox All healthcare processes

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