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Standard Operating Procedure for Re-consent Procedures in Clinical Trials

Purpose

The purpose of this SOP is to describe the standardized process for re-consenting clinical trial participants whenever new information, safety updates, or protocol amendments arise that may affect their willingness to continue participation. This ensures protection of participants’ rights, safety, and autonomy, in compliance with ICH GCP, FDA, EMA, CDSCO, and WHO guidelines.

Scope

This SOP applies to all investigators, sub-investigators, study coordinators, and regulatory personnel involved in obtaining and documenting re-consent from participants in ongoing clinical trials. It covers situations such as safety updates, protocol amendments, administrative corrections, and regulatory-mandated re-consent.

Responsibilities

• Principal Investigator (PI): Ensures participants are re-consented when required and that accurate documentation is maintained.
• Study Coordinator/Sub-Investigator: Assists in conducting the re-consent process and maintains updated participant records.
• Regulatory Affairs Manager: Ensures all re-consent forms are EC/IRB-approved before implementation.
• Quality Assurance Officer: Audits re-consent records for compliance.
• Head of Clinical Research: Oversees re-consent process implementation.

Accountability

The Principal Investigator is accountable for ensuring re-consent procedures are carried out correctly and in compliance with applicable regulations. Failure to re-consent participants in a timely and documented manner may lead to ethical and regulatory violations.

Procedure

1. Identification of Need for Re-consent
Assess whether new information (e.g., safety updates, protocol amendments, revised study design) necessitates re-consent.
Determine the type of re-consent required (substantial or administrative).
Seek EC/IRB approval for the updated Informed Consent Form (ICF) prior to implementation.

2. Preparation of Re-consent Forms
Draft revised ICFs incorporating new information.
Translate into local languages as required.
Submit updated versions to EC/IRB for review and approval.

3. Conducting the Re-consent Process
Provide participants sufficient time to review revised ICF.
Explain the new information clearly, addressing risks, benefits, and participant rights.
Encourage participants to ask questions and confirm their understanding.
Obtain participant signature (or legally authorized representative), date, and witness signature (if required).
Provide a copy of signed ICF to the participant.

4. Documentation and Record Keeping
File signed re-consent ICFs in the site master file and participant trial records.
Record re-consent activity in the Consent Documentation Log.
Maintain version control of all ICFs used.

5. Re-consent for Vulnerable Populations
For minors or legally incapacitated subjects, ensure consent is obtained from legal guardian and assent (if appropriate).
For illiterate participants, ensure presence of impartial witness during re-consent.

6. Electronic Re-consent (eConsent)
Use validated systems for eConsent compliant with FDA 21 CFR Part 11, EMA, and ICH GCP.
Ensure identity verification and maintain secure audit trails.

7. Archiving
Store all re-consent forms securely with restricted access.
Retain records for minimum of 5 years post trial completion or as per local regulations.

Abbreviations

• SOP: Standard Operating Procedure
• ICF: Informed Consent Form
• PI: Principal Investigator
• EC: Ethics Committee
• IRB: Institutional Review Board
• QA: Quality Assurance
• eConsent: Electronic Consent

Documents

1. Re-consent Form Template (Annexure-1)
2. Re-consent Documentation Log (Annexure-2)
3. EC/IRB Re-consent Approval Letter (Annexure-3)

References

• ICH E6(R2) – Good Clinical Practice
• US FDA 21 CFR Part 50 – Informed Consent
• EMA Guidance on Re-consent Requirements
• WHO GCP Guidelines
• CDSCO Clinical Trial Rules, 2019

Version: 1.0

Approval Section

Annexures

Annexure-1: Re-consent Form Template

Annexure-2: Re-consent Documentation Log

Annexure-3: EC/IRB Re-consent Approval Letter

Revision History

For more SOPs visit: Pharma SOP

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Standard Operating Procedure for Informed Consent Process in Clinical Trials

Purpose

The purpose of this SOP is to establish a standardized informed consent process for clinical trials, ensuring that participants or their legally authorized representatives are adequately informed about the nature of the trial, potential risks, benefits, and their rights. This process ensures compliance with ICH-GCP, WHO, FDA, EMA, and CDSCO guidelines and safeguards the autonomy and welfare of trial participants.

Scope

This SOP applies to all investigators, sub-investigators, clinical research coordinators, and trial staff responsible for obtaining informed consent in clinical trials conducted under the Clinical Research Department. It also applies to situations requiring re-consent or electronic consent.

Responsibilities

• Principal Investigator (PI): Ensures the informed consent process is conducted properly and in compliance with applicable regulations.
• Sub-Investigator/Study Coordinator: Assists in explaining study procedures and obtaining consent.
• Witness (if required): Signs the consent form when a participant is illiterate or unable to read.
• Quality Assurance Officer: Reviews consent records during audits to verify compliance.
• Head of Clinical Research: Provides oversight and approves SOP implementation.

Accountability

The Principal Investigator is accountable for ensuring that no trial-related procedure is performed before obtaining valid informed consent. The PI must also ensure appropriate documentation and safe custody of signed informed consent forms (ICFs).

Procedure

1. Preparation of Informed Consent Form (ICF)
Draft ICFs in accordance with ICH GCP and regulatory requirements.
Translate ICFs into local languages where necessary.
Obtain EC/IRB approval for all versions of the ICF before use.

2. Conduct of Informed Consent Process
Provide potential participants sufficient time to read and understand the ICF.
Explain the purpose, procedures, risks, benefits, rights, and confidentiality protections.
Allow participants to ask questions freely before signing.
Ensure participants understand that participation is voluntary and withdrawal is possible at any time.

3. Documentation of Consent
Obtain signatures of participant (or legal representative), PI/sub-investigator, and witness (if applicable).
Record date and time of consent.
Provide participant with a signed copy of the ICF.
File original ICF securely in site trial records.

4. Re-Consent Process
Re-consent participants if new safety information emerges, protocol is amended, or ICF content changes.
Conduct re-consent in the same manner as initial consent, with signatures and dates documented.

5. Electronic Consent (eConsent)
Use validated electronic systems that meet regulatory requirements (FDA 21 CFR Part 11, EMA guidelines).
Ensure participant identity is verified and audit trails are maintained.

6. Archiving
Store ICFs in a secure, access-controlled environment.
Retain records for minimum of 5 years post trial completion or as per regulatory requirement.

Abbreviations

• SOP: Standard Operating Procedure
• ICF: Informed Consent Form
• PI: Principal Investigator
• EC: Ethics Committee
• IRB: Institutional Review Board
• QA: Quality Assurance
• eConsent: Electronic Consent

Documents

1. ICF Template (Annexure-1)
2. Informed Consent Process Checklist (Annexure-2)
3. Consent Documentation Log (Annexure-3)

References

• ICH E6(R2) Good Clinical Practice
• US FDA 21 CFR Part 50 – Informed Consent Regulations
• EMA Guidance on Electronic Consent
• WHO Guidelines on Informed Consent
• CDSCO Clinical Trial Rules, 2019

Version: 1.0

Approval Section

Annexures

Annexure-1: ICF Template

Annexure-2: Informed Consent Process Checklist

Annexure-3: Consent Documentation Log

Revision History

For more SOPs visit: Pharma SOP