Guidance on the Re-consenting Process

May 14 2024

Written by Minh N. Tran, BSN, OCN, CCRP, Kaiser Permanente Southern California, Research & Evaluation Department-Clinical Trials Division

Consenting is not just about asking patients or their Legally Authorized Representative (LAR) to sign their names on the consent form. As you have heard or read, consenting in clinical trials is an ongoing communication process with patients and/or LARs to confirm their willingness to participate and provide important study updates throughout their participation. When there are important study changes, the formal process to re-confirm and document the patient's voluntary participation under the new conditions is reconsenting.  

What are some study changes that may require re-consenting?

• Important changes that could affect patient safety, e.g., new adverse events or additional risks to the patient, changes in the severity of adverse events or risks.
• Changes that required submission of additional data, e.g., additional imaging submission to another vendor.
• Important administrative changes such as a change in the study Principal Investigator.
• Re-consent requirements are shared in broadcast messages and are posted in the Protocol Related Documents area on the CTSU website. Requirements are also found in the CIRB Approved Documents, in the CIRB Application associated with any amendment. 

Who may determine reconsenting requirements?

• The sponsor
• The study IRB of Record. For NRG Oncology NCTN studies, the CIRB is most often the IRB of Record.
• The local site IRB/REB/IEC
• Local institutional policy

What methods may be used for re-consenting?

• Verbal and/or written re-consenting may be required.
• Sometimes, new information, such as new risks, could impact a patient’s willingness to continue participation in research.  It’s important to share new risk information with the patient as directed. The site may be required to notify the patient verbally first to allow the patient to understand and acknowledge the new study information. Once the approved written consent form is implemented, the site may be required to obtain written reconsent with an updated consent form.

Which patients must be re-consented?

• Re-consentmay be required for all consented patients or certain subsets of patients.
• Dependingon the changes to the study, the subsets may be:
  • patientscurrently receiving specific treatment(s).
  • patientswho are randomized to a particular arm.
  • patientswho discontinued treatment within a certain number of days of the new amendmentactivation.

When will patients be re-consented?

• Re-consent may be done as soon as possible or at the next study visit or by a certain time.
• It is important to reconsent patients within the required timeline to ensure patient’s autonomy is being respected and to promote patient’s safety.

What modes may be used for re-consenting?

• In-person re-consenting at the required time frame as directed.
• Remote or eConsent, provided the process for these consent mechanisms is supported by a local policy that has been approved by the CIRB. Sites under an IEC or REB should follow local regulatory requirements for remote or eConsent. 

What happens if the site doesn’t reconsent the patient?

• Missed re-consenting is a serious matter.  When it is discovered that re-consenting was not obtained as required, the site must reconsent the patient immediately with the current consent and notify the CIRB/IEC/REB.
• Local policy should also be followed for internal reporting and documenting.
• Required follow-up actions will be determined by the CIRB/IEC/REB.

Do I need to document the re-consenting process?

• Documenting the re-consenting process in the patient’s chart is an important step of the re-consenting process.  As you already know, this expression, “if it’s not documented, then it’s not done.” 
• Similar to initial consenting documentation, the re-consenting process should be thoroughly documented. The following are best practice considerations for the re-consent process that should be clearly documented
  • Local requirements: e.g., Reviewed Bill of Rights with the patient/LAR in California.
  • Consent changes that were discussed with the patient/LAR.
  • The review of all sections of the new consent form with the patient/LAR.
  • The review of the contact person if the patient/LAR has any questions.
  • The wishes of the Patient/LAR regarding continuing interest in participating in the research study.
  • That all questions from patient/LAR were answered.
  • Ensure that the Patient/LAR and consenter have accurately signed and dated the study consent and that every yes/no consent question has a response.
  • A copy of all signed consent pages have been provided to the patient/LAR.

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