When reconsenting research participants, it's crucial to communicate clearly and explain any significant changes in the study. Provide a new consent form or addendum if applicable. Ensure participants fully understand the updated information and give them the option to withdraw if they choose not to continue under the new conditions.

Reconsenting should occur when advised by the Institutional Review Board (IRB) or whenever there are substantial changes to the research protocol that might affect participants' willingness to remain in the study, especially in complex or long-term trials. These changes might include new adverse events or additional risks.

Teams Roles and Responsibilities in the Reconsenting Process

• PI: The PI should be informed of the consent form changes and should introduce and explain the changes to the participant in detail. PIs should answer any questions that the participant may have about the updates to the Informed Consent Form (ICF). The same informed consent process should be followed to update participant including proper documentation.
• Coordinator/ Nurse Coordinator: Responsibilities include being informed of changes to the ICF, having a detailed discussion to explain what was changed in the ICF with participant, answering questions, documenting the complete process of the ICF discussion, using the teach-back method to verify understanding, keeping a log of the approved version and date of ICF used, charging for the ICF process or informing team member that handles charging and updating OnCore. Remember to give a copy of the signed ICF to the participant. Post ICF in Electronic Medical Record (EMR) when applicable.
• Regulatory Coordinator: Submitting the redlined version and a clean updated copy of the ICF to the IRB. If you have a central IRB that is submitting on your behalf, you must receive the approvals and file in your regulatory binder. The Regulatory coordinator needs to update team and follow their team’s process to file the updated ICF. Updated approvals and ICF needs to be placed in OnCore and follow your site’s SOP. The training log also needs to be updated that the team has been trained on the changes to the ICF.
• Data Coordinator: The data coordinator will need to enter that the participant has been reconsented. Elements to report may include date of reconsent, version of ICF and date of version.
• Administrative Coordinator/ Finance or Budget staff member: Should charge for the reconsent as allocated in the trial budget. This person should reconcile the payment in OnCore.
• Oncore Perspective: Indicate in OnCore that participant needs to be re-consented by using R symbol. Link invoicable of re-consent process to invoicables. Update ICF in Regulatory Documents.

It is important to hold REGULAR staff meetings to discuss the process and inform your team of the need to reconsent. It truly is everyone’s responsibility, and all team members play a role in reconsenting. Remember informed consenting is an ongoing interactive process that lasts throughout the duration of the trial. Ensuring that participants are well-informed and understand what their participation involves will help keep the participants engaged and aid in retention.

Resources on Clinical Trial Kiosk

PI: 

• https://www.uab.edu/ccts/education-training/clinical-translational-science/crsp-training
• ICF On the Go Podcast

Regulatory Coordinator:

• Regulatory Coordinator Toolkit on the Clinical Trials Kiosk

Coordinator:

• Informed Consent Checklist, Best Practices in obtaining ICF
• https://www.uab.edu/ccts/clinical-trials-kiosk/study-coordinator-toolkit

Common Regulations relating to Informed Consent:

• 21 CFR Part 50 subpart B 50.25
• 45 CFR 46.116-117
• 21 CFR 812
• 38 CFR 17.32
• CFR 431.117
• ICH GCP E6-2.9, 4.8