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When should we re-consent subjects?

The key question to ask is: Could this new information influence a reasonable person’s decision to continue participating in the study? A reasonable person may be influenced by factors that affect their values, goals, or personal interests. For instance, changes such as adding or removing co-/sub-investigators or updating investigator addresses are unlikely to impact a participant’s decision. However, changes like identifying a new significant risk related to the study drug, introducing additional procedures, or reducing participant compensation could affect their willingness to continue.

If you're unsure, contact the IRB office for guidance. Keep in mind that any revised consent form or addendum must be reviewed and approved by the IRB before it can be used.

Continuing Review and Total number of subjects enrolled/accrued

Federal regulations set the criteria for IRB approval of research undergoing continuing review. Under these regulations, the investigators and the IRB are responsible for fulfilling specific requirements associated with the continuing review. In particular, investigators are responsible for submitting sufficient materials and information regarding their project so that the IRB is able to meet its regulatory obligations prior to the expiration date of the current IRB approval. The investigator meets these obligations through the submission of a Form 3 (Continuing Review Submission Form) via iMedRIS, the IRB electronic system. As part of the continuing review of a research project, the IRB evaluates the number of subjects who have been enrolled or accrued to the study. Therefore, investigators must supply to the IRB the total number of subjects who have been enrolled or accrued to the study. Enrollment in a research study occurs when the consent form is signed, not when the subject is randomized or completes a visit. Even if the subject drops out of the study before undergoing any procedures, he/she counts as being enrolled. The total number of subjects enrolled in a research study also includes the number of subjects who failed screening procedures after signing a screening consent form, subjects who were lost to follow-up, and subjects whose participation was terminated early by the investigator. For medical record/chart reviews, subjects are considered to have been accrued after their data has been collected.

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Federal regulations outline the requirements for IRB approval of research undergoing continuing review. Both the investigator and the IRB have specific responsibilities under these rules. Investigators must submit enough information about their study to allow the IRB to fulfill its regulatory obligations before the current IRB approval expires. This is done by submitting a Form 3 (Continuing Review Submission Form) through iMedRIS, the IRB’s electronic system.

As part of the continuing review, the IRB evaluates how many subjects have been enrolled or accrued. Investigators must therefore report the total number of participants who have enrolled in the study. A subject is considered enrolled once they sign the consent form, even if they withdraw before any procedures take place. This number should also include:

• Subjects who signed a screening consent but did not pass screening,
• Subjects lost to follow-up, and
• Subjects whose participation was ended early by the investigator.

For studies involving medical records or chart reviews, subjects are considered accrued once their data has been collected.