IRB Tip Archive

When should we re-consent subjects?

The basic criterion is this: Does the new material represent information that might affect the decision of a reasonable person about whether to continue participation in the study? The decision of a reasonable person might be affected by considerations that impact his or her values, goals, or interests. For example, changes in co-/sub-investigators or the addresses of investigators would be unlikely to impact on the values, goals, or interests of study participants. On the other hand, the addition of an important new risk of the study drug, the inclusion of new procedures the subject must undergo in the study, or a decrease in study payment are examples of changes that may affect a reasonable person's decision about whether to continue study participation. When in doubt, just call the IRB office! Remember that your revised consent form or the addition of a consent form addendum must be reviewed and approved by the IRB before you use it.

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.