PI submits the Continuing Review Form in eIRB
The IRB Review Process Begins
The Continuing Review will undergo a pre-review by an IRB coordinator. The coordinator will ensure that the application is complete and in keeping with the IRB’s requirements. The investigator may be asked to make changes to the application and study documents during this time. Once the coordinator has determined that the submission is complete, it will be routed for Expedited or Full Board Review.
For Expedited projects:
• The submission is sent to an IRB member for review
• The study may be approved or the investigator may be asked to make some changes to the study before approval will be granted. If the reviewer doesn’t agree that the continuing review can be expedited, the study will be sent to Full Board Review.
• Once approved, the approval letter with links to the approved study materials and stamped consent forms (when applicable) will be sent to the PI via eIRB.
For Full Board projects:
• The submission will be assigned to one IRB member for review
• The project will be presented at a convened IRB meeting
• The study will receive the one of the following determinations by the IRB:
o Approved: This means the application has been approved by the IRB. The approval letter with links to the approved study documents, and newly stamped consent forms, when applicable, will be sent to the PI via eIRB (unless your research is conducted at the Jesse Brown VAMC, in which case the IRB Office will forward your stamped consent document to the R&D Committee—which will release it upon R&D Committee approval).
o Modifications Required to Secure Approval: This means that the application is approved on the condition that the PI meets specific conditions set forth by the IRB. These conditions will be sent in a letter to the PI in eIRB. The PI’s response will be reviewed by an IRB Chair or designee to ensure that the conditions for approval have been met. If they have been met, an approval letter with links to the approved study documents, and newly stamped consent forms, when applicable, will be sent to the PI via eIRB. If the conditions are not met satisfactorily, the study will require further review at a convened meeting.
o Deferred: This means that the application is lacking the information the IRB requires in order to approve the study. For example, the IRB may be missing information about research risks and benefits, the adequacy of privacy and confidentiality protections, or the adequacy of the informed consent process because the research protocol provides insufficient information related to these aspects of the research. The PI will be sent a letter which explains the basis for the deferral and the information that the IRB needs to review the project. After the PI responds to the letter, the study will be sent back for review to the same IRB that originally reviewed the continuing review. If the study expires during this time, the research may not continue until the IRB reviews the research project and approves it. Once approval is granted, an approval letter with links to the approved study documents, and newly stamped consent forms, when applicable, will be sent to the PI via eIRB.
o Disapprove: Disapproval means that the application did not meet the criteria for approval as set forth in the regulations and the IRB cannot describe modifications that might make the research approvable. The PI will be sent a letter in eIRB which explains the basis for the disapproval. The PI will be given an opportunity to respond to the IRB. The response will be reviewed by the same IRB that disapproved the study. In rare cases, the disapproval may be overturned, and approval granted. If however, the IRB concludes that the submission should remain disapproved, the study will be closed in eIRB.
- If your project expires: If the study expires prior to approval of the Continuing Review, all research activities must stop until IRB approval of the study is re-instated. If, in the Principal Investigator's opinion, it is in the best interests of the research subjects to continue the study procedures (i.e., when the research interventions hold out the prospect of direct benefit to the subjects or when withholding those interventions poses increased risk to the subjects), please contact IRB staff via email at email@example.com to seek confirmation that the IRB agrees with this determination. If the investigator or IRB determines that it is not in the best interests of already enrolled subjects to continue participation, the PI must stop all human subjects research activities on this study, including intervening or interacting with subjects and obtaining or analyzing identifiable private information about human subjects.