Post-submission Process for New Studies
- PI submits the eIRB+ Application
- The IRB Review Process Begins Pre-Review
The submission 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 Exempt, Expedited or Full Board Review.
- IRB Review For Non-Committee Studies
- 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 feel that the study qualifies for Exempt or Expedited Review, 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.
- Note: The IRB member may also determine that the study under review does not meet the definition of human subjects research, or that the study meets the definition of human subjects research but the institution is not engaged in research.
For Full Board studies
- The submission will be assigned to two IRB members for review.
- If the reviewers have questions, concerns or edits, they will be relayed to the submission preparer in advance of the meeting (as time allows). An analysis of studies across all panels found that responding to pre-meeting requests for changes reduced overall time from Meeting date to final approval from 27.6 days to 4.7.
- The project will be presented at a convened IRB meeting.
- The study will receive the one of the following determinations by the IRB:
- 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).
- 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.
- Tabled: This means that the IRB cannot approve the research at a meeting for reasons unrelated to the research, such as loss of quorum. When taking this action, the IRB automatically schedules the research for review at the next available meeting.
- 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 to the same IRB panel that reviewed it previously. Since all but one of the IRB panels meets monthly, this means that the response will not be reviewed until the next month. The research may not proceed until the IRB reviews the revised 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.
- 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 sent back to the same IRB panel 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.