This section of the Investigator Manual outlines the types of IRB review decisions, how those decisions are communicated, and options available when there is disagreement with a decision.
Types of Decisions
The IRB may approve research, require modifications to the research to secure approval, table research, defer research, or disapprove research:
- Approve: Made when all criteria for approval are met. See “IRB Approval Criteria” above.
- Modifications Required to Secure Approval: Made when IRB members require specific modifications to the research before approval can be finalized.
- Tabled: Made when 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 meeting.
- Deferred: Made when the IRB determines that the board is unable to approve research and the IRB suggests modifications that might make the research approvable. When making this motion, the IRB describes its reasons for this decision, describes modifications that might make the research approvable, and gives the investigator an opportunity to respond to the IRB.
- Disapproval: Made when the IRB determines that it is unable to approve research and the IRB cannot describe modifications that might make the research approvable. When making this motion, the IRB describes its reasons for this decision and gives the investigator an opportunity to respond to the IRB in person or in writing.
Communication of IRB Decisions
The IRB will provide you with a written decision indicating that the IRB has approved the Human Research, requires modifications to secure approval, or has disapproved the Human Research.
- If the IRB has approved the human research:The human research may commence once all other institutional approvals have been met. IRB approval is usually good for a limited period of time which is noted in the approval letter. If no continuing review for your study is required, this also will be noted in the approval letter.
- If the IRB requires modifications to secure approval and you accept the modifications:Make the requested modifications and submit them to the IRB via ARROW. If all requested modifications are made, the IRB will issue a final approval. Research cannot commence until this final approval is received. If you do not accept the modifications, write up your response and submit it to the IRB.
- If the IRB defers the Human Research:The IRB will provide a statement of the reasons for deferral and suggestions to make the study approvable and give you an opportunity to respond in writing. In most cases if the IRB’s reasons for the deferral are addressed in a modification, the human research can be approved.
- If the IRB disapproves the human research:The IRB will provide a statement of the reasons for disapproval and give you an opportunity to respond in writing.
In all cases, you have the right to address your concerns to the IRB directly.
Disagreeing with IRB Decisions
Researchers may request that the IRB reconsider a decision by submitting a written response to the IRB. When submitting a request to reconsider, the researcher must provide rationale for the request, including any additional supporting documents.
Grounds for a request are limited to:
- New information not reasonably available during the IRB review/investigation
- Material failure by the IRB to follow IRB policies and procedures
- The sanction exceeds the severity of the noncompliance violations, if applicable
- The action is disproportionate to the risks to subjects safety/welfare
These considerations also apply to all other submissions, including changes, continuing reviews, reportable events, and also where the IRB has suspended or terminated the research.