The information in this section applies to all types of research reviewed by the UAB IRB and to all types of application for IRB review. Because this information is general in nature, it includes directions to several sources of further information. The specific requirements for each type of IRB application are described in separate sections of this guidebook.
Before Applying for IRB Review
Scientific, Scholarly Integrity (Protocol Oversight Review Form)
Conflict of Interest
Subcontracts
Material Transfer Agreements (MTAs)
Devices, Inventions and Patent Policy, and Protocol-Specific Approvals
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Data Safety Monitoring Information
Women and Minorities
Pregnant Women, Fetuses, Neonates and Non-Viable Neonates
Prisoners
Children, Minors
Additional Regulatory Requirements
The documents linked below contain details on regulations specific to research under the following categories:
Funded by the Department of Defense (DOD) - GUI339
Funded by the Department of Energy (DOE) - GUI338
Funded by the Department of Justice (DOJ)/National Institute of Justice (NIJ) - GUI341
Conducted within the Bureau of Prisons (BOP) - GUI341
Generating clinical trial data that is intended to be submitted to regulatory authorities – ICH-GCP (E6) applies - GUI 344 UAB Investigator ICH-GCP Checklist
No work may begin until formal IRB approval has been issued by the OIRB.
IRB Review—Outcomes and Approval Details
Outcomes of IRB Review
Approval Period
Approval of Informed Consent Documents
Consent forms used with participants must bear the IRB approval stamp.
No Modifications Without Prior IRB Approval
Notify OIRB of all Reportable Problems
Provide OIRB with Copies of All Monitoring Reports
Participant Withdrawal from Research—Guidance for Investigators