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.
Scientific, Scholarly Integrity (Protocol Oversight Review Form)Conflict of InterestSubcontractsMaterial Transfer Agreements (MTAs)Devices, Inventions and Patent Policy, and Protocol-Specific ApprovalsAdvertisementsData Safety Monitoring Information
Women and MinoritiesPregnant Women, Fetuses, Neonates and Non-Viable NeonatesPrisonersChildren, Minors
Additional Regulatory RequirementsThe documents linked below contain details on regulations specific to research under the following categories:
Funded by the Department of Defense (DOD) - GUI339Funded by the Department of Energy (DOE) - GUI338Funded by the Department of Justice (DOJ)/National Institute of Justice (NIJ) - GUI341Conducted within the Bureau of Prisons (BOP) - GUI341Generating 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 ReviewApproval PeriodApproval of Informed Consent Documents
Consent forms used with participants must bear the IRB approval stamp.
Conducting the Research
No Modifications Without Prior IRB ApprovalNotify OIRB of all Reportable ProblemsProvide OIRB with Copies of All Monitoring ReportsParticipant Withdrawal from Research—Guidance for Investigators