Consent
Describes required and as-applicable information that must be included in the informed consent process
FDA Sponsor Requirements for Investigators Who are Serving as Sponsors of Investigational Drug or Biologic Studies (GUI307)
Requirements for a sponsor-investigator on an investigational drug or biologic study
Investigator Responsibilities for Drug Supplies (GUI336)
Highlights responsibilities of investigators who sign FDA Form 1572.
Investigator Responsibilities for Handling, Inventory, and Disposing of Devices (GUI337)
Highlights the responsibilities of investigators conducting FDA-regulated research involving devices.
Responsibilities of Investigators Under FDA Regulations (GUI331)
Outlines responsibilities for investigators conducting research that is subject to FDA regulations (e.g., drugs, devices, biologics).
Draft Guidance for Expedited Status Update
Outlines requirements for consideration when research will involve the use of educational records (FERPA) and/or programs receive funding from the U.S. Department of Education (PPRP).
Guidance on Additional Requirements for Protocols Conducted by UAB and Sponsored by a Department of Defense (DoD) Component (GUI339)
Outlines regulations and directives that specifically address the protection of human subjects in research sponsored by any component of the US Department of Defense (DoD).
Guidance on Additional Requirements for Protocols Conducted by UAB and Sponsored by the Department of Department of Justice (DOJ)/National Institute of Justice (NIJ) and Research Conducted with the Bureau of Prisons (BOP) (GUI341)
Outlines requirements for the conduct of research sponsored by DOJ, NIJ, or BOP.
Guide to Mandatory Reporting Laws Affecting Research Conducted in Alabama (GUI326)
A survey of relevant statues requiring disclosure to public health officials and/or other individuals under law.
IRB Guidance for Case Reports
Describes UAB IRB policy for review of case reports.
Key Personnel Flowchart
Key Personnel for IRB
Public Dataset Nomination - Sample (FOR240-sample)
Special Approval Requirements for Research Undergoing IRB Review (GUI303)
Outlines requirements for approval from other UAB areas (e.g., radiation safety, Clinical Research Unit).
Statement on Institutional Conflicts of Interest (SUP401)
Preliminary guidelines for UAB's management of institutional conflict of interest.
Summary of Reporting Requirements for Investigators to the IRB (GUI325)
Requirements for investigator reporting of events, issues, changes, etc.
UAB Investigator Checklist ICH-Good Clinical Practice (GCP) Guidance (GUI344)
Details additional investigator responsibilities that are required when the study is being conducted to comply with ICH-GCP guidance.
Which Review Is for Me?
Used as a guide in deciding whether to apply for Exempt, Expedited, or Convened IRB review.
HIPAA
Recruitment and HIPAA
Describes effects of HIPAA on use of PHI in seeking participants for studies.
Institution Review Form
Used to apply to rely on an external IRB. Version: December 5, 2019
Policies and Procedures