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UAB Policy on Use of and Investigation with Drugs, Biologics, Devices, or Test Articles under FDA Regulations - IRB POL021
Clinical investigations involving human subjects and drugs, biologics, devices or test articles are subject to review. In order to comply with federal regulations, the IRB will determine what types of applications and exemptions (when applicable) are required for the study. This document describes various types of studies and instructions for submission and compliance.
Procedure for Communication Among IRBs - IRB PRO118
This procedure lists responsibilities of the investigator, ORIB and IRB for communication among IRBs.
Procedure for Compliance Issues with Human Subjects Regulations or IRB Requirements or Determinations - IRB PRO128
This procedure outlines responsibilities for dealing with compliance issues with Human Subjects regulations or IRB requirements or determinations.
UAB Policy on Reporting to Institutional Officials and Regulatory Agencies- IRB POL024
This policy describes the IRB's obligation to report certain determinations to UAB officials, regulatory and other federal regulatory agencies, and sponsors.
Procedure for Quality Assurance (Monitoring of Human Subjects Research) - IRB PRO102
This document lists specific responsibilities of the investigator, OIRB and IRB for monitoring human subjects research
UAB Policy on Determination of Human Subject Research on Cell Lines - IRB POL042
This policy outlines UAB's approach to determining whether use of commercially available cell lines is defined as human subjects research.
Procedure for Determination of Exemption from Human Subjects - IRB PRO105
This procedure documents the requirements for determining an exemption from Human Subjects research regulations, including the responsibilities of the Investigator, OIRB and IRB. An attachment that details federal criteria for determining exemption is also included in the document.
Procedure for Policy Development and Communication for the Human Research Protection Program - IRB PRO110
This procedure lists the responsibilities delegated to the investigators, OIRB and IRB, and Institutional Official to ensure proper maintenance, development and use of IRB policies.
Procedure for Not Human Subjects Research Designation - IRB PRO117
This procedure describes how human materials or data not involving human subjects may be classified as Not Human Subjects Research.
Procedure for Waiver to Informed Consent Process in Research Planned for Emergency Settings - IRB PRO119
This procedure lists responsibilities of the investigator, IRB, OIRB, and sponsor for waiver to the informed consent process in research planned for emergency settings.
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