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UAB Policy on Case Reports - IRB POL043
This policy differentiates case reports from human subjects research.
Procedure for the Informed Consent Process and Documentation of Informed Consent - IRB PRO113
This procedure outlines the responsibilities of the Investigator, OIRB and IRB regarding the informed consent process and documentation of informed consent.
Procedure for Documentation of Convened IRB Proceedings - IRB PRO146
This procedure outlines the responsibilities of the OIRB and the IRB for documentation of convened IRB proceedings.
Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation - IRB PRO153
This procedure outlines the responsibilities of the investigator, OIRB and IRB for approving a waiver or alteration of the consent process and the waiver of consent documentation.
UAB Policy on Minimizing Risks to Subjects - IRB POL027
This policy describes the process by which the IRB determines if risks are minimized for participants in a proposed project. Review process and relevant definitions are included in the document.
UAB Policy on Quality Assurance and Quality Improvement for the Human Research Protection Program - IRB POL034
This policy requires the implenmentation of a quality assurance and quality improvement program to monitor compliance with federal regulations and improve the Human Research Protection Program processes
UAB Expectations for Research Sponsors - IRB POL005
This policy outlines the requirements for formulating contracts with sponsors of proposed research.
Procedure for Identifying and Managing Investigator and Institutional Conflicts of Interest - IRB PRO123
This procedure outlines the responsibilities of the Investigator, IRB, and OIRB for handling Investigator and Institutional Conflicts of Interest.
Procedure for Continuing Review of Research Approved by the Convened IRB - IRB PRO147
This procedure outlines the responsibilities of the investigator, OIRB and IRB for continuing review of research approved by the convened IRB.
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.
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