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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.
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.
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 Initial Review Using the Expedited Procedure - IRB PRO120
This procedure lists responsibilities of the investigator, OIRB and IRB for carrying out the initial review using the expedited procedure.
Procedure for Suspension or Termination of IRB-Approved Research and Administrative Hold - IRB PRO140
This procedure outlines the responsibilities of the investigator, OIRB and IRB with regard to suspension or termination of IRB-Approved research and administrative hold.
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.
Procedure for Review of Modifications to Previously Approved Research - IRB PRO148
This procedure outlines the responsibilities of the investigator, IRB, OIRB for the review of modifications to previously approved research by the convened IRB.
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