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Definition of a Principal Investigator
This policy defines the UAB employee classification/status of a UAB employee who may serve as a principal investigator on externally sponsored grants and contracts. This policy will also help OSP’s user community understand why, in certain cases, the PI of record for the funding entity may not be the PI of record for UAB. For example, on certain training or fellowship grants, UAB designates the mentor as the PI, whereas NIH designates the student as the PI.
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.
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
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 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.
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
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.
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