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.

This policy requires relevant administrators and employees of UAB and UABHSF to ensure that clinical services associated with research studies are billed appropriately and in compliance with relevant laws, regulations, and contractual obligations.

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.

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

This policy outlines the requirements for formulating contracts with sponsors of proposed research.

This policy describes the IRB's obligation to report certain determinations to UAB officials, regulatory and other federal regulatory agencies, and sponsors.

This document lists specific responsibilities of the investigator, OIRB and IRB for monitoring human subjects research

This policy outlines UAB's approach to determining whether use of commercially available cell lines is defined as human subjects research.

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.

This policy clarifies rights and benefits (individual and institutional) associated with ownership of copyrights and intellectual property.