The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by the federal regulation, state law and local institutional policy.
The Office of the IRB (OIRB) provides administrative support to the on-campus IRBs and coordinates applications to off-campus IRBs approved for use by UAB:
Regardless of which IRB reviews a proposal, UAB investigators always apply for initial review through the OIRB at UAB.
The IRB reviews research involving human subjects. The aim of the IRB review is to ensure that research involving human subjects is conducted in an ethical manner. This includes ensuring that risks to participants are minimized, the selection of participants is equitable, and participants are informed fully of what their participation will entail and of the potential risks and benefits.
The IRB review is based on the principles outlined in the Belmont Report (Ethical Principles and Guidelines for the Protection of Human Subjects of Research), written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report was published in the Federal Register in 1979 and is the cornerstone on which the federal regulations protecting human research participants are based.
The definitions of "research" and "human subjects" (see Definitions) encompass not only clinical studies, but also projects that involve human tissue, blood samples, pathologic or diagnostic specimens, medical records, observation of public behavior, questionnaires, and surveys. Also included is research done for classes or research projects and studies using personal health information databases.
Graduate students who plan to complete a thesis or dissertation should usually have their own IRB-approved protocol. In cases where the student is listed as an investigator on a mentor's protocol, the protocol must clearly describe the student's research.
Individuals should direct questions about whether a proposed activity would constitute "research" and/or "human subjects research" to the OIRB.
IRB Approval Must Be Obtained Prior To Beginning Any Research Activity Involving Human Subjects.
The OIRB staff reviews all applications for extramural support as part of the review by the Office of Sponsored Programs (OSP). The OIRB staff reviews each application for involvement of human subjects. A separate IRB approval is required for each supported project.
UAB has a Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS) through the Office for Human Research Protections (OHRP). The assurance number is FWA00005960. The assurance document outlines UAB´s commitment to human subjects protections. The FWA became effective on November 24, 2003 and will expire, unless renewed, on September 19, 2010 (as of this printing). The current expiration date is always available online at the IRB Assurance web page.
The UAB IRB is in compliance with the applicable Code of Federal Regulations (e.g., DHHS 45 CFR 46; Food and Drug Administration 21 CFR 50, 21 CFR 56). The UAB OSP and IRBs operate in accord with ICH guidelines only to the extent that they are compatible with FDA and DHHS regulations. If a sponsor requires the additional requirements in the ICH-GCP (E6) guidance be followed, then the clinical trial involving drugs, devices, or biologics will be submitted to the Western IRB for review or proceed internally following that guidance.
Based on its review of regulations and guidance documents, UAB has determined that a case report of three or fewer cases (i.e., n = 3) does not constitute human subjects research and does not require review by the UAB IRB. (See POL043, UAB Policy on Case Reports, as well as the UAB HIPAA FAQ on using protected health information [PHI] in such cases.) Similarly, the use of human cell lines for in vitro research and research in animals is not considered human subjects research and does not require review by the UAB IRB if—and only if—the human cell lines are either (a) commercially available or (b) already derived and established and the identity of the donor(s) cannot readily be ascertained by the investigator (See POL042, UAB Policy on Determination of Human Subject Research on Cell Lines.)
In the cases described above, an investigator can request documentation from the IRB stating that a specific project does not require review. For case reports, see the IRB Guidance for Case Report. For commercially available cell lines and established cell lines for which the investigator cannot obtain any identifiers, complete the form for Established Human Cell Lines Not Requiring IRB Review.
NOTE: IRB review is required—before the project is initiated—if the project involves (a) case reports or retrospective medical record reviews with more than three patients (i.e., n > 3); (b) a cell line that is not commercially available if the identity of the donor is known—or can be readily ascertained—by the investigator; or (c) in vitro use of cells that is part of a larger project that involves human subjects research.
Submit all IRB materials and correspondence to the OIRB, in Room 470 of the Administration Building (AB). The Administration Building is located at 701 20th Street South, Birmingham, AL 35294-0104.
Page updated: May 8, 2013