Introduction

Introduction

What Are the IRB and OIRB?

At UAB, the IRB is a committee that reviews all research involving human subjects, regardless of sponsorship, if one or more of the following applies:
  • The investigators are acting as agents of UAB regardless of the site of the activity.
  • The research involves any UAB personnel, patients, students, or facilities owned and operated by UAB or UAB-affiliated entities.
  • The research is supported by extramural funds granted to (or applied for through) UAB.
  • The research is conducted using UAB funding at non-UAB performance sites.
  • The research is a "clinical investigation" or other clinical activity requiring IRB review under FDA regulations.
  • The research is regulated by other federal agencies.
  • Research studies involving humans not covered by UAB’s FWA will be conducted according to the guiding ethical principles outlined below.

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:

  • Two on-campus IRBs review most proposals that require convened review and all proposals that qualify for expedited review.
  • Western IRB (WIRB), in Olympia, Washington, provides convened review of most protocols sponsored by industry.
  • The Pediatric Central Institutional Review Board (PedCIRB), based in Rockville, Maryland, provides review of most pediatric oncology protocols conducted by the National Cancer Institute.
  • IRBs associated with the Multicenter Academic Clinical Research Organization (MACRO)—which currently includes Washington University, Vanderbilt University, University of Pennsylvania, and UAB—may review proposals through this cooperative agreement.

Regardless of which IRB reviews a proposal, UAB investigators always apply for initial review through the OIRB at UAB.

What Does the IRB Review?

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.

Basic Principles of The Belmont Report
Respect for Persons Beneficence Justice
View The Belmont Report

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.

Projects Not Requiring IRB Review

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.

What Is The Application Process?

The decision trees published by OHRP and available online may be helpful in determining which type of review is suitable. If an investigator is uncertain about how to categorize a research project, he or she should discuss the project with an OIRB staff member. The IRB accepts four types of applications for initial review of research involving human subjects:
  1. Not Human Subjects Research (NHSR) Designation
    • Only the IRB can designate activities as NHSR.
    • See Section 8 for details on how to apply.
  2. Exempt Review
    • Only the IRB can assign Exempt status.
    • See Section 9 for details on how to apply.
  3. Expedited Review
    • Only research that meets certain criteria is eligible:
      • Some or all of the research appearing in the “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Review” published by the Department of Health and Human Services (DHHS) and the reviewer finds that:
        • The research involves no more than minimal risk.
        • The research is not “classified” research.
        • The identification of the participants or their responses will not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
      • Minor changes in previously approved research during the period (of 1 year or less) for which approval is authorized, which are submitted as described in the section on Project Revisions & Amendments.
    • See Section 10 for details on how to apply.
    • See Section 12 for details on continuing review.
  4. Convened Review
    • All human subjects research that does not qualify for the above types of review is reviewed by the convened IRB.
    • See Section 11 for details on how to apply.
    • See Section 12 for details on continuing review.

How Can I Contact the IRB?

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.

Telephone: (205) 934-3789
Fax: (205) 934-1301

Page updated: May 8, 2013