Office of the IRB

Office of the IRB

Office of the IRB
AAHRPP_Full_Color_150.gifThe UAB Institutional Review Board for Human Use (IRB) is a committee established under federal regulations for the protection of human subjects in research (45 CFR 46). Its purpose is to help protect the rights and welfare of human participants in research conducted under the auspices of the University of Alabama at Birmingham.
 
The guiding ethical principles of the IRB— respect for persons, beneficence and justice—are embodied in the “Belmont Report”: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979).
 
University policy requires that all research involving human subjects be reviewed and approved by the UAB IRB before the research begins. This requirement applies to all human subjects research conducted by faculty, staff, and students, on- and off-campus, regardless of funding.
 
Research involving human subjects includes the collection of data about or from human subjects and the use of existing data or specimens. Any changes to an IRB-approved project must be reviewed and approved by the IRB before they can be implemented. Continuing review is also required at regular intervals for protocols reviewed by the convened IRB and through expedited procedures.
 
The UAB IRB requires Principal Investigators and all other research team members to complete and document appropriate training in the protection of human subjects. Additionally, the IRB monitors ongoing research for adherence to applicable regulations, policies, and procedures.
 
More information about the IRB and its role in the UAB Human Research Protection Program can be found on this website or by contacting the staff in the Office of the IRB.​

IRB News and Announcements

  • New Guidance Information on IRB Website

    The OIRB has provided updated guidance information on our website.  New information has been posted regarding the following:
    • Flowchart to determine who are key personnel
    • NIH description of ethnic and racial categories
    • IRB form compatibility

    Key Personnel

    The IRB has created a flow chart to help determine whether individuals involved with research should be considered to be key personnel involved in the conduct of human subjects research.  The Key Personnel Flowchart is available under the General category on the Other Guidance page of the IRB website.

    Ethnic and Racial Categories

    The table on the Investigator's Progress Report follows the reporting requirements of the NIH. The following is their description of how the ethnic and racial categories are defined:​​

    Ethnic Categories

    • ​​Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.  The term “Spanish origin” can also be used in addition to “Hispanic or Latino.
    • Not Hispanic or Latino​.

    ​​​​​​Racial Categories

    • ​American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.​
    • Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.) 
    • Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
    • Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”
    • White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

    IRB Form Compatibility Issues

    IRB forms on this page are compatible with Microsoft Word 2010 and newer on Windows and Microsoft Word 2016 for Mac. Some features (e.g., checkboxes) are not compatible with older versions of Microsoft Word or any version of Pages for Mac. The newest versions of Microsoft Word are available at no charge to UAB faculty, staff, and students through UAB IT. Contact UAB IT for more information on upgrading your software. If you are unable to upgrade to a compatible version of MS Word, you may simply place an "X" before the checkbox that corresponds to your answer in the form.
     
    Posted by Office of the Institutional Review Board for Human Use | 04/22/16
  • Notice of Proposed Rulemaking for the Federal Policy for Protection of Human Subjects

    ​A Notice of Proposed Rulemaking (NPRM) has been published seeking comments on proposed changes to the Federal Policy for the Protection of Human Subjects. The UAB Office of the IRB (OIRB) is requesting input from the UAB research community on the proposed changes in order to respond most effectively to the NPRM. The proposed rule includes significant changes to the regulations governing human subjects research. Among these changes are more relaxed requirements for certain categories of lower risk research and more stringent requirements for informed consent, especially in regard to use of biospecimens.
    Posted by Office of the Institutional Review Board for Human Use | 10/30/15
  • IRB Continuing Training Requirement for 2015

    ​UAB IRB policy requires continuing training once in every three year period for key personnel involved in human subjects research.  The UAB Office of the IRB has worked with the CITI Program to create different continuing training courses for (1) Biomedical and (2) Social/Behavioral/Educational researchers.  UAB personnel may complete either of these courses to meet continuing training requirements.  Both courses require investigators to complete three required modules and three of six elective modules. 
     
    Key personnel who completed their initial human subjects training before January 1, 2015 are required to complete one of the continuing training courses prior to December 31, 2015.  This continuing training will be valid for the 2015-2017 period.
     
    Additional information, including step by step instructions for registering, can be found on the OIRB website:  Continuing IRB Training.
     
    If you have questions about IRB training requirements, please contact the Office of the IRB at 934-3789.
    Posted by Office of the Institutional Review Board for Human Use | 10/09/15
  • Change in State Law Regarding Age of Consent

    On May 7, 2015, Governor Bentley signed into law Act 2015-167, which lowered the age of consent to 18 years old (previously 19 years) for IRB-approved research conducted by an accredited college or university. This means that 18 year olds may now consent for themselves to participate in research conducted at UAB under IRB approval. The IRB has updated most of its forms with this information and will continue to revise policies and procedures to recognize this change in the law. The revised forms must be used for all submissions received in the OIRB after September 1, 2015.
    Posted by Office of the Institutional Review Board for Human Use | 06/26/15
  • IRB Form Changes - June 2015

    UAB IRB forms have been revised as of June, 2015. New versions of these forms will be required for all submissions received after September 1, 2015. These include: Human Subjects Protocol, Investigator's Progress Report, Sample Consent Form, Checklists for new submissions for both full and expedited reviews, Checklists for renewal submissions for both full and expedited reviews.
    Posted by Office of the Institutional Review Board for Human Use | 06/26/15
  • Expired Form FDA 1572 continued use approved

    ​On April 30, 2015 the Form FDA 1572 on the FDA website at http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsAlphabetically/ is expired.

    The FDA is in the process of updating and posting a new Form FDA 1572. Even though it is expired, the FDA approved continued use of the current form.

    We will monitor the FDA website and will post notice of the new form's release, when available.

    Posted by Office of the Institutional Review Board for Human Use | 05/06/15
  • Changes to Consent Form May 2014

    ​The following are changes to the Sample Consent Form, version 05/29/14

    • Font has been changed to Calibri to comply with Institutional style guidelines.
    • Header:  The header has been updated to include Sponsor Protocol No., when applicable.
    • Risks and Discomforts:  Clarification to instructions in Randomization section and revisions to the example paragraph have been made.
    • Confidentiality:  
      • Change in language regarding publishing results of research
      • Updated Billing Compliance language
      • Addition of clinical trials indicator in medical records
    • Voluntary Participation and Withdrawal:  Instructions have been updated.
    • Cost of Participation:  Addition of sample language regarding Category B medical devices.
    • Signatures:  Several changes in the guidance.
    • HIPAA Authorization Form:  Revision to consent cancellation language.

    Click here for a more detailed summary of the changes.

    The sample consent form is available online by clicking this link.

    Posted by Office of the Institutional Review Board for Human Use | 06/04/14
  • FDA 1572 Updated

    Version date 07/2013, available at the following link:
    Posted by Office of the Institutional Review Board for Human Use | 01/01/13

 

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