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

  • 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
  • IRB Website Changes

    The IRB has made several important changes and improvements to its website.

    1. Changes to the navigation menu at the top of the website:
      • Contact Information is now located in he About tab.
      • Links and FAQs are now located in the Guidance tab.
      • The WIRB tab has been renamed Industry Protocols to reflect the expanded focus of our external associations.
    2. The search box in the upper right-hand corner of the IRB website now allows you to search for contents specifically within the IRB website. It is labeled "Search the IRB Site".
    3. The IRB Guidebook has been reformatted with navigable chapter listings. The search box in the upper right-hand corner of the Guidebook section of the IRB website now allows you to search for content specifically within the Guidebook. It is labeled "Search the Guidebook".
    4. The FAQs have been reorganized. The display has been redesigned for ease of navigation. 

    We hope the changes will help serve your needs better, and make finding content on our website easier. 

    Posted by Office of the Institutional Review Board for Human Use | 02/09/15
  • 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

 

Give Feedback