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

  • Revised IRB Forms, Changes Regarding Witness Signatures, and Genomic Data Sharing Policy

    Revisions to IRB Forms
    The UAB Office of the IRB (OIRB) has revised the Human Subjects Protocol (FOR200) and Sample Consent Form (FOR206) to reflect updated guidance and necessary corrections throughout. Please begin using these forms immediately. The outdated version of the Human Subjects Protocol will no longer be accepted as of March 1, 2017.
     
    NIH Genomic Data Sharing (GDS) Policy
    The National Institutes of Health (NIH) issued the Genomic Data Sharing Policy (GDS Policy) effective January 25, 2015. The GDS Policy applies to all NIH-funded research that generates large-scale human or non-human genomic data, as well as the future use of the data. This policy describes the responsibilities of investigators and institutions for the submission of human and non-human genomic data to data repositories and the secondary research use of such data as well as expectations regarding intellectual property.
     
    The UAB IRB website has been updated to include information regarding this policy and the requirements for submission.
     
    Click here to learn more about the UAB IRB requirements related to the GDS Policy.
     
    Revision to UAB Procedure 113 regarding the Witness Signature on the consent form
    The UAB Procedure 113 has been revised to reflect the witness signature is not always required by the UAB IRB. If a study will enroll illiterate participants or use a Short Form, the witness signature is required. If required by the sponsor or requested for some other reason, the justification should be described in the Human Subjects Protocol. The convened IRB may also request a witness signature based on the nature of the study.
     
    New studies:
    Beginning immediately, new studies submitted to the IRB may reflect this change.
     
    Ongoing studies:
    Note that no changes to ongoing studies may be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject. The approved protocol, including consent/assent procedures must be followed until changes (including the change in witness signature requirement described above) are approved by the IRB. Please follow the instructions below for the IRB to review and approve these changes for ongoing studies.
     
    UAB IRB reviewed studies:
    You may either submit your revision at any time via a Project Revision/Amendment Form (PRAF) or at the time of continuing review on the Investigator’s Progress Report (IPR).
    If submitting the revisions via a PRAF, do the following:
    1. Submit the PRAF with this change as the only item for review. Please do not include other changes to your ongoing study with this change as this will slow down the review.
    2. On the PRAF under item #4, mark Protocol revision and Revise or amend consent, assent form(s).
    3. Under item #5.c, paste the following information into the PRAF as applicable to help expedite the IRB’s review (include only one of the below options):
      • This protocol is currently approved with a witness signature required on the consent form(s). Because all participants are literate, I would like to remove the witness signature line from the consent form(s).
    4. Include tracked changes and clean versions of all revised consent forms.
    If submitting the revisions via the IPR at the time of continuing review, do the following:
    1. On the IPR (version 6/25/15) under item #10.c, mark “Yes” and paste the following information as applicable (include only one of the below options):
      • This protocol is currently approved with a witness signature required on the consent form(s). Because all participants are literate, I request the witness signature line be removed from the consent form(s).
    2. Include tracked changes and clean versions of any revised consent forms.
    Posted by Office of the Institutional Review Board for Human Use | 02/01/17
  • Revisions to the Federal Policy for the Protection of Human Subjects

    The U.S. Department of Health and Human Services (HHS) announced this morning revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule").  The rule is effective January 19, 2018, with the exception of the requirements for cooperative research, which are effective January 20, 2020.
     
    Please read the full announcement for further details.
    Posted by Office of the Institutional Review Board for Human Use | 01/18/17
  • New GCP Training Requirements for Clinical Trials

    The IRB has added a Good Clinical Practices (GCP) refresher course to its CITI course offering list in response to the new NIH policy on GCP training. The policy requires basic GCP training, then refresher GCP training every three years.
    Posted by Office of the Institutional Review Board for Human Use | 12/07/16
  • ​Victoria Leslie Cooper, CIP, named Director of the Office of the Institutional Review Board (OIRB)

    Victoria Leslie Cooper, CIP, has been named director of the UAB Office of the IRB (OIRB) effective January 1, 2017.  Leslie comes to this position with over 17 years of experience in human research protections.  Over 13 years of that experience is with the OIRB, having previously held positions of assistant director and associate director in the OIRB.
     
    During her tenure in the OIRB, Leslie has coordinated submissions of industry-sponsored trials to Western IRB (WIRB).  More recently, Leslie has been a leader in the field as human research protection programs develop single and central IRBs.
    Posted by Office of the Institutional Review Board for Human Use | 12/02/16
  • 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
  • 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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