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Institutional Review Board (IRB)

The purpose of the University of Alabama's Institutional Review Board (IRB) is to ensure the safe and ethical treatment of humans as subjects in research, public service, and training programs. In accordance with federal and university regulations, it is required that the IRB review all research involving human subjects conducted at or sponsored by the University of Alabama regardless of the funding source. The University of Alabama's IRB has a moral duty and obligation to protect human subjects prior to the commencement of any research study and to discontinue any protocol upon notification of irregular activity warranting such action.

IRB Board Members Login Resources
Medical   Non-Medical Alphabetical listing of Forms, Guidance Documents, Policies
FIND IT FAST: Topical list of forms, documents, policies
IRB Mini-Guides
Meeting/Deadline Schedule IRB Review
Medical   Non-Medical Research, Ethics, and IRB Resources



IRB Notes


The UA guidance document on Department of Defense Regulations for Human Subjects Research has been updated.  The following changes have been made to the document at this time:

  • Additional protections for military research participants to minimize undue influence
  • Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C, and D
  • Waiver of consent is prohibited for classified research and “experimental subjects”
  • If obtaining consent from the LAR of an experimental subject, the IRB must determine that the research will benefit the subject.
  • Additional safeguards for international research to minimize risks, host country approval, investigator permission, and international collaborators
  • Additional requirements for reporting of non-compliance or suspension/termination of DoD-sponsored research
  • Formal agreement between organizations is required for multi-site research

Investigators working on FDA regulated studies should note the following additional FDA requirements for informed consent:

  • As of March 7, 2012, the FDA requires the following language in all consent forms for drug or device clinical trials that are initiated on or after that date:  “A description of this clinical trial will be available on, as required by U. S. Law. This website will not include information that can identify you.  At most, the website will include a summary of the results. You can search this website at any time.”
  • The FDA does not allow a waiver or alteration of the requirements for obtaining informed consent except in circumstances where the research meets criteria for “emergency research”. 
  • The FDA permits waiver of documentation of informed consent if certain criteria are met.
The Survey for Participants in UA-Sponsored Research has been updated.  Please use the new version.  And please do encourage participants to complete this or give them a copy when they have consented. These surveys will be very helpful to us in improving participant protection.
First IRB FORUM: Adults' Capacity to Consent in Research Settings. Rose 358, Research Compliance Conference Room, Friday January 27th, 9-9:50 a.m.; Tuesday, January 31, 3-3:50 p.m. RSVP to 349-6749 by 1/23 for first session or 1/26 for second session--just so we have a large enough room and enough handouts.  Printable Invitation

CONTACT AND PARTICIPANT SURVEY INFORMATION ON CONSENT DOCUMENTS:  Investigators, please be sure that contact information for yourselves and for the Office for Research Compliance  and information about the participant survey is included on all consent documents.   The current phone numbers for the ORC  are  205-348-8461 and  877-820-3066 toll-free.  Participants with questions or complaints can reach ORC at   Also state that a participant survey is available from you or at the participant outreach website which is . Please encourage your participants to complete this survey, as it is part of our quality assurance effort.  Examples are available online on the sample consent forms for medical and non-medical studies.


Training sessions on how to submit a human subjects research protocol are held twice monthly by the IRB research compliance specialists. The schedule and registration information are  posted on the website.  These sessions not only provide information but allow time for participants to raise questions about their own research protocol needs. New faculty, first-time investigators, and student researchers are urged to attend. 


PARENTAL PERMISSION REMINDER:  Federal regulations for research with children require that permission for children’s participation in research be obtained from both parents.  However, IRBs may determine that the consent of only one parent will suffice, if, for example, one parent is not reasonably available or one parent is not capable of providing permission. If you wish to obtain consent from only one parent, justify your rationale in your application.  Remember  to relate this justification to the level of risk posed by the research and that more levels of risk apply to research with children than to research with adults.  Review the policy “Protection of Children in Research” for all the details.  


NEW GUIDANCE: INVESTIGATORS AND LEGALLY AUTHORIZED REPRESENTATIVES.  At our recent site visit for accreditation, the site visit team recommended that we strengthen our procedures for ensuring that LARs are correctly identified and informed of their responsibilities. A new guidance document for investigators  about the identification, education, and assessment of Legally Authorized Representatives (LARS) for adults with diminished capacity for informed consent is now posted.  If your research involves a LAR, please read and implement this guidance in your IRB application and on the informed consent document.  Several other online documents, including the consent templates, the policy on informed consent process and documentation, and the IRB application guide have also been changed to reflect the new guidance.


WHO ARE KEY STUDY PERSONNEL? Investigators are responsible for seeing that key study personnel complete human subjects or HIPAA training. “KEY PERSONNEL” includes principal and co-investigators, study coordinators, project directors, recruitment coordinators and schedulers, interviewers, statisticians and data analysts working with identifiable data, students, consultants, and persons with other titles who have contact with study participants in any capacity. People who only give permission to conduct a study on site (such as school principals) or have no contact with subjects or identifiable data (such as a consultant who only offers advice on design or procedures) are not key personnel.  


NEW RENEWAL AND CLOSURE DOCUMENTS: The Office for Research Compliance  has created a new POLICY (Closure of Approved Protocols) and a new separate FORM (Closure of an Approved Study). The former policy and form  called “Continuing Renewal and Closure of  Approved Protocols” have been revised to deal only with continuing renewal.   Changes of special importance to investigators are that (1) if a student does not close a study upon graduation—or transfer it to another UA investigator—the faculty member is responsible for doing so, and (2) successive failures to close a protocol will be considered noncompliance (See POLICY Allegations and Findings of Noncompliance).  


IRB Mini-Guides:  Note that the  website now has a heading called  “IRB Mini-Guides”.  Here you will find lists of  essential documents needed for various interactions with the IRB.  (Do remember that , depending on the nature of the application, additional documents may be required.) We hope this feature will be useful to investigator


NEW GUIDANCE DOCUMENT  “Department of Defense Regulations for Human Subjects” has been added to the List of Guidance Documents and the topic  “Department of Defense Research” and the document have been added to the FIND IT FAST grid.

USE IRB WEBSITE FOR DOCUMENTS!  Although some UA websites and departments provide links to or even compilations of IRB documents, the IRB website is the only CURRENT, OFFICIAL source for documents.  Please check it whenever you submit something to IRB, as documents are changed frequently in response to user feedback or IRB members’ suggestions. Applications not using the current form will be returned to investigators.


IRB Office and Mailing Address

358 Rose Administration
Box 870127
Tuscaloosa, AL 35487



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