IRB Launches Prereview Process

IRB Launches Prereview Process

Institutional Review Board (IRB) News IRB Launches Prereview Process

IRB Launches Prereview Process

In an effort to better serve our research community here at UAB, the Office of the IRB (OIRB) will modify its procedures for new protocol submissions that require full board review.  After the December 5, 2013 deadline, all new protocols submitted for full board review will undergo an administrative pre-review by an OIRB staff member. The outcome of this administrative review will be e-mailed to the PI and contact person. After all required revisions are complete, the protocol will be scheduled for formal review at the next available convened IRB meeting.
By addressing these items before the board's review, the protocol will be in better shape for discussion at the convened meeting, reducing the number of deferred protocols that subsequently must go back to the convened board for review.
The current submission deadline system and review process will remain unchanged for renewals. 
The OIRB always welcomes feedback and suggestions. Please feel free to send any comments to
Why is this change being made? 
Under the previous system, almost 25% of initial submissions that went to a board meeting were deferred or deferred for response and had to be scheduled for review at another meeting.  Conducting a pre-review will allow IRB staff to facilitate revisions before a meeting that would otherwise cause deferral.
Doesn’t a member of the IRB staff already review my protocols before the meeting?
In the past, an IRB staff person conducted a very high level review to ensure protocols submitted for full board review actually required full board review.  However, the protocol was then directly distributed to board members for review.  The IRB staff person supporting the board meeting received the protocols the same time the board members received them, which did not allow issues to be addressed prior to the meeting.
Will the pre-review process slow down my approval?
It is hoped the pre-review process will actually speed up your approvals.  Addressing issues prior to the meeting will allow board members to focus on substantive issues during the board meeting, rather than missing forms and contradictions in the submission.  As such, there should be fewer revisions needed after a meeting since the majority of those will have been handled prior to the meeting.  It will be easier for IRB staff to get the results of the board meeting review to the investigator, easier for the investigator to respond, and easier for the IRB staff or chair to review the response.
How soon can I expect to receive a response after submitting a protocol for full board review?
                Investigators will receive results of the pre-review within 10 business days of submission.
What if I don’t want to make a revision suggested during the pre-review process?
Protocols will not be scheduled for review at a full board meeting until all items noted during the pre-review have been addressed.  However, if there is a justifiable reason not to  make a change suggested by the IRB staff person conducting the pre-review, the investigator should just reply with such reasoning and the protocol will be scheduled for review by the board.  It may be advisable to have a conversation with the IRB staff person in this regard so that information can be conveyed to the board.  The IRB staff can advise an investigator on the regulatory criteria that apply to a research study and can be a resource for navigating potentially challenging areas.
There may also be times when an item is not yet available, but the board can proceed with the review so as not to otherwise hold up approval once the missing item is available.  Again, communication with the IRB staff person reviewing the protocol can help in this regard.
May I choose which IRB staff person will review my protocol?
In order to equally distribute submissions, it will not be possible to select a specific staff person to initially review your protocol.  However, the staff person who conducts the pre-review will work with you and be your contact until the revisions are complete.
Will I have to submit all of my revisions in hard copy?
Unless noted in the pre-review, revisions may be sent via e-mail reply directly to the IRB staff member who reviewed your protocol.
May I submit my initial submission electronically?
At this time, the IRB doesn’t offer electronic submission.  However, future implementation of the Human Subjects module in IRAP will allow electronic submission.  Please continue to submit original submissions in hard copy.

Additional News and Announcements

  • UAB Institutional Signing Official Change Effective November 9, 2015

    Effective Monday, November 9, 2015, please use the following name and title on all OSP submissions for external sponsors requiring the name of the UAB Institutional Signing Official:
    Richard B. Marchase, Ph.D.
    Vice President for Research and Economic Development
     The remaining contact information, address, email and phone numbers, should remain the same:
    AB 1170
    1720 2nd Avenue South
    Birmingham, AL   35294-0111
    Phone:  205.934.5266
    Fax:  205-975-5977

    Any submissions in progress, in route or received by the OSP, will be updated to reflect the correct signing official.

    If you have any questions please contact the OSP at

    Posted by Office of Sponsored Programs | 11/05/15
  • Research Infrastracture Update

    IRAP - the Integrated Research Administration Portal - is an electronic tool that uses interconnected software modules to enhance each phase of the research process at UAB, from alerting investigators to new funding opportunities with the SPIN and SMARTS modules, to facilitating transfer agreements on research materials. Many documents can be shared across modules, eliminating the need to fill out redundant forms. Significantly, IRAP’s battery of more than 130 reports gives investigators granular data on the status of their submissions, so they always know where they are in the process. IRAP also allows administrators to improve workflows and procedures by finding and fixing bottlenecks in the system. In turn, this helps Research Administration offices work to deliver a better customer experience and to focus on improving customer service overall.
    Posted by Office of the Vice President for Research and Economic Development | 10/30/15
  • 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
  • New UAB Institutional Core Facility Program Launched

    The UAB Office of the Vice President for Research and Economic Development (OVPRED) announces the launch of the UAB Institutional Core Facility Program (ICFP), created to promote the development and operation of outstanding Core Facilities that can serve the needs of UAB investigators.
    Posted by Office of the Vice President for Research and Economic Development | 10/02/15
  • 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
  • Confidential Disclosure Agreement Templates Updated

    UAB’s template confidential disclosure agreements have been updated and are available at the OSP Confidentiality Disclosure Agreement (CDA) webpage. The following confidential disclosure agreement (CDA) templates are available:

    Mutual Confidential Disclosure Agreement (Company and UAB disclosing confidential information);

    Unilateral Confidential Disclosure Agreement (Company Disclosing to UAB); and

    Unilateral Confidential Disclosure Agreement (UAB Disclosing to Company)

    Please use, and encourage the contracting party to use, the appropriate UAB template CDA. If the contracting party can agree to the terms of one of UAB’s template CDAs, UAB will sign the agreement without further routing and review, resulting in a more expeditious process.

    Please forward any questions regarding the CDA process, or UAB’s template CDAs to

    Posted by Office of Sponsored Programs | 06/22/15
  • Policy Update: Definition of a Principal Investigator

    Effective May 18, 2015 UAB’s Definition of a Principal Investigator policy is modified with regard to UAB employees in the 02 (Full-time Temporary) employment status or other UAB employment categories. See the full policy at the link or via the UAB Policies & Procedures Library.

    Case-by-case inquiries should be addressed to
    Posted by Office of Sponsored Programs | 06/01/15
  • Expired Form FDA 1572 continued use approved

    ​On April 30, 2015 the Form FDA 1572 on the FDA website at 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
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