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 irb@uab.edu.
 
FAQs
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

  • REACT Center Survey: What Can We Do For You?

    The REACT Center is requesting input which will help better meet the needs of the rehabilitation research community and direct activities of the new National Resource Center for High-Impact Clinical Trials in Medical Rehabilitation (NIH grant P2CHD086851). They have posted a brief  medical rehabilitation clinical trials needs assessment survey. The Center will base education materials, workshops, and collaborative opportunities on survey results; thus guidance from the research community is central to its mission. 
     
    Posted by Center for Exercise Medicine | 02/04/16
  • Reminder Regarding ASSIST Grant Applications

    As the February 5th deadline for new NIH R01 submissions approaches, OSP would like to remind you that all competing, single-project NIH grant applications can now be submitted through ASSIST.
    Posted by Office of Sponsored Programs | 01/25/16
  • Request for Nominations for Director of the Center for Structural Biology (CSB)

    ​The UAB CSB Internal Search Committee invites nominations of UAB faculty members for the position of Director of the Center for Structural Biology (CSB). The CSB was established in 2011, and is one of 24 University-wide Interdisciplinary Research Centers (UWIRCs); it has been led by Lawrence J. DeLucas, Ph.D., since its inception. The mission of the Center for Structural Biology is to support research and education through exploration of structure/function relationships for biological macromolecules and the development of novel technologies for biomedical research which enhance UAB’s basic and translational research goals. Center membership includes more than 125 faculty and non-faculty members and hosts a number of on-site core facilities, as well as access to a national laboratory x-ray beam. The Director will oversee all of the interdisciplinary center activities, be a member of the Council of Center Directors and be responsible for interfacing with participating schools and managing the budget. Nominations, including self-nominations, should include a CV and a one (1) page summary outlining the qualifications of the proposed Director and summarizing ideas and plans if appointed to the position. The decision will be made after review and interviews by the Search Committee. Nominations should be submitted to Jamie Seitz (jbseitz@uab.edu) by Friday, January 29, 2016.
    Posted by Office of the Vice President for Research and Economic Development | 01/19/16
  • ASSIST Now an Option for All NIH Competing Grant Applications and Some Post-Award Administrative Actions

    ASSIST is now an option for all single and multi-project, competing grant applications; single-project administrative supplements; single-project, post-award successor-in-interest (type 6) requests; and single-project, post-award change of institution (type 7) requests.
    Posted by Office of Sponsored Programs | 01/14/16
  • Important NIH Notices

    • Updates to NIH & AHRQ Research Performance Progress Reports (RPPR) to Address Rigor and Transparency
      (NOT-OD-16-031) National Institutes of Health
      Agency for Healthcare Research and Quality

    • New Salary and Research Cost Allowances for K08 and K23 Career Development Awards
      (NOT-OD-16-032) National Institutes of Health

    • Advanced Notice of Coming Requirements for Formal Instruction in Rigorous Experimental Design and Transparency to Enhance Reproducibility: NIH and AHRQ Institutional Training Grants and Individual Fellowships
      (NOT-OD-16-034) National Institutes of Health
      Agency for Healthcare Research and Quality
    Posted by Office of Sponsored Programs | 01/14/16
  • NIH eSubmission Items of Interest

    NIH eSubmissions Items of Interest for January 5, 2016. ASSIST support has expanded for single-project grant applications in 2015. ASSIST copy application feature is now enhanced to copy attachments. New application forms and policy changes will soon take effect for on January 25, 2016.
    Posted by Office of Sponsored Programs | 01/14/16
  • NIH Update: Incoming Applications, Due Dates; NIH's Strategic Plans; Considering Variables in Pre-Clinical Research

    The latest updates from NIH Extramural Nexus for December 2015 and January 2016 containing relevant announcements and notices have been released. Topics include incoming applications, due dates; NIH's strategic plans; and considering variables in pre-clinical research.
    Posted by Office of Sponsored Programs | 01/14/16
  • Announcing The 2017 Mississippi-Alabama Sea Grant Knauss Marine Policy Fellowship Opportunity

    The Mississippi-Alabama Sea Grant Consortium is now seeking applicants for the 2017 National Sea Grant College Program Dean John A. Knauss Marine Policy Fellowship. The fellowship is funded through the National Sea Grant Office and administered through individual state Sea Grant programs. Knauss Fellows spend a year in marine policy-related positions in the legislative and executive branches of the federal government in Washington D.C. Past fellows have worked in the offices of U.S. Senators and Representatives, on Congressional subcommittees, and at agencies such as the National Science Foundation and the National Oceanic and Atmospheric Administration.
    Posted by Office of the Vice President for Research and Economic Development | 12/15/15
  • MTO Change in Process for Finalized Agreement Documents

    The Material Transfer Office is changing the process for providing finalized agreements to the campus. Previously the finalized documents were emailed to the investigator, now the investigator will be notified that the finalized agreement is available for viewing through an eReport.

    Details can be found on the IRAP Website.

    Posted by Office of the Vice President for Research and Economic Development | 12/10/15
  • Jonathan Miller Joins UAB OVPRED

    Jonathan Miller has joined the UAB Office of the Vice President for Research and Economic Development as assistant vice president for research administration operations and systems, moving from the UAB Office of the Institutional Review Board (IRB). Leslie Cooper, associate director of the IRB, has been named interim director. Leslie has worked in the Office of the IRB since 2003.
    Posted by Office of the Vice President for Research and Economic Development | 12/04/15
View RSS feed