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

  • NIH Notices - September 19, 2016

    Notices:
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      (NOT-OD-16-147) National Institutes of Health
    • Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
      (NOT-OD-16-148) National Institutes of Health
    • NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
      (NOT-OD-16-149) National Institutes of Health
    See the full web version of these notices and more here.
    Posted by Office of Sponsored Programs | 09/19/16
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    The goal of the Inter-CFAR collaborative symposium on HIV in Women is to share cutting edge research, extend knowledge and foster action to address gaps toward understanding the complex clinical, biological and social aspects of HIV in women. This meeting will be held in conjunction with the 2016 Women’s Interagency HIV Study (WIHS) EC meeting to allow for joint activities with WIHS investigators. The meeting will consist of three sessions:
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    • The HIV Continuum of Care Across the Lifespan of Women
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    Posted by Center for AIDS Research | 09/15/16
  • Research Administration Announces Melinda Cotten as Assistant Vice President for Sponsored Programs

    ​Dr. Richard Marchase, Vice President for Research and Economic Development, is pleased to announce the appointment of Melinda Cotten as Assistant Vice President of Sponsored Programs. She will be starting on September 19, 2016. Ms. Cotten will be working with her staff in assisting UAB researchers in their efforts to secure and fulfill extramurally funded sponsored programs by performing pre-award and non-financial post-award administration. With a focus on customer-centric approaches for continuously improving UAB’s processing of submissions, Cotten’s extensive experience will be critical to ensuring the continued success of the UAB research community, and maintaining UAB’s national position as a top research university.
    Posted by Office of the Vice President for Research and Economic Development | 09/12/16
  • NIH Notices – September 12, 2016

    Notices

    • Optional Electronic Method to Request Withdrawal of Applications from Consideration for Funding
      (NOT-OD-16-143) National Institutes of Health
    • Notice of Correction to PA-16-309 "Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)"
      (NOT-OD-16-146) National Institutes of Health
    • AHRQ Retires Policy on Post-Submission
      (NOT-HS-16-017) Agency for Healthcare Research and Quality
    Posted by Office of Sponsored Programs | 09/12/16
  • National Science Foundation (NSF) System Shutdown on September 17-18, 2016

    All National Science Foundation (NSF) systems, including the NSF websiteResearch.gov and FastLane, will be unavailable from 5:00 PM on Saturday, September 17, until 4:00 PM on Sunday, September 18. This downtime is scheduled to coincide with repairs to the Foundation's electrical systems. Affected deadlines that fall on Monday, September 19, are extended to Tuesday, September 20, submitter's local time. See the attached NSF downtime notice for more information on affected solicitations.

    Attachments:
    Posted by Office of Sponsored Programs | 09/09/16
  • eRA Enhancements – September 9, 2016

    Effective September 8, 2016, Signing Officials have the ability to electronically request the withdrawal of an application through eRA Commons. A Signing Official has two business days after successfully submitting an error-free application to reject the application. If more than two business days have elapsed, the Signing Official must contact the Division of Receipt and Referral (DRR) to request an application be withdrawn. Contacting DRR directly may now be done electronically. Requesting the withdrawal of an application will remain available while the application has not undergone review and the summary statement posted.

     

    Features

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    • A new navigation tab, Prior Approval, was added to Commons.
    • Signing Officials have the ability to search for requests.
    • Automated notifications are generated on submission and on approval of DRR withdrawal requests.

     

    For more details on the features listed above, please review the original announcement. For more information concerning Prior Approval for Withdrawals, please see Guide Notice NOT-OD-16-143 and the Prior Approval section in the eRA Commons online help.

    Posted by | 09/09/16
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    Posted by Office of Sponsored Programs | 09/08/16
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    • National Research Service Awards (NRSAs) Postdoctoral Stipend Guidelines for Fiscal Year 2017
    • NIH Loan Payment Programs (LRPs) Accepting Applications from September 1 through November 15
    • Changes to Post-submission Materials and Appendix Policies Take Effect January 25, 2017
    • Withdrawing Applications Electronically in eRA Commons, Available on September 8, 2016
    • FAQ: How May a PI Check Their Eligibility for a Continuous Submission?
    • NIH Closed for Federal Holiday: September 5, 2016 (Labor Day)
    • See the original digest or attachment for more information.
    Posted by Office of Sponsored Programs | 09/02/16
  • Marilyn Hilton Award for Innovation in MS Research

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    Posted by Office of Sponsored Programs | 08/30/16
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    The National Heart, Lung, and Blood Institute (NHLBI) have announced important changes impacting the acceptance, review, and funding of investigator-initiated single-site clinical trials (Phase II and beyond). These changes will affect applications with a due date on or after January 8, 2017. Review the full notice for more details on the changes.
    Posted by Office of Sponsored Programs | 08/30/16
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