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 – August 22, 2016

    Notices

    • New Policy Eliminates Most Appendix Material for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After January 25, 2017
      (NOT-OD-16-129) National Institutes of Health
      Agency for Healthcare Research and Quality
      National Institute for Occupational Safety and Health
    • Changes to the NIH/AHRQ Policy on Post-Submission Materials for Applications Submitted for Due Dates On or After January 25, 2017
      (NOT-OD-16-130) National Institutes of Health
      Agency for Healthcare Research and Quality
      National Institute for Occupational Safety and Health
    • Projected FY 2017 Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA)
      (NOT-OD-16-131) National Institutes of Health
      Agency for Healthcare Research and Quality
      Health Resources and Services Administration
    • Revised: Projected FY 2017 Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA)
      (NOT-OD-16-134) National Institutes of Health
    Posted by Office of Sponsored Programs | 08/22/16
  • UAB Joins Federal Demonstration Partnership’s (FDP) Clearinghouse Pilot Program

    In an effort to streamline the process for both incoming and outgoing federal subawards, UAB has joined the Federal Demonstration Partnership’s (FDP) Expanded Clearinghouse. This is a pilot program for certain FDP institutions and provides audit, demographic and fiscal information needed by pass-through entities (PTEs) when they are issuing federal subawards. Now, when UAB issues a federal subaward to another entity in the pilot program, collection of the Subrecipient Assurance form is no longer required. Instead, the necessary information will be obtained from the entity’s profile in the Expanded Clearinghouse; a searchable list of the participating entities along with their profiles can be found FDP Expanded Clearinghouse website.

    Attached is a PDF of the participating institutions. Project-specific information (such as Human Subjects use, Animal Subjects use, etc.) will still need to be collected from the entities including a new, project specific form for that will be released shortly.

    For incoming subawards, we will no longer need to complete forms containing this information from other pilot institutions. The FDP web site has sample language to send to other pilot participants when we are asked to complete such forms.

    Additional information can be found on the FDP website and will be available shortly the Office of Sponsored Programs website. If you have questions, please contact askosp@uab.edu.

    Posted by Office of Sponsored Programs | 08/22/16
  • Conflict of Interest Re-training Required for Many Investigators this Year

    On August 24th 2012, financial conflict of interest training became mandatory for all research personnel responsible for the design, conduct or reporting of research. The Federal Final Rule that established this requirement also stipulates that re-training is required every four years. For many investigators, re-training will be required this year. Email notifications will be sent out informing investigators when they need to re-train. Please contact the Office of the Conflict of Interest Review Board (OCIRB) at (205) 975-9691 if you have any questions about re-training.

    Posted by Office of the Conflict of Interest Review Board | 08/22/16
  • Department of Defense Breast Cancer Research Program Funding Opportunities for Fiscal Year 2016

    Per the Fiscal Year 2016 (FY16) Defense Appropriations Act, $120 million was allocated to the Department of Defense Breast Cancer Research Program (BCRP) in support of breast cancer research. FY16 BCRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov.
    FY16 BCRP applications must address one or more of the following challenges:
    • Prevent breast cancer (primary prevention)
    • Identify determinants of breast cancer initiation, risk, or susceptibility
    • Distinguish deadly from indolent breast cancer
    • Conquer the problems of overdiagnosis and overtreatment
    • Identify what drives breast cancer growth; determine how to stop it
    • Identify why some breast cancers become metastatic
    • Determine why/how breast cancer cells lay dormant for years and then re-emerge (recurrence); determine how to prevent recurrence
    • Revolutionize treatment regimens by replacing them with ones that are more effective and less toxic
    • Eliminate the mortality associated with metastatic breast cancer
    Please review the attached announcement (PDF) for more detailed information and instructions regarding applications.
    Posted by Office of Sponsored Programs | 08/22/16
  • Research Town Hall: The Implications of the FLSA Mandate on Postdoc Salaries

    ​​Join us on Wednesday, August 24 in Spain Auditorium at 4 pm for an open discussion on the implications of the FLSA mandate on postdoc salaries.  Deans and Central Administration are investing in a plan that we see as striving to be fair to all our postdocs, while at the same time easing the burden on our investigators in order to minimize disruption to ongoing research programs. We will also discuss the Research Career ladder and its implementation.  Event information can be found here.

     

     

    Posted by Office of the Vice President for Research and Economic Development | 08/18/16
  • eRA Enhancements - August 17, 2016

    Expect new features and improvements to be released on August 18, 2016, for the Extramural Trainee Reporting and Career Tracking (xTRACT) system. 

    Features

    • Citations for publications from Pubmed may now be searched and imported.
    • Delegated assistant access has expanded for users with the “ASST” role.
    • “NIH Support” sections have been relabeled to “NIH and Other Agency Sources of Support on Record.”
    • The column for “Funding Source” in Table 4 interprets the funding agency as NIH, AHRQ, or Other Fed.
    • Calculated means across all years have an increased precision, displayed with up to one decimal point.
    • Output PDF documents now have internal bookmarks linking to the beginning of each training table.

    Fixes

    • A defect in Table 8 generation that allowed duplicate citing of the same source within a training year is now corrected.
    • Navigating to the list of Participating Faculty for an RTD should now see reduced response times and increased performance.

    Post-release details and screenshots will be made available through Online Help for xTRACT resources. Review the original article in the attached PDF or on the eRA News website.

    Posted by Office of Sponsored Programs | 08/17/16
  • Comprehensive Cancer Center 18th Annual Research Retreat

    UAB Comprehensive Cancer Center

    18th Annual Research Retreat – Monday, October 17, 2016

    Sheraton Hotel Downtown Birmingham

    2016 Meeting Theme – Immunotherapeutics

    Program Chairs:  Ravi Bhatia, M.D. and Harry Erba, M.D., Ph.D.

    Meeting Website:  http://www3.ccc.uab.edu/index.php/research/research-retreat/  

    Abstract submission: August 1 – September 16, 2016

    Online Registration: August 1  – September 16, 2016

    RESEARCH COMPETITION

    Abstract submission: Monday, August 1  – Friday, September 16, 2016

    Eligible participants may submit an abstract of their original cancer research for presentation as a poster in the research competition.  First, second, third place and honorable mention awards are presented for the most outstanding posters.  Winners receive cash awards.  See meeting website for details.

    Cancer Research – Open Category (non-award)

    Cancer researchers not eligible for participation in an award category are encouraged to submit an abstract for presentation as a poster in the Cancer Research – Open Category.  This non-award category offers the opportunity for researchers to discuss their work with meeting participants.

    MEETING PRESENTATIONS

    On-line registration:  Monday, August 1 – Friday, September 16, 2016 

    The annual Research Retreat provides the opportunity to stimulate interdisciplinary research collaboration and development among participants.  This year’s event features presentations by experts in the field of Immunotherapeutics.

    We hope to see you there!


    Attachments:
    Posted by | 08/11/16
  • UAB Extramural Support Checklist Updated

    A new version of the UAB Extramural Support Checklist is now available. Revisions include:

    • Fee for Service is available as a Submission Type and F&A Base on numbers 3 and 27 respectively.
    • In accordance with the OSP Review Plan, options for either a complete or limited review are available at the top of the form.
    • A check box for CME/CPE was added above the Dean’s signature on the signature page of the form.

    Please take this opportunity to download the 8/10/2016 version of the UAB Extramural Support Checklist from the Office of Sponsored Programs Forms webpage.

    Posted by Office of Sponsored Programs | 08/10/16
  • 4th Annual UAB Center for Exercise Medicine Symposium

    The 4th annual UCEM Symposium is set for Thursday, Sept. 22, at the Hill University Center (Ballroom). Register today (it's free!); submit an abstract for the poster competition, and become a center member. Visit our website to do all three: http://www.uab.edu/medicine/exercise/center-for-exercise-medicine-annual-symposium

    UAB Speakers:

    David Brown, PT, PhD, SHP Department of Physical Therapy
    Dori Pekmezi, PhD, SOPH Department of Health Behavior
    Ceren Yarar-Fisher, PT, PhD, SOM Department of Physical Medicine & Rehabilitation
    Rob Motl, PhD, SHP Department of Physical Therapy

    External Guests and Speakers:

    P. Darrell Neufer, PhD
    Director, East Carolina Diabetes and Obesity Institute
    Professor, Departments of Physiology and Kinesiology
    East Carolina University

    Krista Vandenborne, PT, PhD
    Professor and Chair, Department of Physical Therapy
    University of Florida

    Scott Trappe, PhD
    Professor and Director, Human Performance Laboratory
    Ball State University

    Anne McTiernan, MD, PhD
    Professor, Department of Epidemiology, School of Public Health
    Member, Fred Hutchinson Cancer Research Center
    University of Washington

    Mike Roberts, PhD
    Assistant Professor, School of Kinesiology
    Auburn University

    Posted by Center for Exercise Medicine | 08/08/16
  • NIH Extramural Nexus Updates - July 2016

    The NIH Extramural Nexus Updates for July 2016 have been released. Stories highlighted this month include:

    • Criterion Scores and Funding Outcomes
    • Data on Model Organism Funding
    • Fellowship Application Tips
    • And more…
    Posted by Office of Sponsored Programs | 08/02/16
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