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

  • OSP Announces Streamline of NCC Submission Process and Updated Checklists

    ​In a continuing effort to streamline submission processes, the Office of Sponsored Programs is pleased to announce that NIH Research Performance Progress Report submissions (also known as RPPRs), other Noncompeting Continuation/Continuation submissions, and Pre-Application submissions no longer require a signed UAB Extramural Support Checklist, but should now be sent to osp@uab.edu with a UAB Expedited Checklist.
    Posted by Office of Sponsored Programs | 05/27/16
  • NIH Proposal Submission Revised Procedure

    The UAB Office of Sponsored Programs is pleased to announce the newly revised procedure for review of NIH proposal submissions for large submission deadlines involving NIH Research Project Grants (R01), Research Career Development Awards (K) and Research Fellowship (F) proposals. In order to review NIH proposals as quickly as possible, OSP has implemented a proposal review pool which will allow OSP to introduce additional reviewers to assist with proposal review when needed.

    NIH proposal submissions to OSP for deadline dates of June 5th and July 5th (R01), June 12th and July 12th (K) and August 8th and 13th (F), will  be assigned rotating through a  pool of reviewers instead of an assignment to a specific officer by department. The reviewer will be identified in the Receipt of Submission email once a complete submission is received by OSP. This change is effective immediately.

    NOTE: This is only applicable to new NIH proposal submissions for the above mentioned NIH deadlines. All other NIH proposal submission deadlines will be routed to the officer assigned to your specific department. All NIH awards will continue to be processed by the OSP officer assigned to your specific area.

    Please continue to follow the OSP Review Plan to ensure that your reviewer has sufficient time to properly review the proposal. 

    Please forward any questions regarding the NIH proposal review process to Tim Parker at tmparker@uab.edu or askosp@uab.edu.

    Posted by Office of Sponsored Programs | 05/26/16
  • Call for Nominees: 2017 Pew Scholars Program in the Biomedical Sciences Award

    The Pew Charitable Trusts has invited UAB to nominate one candidate for the 2017 Pew Scholars Program in the Biomedical Sciences award.
     
    The Pew Scholars Program supports assistant professors of outstanding promise in science relevant to the advancement of human health. The award provides $240,000 in flexible support-$60,000 per year for a four-year period.
    Posted by Office of the Vice President for Research and Economic Development | 05/10/16
  • UAB Industry-Sponsored Clinical Trials F&A Rate Will Increase Effective July 1, 2016

    ​Effective July 1, 2016, the UAB Facilities & Administrative (F&A) rate for industry-initiated and sponsored clinical trials will increase to 30%.  This change is only applicable to new submissions to the Office of Sponsored Programs (OSP) on or after July 1, 2016.
    This increase, which will put UAB in the mid-range among peer institutions, will be used to offset costs associated with the recently established Office of Clinical Trial Administration, in particular the purchase and implementation of new clinical trial support software programs, PowerTrials and OnCore.  Clinical trials initiation fees charged to the sponsor, such as the UAB Human Subjects Review Fee, will not be affected.
    Please note:  this rate is only applicable to qualifying industry-initiated and sponsored clinical trials and is not applicable to (1) investigator-initiated clinical trials or (2) those supported by non-profit foundations or government sponsors.   Certain terms and conditions may require application of a higher rate.
    Beginning May 15, please contact the newly appointed Director of the Clinical Trials Administrative Office (CTAO), Mark Marchant, via email at marchant@uab.edu if you have any questions about this fee.
    Posted by Office of Sponsored Programs | 05/05/16
  • New Guidance Information on IRB Website

    The OIRB has provided updated guidance information on our website.  New information has been posted regarding the following:
    • Flowchart to determine who are key personnel
    • NIH description of ethnic and racial categories
    • IRB form compatibility

    Key Personnel

    The IRB has created a flow chart to help determine whether individuals involved with research should be considered to be key personnel involved in the conduct of human subjects research.  The Key Personnel Flowchart is available under the General category on the Other Guidance page of the IRB website.

    Ethnic and Racial Categories

    The table on the Investigator's Progress Report follows the reporting requirements of the NIH. The following is their description of how the ethnic and racial categories are defined:​​

    Ethnic Categories

    • ​​Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.  The term “Spanish origin” can also be used in addition to “Hispanic or Latino.
    • Not Hispanic or Latino​.

    ​​​​​​Racial Categories

    • ​American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment.​
    • Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been recorded as Pacific Islanders in previous data collection strategies.) 
    • Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
    • Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”
    • White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

    IRB Form Compatibility Issues

    IRB forms on this page are compatible with Microsoft Word 2010 and newer on Windows and Microsoft Word 2016 for Mac. Some features (e.g., checkboxes) are not compatible with older versions of Microsoft Word or any version of Pages for Mac. The newest versions of Microsoft Word are available at no charge to UAB faculty, staff, and students through UAB IT. Contact UAB IT for more information on upgrading your software. If you are unable to upgrade to a compatible version of MS Word, you may simply place an "X" before the checkbox that corresponds to your answer in the form.
     
    Posted by Office of the Institutional Review Board for Human Use | 04/22/16
  • Office of Sponsored Programs Announcement - New Website Launch

    The Office of Sponsored Programs is pleased to announce the launch of our new OSP website. The new OSP website offers users a more efficient navigational design structure with enhanced content categories.

    Enhancements include:

    • Improved Search - Utilizing the search field found at the top right corner of every page on our site now yields more accurate, more relevant results, helping you find desired content easily and quickly.
    • Improved Quicklinks - Visitors can now immediately jump to desired content from our home page through the creation of an improved Quicklinks menu that links to our most demanded/visited pages based on page-view statistics.
    • Featured Pages - The website will now periodically feature pages promoting higher awareness of existing content or new content. This reinforces our commitment to providing users with effective knowledge, resources, and tools.

    For more information about changes to the new OSP website, please visit our welcome page. If you currently have forms or pages from our existing website bookmarked, these links should be automatically redirected to the new the website content. 

    For additional information, please contact Mike Matthews at mimatt@uab.edu or Jonathan Price at jonprice@uab.edu.

    Posted by Office of Sponsored Programs | 04/21/16
  • Center for Disability Health and Rehabilitation Science Guest Lecturer: Dr. Robert Motl

    Center for Center for Disability Health and Rehabilitation Science presents

    Professor Robert W. Motl, PhD
    Department of Kinesiology and Community Health Neuroscience Program
    University of Illinois at Urbana - Champaign: 

    Physical Activity and Multiple Sclerosis - What We’ve Learned and Where We Need To Go

    Thursday, April 14, 2016 12:00-1 p.m.
    School of Health Professions Building Executive Learning Center, Room 640

    Bring Your Lunch

    Beverages will be provided

    To RSVP, please contact Jane Moore at (205) 934-5909 or Email: djmoore@uab.edu  no later than Noon Wednesday 4/13

    Posted by Center for Disability Health and Rehabilitation Science | 04/12/16
  • NIH eSubmission Items of Interest - March 25, 2016

    The NIH Grants and Funding website has been redesigned and simplified with a video tour available. FORMS-D Application Instructions are now available. FORMS-D Application Packages are now available for some FOAs. FORMS-C should be used for applications with due dates on or before May 24, 2016. FORMS-D should be used for applications with due dates on or after May 25, 2016.
    Posted by Office of Sponsored Programs | 03/25/16
  • NIH eSubmission Items of Interest - February 29, 2016

    NIH eSubmissions Items of Interest for February 29, 2016. FORMS-D application changes are on the way. FORMS-D must be used for applications with due dates on March 25, 2016 or after. Read full article for a preview of FORMS-D and guidance on determining when and how to use FORMS-D.
    Posted by Office of Sponsored Programs | 03/01/16
  • 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
View RSS feed