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

  • 2017 Rita Allen Foundation Scholars Program

    ​​UAB has been invited to nominate an early stage investigator for the 2017 Rita Allen Foundation Scholars ProgramThe full application is not due until January 20, but our office has to formally nominate UAB’s candidate by December 9. 
     
    It is asked that interested investigators please discuss with the Chair or Division Director and then contact Dr Kent Keyser by Wednesday, December 7th with a 1 page summary of the project and a 2 paragraph assessment of the candidate, signed by the Chair or division director.
     
    We apologize for the short timeline. 
    Posted by Office of the Vice President for Research and Economic Development | 12/02/16
  • ​Victoria Leslie Cooper, CIP, named Director of the Office of the Institutional Review Board (OIRB)

    Victoria Leslie Cooper, CIP, has been named director of the UAB Office of the IRB (OIRB) effective January 1, 2017.  Leslie comes to this position with over 17 years of experience in human research protections.  Over 13 years of that experience is with the OIRB, having previously held positions of assistant director and associate director in the OIRB.
     
    During her tenure in the OIRB, Leslie has coordinated submissions of industry-sponsored trials to Western IRB (WIRB).  More recently, Leslie has been a leader in the field as human research protection programs develop single and central IRBs.
    Posted by Office of the Institutional Review Board for Human Use | 12/02/16
  • OSP News and Updates - November 29, 2016

    • Unit Assignments/OSP: OSP Officers are assigned by unit to more evenly distribute the workload.  The listing will help you identify the appropriate contact(s) when you need assistance in proposal preparation, contract assignment, or help with post award issues and questions.
    • Training Needs Survey: OSP would like your feedback on campus training needs in the area of sponsored projects.  We encourage you to complete this short survey so that we can develop a comprehensive training program. 
    • Fee for Service (FFS)- Amended policy for research related FFS to be retroactive to 7/1/16: The F&A rate is changing from 30% to 15%.  Executed fee-for-service agreements assessed at the 30% F&A rate will be retroactively corrected to 15% F&A rate.  To assist the campus in determining to which office to send your FFS, we have developed a decision tree.  Please note submission through OSP requires completion and attachment of the Extramural Checklist including the Responsible Personnel List.
    • Uniform Guidance (UG) Brochure: A Uniform Guidance Quick Guide brochure has been developed with faculty and administrators in mind.  This brochure highlights the most important aspects of UG that faculty need to know regarding federal funding.  We hope you find it useful. Please print 2-sided in color for best effect.
    • At-Risk Accounts for Industry Sponsored Clinical Trial Agreements: Along with three academic departments, OSP, the IRAP support team, and GCA have been piloting a pending account process for industry sponsored clinical trial agreements for the last several months.  “At-Risk Accounts” (aka “Pending Accounts”) are used to assist in tracking the actual cost of conducting a clinical trial, therefore, it is very important that the clinical departments use the At-Risk Account to facilitate appropriate accounting for expenditures associated with study activation including, study start-up fees and personnel expenses. 
      Effective January 1, 2017, this process will be rolled out across campus.

      What is the Process?
      1. OSP receives your complete submission; including a signed Extramural Checklist for an Industry sponsored clinical trial.
      2. The OSP Officer reviews the Extramural Checklist and updates IRAP, which triggers a notification to grants and contracts accounting.
      3. Accounting sets up the At-Risk Account and notifies the PI/department. The start date of the pending/at risk account will be 1 year prior to the receipt date of the checklist by OSP to enable sites to charge activities related to study start up. And the account will remain ‘pending’ for 1 year after creation unless the account is either activated or terminated.
      4. Department/Site applies start-up charges to the new account and then continues to use when becomes active. This includes start-up fees for IRB, Pharmacy, Radiology, etc., as well as personnel expenses associated with the time required for study activation procedures.
    • Reminder Regarding Revised Responsible Personnel List (RPL) Instructions: Revised RPL submissions are submitted when you are adding or removing responsible personnel from an existing project.  When submitting a Revised RPL, please only include the names of those Responsible individuals being added to or removed from the project. For each individual, list the name, BlazerID, and project role and check the Add or Remove box, as applicable.  Do not list everyone on the proposal; only list changes.  For full instructions, please click here.
    Attachments:
    Posted by Office of Sponsored Programs | 11/29/16
  • Final RPPR To Be Used Effective Jan. 1, 2017

    The Final Research Performance Progress Report (F-RPPR) will replace the Final Progress Report (FPR) for grants closeout, effective January 1, 2017.  The F-RPPR will be available for use in eRA Commons on January 1, 2017. For small businesses, the new F-RPPR will be in effect at least 2 months later, due to the unique final reporting requirements that they face under the SBIR/STTR policy directive. If you have a final progress report due, and you wish to use the old FPR format of an uploaded document, you must submit the FPR before January 1, 2017. NIH will no longer accept any of the old format FPRs on or after January 1, 2017.
     
    For more information, see Guide Notice NOT-OD-17-022. Visit the NIH RPPR web page, and check out November’s eRA Items of Interest article
    Posted by Office of Sponsored Programs | 11/25/16
  • UAB Effort Reporting Policy FAQs Published

    UAB has recently published Effort Reporting Procedures in the UAB Policy Library.  Subsequent to its publication, additional information has been added in the form of FAQs.  These FAQs have been appended to the bottom of the page. 
    The Effort Reporting Pocedures page can be found in the UAB Policies and Procedures  Library here:   
    http://www.uab.edu/policies/content/Pages/UAB-UC-PRO-0000778.aspx.  Please note that additional FAQs may be added over time, so please reference the official page for any updates.
     
     
    Posted by Office of the Vice President for Research and Economic Development | 11/16/16
  • NIH Notices - November 14, 2016

    Notices:

    • Adjustment to Stipend Levels for Postdoctoral Trainees and Fellows on Ruth L. Kirschstein National Research Service Awards (NRSA)
      (NOT-OD-17-002) National Institutes of Health

    See the full web version of these notices and more here.

    Posted by Office of Sponsored Programs | 11/14/16
  • NIH eRA items of Interest - November 2016

    The latest NIH eRA Items of Interest for November 2016 is now available.
     
    Included Topics:
    Review the attached PDF or visit the NIH eRA Items of Interest page for more information.
    Posted by | 11/09/16
  • Selection process for UAB NSF Major Research Instrumentation Grant Now Open

    NSF Major Research Instrumentation grant applications are due at NSF on January 11th, 2017.
     
    Further information is available at this link: https://www.nsf.gov/funding/pgm_summ.jsp?pims_id=5260 
     
    UAB is allowed up to three submissions, two for instrument acquisition and one for instrument development. In the event that more than 3 groups express interest, the VP for Research Office will assemble a panel to select the three UAB proposals.
     
    If you are interested, please submit a letter of intent including an abstract for the NSF MRI proposal, biosketches for each of the lead faculty, and a list of participants, to Dr. Kent Keyser (kkeyser@uab.edu) by 5 p.m. on Monday, November 21, 2016.
     
    Submitters will be notified of the selection panel's decision by December 1.
    Posted by Office of the Vice President for Research and Economic Development | 11/03/16
  • Request for Proposals (RFP) for Research Infrastructure Improvement (RII) Program Track 4: EPSCoR Research Fellows (RII Track-4)

    ​UAB would like to solicit white papers for a university down-select to choose UAB’s three proposal submissions to the Research Infrastructure Improvement (RII) Program Track-4: EPSCoR Research Fellows (RII Track-4). 
     
    RII Track-4 provides opportunities for non-tenured investigators to further develop their individual research potential through extended collaborative visits to the nation’s premier private, governmental, or academic research centers.  Through these visits, the EPSCoR Research Fellows will be able to learn new techniques, benefit from access to unique equipment and facilities, and shift their research toward transformative new directions.
     
    For complete details, please read the full announcement.
     
     
    Posted by Office of the Vice President for Research and Economic Development | 11/03/16
  • Call for Proposals: NSF Research Infrastructure Improvement (RII) Program: Track-2 Focused EPSCoR Collaborations (RII Track-2 FEC)

    UAB is soliciting white paper submissions for NSF EPSCoR published a new Request for Proposals (RFP) for Research Infrastructure Improvement (RII) Program: Track-2 Focused EPSCoR Collaborations (RII Track-2 FEC), see: (https://www.nsf.gov/pubs/2017/nsf17503/nsf17503.pdf), in the following focus area:
     
    “Understanding the relationship between genome and phenome – Our vast and ever-increasing storehouse of genomic data has enabled rapid progress in many fields allied with the biological sciences, but it remains a challenge to mechanistically understand how genotype elicits phenotype. A fuller understanding of the emergent processes underlying this relationship would have profound implications in medicine, agriculture, biotechnology, ecology, evolution, and other fields. Proposals should pursue innovative, interdisciplinary approaches toward quantitative, predictive understanding of the complex interactions between genome and environment that generate variable phenotypic traits. These efforts may include the work of biologists, physicists, chemists, engineers, informaticians, and other scientists. Proposals may use any combination of experimental, computational, and/or theoretical approaches with any appropriate model system(s).” 
     
    Please click here for more information about how to submit, requirements, and deadlines. 
    Posted by Office of the Vice President for Research and Economic Development | 10/28/16
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