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

  • Research News Digest for Thursday, February 23, 2017

    Posted by Office of the Vice President for Research | 02/23/17
  • IRB Forum: Revised Human Subjects Protocol and Sample Consent Form

    The UAB Office of the IRB will host a forum go over the revisions to the Human Subjects Protocol and Sample Consent Form. This forum will be offered on two occasions:
    • Thursday 3/02/17 from 9am - 10:30am in Finley Conference Center, Kaul Building
    • Monday, 3/06/17 from 1:30pm - 3:00pm in Finley Conference Center, Kaul Building
    The same information will be presented at both forums. Registration is not required.
    Posted by Office of the Institutional Review Board for Human Use | 02/21/17
  • Input from Faculty and Core Users Requested

    The UAB Faculty Senate Research Committee is seeking institution-wide input from UAB faculty and Core users on the best way to achieve our institutional research goals.
     
    Please provide your constructive comments and suggestions below on the UAB Spark website: https://ideas.uab.edu/a/ideas/top/campaigns/19237. You will be required to log in with your blazerid to access the site. If you would like an idea posted anonymously, please contact moderators Karen Gamble at klgamble@uab.edu, Zdenek Hel at zhel@uab.edu or David Chaplin at dchaplin@uab.edu.
    Posted by UAB Faculty Senate | 02/20/17
  • Call for Abstracts for UAB Health Disparities Research Symposium

    The UAB Minority Health & Health Disparities Research Center (MHRC) will host the 12th annual UAB Health Disparities Research Symposium, on May 3, 2017 at the DoubleTree Hotel. This year's symposium will take an in-depth look at the role of social determinants in population health.
     
    The symposium showcases the work being done to reduce health inequities in Alabama, the south, and the U.S. It provides an overview of the latest in health disparities research. Scientists and scholars look to it as an excellent opportunity to share discoveries, new approaches, and successful models.
     
    Abstracts for original health disparities research by investigators, students, and community partners are now being accepted. In addition to the fields of basic science, clinical research, social and behavioral science, community-based and health outcomes research, abstract submissions are encouraged for social determinants of health, behavioral and biological mechanisms of health disparities, community-based approaches to health, health policy, and population health. The deadline for abstracts is Friday, March 3.
     
    Featured speakers include Catarina Kiefe, Phd, MD, the Chair of Department of Quantitative Health Sciences, University of Massachusetts Medical School.
    Dr. Kiefe combines the rigor of mathematics with the needs of clinical medicine. She draws upon the intellectual curiosity and drive for discovery that marked her early career as an abstract researcher, using it to help her lead an applied research program with the objective of improving healthcare outcomes for individuals and populations.
     
    Jeroan Allison, MD, MS is Professor and Vice Chair of the Department of Quantitative Health Sciences at the University of Massachusetts Medical School, where he also serves as Associate Vice Provost for Health Disparities Research. Dr. Allison’s research focuses on quality measurement, implementation science, and statistical methodology, with an emphasis on eliminating racial/ethnic disparities in medical care and health outcomes. 
     
    The 2017 UAB Health Disparities Research Symposium is produced by the UAB Minority Health & Health Disparities Research Center and co-sponsored by two national centers for health disparities research: Mid-South Transdisciplinary Collaborative Center, led by Mona Fouad, MD, MPH Director of Professor, UAB Division of Preventive Medicine and Director of the UAB MHRC, and Gulf States Health Policy Center, led by Regina Benjamin, MD, MBA, Founder and CEO of BayouClinic and 18th U.S. Surgeon General.

    Attachments:
    Posted by Minority Health and Health Disparities Research Center | 02/20/17
  • Research News Digest for Monday, February 20, 2017

    In this edition of the Research News Digest:
    Announcements
    UAB-HudsonAlpha Genomic Medicine Post-Doctoral Training Program
    Input from Faculty and Core Users Requested
    Call for Abstracts for UAB Health Disparities Research Symposium
    Upcoming Events
    CCTS Lunch and Learn
    Genetics and Genomics Seminar Series - Lysosomal Acid Lipase Deficiency (LAL-D): An Underrecognized but Treatable Disorder
    2017 NIH NHLBI PCTC Cardiovascular Tissue Engineering (CVTE) Symposium
    Renal Symposium on Acute Kidney Injury; Cystic Disorders and Therapeutic Intervention
    Funding Opportunities
    REMINDER: 2017 Special Interest Projects (SIPs)
    Weekly Grants and Contracts Awarded Report
    Reports for 2017 (Updated every Tuesday)
    Posted by Office of the Vice President for Research | 02/20/17
  • UAB-HudsonAlpha Genomic Medicine Post-Doctoral Training Program

    The Helflin Center for Genomic Sciences is currently accepting applications for the NHGRI funded UAB-HudsonAlpha Genomic Medicine Post-doctoral training program.  The purpose of this training grant is to recruit postdoctoral trainees from various disciplines and provide mentorship and clinical research training in genomic medicine.  Trainees will receive a monthly stipend, tuition and fees assistance, health insurance and travel funds (at NIH-defined level).
     
    Sponsor: National Human Genome Research Institute
     
    Deadline: April 1st, 2017
     
    To read about eligibility, deadline and to apply please visit https://www.uab.edu/medicine/genetics/t32  
     
    Contact: Shaila Handattu PhD, MBA hande@uab.edu
     
     
    Posted by Heflin Center for Genomic Science | 02/17/17
  • Research News Digest for Thursday, February 16, 2017

    In this edition of the Research News Digest:
    Agency Notifications
    eRA Enhancements - February 14, 2017
    Announcements
    Free Training Sessions for NSF CAREER Awards
    New Effort Reporting LMS Course for the New Year
    Upcoming Events
    Genetics and Genomics Seminar Series - Lysosomal Acid Lipase Deficiency (LAL-D): An Underrecognized but Treatable Disorder
    2017 NIH NHLBI PCTC Cardiovascular Tissue Engineering (CVTE) Symposium
    Renal Symposium on Acute Kidney Injury; Cystic Disorders and Therapeutic Intervention
    UAB Postdoctoral Research Day
    Funding Opportunities
    REMINDER: 2017 Special Interest Projects (SIPs)
    Weekly Grants and Contracts Awarded Report
    Reports for 2017 (Updated every Tuesday)
    Posted by Office of the Vice President for Research | 02/16/17
  • eRA Enhancements - February 14, 2017

    New features and improvements will be released on February 16, 2017, for the Extramural Trainee Reporting and Career Tracking (xTRACT) system.
     
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    • Text styling of names that are in all-caps.
    • Upload feature for participating faculty members on a Research Training Dataset (RTD).
    • Ability to cite publications with a large number of authors.
    • Year Awarded correctly shown in Table 8 for subsequent grants.
    Post-release details and screenshots will be made available through Online Help for xTRACT resources. The original announcement may be found on the eRA News website.
     
    Posted by Office of Sponsored Programs | 02/14/17
  • New Effort Reporting LMS Course for the New Year

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    This course is required of all employees who must certify effort on sponsored project(s) (UAB Project Employees, excluding non-exempt/biweekly paid employees) and Departmental Effort Officers (DEOs). Additionally, the school/college dean’s offices may elect to assign this training to other employees that may benefit from the course information as well.  The expectation is this course should be completed prior to certifying effort or distributing effort reports (i.e., before the 3/31/17 end date of the current effort reporting period). For those required to complete this training, the course was automatically assigned in the LMS system in early January 2017.  Those individuals received an email from hs-alerts@healthstream.com with the subject line, “New Assignment in the UAB Learning System”.
    Posted by University Compliance Office | 02/14/17
  • Free Training Sessions for NSF CAREER Awards

    The UAB College of Arts and Sciences is pleased to again offer campus-wide training to junior faculty planning to apply for a National Science Foundation (NSF) CAREER Award. The NSF awards CAREER research grants to new faculty at universities who are at the rank of Assistant Professor (or equivalent) in any of the broad science and social science disciplines that are eligible for NSF grants.  
    Posted by College of Arts and Sciences | 02/14/17
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