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News and Announcements

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FEBRUARY 2018

We have some very exciting and innovative changes to bring to your attention!! 

Regulatory Services is committed to providing excellent customer service while maintaining efficient compliance operations.  To that end, we have made some exciting procedural changes for the IRB with the intent of reducing burden (for investigators, the IRB, and IRB Staff), improving efficiency of protocol reviews, and enhancing the overall quality of the human subject protection program. 

Background

As many of you know, DHHS is planning revision to the Common Rule 45 CFR 46, but has delayed the new version until at least January 2019.  When considering the changes DHHS is planning for the New Rule, it is clear that DHHS is comfortable with (and will move toward) a risk-based approach for human subject research.  In the spirit of this approach and in the best interest of UTA researchers and the IRB Program, we have decided to implement simplified and flexible procedures for research that is not federally funded/FDA regulated (we are still required to comply fully with the existing Common Rule 45 CFR 46  for research that is federally funded or FDA regulated).  UTA will maintain the same ethical standards for research, but the review process limitations/requirements will be simplified to allow for additional flexibility and efficiency.

Major Procedural Changes for Non-Federally Funded, Non-FDA Regulated Research

 1.      Simplified Classification of Research: Research will be classified simply as Minimal Risk (MR) or Greater than Minimal Risk (GMR), instead of the traditional classifications of exempt, expedited, or full board.

  • A simplified process will reduce review time since it will no longer be necessary to determine if the protocol is exempt, expedited, or full board, plus determine which category of exempt or expedited applies.
  • The terms “minimal risk” and “greater than minimal risk” are more meaningful (and easier to understand) labels that will help identify higher-risk research.

2.      Efficient Review of Research: The new process will allow flexibility during review of protocols, which will reduce turnaround time for approvals.

  • MR research will be reviewed and approved by IRB Staff with consultation or review by the IRB only when the staff determines that the research and human subject protection could benefit from specific expertise of the IRB.
  • GMR research will be reviewed and approved by the IRB via one or more IRB members (through consultation or full protocol review), or by the full committee at a convened board meeting.  The method of review will be determined by IRB Staff in consultation with the IRB Chair or Vice-Chair.

 3.      Reduced and Flexible Continuing Reviews: The determination for requiring Continuing Review will be risk-based and allow for flexible, alternative methods.

  • Continuing Review will not generally be required for MR research.
  • For GMR research, the requirement and method for Continuing Review will be at the discretion of the IRB.
  • For both MR and GMR research, Continuing Review may be required in cases where the IRB determines the review will enhance human subject protection.
  • Alternative methods of Continuing Review may be considered to further enhance human subject protection and allow for methods that are tailored to the research and subject population.  Examples might include: continuing review with extended frequency (ex. every 2 years), simplified progress reports, IRB observation of the consent process, or a records review.
  • When Continuing Review is not required, investigators will receive automated emails on an annual basis as a courtesy reminder to: close protocols when applicable, update COI disclosures as applicable, complete training as required, submit modification requests for any proposed changes to the research, and report any unanticipated problems in accordance with the IRB Operating Procedures.

Other Changes

First, we have another exciting announcement, the electronic IRB submission system in Profiles has been improved to be much faster!!!  This is probably just as exciting for us (maybe even more) as it will be for all researchers!!  We hope this will improve your experience with the system and allow you to work faster.

Secondly, we hope you will bear with us as we adjust other parts of our program to accommodate our new changes – for example, we will be revising and simplifying our application forms, the electronic system (adding MR and GMR labels), and the content of our approval letters.  We did not want these programmatic pieces to delay us from moving forward with these positive changes, so we will be working very hard to catch everything up!

Additional Information and Resources

  • To address these flexible procedures for non-funded/non-FDA regulated research, we have prepared an Addendum to the IRB Operating Procedures with details about how research will be classified and processed.  We also have a Flowchart to provide a visual representation of the new review pathways.
  • If you would like a presentation regarding these changes for your lab, a group of faculty, department, classroom, etc., Alyson Stearns is happy to schedule a time: astearns@uta.edu, 817-272-1173.  Alyson has also prepared a very helpful “Prezi” presentation which provides an overview: https://prezi.com/view/ODoDhzpKM2vkjamurW8f/.    
  • We are here to help!  If you have questions about any of these changes or the IRB, please feel free to contact Alyson or our Office!!  General Office Contact Information:  regulatoryservices@uta.edu, 817-272-3723, 202 E. Border St. Suite 300, Open Office Hours every Thursday 9am – 11am.

Thank you to the IRB and our Institutional Official, Dr. Duane Dimos, for supporting these innovative initiatives!  We are excited to see the benefit it will bring to investigators, the IRB, and the University’s research program as a whole, and we look forward to working with you to take UTA research to the next level!!

Have Questions?

For questions regarding IRB, policies, or protocol
submissions and departmental/classroom IRB training
opportunities, please contact
Alyson Stearns at 817-272-1173 or astearns@uta.edu

Join us for IRB Office Hours!
Visit the Center for Innovation (202 E Border St)
Thursdays from 9:00 - 11:00AM without an appointment.

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