December, 2016 - Printable Version

Inside this issue:



Message from the Director

At the beginning of this year (January 2016 OPRS Newsletter), I wrote the following, “We have closed the book on 2015 and can look forward to an interesting and challenging new year. Change is coming as the UIC Human Subject Protection Program progresses. While change can be unsettling, 2016 will be rewarding as several advances in human subject research protections move forward.” Change did occur, and as we rapidly approach 2017, I am confident more change is on the way.

First, the National Institutes of Health (NIH) published a new policy for NIH-funded, multi-site studies involving non-exempt human subject research. Effective May 25, 2017, most NIH-funded, multi-site research studies will be eligible for single IRB review. The goal of the initiative is to allow research to proceed as effectively and expeditiously as possible. To achieve this goal, significant “behind the scenes” effort has been made to develop UIC’s policies and procedures for complying with this initiative. Please see Charles Hoehne’s and Brandi Drumgole’s article in this newsletter for additional information.

Next, electronic submissions became a reality for all UIC investigators conducting human subject research in 2016. The rollout of OPRS Live (beta) was completed in early fall. During planning consultations with other institutions and commercial developers, we were told the rollout would take at least two years. We did it in one. In homage to our current political climate, the development and rollout effort, led by Bhavin Patel, Shreyas Chandrakant and the OVCR Tech Team, was YUGE! While still a work in progress, investigators have submitted approximately 3600 applications electronically through the new system. Make no mistake- The learning curve has been significant for investigators, OPRS staff, IRB members and other users, which initially slowed down the submission and review process. We are now, however, starting to see the benefits of electronic submissions. Turnaround times are decreasing and OPRS Live (beta) enhancements are being implemented to make the system as user friendly as possible. For a brief overview of OPRS Live (beta), along with a sneak peek at future enhancements, please see Charles Hoehne’s article in this newsletter.

In other news regarding efforts to streamline the IRB review and approval process. I am pleased to announce that UIC will be implementing in  Spring 2017 a new flexibility policy which will allow the IRB to grant three-year approval periods for minimal risk, non-federally funded research studies. Please see the article entitled, “Important HSPP Policy Change -

Extension of Approval Periods for Minimal Risk Non-Federally Funded IRB-Approved Research” included in this newsletter for additional information about this exciting initiative.

Finally, 2016 marks the end of an era at OPRS with the retirement of Dr. Clyde Wheeler, OPRS Associate Director. Dr. Wheeler was an integral part of OPRS since 1997. During this time, OPRS grew from a small office to a fully accredited Human Subject Protection Program. We thank Dr. Wheeler for his service and wish him well in retirement.

To the entire UIC research community, thank you for your patience and cooperation during the past year. 2017 promises to be another year of change. In particular, Department of Health and Human Services (DHHS) revisions of the Common Rule are still pending. At the 2016 Advancing Ethical Research Conference held in Anaheim in November, the message was very clear: Change is coming, but no one knows what those changes will be.  In the meantime, stay tuned. We will let you know what the changes are and how we will adapt to them as they emerge.

Happy Holidays and good luck with your research endeavors in 2017!

Jim Fischer
OPRS Director


New Policy for NIH-Funded, Multi-Site Research 

Contributed by Charles Hoehne and Brandi Drumgole

The National Institutes of Health (NIH) published a new policy for NIH-funded, multi-site studies involving non-­exempt human subject research. Effective May 25, 2017, a single Institutional Review Board (sIRB) will be used to conduct the ethical review required by the Department of Health and Human Services (DHHS) regulations for the protection of human subjects.

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OPRS Live (beta) Update

Contributed by Charles Hoehne
 

As the OPRS Director, Dr. Jim Fischer, noted in his newsletter introduction, electronic submission of all human subject research applications is now a reality at UIC. Approximately 3600 applications have been submitted through OPRS Live (beta). As familiarity with the electronic submission process has increased, turnaround times have decreased. It is fully expected that this trend will continue, especially as enhancements of the system are implemented.  Here is a brief overview, notes and highlights of OPRS Live (beta):

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Important HSPP Policy Change Extension of Approval Periods for Minimal Risk Non-Federally Funded IRB-Approved Research  

Contributed by Charles Hoehne
 

OPRS is pleased to announce that beginning in  Spring 2017, IRB approval for minimal risk, non-federally funded research will be extended from a maximum of one year (365 days) to a maximum of three years (1095 days).  UIC has chosen to limit the scope of its Federalwide Assurance (FWA) to federally funded research. “Unchecking the box” allows UIC to utilize greater flexibility for oversight of non-federally funded human subject research involving no greater than minimal risk to subjects. This exciting new Flexibility Policy will allow the IRB to focus more resources on greater than minimal risk studies while reducing regulatory burden on investigators, research personnel and OPRS staff.

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Did you Know? 

Contributed by Charles Hoehne

  • OPRS has begun the process of applying for American Association of Human Research Protection Programs (AAHRPP) reaccreditation. The application is due in the spring, and the site visit will be scheduled after the application process has been completed. The reaccreditation process will require analysis and modifications of institutional policies and procedures. It will likely also require additional education and training for individuals involved in the UIC Human Subjects Protection Program (HSPP). The UIC HSPP was initially accredited in March 2010 and received reaccreditation for five years in September 2012. AAHRPP accreditation is important to the institution in part because it helps promote the ethical conduct of research benefiting everyone equally.
  • 2016 Holiday Schedule - The Office for the Protection of Research Subjects (OPRS) will observe the UIC reduced service schedule for non-essential services that begins on Thursday, December 22nd.  OPRS will close at 5:00 PM on Thursday, December 22, 2016, and will reopen at 8:30 AM on Tuesday, January 3, 2017.  OPRS Live submissions will not be accepted by the OPRS Front Desk during the reduced service period.  OPRS will make every effort to process submissions that were received by December 1, 2016 prior to the December 22, 2016 closure; however, please note that our ability to do this depends on the volume of submissions received and staffing during this period.  Convened submissions will be processed based on the current submission/meeting schedule.  Please refer to the OPRS Web Site for the specific deadline and meeting dates.  Please be mindful of your protocol expiration date. If your protocol expires before January 9, 2017, please have your Continuing Review in to OPRS at least four weeks ahead of the expiration date to prevent a lapse. Requests for emergency use of an investigational drug or device may continue to be submitted during this time. 
  • Prior to his retirement from OPRS in November, Dr. Clyde Wheeler began his affiliation with UIC as a student in 1980. He began his career at UIC as an animal researcher; however, he changed career paths to human subject protections after developing severe allergies to animals. The rest, as they say, is history. Bon Voyage, Clyde! Thank you for a job well done!

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