February, 2017 - Printable Version

Inside this issue:



Message from the Director 

This issue of the newsletter brings my last “Message from the Director”.  I am retiring after 36 years as faculty at the UIC.  As one might imagine, over this time I have experienced a number of memorable events, one of the more notable being the outpouring of support the OPRS and I received from investigators at the time of a for-cause site visit from OHRP in 2014.  Specifically highlighted in the site visit report as a strength of the UIC human subject protection program (HSPP) was the atmosphere of collegiality and respect between the research community and OPRS.   Having benefitted from the collaborative atmosphere on this campus for almost 4 decades as a clinical researcher, this observation was not surprising and reinforced my pride in UIC. 

The last 10 years have been eventful for the UIC HSPP.  The HSPP achieved accreditation and re-accreditation from AAHRPP for both UIC and the Jesse Brown VAMC, added staff dedicated to investigator training, education and outreach, established three regional central IRBs to facilitate collaboration between UIC and non-UIC investigators, provided the option for external IRB review for pharmaceutical funded clinical trials, initiated an electronic IRB submission system, and successfully weathered site visits from the U.S. FDA and OHRP.  These achievements reflect the vitality of the UIC research mission and the priority the institution places on conducting ethical research.  I am honored to have had the opportunity to serve as OPRS Director during this time.

I want to thank the three Vice Chancellors for Research who entrusted me with the opportunity to oversee the HSPP since 2007.  I want to express my appreciation to the staff of OPRS and IRB chairs and members whose efforts are primarily responsible for all we have achieved together.  If any of you happen to pass through Grayling, Michigan after February 28, please feel free to stop in at the Fischer’s Cѐili Cottage for an afternoon of fly-fishing and refreshment.  The crew at Spike’s will be able to provide directions.  

Wishing each of you every success in your research endeavors.

Jim Fischer
OPRS Director


Introducing the New OPRS Director, Elaine Fluder 

On January 17, 2017, the UIC Vice Chancellor for Research, Dr. Mitra Dutta, announced the appointment of Elaine Fluder as OPRS Director.

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NIH-Mandated GCP Training Update

Contributed by Charles Hoehne
 

In the fall of 2016, the National Institutes of Health (NIH) announced a new Good Clinical Practices (GCP) training requirement with the “expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).”

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New NIH Mandate: Reporting Requirements for ClincalTrials.gov  

Contributed by Patricia Fischer and Charles Hoehne
 

ClinicalTrials.gov is a web-based resource maintained by NIH’s National Library of Medicine (NLM). The registry was established nearly two decades ago as a mechanism for the public to access information on human subject research involving clinical trials. This effort has unfortunately been hampered by the limited amount of information submitted, lack of clarity regarding registration requirements and lack of enforcement.

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Update on Flexibility Initiative  

Contributed by Charles Hoehne
 

The December 2016 OPRS newsletter included an article regarding an important Policy Change - Extension of Approval Periods for Minimal Risk Non-Federally Funded IRB-Approved Research. The article explained that beginning in spring 2017, IRB approval for most 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). OPRS has been working to implement this exciting policy change (aka the “Flexibility Initiative”) as quickly as possible within the framework of federal research regulations.

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Did you Know? 

Contributed by Charles Hoehne

 

  • The UIC Student Research Form will be held on Monday, April 3, 2017 from 1:00pm – 5:00pm at the UIC Forum (725 West Roosevelt Road)
    The Office of the Vice Chancellor for Research, in conjunction with the Office of the Vice Provost for Undergraduate Affairs, the Honors College and the Center for Student Involvement, is pleased to announce the 2017 Student Research Forum (SRF) and UIC Impact Day, which will be held on Monday, April 3, 2017. This important campus-wide event showcases undergraduate, graduate and professional student research covering a broad range of scholarship: Art/Design/Humanities; Business/Computer Science/Mathematics; Engineering/Physical Sciences; Life Sciences; and Social Sciences.

    This year the Student Research Forum will include a new initiative, UIC Impact Day, as a part of this event.  UIC Impact Day will provide students with an opportunity to showcase pursuits in and beyond the classroom such as service, study abroad, internships, student employment, career development, and/or leadership.

    Student Research Forum Submission Deadline:  Friday, March 17, 9AM
    UIC Impact Day Submission Deadline:  Monday, March 20, 9AM
    Link for additional information: http://research.uic.edu/srf

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