June, 2017 - Printable Version

Inside this issue:



Message from the Director

Having spent much of my first six months at UIC analyzing the Human Research Protection Program and examining ways to strengthen the program while promoting the ethical conduct of research, I am reminded of the following paradoxical quotes:

“No matter what business you're in, you can't run in place or someone will pass you by. It doesn't matter how many games you've won.” -- Jim Valvano, Hall of Fame Basketball Coach and Founder of the V Foundation, striving for victory over cancer

“We face a challenge in our time. Science and technology are rapidly changing our lives with the promise of making us much healthier, much more productive and more prosperous. But with these changes we must work harder to see that as we advance we don’t leave behind our conscience. No ground is gained and, indeed, much is lost if we lose our moral bearings in the name of progress.” -- Bill Clinton, Remarks by the President in Apology for Study Done in Tuskegee, Alabama, May 16, 1997

There is no question UIC has a winning research program. UIC ranked 65th nationally in FY2015 with federally financed expenditures of $196,010,000. In FY2016, 1,518 projects at UIC were awarded $313,280,019. UIC faculty, staff and students submit approximately 1,300 new studies for IRB review annually, along with thousands more amendments, continuing review applications, final reports, and yes, the occasional prompt report related to unanticipated problems or adverse events. UIC is a massive research entity. We are indeed “Chicago’s Public Research University.”

Our stature, however, comes with a great deal of responsibility. We must strive to conduct ethical research that benefits everyone equally. For this reason, we must have a robust Human Research Protection Program at UIC. And we do.

UIC has been accredited twice by the Association for the Accreditation of Human Research Protections Programs (AAHRPP), the gold standard for research ethics, quality and human protections. This year, we are in the process of obtaining our second five-year AAHRPP reaccreditation. We have successfully completed FDA audits and OHRP site visits. OPRS has grown from an office of six staff members in the mid-late 1990’s to an office of twenty-four. We have grown to three IRBs, each meeting twice per month. We have partnered with the Western IRB and the NCI Central IRB to review certain multi-center clinical trials. We are honored to be the IRB of record for the American Medical Association.

Most importantly, OPRS is proud to share responsibility for protecting human subjects with so many talented researchers. Together, challenges such as those related to HIPAA and federally-mandated data security requirements for Protected Health Information and other sensitive information have been managed. Together, we will navigate over the next several months the challenging process of enacting the much anticipated revisions to the Common Rule.

As President Clinton predicted, the past twenty years has seen tremendous change in the way research is conducted. For example, technology has significantly altered the way we gather, share, and analyze data. Today, we can access enormous amounts of data with just a few keystrokes. Genetic and DNA research has helped develop personalized treatment options for patients facing daunting medical conditions. It is a brave and complex new research world. As Jim Valvano noted, if we do not adapt, we will fall behind. In this newsletter, we will highlight some of the recent ways the UIC Human Research Protection Program has evolved and is evolving to meet new research demands and methodologies while still maintaining high ethical standards.

To all of you that I have gotten to know during my first six months at UIC, it is an honor to share responsibility for the protection of research participants with you. To those whom I have not had the opportunity to meet, I very much look forward to working with you as well.

I wish each of you every success in your research endeavors.

Elaine Fluder
OPRS Director


Common Rule Revisions Update 

Contributed by Charles Hoehne

 

“I think if you look at exactly where you are, you can't really focus without looking back and forward at the same time.” -- Bill Laswell, Musician

First, a look back: The U.S. system for human research protections is based upon the Belmont Report. Written in 1979, the Belmont Report details three basic ethical principles for the conduct of human subject research: Respect for Persons, Beneficence and Justice.

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Revised Initial Review Form for Social and Behavioral Research

Contributed by Charles Hoehne
 

The UIC Vice Chancellor for Research, Dr. Mitra Dutta, and the Office for the Protection of Research Subjects (OPRS) are pleased to inform the campus of a significant revision of the Initial Review Application for Social and Behavioral Sciences.

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Association for the Accreditation of Human Research Protection Programs (AAHRPP) Re-Accreditation Update  

Contributed by Charles Hoehne
 

“Do right. Do your best. Treat others as you want to be treated.” -- Lou Holtz, Football Coach

While Lou Holtz’s quote is not directly related to human research protections, it does help explain why AAHRPP accreditation is so important to the UIC Human Research Protection Program. While the primary purpose of AAHRPP accreditation is to strengthen protections for research participants (do right), accreditation advances that objective (do your best) and helps build public trust and confidence in research (treat others as you want to be treated).  

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NIH Single IRB Policy and SMART IRB Update  

Contributed by Brandi Drumgole
 

The December 2016 OPRS Newsletter (http://research.uic.edu/dec2016#new) included an article detailing a new NIH policy for NIH-funded studies involving non-­exempt human subject research. Effective January 25, 2018, 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. Yes, this date differs from the revised Common Rule requirement. The date for compliance for all other multi-institutional research studies is January 20, 2020.

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Did you Know? 

Contributed by Charles Hoehne

 

  • OPRS is in the process of updating the UIC Unanticipated Problems and Other Events Requiring Prompt Reporting Policy. Highlights of the revised policy will include:
    • Investigators will be required to determine whether the unanticipated problem is related to the research.
    • Two (2) types of events will be moved from reporting within 15 business days to 5 business days:
      • New information indicating an unexpected change to the risks or benefits of the research (i.e., an unanticipated problem)
      • External adverse events that are i) unanticipated, ii) indicate research associated with a greater risk of harm to participants or others than previously known, and iii) more likely than not to have been caused by the procedures associated with or subject’s participation in the research.  An analysis from the sponsor, coordinating center, or DSMB/DMC supporting that the event or problem meets the three (3) criteria above must be included.
    • Removal of the VA Collaborative IRB (IRB #4). Addition of CHAIRb

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