September, 2015 - Printable Version
Message from the Director
Welcome to all new faculty, staff and students! We are glad you are here to be part of this unique institution.
UIC’s deepest roots are based in medicine. The Chicago College of Pharmacy was founded in 1859. The College of Pharmacy, the College of Physicians and Surgeons and the College of Dentistry consolidated in 1913. Research was and continues to be a fundamental mission of the combined Health Science Colleges. In the decades following incorporation, several other health science colleges were created. Together with the Colleges of Medicine, Dentistry and Pharmacy, they formed the Chicago Professional Colleges of the University of Illinois. In 1961, the professional colleges became the University of Illinois Medical Center.
Paradoxically, UIC is also a very young institution, born in 1982, when the University of Illinois Circle (1965-1981) joined forces with the Medical Center. This merger helped UIC reach the elite Carnegie “Research I” status.
Today, one of UIC’s greatest strengths is its diverse faculty, staff and student population. In its urban setting, UIC’s diversity, combined with a strong commitment to community engagement, makes UIC uniquely suited to addressing a wide range of urban challenges. To meet these challenges, each of us must commit to extending our academic and research endeavors beyond the borders of our campus to uphold our fundamental belief that everyone should benefit from research equally.
I encourage you to learn more about UIC’s rich history. The UIC website is an excellent resource for learning more about UIC’s past, present and future. It is a truly fascinating institution.
Remember- What you do today will be tomorrow’s history. What do you want your legacy to be?
"Today, one of UIC’s greatest strengths is its diverse faculty, staff and student population"
The following topics are addressed in this issue of the newsletter:
- Research protocols eligible for review by the Western IRB;
- A brief update on the electronic submission process, OPRS Live, in development; and
- How to manage Institutional Conflict of Interest
To all UIC faculty, staff and students, I wish you much academic and research success!
Contributed by Charles Hoehne
In an effort to streamline the IRB review process by eliminating the need for multiple convened reviews, UIC has contracted with Western IRB (WIRB), an established and AAHRPP Accredited independent IRB, for the review of industry-sponsored and industry-initiated research studies. UIC investigators have the option of submitting industry-sponsored clinical trials, with some exceptions, to the WIRB for review and approval instead of the UIC IRBs.
The following studies qualify to be reviewed by the Western IRB:
- Research that meets the National Institute of Health (NIH) definition of a clinical trial, i.e. “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”.
- Research is a Phase II / III / IV clinical trial.
- Research is designed and research protocol written by the sponsor.
- The sponsor is a for-profit entity or company.
- The sponsor holds all INDs / IDEs.
- The research has not previously been submitted to the UIC IRB for review.
- The research is greater than minimal risk.
Research that includes the following criteria may qualify for submission to WIRB depending upon the design of the study. It is requested that the Protocol Synopsis be provided to the OPRS WIRB Administrator for review:
- Research that involves subjects under the age of 18 (i.e., Children, Minors)
Any industry-sponsored study that meets any of the following criteria does not qualify for submission to WIRB:
- Phase I studies (including I/II, Ib or similar studies)
- Planned Emergency Research
- Transplant Research, including Cadaveric Research
- Embryonic Stem Cell Research
- Research involving Jesse Brown Veterans Administration Medical Center
- Research that involves funds from a federal or non-profit funding agency
- Research that is investigator-initiated
- Research that involves the use of recombinant DNA and its derivatives, such as vectors, and infectious agents
- Research that involves the use of radioactive drugs or biologics or radioactive materials. A full list of research that requires Institutional Biosafety Committee approval is available on the OPRS website through the link provided below.
Note: The UIC IRB reserves the right to withhold any new research protocol, regardless of industry sponsorship, from being sent to WIRB for review.
The following additional information regarding WIRB is available on the OPRS website: http://research.uic.edu/compliance/irb/investigators-research-staff/review-research-western-institutional-review-board-wirb:
- How to request submission to the WIRB
- A description of the initial OPRS review process of WIRB submissions
- An explanation of what happens after the WIRB accepts a submission
- An explanation of the processing/administrative fees for the WIRB review
When using the WIRB, your contacts within the UIC OPRS are the WIRB Administrators. The WIRB Administrators are the UIC OPRS liaisons between the UIC OPRS and WIRB and can provide additional guidance:
Laura Litman: OPRS Coordinator, 312-413-2058 or email@example.com
Cynthia Tom-Klebba: Associate Director, IRB Operations, 312-413-4006 or firstname.lastname@example.org
Contributed by Charles Hoehne
As many of you have heard, UIC is moving towards an electronic submission process for IRB reviews. OPRS Live will be a significant enhancement of the UIC Human Subjects Protection Program. Please understand that the OVCR Tech Team in conjunction with OPRS is working extremely hard to have OPRS Live available to all UIC investigators as soon as possible, but we must make sure that the system is functioning correctly and effectively prior to rolling it out to the entire campus.
Please keep your eyes and ears open for announcements for when OPRS Live will be rolled out in your department. In the meantime, please remember that you can and should continue to submit paper applications to OPRS until your department has been added to the OPRS Live list.
Contributed by Jacquelyn Jancius, Director, UIC COI Office
Institutional Conflict of Interest (ICOI) - The principal investigator (PI) is required to disclose conflicts of interest of investigators and key research personnel on a study, but you should also know that the PI is required to disclose institutional conflicts of interest on a study.
What is institutional conflict of interest?
Per the Office for the Protection of Research Subjects Policy on Investigator Conflict of Interest Disclosure for Human Subjects Research (May 2011), Institutional Conflict of Interest (ICOI) is defined as:
The possibility that financial interests of the university or a university official acting within his or her authority on behalf of the institution might affect or reasonably appear to affect institutional processes for the design, conduct, reporting, review, or oversight of human subjects research. Examples of institutional conflict of interest include but are not limited to:
- The university has an equity interest in a company or the university holds a patent, license, or some type of intellectual property interest related to the product that is the subject of the research.
- A university official acting within his or her authority on behalf of the institution has equity interest, serves on an advisory or other Board, or serves in a fiduciary role in an entity that has an interest in the outcome of human subjects research.
- Gifts to the university or university official from a company or other entity that has an interest in the outcome of human subjects research.
What should you do if you identify ICOI on your study?
Identify the ICOI on the initial application. If discovered after the initial application has been approved, then as soon as possible, disclose the ICOI to the IRB by submitting an amendment to study. Identify the ICOI on the amendment application. Submit the amendment to the OPRS. OPRS will notify the Conflict of Interest Office. The COI office will work with the PI to develop the Institutional Interest-Disclosure and Management Plan.
You may contact the COI Office for advice or guidance at any time. COI Office can be reached COI@uic.edu or (312) 996-4070.
Contributed by Charles Hoehne
- UIC jumped up 20 spots in the U.S. News and World Report’s Best Colleges Rankings for 2016. UIC climbed from No. 149 to No. 129 of nearly 1800 colleges and universities based on their academic prowess. UIC is tied with Arizona State University, Louisiana State University, SUNY Albany, the University of Kentucky and the University of Arkansas, but UIC is the fastest climber of these six institutions.
- The UIC College of Pharmacy has received a five-year, $9 million grant from the National Institutes of Health to continue its research into the safety and efficacy of botanical dietary supplements for women’s health and another $1.2 million over five years to develop new chemical and biological approaches to the investigation of natural products. Link to full article: http://news.uic.edu/10m-in-federal-grants-to-study-botanicals-for-human-health
- In partnership with Erie Family Health Center, UIC received a five-year, $3.2 million federal grant to examine the effectiveness of two interventions to improve asthma control for children in low-income families in Chicago. Link to full article: http://news.uic.edu/grant-helps-low-income-asthmatic-children-breathe-easier
- On July 25, 2015, Tonda Hughes, Professor of Health Systems Science and Associate Dean of Global Health, was inducted into the Nurse Researcher Hall of Fame of the Honor Society of Nursing, Sigma Theta Tau International. Fewer than 100 nurses worldwide have earned this distinction. Link to full article: http://news.uic.edu/uic-researcher-inducted-into-nursing-hall-of-fame.