July, 2015

Inside this issue:


Message from the Director

"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."
 
President Bill Clinton
May 16, 1997
Remarks by the President in an Apology for the Study Done in Tuskegee

A colleague recently suggested that “Initial Investigator Training” may be a bit of a misnomer. He felt a better name for the program might be “Investigator Orientation” as it would more accurately capture the fact that investigator training is far too complex to ever be “completed.”

While my colleague’s point is well-taken, OPRS is not planning to change the name of this particular training program. Nevertheless, as President Clinton remarked eighteen years ago, investigators must remain vigilant about the evolution of research requirements as the nature and sophistication of human subject research is ever-changing. That you are reading this newsletter demonstrates you are on the right track.

The following topics are included in this newsletter:

  • New policy regarding sponsor payment for costs related to subject injury in industry-sponsored clinical trials;
  • Key differences between exempt and expedited research;
  • Overview of the OPRS web-based protocol management system; and
  • An explanation of why a research protocol is required when submitting an initial application for IRB review.

I wish you all the best this summer and much continued research success!


Sponsor Payment for Costs Related to Subject Injury in Industry-Sponsored Clinical Trials

Contributed by Dr. Clyde Wheeler, Barbara Corpus and Charles Hoehne

Important Note: While injury costs are an important consideration for all greater than minimal risk research studies, this article is aimed exclusively at industry-sponsored clinical trials.

A important required element of informed consent is related to the cost of participating in the research [21CFR50.25(a)(6) and 45CFR46.116(a)(6)]. This is particularly true when the research involves greater than minimal risk to subjects. The informed consent document, therefore, must clearly and accurately explain to potential subjects who will pay for treatment if an injury is suffered related to participation in an industry-sponsored clinical trial.

 

Comparing Exempt and Expedited Human Subject Research 

Contributed by Charles Hoehne

OPRS staff frequently receives calls from investigators asking whether they should submit their research protocols for exempt or expedited review. The purpose of this article is to identify the key considerations when answering this question.

Note: This article assumes the activity constitutes “Human Subjects Research” as defined by 45 CFR 46.102(d) and (f): http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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Understanding RiSC: What is it? How can it be helpful?

Contributed by Charles Hoehne

There is understandable excitement around campus regarding efforts to allow for electronic submission of applications to OPRS. The purpose of this article is to provide a brief overview of the OPRS web-based protocol management system and to explain the web-based features currently available to UIC research personnel. This information may help you utilize the currently available web-based features while promoting a better understanding of future enhancements as they become available.

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Registration Open for the Clinical Research Boot Camp 2015

Contributed by Lynn Podraza and Charles Hoehne

OPRS is pleased to announce that registration for the Clinical Research Boot Camp 2015 (Boot Camp) is now open.  Boot Camp is sponsored by the Center for Clinical and Translational Research and the Office of the Vice Chancellor for Research. The program is designed to enable participants to implement best practices for human research subject protection, recruitment, consent, study conduct, and data safety/security.

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Did you Know?

Contributed by Charles Hoehne

  1. … Each Initial Review Application (exempt, expedited, convened) requires submission of a research protocol: 
    • The research protocol represents the primary documentation of the proposal for the purpose of IRB review. 
    • The research protocol should provide a complete explanation of the research plan, and should be used as the basis for completion of the other IRB submission documents. 
    • The Application form is used to summarize the research protocol and to provide specific information about the human subjects protection issues related to the protocol.
    • The research protocol is distinct from Initial Review Application, Claim of Exemption Application and the grant/contract/subcontract.
    • In most cases, a sufficiently detailed thesis or dissertation proposal can serve as the research protocol for student research studies.
    • Link to OPRS Research Protocol template: http://research.uic.edu/compliance/human-subjects-irb/forms
  2. … UIC serves as the IRB of record for the American Medical Association and Easter Seals.
  3. … UIC ranks among the nation’s leading research universities as one of the top research-funded institutions in the nation. Over $347 million was awarded to our outstanding faculty in FY14, supporting ground breaking research. UIC boasts one of the most diverse student bodies in the country, offering a cultural experience second to none with more than 27,000 students, nearly 10,000 faculty and staff, 15 colleges, and the state’s major public health system. More interesting research-related facts, figures and information are available via the Office for the Vice Chancellor for Research Annual Report 2014: https://research.uic.edu/sites/default/files/2014AR.pdf
  4. … While OPRS Live is being implemented, investigators can and should continue to submit applications to OPRS in the same manner they have in the past.
    OPRS will accept paper submissions on:
    Mondays: 8:30 am – 5:00 pm
    Wednesdays: 8:30 am – 4:30 pm
    Fridays: 8:30 am - 5:00 pm

OPRS will be closed for the submission of paper applications on Tuesdays and Thursdays.

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