May, 2018 - Printable Version

Inside this issue:



Message from the Director

I am very pleased to announce that the UIC Human Subject Protection Program (HSPP) has received full Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) reaccreditation!  This accreditation is an important designation that reflects the highest quality by which the UIC OPRS and HSPP operates. The purpose of engaging in the accreditation process is to evaluate the ethical, regulatory and quality standards for human research.  The AAHRPP seal places UIC among the world’s most respected, trustworthy research organizations.   

I would like to take this opportunity to thank the many UIC faculty, staff and students who helped support the reaccreditation process. At the exit interview, the AAHRPP site visitors were very complementary of the research knowledge and commitment of UIC investigators and support staff to conduct high quality human research. I sincerely thank everyone involved in this important process!

Common Rule Update

Some of you may be wondering what has happened to the revised common rule.  On April 19, 2018, The U.S. Department of Health and Human Services (HHS) and 16 other federal departments and agencies announced a Notice of Proposed Rulemaking (NPRM) proposing to delay for an additional 6 months the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (the “Common Rule”).

The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018.  Federal departments and agencies later published an interim final rule delaying the effective and general compliance date for the 2018 Requirements until July 19, 2018.

This NPRM is intended to provide regulated entities additional time for the preparations necessary to implement the 2018 Requirements. If finalized, the NPRM would generally require regulated entities to continue to comply with the requirements of the current Common Rule (the “pre-2018 Requirements”) until January 21, 2019.

This means that OPRS may not implement any of the proposed changes to the common rule until January 21, 2019. We will keep the UIC research community informed of any further changes to the proposed rule and the implementation and compliance dates as the information becomes available. 

That said, OPRS is committed to implementing burden reducing measures consistent with ethical standards, research regulations and applicable laws. Please take a few moments to read about some of the recent changes within OPRS. We are particularly excited to announce the release of a new institutional policy that will lengthen the IRB approval period for certain types of research.

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

Elaine Fluder
OPRS Director


New Three-Year Approval Periods for Some Human Subject Research

Contributed By Charles Hoehne and Barbara Corpus
 

Yes, you read the title of this article correctly! As of April 16, 2018, the UIC OPRS is pleased to announce broadening of the institutional approval period to allow some research to be granted an extended approval period of up to 3-years. The goal of this article is to explain the nuances of this exciting new burden reducing initiative.

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Obtaining Informed Consent for Participation in Exempt Research

Contributed by Charles Hoehne
 

OPRS frequently receives questions about obtaining informed consent for participation in exempt research. The discussions seem to run a wide spectrum. Sometimes, investigators indicate informed consent is never required for participation in exempt research. Other times, investigators plan to submit multi-page consent documents for participation in a 10-minute innocuous survey. Both extremes are problematic.

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The OPRS Office Remodel Project is Complete! 

Contributed by Charles Hoehne
 

In the era of big data, multisite studies and increased portability, the way research is being conducted is rapidly changing. In response to these changes, the way research is reviewed is also changing. To meet these new challenges, the UIC Office for the Protection of Research Subjects has been completely remodeled.

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Meet Teresa Johnston, Senior Associate Director for Operations  

Contributed by Charles Hoehne
 

Editor’s note: This is the first article in a series designed to introduce the OPRS staff to the UIC research community.

Teresa Johnston is a familiar name, face and voice around the UIC campus. She recently accepted the position of Senior Associate Director for Operations in OPRS. It has been a remarkable climb for Teresa. Let’s look at her story.

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Did you Know? 

Contributed by Charles Hoehne
 

  • Enhancements of the OPRS electronic submission program, OPRS Live, are ongoing. For example:
    1. OPRS encourages investigators to consider, when appropriate, submitting Final Reports closing out their studies rather than submitting a Continuing Review application. In response to feedback from investigators who are unsure when to submit a Final Report, OPRS Live has been enhanced to include a True/False checklist to help investigators determine whether or not a Final Report can be submitted in place of a Continuing Review application.
    2. Additionally, based on feedback OPRS has received from investigators, the OPRS Live user interface and dashboards are being updated by the OPRS Live Tech Team to enhance usability and to make the system more streamlined and intuitive.

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