Search Roosevelt University

Institutional Review Board

More in this section...

Roosevelt University Federalwide Assurance (FWA) Number: FWA00019042

The Human Research Protection Program at Roosevelt University encompasses all areas of compliance, relevant policies and standard operating procedures that directly affect human research activities. The areas of the Human Research Protection Program include the Institutional Review Board (IRB), conflict of interest in research, and Responsible Conduct of Research. The Human Research Protection Administrator will coordinate trainings, provide policy guidance, and incorporate standard operating procedures for all activities related to human research protection protocols. Please contact Deidra Somerville at (dsomerville@roosevelt.edu) as you begin your IRB submission process. The Office of Research and Faculty Success within the Office of the Provost oversees the activities of the Human Research Protection Administrator.

IRB Committee Membership – 2017-2018

Member Name Phone Number Email Address
Byoung Kim 312-853-4775 bkim@roosevelt.edu
Cara Brock
IRB Chair
847-330-4528 cbrock@roosevelt.edu
Erin Mackinney 312-853-4768 emackinney@roosevelt.edu
Jill Coleman 312-341-2069 jcoleman@roosevelt.edu
La Vonne Downey 312-322-7112 ldowney@roosevelt.edu
Judy Dygdon 312-341-3751 jdygdon@roosevelt.edu
Richard Rowe
community member
   
Sarah Kinnison
community member
   
Susan Weiner 312-341-3683 sweiner02@roosevelt.edu
Zoe Bell
student member
   

Download Version of IRB Application Packet  (Word, 204K -- to open as a WORD file and fill out on your PC)

Common Rule Announcement

Final revisions to the Federal Policy for the Protection of Human Subjects (a.k.a. the "Common Rule") were issued by the Department of Health and Human Services (HHS) on January 18, 2017.  The majority of changes will go into effect on January 19, 2018. A few examples:

  • Continuing Review - Will no longer be required for some minimal risk research, including studies where the only remaining activity is the analysis of identifiable data/biospecimens or activity to obtain follow-up clinical data.  More details to come.
  • Exemptions - New categories and clarification of existing categories.  Some exemptions may require “limited IRB review” (similar to an expedited review process).  More details to come.
  • Informed Consent Forms - A new “Key Elements” section and a rearrangement of content designed to facilitate a potential subject's decision to participate or not.

Many of the changes to the updated Common Rule or the ‘2018 Common Rule’ (2018CR), were made to lessen administrative and investigator burden without compromising participants’ protections.  Institutions have been given the flexibility to implement the 2018 Common Rule early on a study-by-study basis for studies that meet the criteria and can benefit from some of the reduced administrative burdens.  Our institution has decided to take advantage of this flexibility to lessen administrative burdens and to help manage an orderly rollout of these changes.

These changes to the Common Rule will affect all research institutions who conduct human subjects research in the United States, so all research institutions are preparing during this transition time.  The added flexibility in the regulations will be helpful but also means that institutions will be busy reflecting on their current practices and how to move forward with the 2018 Common Rule. We are in the process of updating our forms and procedures and ask for your patience during this transition period.

What to Expect

  • For existing studies: those investigators who currently have ongoing human subject protocols approved before the effective date of January 19, 2018, there is nothing that you need to do at this time.  Your study may not be affected at all, however, if your study qualifies for any burden-reducing changes, you may choose to apply the new rules to minimize your burden and will be notified no later than at the time of your next annual review.
  • Informed consent template revisions available soon! You will be notified when revised Informed Consent Forms and other revised IRB documents are available on our IRB website and when the current (pre-2018 CR) forms will no longer be accepted.
  • Look out for emails, notifications on the IRB webpage about additional information on the 2018 Common Rule implementation. You will soon receive information explaining the main revisions of the 2018 Common Rule that would affect you.
  • Informational sessions will be announced and conducted in the near future.

If you have any questions, please contact the Human Research Protections Administrator, Deidra Somerville at dsomerville@roosevelt.edu or 312-341-2449.

Additional information: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

Implementation of new Common Rule delayed until July 19, 2018

The U.S. Department of Health and Human Services and 15 other federal departments and agencies have announced an Interim Final Rule (IFR) that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149).  Most provisions in the revised Common Rule were scheduled to go into effect on January 19, 2018. 

The IFR delays the effective date and general compliance date to July 19, 2018, providing regulated entities additional time to prepare to implement these revisions.

The IFR has been put on public display by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.

Until July 19, 2018, regulated entities will be required to comply with the pre-2018 Common Rule as published in the 2016 edition of the Code of Federal Regulations (i.e., the Federal Policy for the Protection of Human Subjects, originally published on June 18, 1991, and subsequently amended on June 23, 2005) that can be accessed at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title45-vol1/pdf/CFR-2016-title45-vol1-part46.pdf . This means that before July 19, 2018, institutions may only begin implementing provisions of the revised Common Rule that do not conflict with the pre-2018 Common Rule. An example of a revised provision that does not conflict with the pre-2018 rule is one that addresses new elements of informed consent (revised rule at §__.116(b)(9), (c)(7)-(9)). It is permissible to incorporate these new elements of consent now because the pre-2018 rule does not prohibit including these elements in informed consent.

An example of a revised provision that conflicts with the pre-2018 rule, and thus could not be implemented prior to July 19, 2018, is the provision eliminating the requirement for continuing review in certain circumstances (as described in the revised rule at §__.109(f)). Because the pre-2018 regulations require continuing review at least annually for all ongoing non-exempt human subjects research, halting continuing review for such research before that date would be considered non-compliance.

IRB Submission Deadlines

IRB Application Submission and Review Dates, 2018-2019

IRB Application Due Date IRB Committee Meeting
August 23, 2018 - 5:00pm September 6, 2018
September 20, 2018  - 5:00pm October 4, 2018
October 18, 2018 - 5:00pm November 1, 2018
November 21, 2018 - 5:00pm December 6, 2018
December 20, 2018 - 5:00pm January 10, 2019
January 24, 2019 - 5:00pm February 7, 2019
February 21, 2019 - 5:00pm March 7, 2019
March 21, 2019 - 5:00pm April 4, 2019
April 18, 2019 - 5:00pm May 2, 2019
May 23, 2019 - 5:00pm June 6, 2019
June 20, 2019 - 5:00pm July 11, 2019
July 18, 2019 - 5:00pm August 1, 2019