Institutional Review Board 

News: 

New Staff 

The Office of Research Integrity and Compliance (ORIC) is pleased to welcome Cathy Powers to the role of Associate Director.  Cathy brings with her more than 25 years of clinical research experience having coordinated over 60 clinical trials.  She comes to us from the Division of Pulmonary Medicine where she has served as the Clinical Research Manager for the past ten years. Her knowledge and expertise will support ORIC’s mission to collaborate with our investigators and facilitate the conduct of research at CMMC.  

In her new role, Cathy will oversee the day to day operations of the IRB as well as work closely with me on general research compliance initiatives related to all of the compliance committees including IACUC and IBC.  

Cathy’s office is located in CMRC C118b (Mailbox #205), she can be reached at ext. 57489 or via e-mail .    

Please join us in welcoming Cathy!   

Annie Munana
Director, Office of Research Integrity and Compliance
 


Clarification Regarding DSMB/C Reports

Reminder: ORIC requests that DSMB/C Reports be submitted for acknowledgment in both electronic and hard copy. Please send the hard copies to Box #205 and the electronic copies to
 

Updated Parental and Adult Consent Templates 

Please use the newly revised templates for the Parental and Adult Consents. Note the new language regarding compensation and reimbursement.  

ClinicalTrials.gov 

 Clinicaltrials.gov: In compliance with FDA requirements Investigators/sponsors must register clinical trials with a clinical trials registry that is electronically searchable and accessible to the public at no charge. The site for registration is maintained by the National Library of Medicine on www.clinicaltrials.gov. For additional information on this requirement and to register your clinical trial please contact the Clinical and Translation Research Office https://childrensmrc.org/clinical_translational_research and Marianne Reed at ; phone (773) 755-6328.

New Research Plan Template:
 

Please follow the new Research Plan Template when writing a research plan for a new submission.

Communication to Potential Subjects – Research Studies

If you are using a Global Email, letter to subjects, brochures, posting on websites, or other forms of recruitment to advertise for a study involving human subjects, you must include in the text the CMH IRB protocol number, PI name, and an assurance statement that you have CMH IRB approval for the content.

We suggest the following wording: “This study is CMH IRB # (fill in the #), (Name), Principal Investigator. The content of this <Insert Recruitment Method> has been approved by the CMH IRB”.

IRB Open House
We invite all researchers, CRA's and other study staff to stop by the IRB office to meet the staff and to ask any questions that you may have about the IRB, the regulations, the IRB review process, etc...or any question regarding research involving human subjects. Even if your research work focuses primarily on research utilizing cell lines or other exempt human subjects' research, you are welcome to stop by to speak with us. We look forward to speaking with you!

When: Every Wednesday
Time: 1:30PM to 3:30PM
Where: The IRB office in the CMRC building, 2430 N. Halsted, 1st Floor
 
 

IRB Submission Deadline:
The next IRB deadline is Monday, October 31, 2011. Only complete submissions are accepted for review. Incomplete submissions will be returned and may prevent a submission from being reviewed at the next convened meeting. Please contact us with any questions.
 

Deadlines and Meeting Schedules:
The IRB and ORIC are committed to facilitating the timely review of human subject research proposals and may opt to schedule additional meetings to accommodate heavy submission cycles and special requests.
2011 Deadlines and Meeting Dates -UPDATED
2011 Major Contingency Conference Call Deadlines and Dates 

2012 Deadlines and Meeting Dates

 


 

FAQ's & Tip Sheet:     

Frequently Asked Questions -- Can't find the information you need? Please take a look at our new FAQ section  
IRB Tip Sheet- The IRB created a Tip Sheet to assist in research submissions. Please refer to this sheet before submitting to the IRB, as well as the other resources located on the website.
 
 


Definitions: 

As defined in 45 CFR 46.102:

(a) Department or agency head means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

(b) Institution means any public or private entity or agency (including federal, state, and other agencies).

(c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.


    


Contact Us: 

When you call us, please have the IRB number handy (once it has been assigned). When sending an email, please include the PI and IRB number in the subject line.

Send electronic submissions to the IRB Mailbox at
. For general correspondence, please contact the IRB staff directly.  

Jessica Banks, Research Compliance Coordinator (all submissions, PIs A-H)
773-755-6592,
 

Andrea Slay, Research Compliance Coordinator (all submissions, PIs I-P)
773-755-7424,
        

Joshua Fedewa, Research Compliance Coordinator (all submissions, PIs Q-Z)
773-755-6324,  

Sharon Modelski, Administrative Assistant (inactivations and human subjects education)
773-755-7425,
 
 

Cathy Powers, RD LDN CRRC, Associate Director, Office of Research Integrity and Compliance 
773-755-7489,
 

Annie Munana, Director, Office of Research Integrity & Compliance (adverse events, exemptions, FWAs)
773-755-6306,
Vita J. Land, MD MBA, Chair

Denise Rizzo, PharmD MBA, Vice-Chair

Katherine Lerner, JD, Vice-Chair

Mailing address: 2300 Children’s Plaza, #205
Chicago, Illinois 60614-3394

Office location: Chilldren's Memorial Research Center, 2430 N. Halsted 
Fax: 773-755-6304