Research Operations Resources

Staff available to help you with regulatory compliance matters.

All Cancer Studies

Michelle Rainer

Regulatory Affairs Manager - Cancer Clinical Trials Office

mrainer@bsd.uchicago.edu

 

Breast Studies

Brenda Gonzales

Clinical Research Coordinator

bgonzales@bsd.uchicago.edu 

 

Non-breast Studies (excluding cancer)

Pamela Carroll, RN, MSN, OCN, CCRC

Research Nurse Associate

pamela.carroll@bsd.uchicago.edu

 

Diep Truong

Director of Finance

dtruong@bsd.uchicago.edu

773-702-6520
 

Jasmine Fields

Pre-award Administrator (for grant submission)

jfields2@bsd.uchicago.edu

773-702-6728

 

Venice Lewis 

Post-award Administrator

venice.Lewis@bsd.uchicago.edu

773-702-6272

 

 

HIRO - Human Imaging Research Office

Samuel Armato III, Ph.D.

Faculty Director - HIRO

s-armato@uchicago.edu

Nick Gruszauskas, Ph.D.

Technical Director - HIRO

ngrusz1@uchicago.edu
 

Abbreviation Guide and Quick Links

Here you will find resources made available to you by the University of Chicago to recruit both study participants and researchers.

Recruiting Patients and Marketing your Study

Bulletin Board Notices - Guidelines and Contact Information

The following guidelines are for posting flyers in glass-cased bulletin boards within the Medical Center:

All research study notices must have an expiration date. There is a three-month limit for posting trials. Extensions may be given upon request.
All research study notices must have IRB approval stamped on each notice. Contact the IRB administrative assistant at (773) 702-6505 for more information. Research study notices will be posted on a first-come, first-served basis.

Because of space considerations, it is best to post flyers only where needed. Request a bulletin board location list and limit posting. Please limit your choice to five to eight bulletin boards to guarantee space for everyone.
To borrow the keys to the boards, or if you have any additional questions, please contact the Multi-Media Services at ext. 2-6265.

Recruiting Student Researchers

Recruiting undergraduate and graduate student researchers to join your team provides a valuable education and professional experience to them, and provides you an opportunity to collaborate with some of our University's young scholars. Advertising to student research assistants can be done through one or more of the following avenues:

• Radiology Residency and Fellowship Program
• Graduate Program in Medical Physics
• Pritzker Summer Research Program
• Biological Sciences Collegiate Division

The following individuals have offered to act as mentors to junior faculty, residents, and fellows who are interested in starting research projects that are primarily related to their sections. In addition to general advice about research methodology, they may be able to suggest new subjects or directions for research in their respective areas of interest. Even if assistance is not specifically required, the appropriate attending should be informed when a project is planned so that they are aware of the research, and so that projects within the sections can be properly coordinated.

Guidance for Faculty and Visiting Scholars

Vice Chairs and Associate Vice Chairs

Clinical Operations

Basic Science Research

Informatics

Section Chiefs of Clinical Faculty

Abdominal

Breast Imaging Chest

Interventional

Musculoskeletal

Neuroradiology

Nuclear Medicine

Pediatrics

Thoracic

Guidance for Residents and Fellows

Residents interested in guidance should contact the most appropriate subspecialty chief listed above. Fellows should contact their section's Fellowship Program Director.

HIPAA

Patient privacy is central to the care we provide to patients at the University of Chicago Medical Center. Our patients entrust us with their confidential health and other information. It is both our duty and our responsibility to earn that trust by handling confidential information with care. Moreover, as Medical Center and University of Chicago employees, we must comply with federal and state laws, including the Health Insurance Portability and Accountability Act of 1996, therefore, we ask that you complete online HIPAA training every fiscal year.

Radiology research at the University of Chicago generally falls into three categories: human subjects, animal subjects, and everything else. This page will provide resources for the regulatory compliance aspects of human and animal subjects. This will include links and documentation pertaining to: BSD IRB (Biological Sciences Division - Institutional Review Board AURA (Automated University-wide Research Administration CITI Training

Human Subjects

A human subjects study is any research that involves human patients at any point in the research process, including clinical trials, healthy subjects in imaging research, and retrospective chart/image reviews/analyses. Even the radiologists participating in a reader study can be considered human subjects.

Before you begin the regulatory compliance process, you are advised to read the materials provided here and reach out to one of the following three research professionals to discuss the most appropriate set of actions.

All Cancer Studies

Michelle Rainer

Regulatory Affairs Manager - Cancer Clinical Trials Office

mrainer@bsd.uchicago.edu

 

Breast Studies

Brenda Gonzales

Clinical Research Coordinator

bgonzales@bsd.uchicago.edu 

 

Non-breast Studies

Pamela Carroll, RN, MSN, OCN, CCRC

Research Nurse Associate

pamela.carroll@bsd.uchicago.edu

 

All cancer clinical trials are administered through the Cancer Clinical Trials Office (CCTO) in conjunction with the Clinical Trials Review Committee (CTRC). An overview of the CCTO's operations can be viewed here.

All studies that involve human subjects must be reviewed by the Clinical Trials Review Committee (CTRC) before the study can be reviewed by the IRB. The committee meets once a month. Utilizing these instructions, construct a detailed protocol and forward it on to Sheila.

Sheila will help you start the submission of the CTRC application and return it to you for review and signature. A consent form needs to be prepared using the University of Chicago consent form template, which can be found linked at the bottom of this page. Sheila will work with the PI to generate the consent form.

Concurrent and centralized routing requires the submission of the IRB documents at the same time as the budgets, schema, and contract (as applicable). This allows protocols to be considered in their entirety both by the IRB and the Regulatory Group rather than separately.

Upon CTRC approval, the protocol, consent form and all required documents (i.e., investigators brochure, flyers, advertisements, etc.) will be submitted to the IRB via the electronic AURA-IRB submission system. The IRB meets twice a month to review new studies.

The IRB will make the final decision regarding level of review:

• Exempt review—Use for research with no more than minimal risk to subjects. Excludes research with prisoners, and some exclusions for children, your own students or employees.
• Expedited review—Use for research with no more than minimal risk to subjects. You will use when dealing with vulnerable populations (children, cognitively impaired, prisoners, Native American population, pregnant women, etc.).
• Full board review—Use for research with more than minimal risk. This is determined by the IRB.

Breast Imaging (excluding breast cancer)

An overview of the breast imaging study process can be viewed here.

All studies that involve human subjects must be reviewed by the IRB. The committee meets once a month. Utilizing these instructions, construct a detailed protocol and forward it on to Sharon.

Sharon will help you start the IRB submission and return it to you for review and signature.
A consent form needs to be prepared using the University of Chicago consent form template, which can be found linked at the bottom of this page. Sharon will work with the PI to generate the consent form.

Concurrent and centralized routing requires the submission of the IRB documents at the same time as the budgets, schema, and contract (as applicable). This allows protocols to be considered in their entirety both by the IRB and the Regulatory Group rather than separately.

Upon approval, the protocol, consent form and all required documents (i.e., investigators brochure, flyers, advertisements, etc.) will be submitted to the IRB via the electronic AURA submission system. The IRB meets twice a month to review new studies.

The IRB will make the final decision regarding level of review:

• Exempt review—Use for research with no more than minimal risk to subjects. Excludes research with prisoners, and some exclusions for children, your own students or employees.
• Expedited review—Use for research with no more than minimal risk to subjects. You will use when dealing with vulnerable populations (children, cognitively impaired, prisoners, Native American population, pregnant women, etc.).
• Full board review—Use for research with more than minimal risk. This is determined by the IRB.

All Other Human Subjects Studies
(excluding all cancer studies and breast imaging studies)

All studies that involve human subjects must be reviewed by the IRB. The committee meets once a month. Utilizing  these instructions, construct a detailed protocol and forward it to Sharon.

Pam will help you start the IRB submission and return it to you for review and signature.

A consent form needs to be prepared using the University of Chicago consent form template, which can be found linked at the bottom of this page. Pam will work with the PI to generate the consent form.

Concurrent and centralized routing requires the submission of the IRB documents at the same time as the budgets, schema, and contract (as applicable). This allows protocols to be considered in their entirety both by the IRB and the Regulatory Group rather than separately.

Upon approval, the protocol, consent form and all required documents (i.e., investigators brochure, flyers, advertisements, etc.) will be submitted to the IRB via the electronic AURA submission system. The IRB meets twice a month to review new studies.

The IRB will make the final decision regarding level of review.

• Exempt review—Use for research with no more than minimal risk to subjects. Excludes research with prisoners, and some exclusions for children, your own students or employees.
• Expedited review—Use for research with no more than minimal risk to subjects. You will use when dealing with vulnerable populations (children, cognitively impaired, prisoners, Native American population, pregnant women, etc.).
• Full board review—Use for research with more than minimal risk. This is determined by the IRB.

Biological Sciences Division - IRB (Institutional Review Board)

Due to the volume of human subjects research conducted at the University, the Biological Sciences Division has its own IRB team. Please review their website for details on which forms and guidelines, a detailed FAQ, and contact information for the knowledgeable and helpful IRB staff. Research generally falls into two categories:

Prospective Study Submission

To conduct a prospective study, the Principal Investigator must submit the following:

• A written protocol
• A completed Clinical Trial Submission Form.
• Protocol priority tree (a list of all protocols, including the study being submitted, which are competing for the patient population under study).
• Investigational Brochure (if applicable).
• Other submission documents (questionnaires, package inserts, assessment forms, etc., as applicable).

Retrospective Study Submission

To conduct a retrospective study the Principal Investigator must be submit the following:

• A written protocol and, if a cancer study, the completed CTRC Submission Form.
• Many radiology studies involve image/chart reviews, which can be either retrospective, prospective, or both. Please review these tips to help you best construct and relay what kind of chart review you'd like to perform.

AURA (Automated University-wide Research Administration)

AURA is the electronic system through which conflict of interest, grants training, and IRB paperwork is submitted and tracked. You can request AURA access here.

AURA IRB training is available here.

CITI (Collaborative Institutional Training Initiative)

We partner with CITI to provide ethics and regulation training to our research professionals. You will be directed to sign up for CITI training by your section administrator.

Animal Subjects

Institutional Animal Care and Use Committee (IACUC)

Using animals in research or teaching requires the prior approval of the Institutional Animal Care and Use Committee (IACUC). The IACUC works closely with the Animal Resources Center (ARC), which is responsible for the animal procurement, facilities, husbandry, and specialized veterinary services. The use of animals in research and teaching is governed by federal regulations issued by the United States Department of Agriculture and the National Institutes of Health Office of Laboratory Animal Welfare (OLAW). The University has developed policies and procedures for both the IACUC and the ARC which ensure institutional compliance with these agencies’ regulations. The Institutional Official for the University of Chicago IACUC is the Dean of the Biological Sciences Division

Integrated Small Animal Imaging Research Resource (iSAIRR)

If you will be using small animal imaging in your research, please review iSAIRR's website and reach out to Lara Leoni, Ph.D. (mailto:leoni@uchicago.edu)

Animal Resources Center

Finding Sources of Grants and Funding

University of Chicago - University Research Administration

The University of Chicago finds support for research, training, and other academic purposes in many places. Numerous federal, non-federal, and corporate agencies and organizations contribute significantly to our research and academic mission. The majority of the funding is for research, however, support is also received for fellowships, training, conferences, equipment, and various other educational purposes. Start your search with the URA's excellent list of funding resources, broken down into federal, non-federal, and limited funding opportunities.

Biological Sciences Division

The BSD maintains a similar list of funding sources and also circulates regular emails of funding opportunities, especially so-called “limited” opportunities in which the division or University may only submit a limited number of proposals and thus hold an internal review to determine which proposals will go forward.

RSNA - Grants and Awards

The RSNA provides some grants of its own. Many major disease-specific organizations such as the American Heart Association and American Cancer Society also provide grants, especially to early career investigators.

Grant Writing Advice and Feedback

The Office of Faculty Affairs often runs sessions on grantsmanship (more info here). The ITM offers a service where experienced faculty will give feedback on the specific aims of a proposed R01 or R21 grant, though you must register 14 weeks ahead of the grant deadline. They also offer programs to support development of career development awards (K awards). The RSNA also has grant writing and research development programs.

Grants and Contracts support

The departmental Grant and Financial team members serve as liaisons between faculty, University Research Administration, Sponsored Award Accounting, the Polsky Center, the BSD, department administrators, sponsors, and funding agencies as it relates to award management. This involves performing accurate pre- and post-award services to the University of Chicago research community for investigators, including proposal review, contract negotiation, subcontracting, and reviewing requests for budget changes, no-cost extensions, spending guarantees, and endorsement of correspondence.

Their names and contact information is listed under the page on operational resources.

The system they use for pre-award proposal preparation is called AURA. As a PI, you will interact with parts of this system. Training is available here.

Human Imaging Research Office (HIRO)

HIRO (pronounced “hero”) is responsible for facilitating University of Chicago investigators conducting clinical trials and research studies that require medical imaging. Its primary goal is to ensure that research-related imaging is performed and distributed in compliance with the research protocol, IRB requirements, and HIPAA regulations. It provides a wide variety of services to the biomedical research community, including assistance with study-related imaging initiation activities (site surveys, sponsor tele-trainings, phantom scans, etc.), assistance with scheduling and billing of research-related imaging exams, and the creation of specialized workflows and scan parameters to accommodate research imaging requirements. The HIRO is also the centralized agent responsible for providing de-identified DICOM-compliant and HIPAA-compliant image data for research purposes.

For further information, please visit the HIRO website or contact the HIRO staff.

Integrated Small Animal Imaging Research Resource (iSAIRR)

If you will be using small animals in your research, please review iSAIRR's website and reach out to Lara Leoni, Ph.D.

iSAlRR offers a broad spectrum of imaging modalities and techniques for in vivo and ex vivo imaging in its state-of-the-art facilities, including a newly renovated 1,800-sq ft suite. A uniquely skilled technical and scientific staff provides the necessary support to accomplish the most complex studies. The Facility’s goal is to provide UChicago investigators with state-of-the-art, quantitative multi-modality imaging technologies to advance in-vivo molecular and physiological research of a broad range of disease and cancer models to accelerate pre-clinical development of novel therapeutics. Currently, iSAIRR subscores feature magnetic resonance imaging and spectroscopy (MRIS); optical imaging; micro-positron emission tomography, single photon emission computed tomography, large animal PET, ultrasound, and computed tomography (microPET/SPECT/CT); and veterinary technology (IVT) support.

Services

Consultation to assist users in planning and designing experimental procedures and animal imaging protocols

Instrument and procedural training
Processing of acquired raw data to produce reconstructed/processed images

Magnetic resonance imaging and scanning of tissues, cells materials, and animal models of cancer and ex vivo surgical specimens to provide information on 3D anatomy, hemodynamic parameters, tumor oxygenation, energy metabolism, metabolic markers, calcium dynamics, etc.

Development and testing of new imaging contrast agents and new imaging methods

Hands-on optical imaging (fluorescence and bioluminescence) or optical imaging services to assess gene expression, protein-protein interactions, tumor growth, vascularization, etc.

CT, PET, and SPECT imaging of small live animals, tissues, cells, materials, ex vivo specimens, mummified or other specimens, including high-resolution detailed 3D anatomy by CT, quantitative metabolic imaging by PET, various functional/physiologic/molecular imaging using radiotracers by PET and/or SPECT

Animal preparation and handling, induction and maintenance of anesthesia, performance of animal surgical procedures, physiological monitoring and recording during imaging sessions, injection of imaging probes/drugs/other interventions, physiologic sampling and measurements, catheter implantation, and inoculation of tumor cell lines

Animal Resources Center

Office of Shared Research Facilities

The Office of Shared Research Facilities (OSRF) manages BSD Core Facilities by providing financial, administrative, IT, and communication support. OSRF works closely with The University of Chicago Comprehensive Cancer Center and the Research Resources Oversight Committee.

Center for Research Informatics

The Center for Research Informatics provides the BSD with advanced, secure technologies and services to enable clinical, translational, and basic science research. Their offerings include a clinical data warehouse, bioinformatics analysis pipelines and consulting, secure data storage and sharing, clinical trial management support, custom application development, high-performance computing resources, and training opportunities.

• Bioinformatics Pipelines & Data Analysis                                  
• Clinical Research Data Warehouse (CRDW)
• CRI Computing Resources                                                                           
• REDCap

Please contact the University of Chicago Polsky Center to pursue the commercialization of a product you have in development, intellectual property protection, or assistance with license and partnership negotiations.