Office of Research Compliance

The Office of Research Compliance promotes a culture of compliance, research integrity and high quality research within the Rush community. We function within the Office of the Vice Provost and Vice President for Research.  To promote this culture of compliance, we partner with the University, Corporate and Legal Offices.  

Programmatic Elements

Oversight of the regulatory, ethical and compliance aspects of all preclinical and clinical research conducted at Rush is a complex, multidimensional undertaking. We advise and consult the research community on navigating regulatory complexities. Our mission is to support each operational area in its primary responsibility to ensure compliance. The following content areas are the focus of the Office of Research Compliance (ORC) program:

  • Human subject protections (biomedical and social/behavioral)
  • Animal use protections
  • Research privacy and security
  • Regulatory compliance 
  • Assessments of scientific integrity 
  • Investigate non-compliance 
  • Conflicts of interest (individual and institutional)
  • Research misconduct 
  • Questionable research practices
  • Financial management associated with funded research

Policies and Procedures

We are responsible for the following policies:

  • CC-RC-0001 Billing for Clinical Research (Non-Device)
  • CC-RC-0003 Coding for Investigational Articles
  • CC-RC-0004 Training and Education Policy for Investigators and Relevant Research Personnel
  • CC-RC-0005 Reporting and Investigating Research Non-Compliance
  • CC-RC-0006 EQuIP: The Evaluation Quality Improvement Program Policy
  • CC-RC-0007 Policy on Governmental and Sponsor Audits
  • CC-RC-0008 External Relationships and Financial Conflicts of Interest in Research
  • CC-RC-0009 Research Misconduct: Policy For Review and Reporting Allegation

Education and training

The Office of Research Compliance provides information to the research community about conducting ethical research. We partner with the Office of Research Affairs on educational initiatives to ensure that research conducted at Rush is consistently performed to high ethical and scientific standards. This includes mandatory and supplementary education and training for the research community. You must complete mandatory training prior to beginning research and update your training annually.

All investigators and research personnel conducting human subject research are required to complete the basic education program developed by the Collaborative Institutional Training Initiative (CITI) and Rush personnel. Log on to the CITI program to access educational modules. If you fail to complete required course work, you may lose research privileges.

Investigators and research personnel are defined to include the following:

  • Faculty and staff
  • Advanced postdoctoral fellows
  • Senior clinical fellows and residents
  • Clinical research coordinators
  • Research nurses
  • Anyone else engaged in human subject research

Training materials cover the following topics:

  • Human subject research protections
  • HIPAA protections related to research
  • Clinical trials billing
  • Conflict of interest

The Institutional Animal Care and Use Committee requires training of research personnel with animal contact.

We have also compiled additional education and training links for researchers.

Contact us

We strive to assist the research community in navigating the complex regulatory matrix in your research endeavors. Our experienced team members are available for consultation.

Office of Research Compliance
Jelke Building 6th Floor
1653 W. Congress Parkway
Chicago, IL 60612-3244
Phone: (312) 942-5303
Fax: (312) 942-6875

Stephanie Guzik, MBA, BSN, RN, CHRC

Director of Research Compliance

Research Integrity Officer

Phone: (312) 942-1296

 

Mary G. Keller, BSN, RN, CCRC

Clinical Research Auditor

Phone: (312) 942-4485

Poorna Nagarajan, MD, CCRC

Clinical Research Auditor

Phone: (312) 942-8613

Colleen Sowinski, MBA, MPH, CCRP

Clinical Research Auditor

Phone: (312) 942-8314