ETHICS, REGULATORY KNOWLEDGE, AND SUPPORT

The Ethics, Regulatory Knowledge, and Support (ERKS) program provides tools and guidance to facilitate ethical compliant research, develops best practices that break down institutional barriers, reduce investigator burden, facilitate collaborations and promote clinical and translational research. Using the resources of multiple programs centrally supported by the CCTST, the core provides institutional support and efficient and effective avenues for clinical researchers that facilitate ethical research and regulatory compliance.

The ERKS program brings together thought leaders from around the world to educate our community on pressing bioethical issues of the day. Engagement and outreach is conducted through a biennial conference on biomedical ethics, our Hutton Lecture in Biomedical Ethics which is conducted each year in conjunction with UC’s Research and Innovation Week, and a Grand Rounds lecture each year focusing on a contemporary topic in clinical and research ethics. Special care is taken to draw upon topics that are not only translational in their focus but cross-cutting with respect to scientific disciplines. Pilot funds are also routinely awarded to stimulate new lines of research related to biomedical ethics.

Working through the Greater Cincinnati Health Council, the CCTST created the Consortium of Greater Cincinnati IRBs (CGCI) which is open to all IRBs in Greater Cincinnati and Northern Kentucky. CGCI works to identify and promote best practices, develop commonly accepted forms, and increase reliance between member IRBs. The consortium is not a community-wide IRB but serves to promote communications among IRBs and to facilitate review of regional multi-site studies.

The CCTST has been at the vanguard of clinical and translational research, having taken the lead in eliminating redundancy while ensuring the protection of human research participants. We serve as the single/central IRB for many studies and participate in SMART IRB. Redundant review at each institution impedes multi-site clinical trials that are essential to developing new treatments and therapies to improve human health.

 
 

Services

Ethics, Regulatory Knowledge and Support consultation and training image of two people writing on a white board.

Consultation and Training

The ERKS program provides ethics consultations to assist with all stages of the research process. Ethics and Regulatory training are available.

Ethics, Regulatory Knowledge and Support protocol development image of two women sitting at a desk talking to each other while reviewing a document.

Protocol Development

ERKS offers assistance with protocol development through the consultative services of a panel of designated specialists, IRB, IACUC, IBC, regulatory specialist, biostatistician, research methodologist, and/or clinical ethicist, depending on need. Assistance can be provided with data management, FDA filings, IRB applications and consent formulation.

Research Central: Use Research Central to request Ethics, Regulatory Knowledge and Support services

 

RESOURCES

Ethics, Regulatory Knowledge and Support information on research compliance image of a woman in a laboratory coat looking through a microscope.
 
 

Team

Headshot of Jane Strasser, Ethics, Regulatory Knowledge and Support Director

Jane Strasser, PhD

Director, Ethics, Regulatory Knowledge & Support
Sr Associate Vice President for Research
Director, Office of Research Integrity
University of Cincinnati
Email: jane.strasser@uc.edu

Headshot of Holly Bante, Ethics, Regulatory Knowledge and Support Co-Director

Holly Bante, PhD, MPH

Co-Director, Ethics, Regulatory Knowledge & Support
Assistant Vice President for the Office of Ethics in Industry Engagement, Office of Research
University of Cincinnati
Email: holly.bante@uc.edu

richard ittenbach, PhD

Co-Director, Ethics, Regulatory Knowledge & Support
Professor, Pediatrics
Division of Biostatistics & Epidemiology, Cincinnati Children’s Hospital Medical Center Email: richard.ittenbach@cchmc.org