Ethics, Regulatory Knowledge, and Support

The Ethics, Regulatory Knowledge, and Support core 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 regulatory compliance. Ethics, Regulatory Knowledge, and Support is led by Jane Strasser, PhD, Associate Vice President for Research and Director of the UC Office of Research Integrity (UCORI).

Ethics, Regulatory Knowledge, and Support highlights:

  • 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.
  • Working through the Greater Cincinnati Health Council, the CCTST has 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.
  • Working together with the 2 other CTSA sites in Ohio (Columbus and Cleveland), the CCTST has established a statewide collaborative agreement allowing a single organization’s IRB to assume responsibility for multi-site studies. The 3 CTSA institutions are at the vanguard of clinical and translational research, having taken the lead in eliminating redundancy while ensuring the protection of human research participants. Redundant review at each institution impedes multi-site clinical trials that are essential to developing new treatments and therapies to improve human health.
  • 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.

Additional information on research compliance: