CCTST

The Research Support and Operations (RS&O) program develops best practices for human subject protection 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 program provides institutional support and efficient and effective avenues for clinical researchers that facilitate regulatory compliance.  RS&O is led by Jane Strasser, PhD, Assistant Professor of Pediatrics and Director of the UC Office of Research Compliance and Regulatory Affairs (ORCRA).

RS&O offers:

• Assistance with protocol development through the consultative services of a panel of designated specialists, including a legal advisor, a regulatory specialist, a biostatistician, a methodologist, and/or a clinical ethicist, depending upon the need.  As a proactive measure to ensure the highest quality science, the IRBs at UC and CCHMC will require pre-review and approval by the BioMETrCS program to certify that research methodology and biostatistical tools are adequate, particularly for studies in which research subjects are exposed to more than minimal risk.   Assistance can be provided with data management, FDA filings, IRB applications and consent formulation.
• Discussion Forum for IRB, Ethical and Community Issues (under development):  a web-based, open access Research information repository and discussion forum, supported by the Biomedical Informatics group, and maintained by regulatory support personnel.  Once operational later this year, this forum will be "open" 24/7 and will ensure answers within 48 hours to a variety of questions related to human subject research. A critical participant will be a Research Subject Advocate (RSA) who will liaise with community groups and representatives to address participant concerns.
• Cincinnati Central (community-wide) IRB (under development): Preliminary efforts have begun toward the development of a community-wide IRB, with either the UC or CCHMC IRB (based upon age of participants) serving as the IRB of record for IRBs within the community hospitals to minimize administrative hurdles for investigators seeking to do community-based research that would include studies within these hospitals.
  

Additional information on research compliance:

• For residents and fellows:  http://cctst.uc.edu/media/residents_research_overview/player.html
• UC IRB: http://researchcompliance.uc.edu/irb/
• UC Researcher's Gateway: http://researchgateway.uc.edu/
• CCHMC IRB (intranet only):  http://centerlink/Portal/DesktopDefault.aspx?g=11210
• Cincinnati VAMC R&D site: https://www.cincinnati.research.med.va.gov/rad/rad.html