Clinical Research Ethics Mission
The ICTS clinical research ethics mission is to improve the quality of clinical investigation at UCI. To implement this goal, we have established a Clinical Research Ethics Consult Service (CRECS) to assist clinical investigators in working out experimental design problems when the nature of the research problem, its subject population or the clinical situation pose ethical issues.
Who We Serve
Ethics consultations are available to all UCI clinical investigators including trainees, so long as the problem relates to clinical research.
Services We Provide
- Project planning consultation (new projects or new aspects of continuing projects). Common issues that have ethical components include use of placebos, vulnerable populations, complex informed consent issues, risk assessment in a pilot clinical study, and studies designed to gather biologic information only. CRECS can provide advice and information about these and other critical ethical issues.
- Suggestions regarding ethical problems raised in external or internal reviews including IRB reviews.
- Education on research ethics issues.
- External consults are available with a nationwide collaborative group of bioethicists for particularly complex problems.
Contact Information
CRECS is coordinated by Prof. Mark Rothstein, JD, who is a renowned medical ethicist who has published seminal work on the ethics of translational science. He was the Founding Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. Currently, he serves as the Hub ethical expert in Quality by Design (QbD) Studios, GCP, and ICTS’s Clinical Research Ethics Unit. He will provide consultations on ethical issues that arise in the development and conduct of translational science research. Investigators interested in obtaining a consultation should email Prof. Rothstein at rothstem@uci.edu. Alternatively, investigators can contact Andria Pontello Meyer, ICTS’s Administrative Director at apontell@uci.edu.
