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INFORMATION FOR

Science and Safety Committee (SSC)

The role of the Science and Safety Committee is to evaluate the scientific merit of clinical research protocols including novelty of the science, impact of the science on the subject area of the protocol, and justification of the utilization of human subjects to answer the scientific question(s) of the protocol. The Committee is also charged with the evaluation of the safety of the protocol with regard to inclusion/exclusion criteria, minimization of risks/maximization of benefits, justification of the research procedures to be utilized, and plans for the provision of overall medical and nursing care for subjects.

Protocols Requiring SSC Review

Requests for YCCI services are accepted on a continuous basis via the YCCI Intake Form. For general questions regarding YCCI services, please contact clinicalresearchresources@yale.edu. High Risk and Phase I studies planning to utilize YCCI services will be provided to the SSC co-chairs to determine if review is required at a convened SSC meeting. The Principal Investigator will be informed if a full committee review is needed along with any relevant information. When approved by SSC, the PI will receive an approval letter from YCCI via email.

For additional information regarding whether or not a protocol needs to go through the SSC please email ssc.ycci.committees@yale.edu.

Guidelines for Review

Requests for YCCI services are accepted on a continuous basis via the YCCI Intake Form. High Risk and Phase I studies planning to utilize YCCI services will be provided to the SSC co-chairs to determine if review is required at a convened SSC meeting. The Principal Investigator (PI) will be informed if a full committee review is needed along with any relevant information.

The following documents will be reviewed and should be submitted with the YCCI Intake Form:

  • Protocol or Yale Human Investigation Committee (HIC) application (if no protocol available)
  • Investigator’s Brochure (as applicable)

The documents may be requested via email if not provided with the YCCI Intake Form. The PI will be informed if a full committee review is needed along with any relevant information. Following committee review, if revisions or clarifications are needed they will be communicated via email by ssc.ycci.committees@yale.edu. PI responses to issues and clarifications will be provided via email, if applicable. When approved by SSC, the PI will receive an approval letter from YCCI via email. Submit the YCCI approval to the Yale Human Research Protection Program via IRES IRB and indicate that Science and Safety Committee review was required in the Study Scope section of the IRES IRB application.

Committee Chairs

  • John Geibel, DSc, MD, AGAF, MS, FRS

    Professor Emeritus of Surgery (Gastrointestinal); Vice Chair, Surgery; Director, Surgical Research; American Gastroenterological Association Fellow; Fellow of the Royal Society of Medicine

    John Geibel is Vice Chairman of the Department of Surgery at Yale School of Medicine and Director of Surgical Research and Professor of Cellular and Molecular Physiology. His early research training was in Innsbruck Austria where he worked in the Physiology Department and investigated renal physiology on the isolated perfused tubule model. He holds a Bachelors of Science Degree in Physiology, an MD and DSc degree as well as a Master’s of Science, and a Master’s of Arts Degree. He has also obtained his Dozent in Medicine from the University of Innsbruck. After obtaining his Dozent he went to Yale University first as a visiting fellow and then joined the faculty in both Surgery and Cellular and Molecular Physiology where he rose through the ranks to Professor in both faculties.Academically, Professor Geibel’s active research interests are on the role of the Calcium Sensing Receptor (CaSR) in gastrointestinal physiology and pathophysiology. In addition, John Geibel has conducted research in fluid and electrolyte transport in the intestine where he was the first to identify that the colonic crypt can both actively secrete and absorb fluid. He has also identified 4 new transport pathways in the stomach that play important roles in acid secretion and may help to explain some of the hypersecretion of acid that occurs in patients. In addition he maintains a research program in the kidney where he was the first to identify a functional role for the H-ATPase in the proximal tubule; he was also the first to demonstrate a role for Angiotensin on the Na/H exchanger and Na/HCO3 and H-ATPase in the proximal tubule. Professor Geibel is the author of over 250 publications and presents his findings both nationally and internationally. He is the holder of 10 patents on the role of the calcium sensing receptor on gastrointestinal models and is currently actively working to begin clinical trials on a method to stop secretory diarrhea in the developing world based on targeting the calcium sensing receptor. He has also patented a new method to suppress acid secretion. Recently Dr. Geibel has actively developed a 3D Bioprinting program for vascular anomalies and  intestinal repair.
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  • John Krystal, MD

    Robert L. McNeil, Jr. Professor of Translational Research and Professor of Psychiatry, of Neuroscience, and of Psychology; Co-Director, Yale Center for Clinical Investigation; Chair, Psychiatry; Physician-in-Chief of Psychiatry, Yale New Haven Hospital; Director: NIAAA Center for the Translational Neuroscience of Alcoholism; Director, Clinical Neuroscience Division, VA National Center for PTSD

    Dr. Krystal is a leading expert in the areas of alcoholism, post-traumatic stress disorder, schizophrenia, and depression. His work links psychopharmacology, neuroimaging, molecular genetics, and computational neuroscience to study the neurobiology and treatment of these disorders. He is best known for leading the discovery of the rapid antidepressant effects of ketamine in depressed patients.He is a member of the U.S. National Academy of Medicine. He also serves in a variety of advisory and review capacities for NIAAA, NIMH, Wellcome Trust, Brain and Behavior Research Foundation, the Broad Institute, the Karolinska Institutet, and the U.S. Department of Veterans Affairs.Dr. Krystal previously served on the National Alcohol Abuse and Alcoholism Advisory Council (NIAAA), the Department of Defense Psychological Health Advisory Committee, the National Institute of Mental Health (NIMH) Advisory Council, and the NIMH Board of Scientific Counselors (chair, 2005-2007). He has led the American College of Neuropsychopharmacology (president, 2012), and International College of Neuropsychophamacology (president, 2016-2018). Currently, he is co-chair of the Forum on Neuroscience and Nervous System Disorders (NeuroForum) of the National Academies of Sciences, Engineering, and Medicine, and he edits the journal, Biological Psychiatry (impact factor: 13.382).
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