Center for Clinical and Translational Science and Training (CCTST)
The Center for Clinical and Translational Science and Training (CCTST) was established in 2005 as the University of Cincinnati (UC) academic home for clinical and translational research, providing “one-stop shopping” for investigators across the Academic Health Center (AHC), main campus and community in need of research guidance, information, support, resources and training. Funded by a National Institutes of Health Clinical and Translational Science Award (CTSA), the UC CCTST and its partner institutions Cincinnati Children’s Hospital Medical Center, UC Health, and Cincinnati Veterans Affairs Medical Center comprise the 39th member of the CTSA Consortium, which now includes over 60 sites. Serving the entire AHC and community, the CCTST’s offices are centrally located in the Cincinnati Children's “Location S” research building, directly across the street from the UC Medical Sciences Building (MSB). With CTSA and institutional funding, the CCTST provides resources in program areas which include biomedical informatics; biostatistics, epidemiology and research design; community engagement; pilot and collaborative translational and clinical studies; regulatory knowledge and support; research education, training, and career development; improvement science/team science; and the Schubert Research Clinic (Clinical Translational Research Center). CCTST membership is free of charge and open to all. For more information, visit https://cctst.uc.edu/.
The University of Kentucky Office of Research Integrity
The University of Kentucky (UK) has a nationally recognized and accredited program for the protection of participants involved in biomedical, social, behavioral, and education research. The Vice President for Research and the Office of Research Integrity provides leadership in ensuring that the University’s Human Research Protection Program meets the highest ethical and regulatory standards. In addition to 17 academic and professional colleges, UK possesses the state of Kentucky’s only National Cancer Institute-Designated Cancer Center and National Institutes of Health (NIH) funded Center for Clinical and Translational Science (CCTS). The CCTS and NCI are part of a trifecta of federal research grants that includes an Alzheimer’s Disease Center. UK is one of only 22 universities in the country to hold all three premier grants from NIH. For more information, visit the University of Kentucky Vice President of Research (http://www.research.uky.edu/vpresearch/index.html) or UK Office of Research Integrity website (www.research.uky.edu/ori).
UK Center for Clinical and Translational Science (CCTS)
The UK CCTS accelerates the translation of basic science discoveries into tangible improvements in public health. Through funding, training, infrastructure, and community engagement, we facilitate and support innovative team science to address critical health issues, with special focus on health disparities experienced in Kentucky and Central Appalachia. The CCTS Regulatory Knowledge and Support Core integrates faculty, staff, and community expertise in bioethics, regulatory knowledge, and research integrity to provide investigators, community practitioners, trainees, and research participants with a single point of access to the spectrum of ethical and regulatory committees and support services applicable to clinical and translational research. For more information, please visit www.ccts.uky.edu.
Schulman IRB provides high quality, rigorous IRB reviews for all therapeutic areas and research phases in North America via streamlined processes, customized technology, and responsive customer service. We provide dedicated, AAHRPP-accredited IRB services for sponsors, CROs, research institutions, and sites and have an unparalleled clean audit history with FDA. We also offer CQA and HRP consulting via Provision Research Compliance Services and Falcon Consulting Group. For more information, visit Schulman’s website at www.schulmanirb.com.
University of Cincinnati
The University of Cincinnati (UC) serves as the Central IRB for StrokeNet, the largest NIH-funded extramural CIRB. UC is actively engaged in building local and regional collaborations aimed at protecting participants and facilitating research. Along with its Academic Health partners, UC is the recipient of a prestigious Clinical and Translational Science Award (CTSA) from the NIH (http://cctst.uc.edu). In addition to conducting a wide range of clinical and pre-clinical trials to develop new medicines, medical devices and/or procedures UC researchers are also actively engaged in social, behavioral, and educational research. For more information, visit UC’s Human Research Protection Program website at www.researchcompliance.uc.edu/HSR/Overview.aspx.
Cincinnati Children’s houses the largest pediatric research program in the Midwest, conducting both basic and clinical research. Through its Cincinnati Children’s Research Foundation, Cincinnati Children’s is recognized for many research breakthroughs, including the Sabin oral polio vaccine, the rotavirus vaccine, the first practical heart-lung machine, and the surfactant preparation used worldwide to prevent premature infant deaths. Cincinnati Children’s has been accredited by AAHRPP since 2007. Annually, its 2,000+ researchers and staff conduct more than 2,500 research protocols. For more information, visit Cincinnati Children’s website at: www.cincinnatichildrens.org/research.
The Cincinnati Veterans Affairs Medical Center (CVAMC)
Located within the Academic Health Center complex, it has 133 general medical and surgical beds and serves veterans within a 50-mile radius of Cincinnati and beyond, encompassing 17 counties in Ohio, Kentucky and Indiana. It is accredited by the Joint Commission on Accreditation of Health Care Organizations (JCAHO). Its major clinical disciplines include Medicine, Neurology, Surgery, Psychiatry, Ambulatory Care, and Dentistry. The CVAMC also supports four community-based outpatient clinics and two healthcare access sites in Greater Cincinnati. The Research Service supports a variety of research projects that are funded by VA Central Office, National Institutes of Health (NIH), private foundations, and the pharmaceutical industry.
In fiscal year 2015, Cincinnati VAMC investigators received $5.1 million in VA funding and $3.6 million in extramural federal funding, which supported 71 active investigators. There are ongoing projects in infectious disease, immunology, psychiatry, psychology, substance abuse, cardiology, endocrinology, pulmonary medicine, nephrology, and neurology. Cincinnati VAMC faculty and staff are actively involved in basic science, clinical, and health services research. The Health Services Research and Development service focuses on patient safety through its Getting at Patient Safety (GAPS) Center; acute care research and quality improvement through its Inpatient Evaluation Center; and HIV quality of life research. The Cincinnati Education and Research for Veterans Foundation (CERV), as well as Clinical Research Unit (CRU) are based at the VAMC. The CRU consists of 3,000 sq. ft. of dedicated research space and contains both inpatient and outpatient rooms, as well as an investigational drug pharmacy.
Office for Human Research Protections
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.
OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary's Advisory Committee on Human Research Protections (SACHRP), which advises the HHS Secretary on issues related to protecting human subjects in research.