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The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of 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 (OASH) in the Office of the Secretary (OS), U.S. Department of Health and Human Services.
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 of human subject protections.
Founded in 1883, its vision is to be the leader in improving child health. Cincinnati Children’s is a 587-bed, not-for-profit organization serving as the only children’s hospital in the Cincinnati metropolitan area (population 2.3 million). It was ranked No. 3 in the U.S. News and World Report Honor Roll of top pediatric hospitals in the magazine’s 2014 Best Children’s Hospitals report. Cincinnati Children’s was nationally ranked in all 10 subspecialty categories. The cancer program was ranked No. 3 in the country. The pulmonology and nephrology services were ranked No. 2, and six other specialty care areas were ranked among the top 10 programs. This was the fifth straight year it has been included in the U.S. News Honor Roll of top pediatric hospitals.
Cincinnati Children’s Research Foundation is a division of Cincinnati Children’s Hospital Medical Center. William Cooper Procter, a benefactor of the hospital, funded a building devoted to research in children’s diseases (the Children’s Hospital Research Foundation, opened in 1931) and a $2.5 million endowment. Research breakthroughs have included the Sabin oral polio vaccine, rotavirus vaccine (Rotarix®), the first practical heart-lung machine, and the surfactant preparation used worldwide to prevent premature infant deaths. Cincinnati Children’s is accredited to conduct clinical research by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Annually, its 1,100 investigators and more than 300 Good Clinical Practices (GCP) trained study coordinators conduct more than 2,250 investigator-initiated, federally- and industry-sponsored IRB active protocols including pediatric Phase I-IV, and select adult Phase I-IV (including vaccine and cancer) clinical trials.
The University of Cincinnati (UC) Academic Health Center (AHC) traces its origins to the Medical College of Ohio, the first medical school west of the Alleghenies, founded in 1819 in Cincinnati through the efforts of Dr. Daniel Drake. Dr. Drake originated the academic health center concept of a single organization encompassing a medical school, other health professional colleges, and teaching hospitals. The UC AHC includes the Colleges of Medicine, Nursing, Pharmacy, and Allied Health Sciences, as well as the Hoxworth Blood Center, UC Cancer Institute, UC Neuroscience Institute, Cincinnati Diabetes and Obesity Center, and Metabolic Diseases Institute. Teaching, research and patient care affiliates include UC Health, UC Medical Center [formerly University Hospital], UC Physicians, Cincinnati Children’s Hospital Medical Center (CCHMC), Cincinnati Veterans Affairs Medical Center (VAMC), Shriners Hospital for Children–Cincinnati, Christ Hospital, Jewish Hospital, Mayfield Clinic, Lindner Center of Hope, and Drake Center rehabilitative hospital.
The University, which in 2013 enrolled a record 42,656 students in 308 programs of study, is classified as a “very high research activity” institution by the Carnegie Commission and is ranked 25th among public institutions by the National Science Foundation in federally-financed research and development expenditures. From all sources, UC and its affiliates received $404.7 million in sponsored program funding in 2012. U.S. News has ranked UC “among the top tier of the best national universities,” while The Chronicle of Higher Education calls UC a “research heavyweight.” The UC AHC is in its 5th year of a $22.8 million, 5 year Institutional Clinical and Translational Science Award (CTSA; James Heubi, MD and Joel Tsevat, MD, MPH, multi-PIs), and is one of 62 members of the national CTSA Consortium. UC’s many “firsts” include the oral polio vaccine, heart-lung machine, Benadryl antihistamine, emergency medicine residency, cooperative education, and baccalaureate program in nursing.
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 4 community-based outpatient clinics and 2 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 2012, Cincinnati VAMC investigators received $4.4 million in VA funding and $7.6 million in extramural federal funding ($6.8 million from NIH), which supported 71 active investigators in 212 research projects. 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 Foundation for Biomedical Research & Education (CFBRE), as well as a satellite location of the UC AHC’s CTSA-funded Clinical Translational Research Center (CTRC, formerly the General Clinical Research Center, or GCRC), are based at the VAMC. The CTRC satellite consists of 3,000 sq. ft. of dedicated research space and contains both inpatient and outpatient rooms, as well as an investigational drug pharmacy.
The Center for Clinical and Translational Science and Training (CCTST) was established in 2005 as the University of Cincinnati 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 guidance, information, support, resources and training. The CCTST spearheaded the AHC’s submission of a National Institutes of Health Clinical and Translational Science Award (CTSA) application, which in April 2009 received funding of $22.8 million over 5 years. UC and its partner institutions: Cincinnati Children’s Hospital Medical Center (CCHMC), UC Health, and Cincinnati Veterans Affairs Medical Center comprise the 39th member of the CTSA Consortium, which now includes 62 institutions. Its offices are centrally located in the CCHMC “Location S” research building, directly across the street from the UC Medical Sciences Building (MSB).
Investigators request services through the CCTST’s online “Research Central” portal which documented 500 project intakes in 2012. The CCTST website features service descriptions, videos, a searchable database of intramural funding opportunities, news, and a comprehensive AHC calendar of on-campus workshops, conferences and lectures of interest to clinical/translational researchers. Faculty, trainees and community/industry partners can establish free CCTST membership online, required to obtain access to consultation services through Research Central as well as special funding, training and networking opportunities. Members are eligible to receive up to 10 hours of doctoral-level research methodology consultation, covered by the CTSA, each grant year. In return, members help promote CCTST goals and services, collaborate and share expertise with fellow researchers, cite CCTST assistance in publications as appropriate, and provide information for surveys and reports. To date, over 2,300 members have joined the CCTST, including more than 250 community representatives. With CTSA and institutional funding, the CCTST provides resources in 7 major program areas, including biomedical informatics; biostatistics, epidemiology and research design (BERD); community engagement; pilot and collaborative translational and clinical studies; regulatory knowledge and support; research education, training, and career development; and the Clinical Translational Research Center (CTRC).
Register for the one-day OHRP conference. Early registration ends March 31st.
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