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The conference host institutions express their appreciation to the following entities for their support:
Huron Consulting Group
At Huron, we help our clients create the best human research protection programs. Huron is the only provider combining the industry’s leading HRPP regulatory and process experts with the #1 enterprise IRB software solution. Working with Huron, your research organization will improve PI satisfaction, strengthen compliance, and increase organizational efficiency.
Cincinnati Children’s Hospital Medical Center/ Office for Clinical and Translational Research (OCTR)
The Office for Clinical and Translational Research (OCTR) is part of Cincinnati Children’s Research Foundation’s (CCRF) infrastructure designed to provide expert support for all Cincinnati Children’s research including:
The OCTR functions as a “one-stop” clinical research support center – from concept development to publication. Its mission is to provide clinical investigators and sponsors with comprehensive support services, research tools, experienced research personnel, and facilities to conduct or facilitate pediatric and adult clinical research – from identification and development of research opportunities to phase I through phase IV clinical research trials. Support services provided by the OCTR include: identification and development of research opportunities, contracts and budgets (for all funding sources), regulatory affairs, project management (single- and multi-center studies), data management, research study management, participant recruitment and retention, integration with institutional research partners and publication support.
If you are a Cincinnati Children’s researcher and would like to learn more about how the OCTR may assist you, contact us:
Office for Clinical and Translational Research (OCTR)Office phone: 513-636-3232Fax: 513-636-0168OCTR@cchmc.org
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 (CCHMC), 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 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 at https://cctst.uc.edu/research, which documented 444 project intakes in 2013. The CCTST website features service descriptions, videos, a searchable database of intramural funding opportunities, news, and a comprehensive AHC events calendar. Faculty, trainees and community/industry representatives can establish free CCTST membership online, required to obtain access to consultation services 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. To date, over 2,500 members have joined the CCTST, including nearly 300 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). Stop by our resource table to learn more about our programs and services!
Cincinnati Foundation for Biomedical Research and Education (CFBRE)
CFBRE serves to improve the health of veterans and society by advancing the research and education mission of the Cincinnati VA Medical Center.
The Cincinnati Foundation for Biomedical Research and Education is a 501(c) (3) non-profit corporation, established in 1991 by congressional mandate. The Cincinnati Foundation for Biomedical Research and Education (CFBRE) is associated with the Cincinnati VA Medical Center. CFBRE’s purpose is to facilitate research and educational activities involving patients, database, personnel, and facilities at the Cincinnati Veterans Affairs Medical Center. CFBRE provides support for researchers and educators with assistance in grant application, management, accounting, compliance, Insurance, human resources, equipment purchase and maintenance.
The CFBRE board of directors comprises individuals with extensive backgrounds in health care, research and technology transfer. CFBRE operates under the guidance of its board of directors, which ensures compliance with the CFBRE bylaws and operational policies.
Collaborative Institutional Training Initiative (CITI)
The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami is a leading provider of research ethics education content. Our web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organizations in the US and around the world.
Comprehensive web-based training courses are offered in Animal Care and Use (ACU), Biosafety and Biosecurity (BSS), Export Control (EC), Good Clinical Practice (GCP), Human Subjects Research (HSR), Information Privacy and Security (IPS), and Responsible Conduct of Research (RCR) including Conflicts of Interest (COI).
Available features of the CITI Program incorporate a variety of administrative tools to manage learners, the ability to provide supplemental content through custom modules, a chance to earn continuing education credits, access to content in a variety of languages, and more.
All training is available to organizational and independent subscribers including international users via our online platform at www.citiprogram.org.
Learn more or subscribe to the CITI Program by contacting us at 305-243-7970 or firstname.lastname@example.org.
Department of Health & Human Services’ (HHS) Office for Human Research Protections (OHRP)
The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being 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), US 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.
Cincinnati Children’s Hospital Medical Center/Office for Research Compliance & Regulatory Affairs (ORCRA)
Cincinnati Children’s Hospital Medical Center (CCHMC) has established the Office of Research Compliance and Regulatory Affairs (ORCRA). The formal process to monitor, evaluate and safeguard human research participants at CCHMC is multifaceted. In addition to federally mandated oversight boards: the IRB, IBC, COI, and IACUC, the ORCRA provides information and guidance to the entire institution.
We would like to thank the following entities for exhibiting at this conference. Please plan to check out the exhibitors before the conference, at breaks, lunch, and after the conference. The following exhibitors will be in attendance:
The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs).
An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence—through policies, procedures, and practices—of their commitment to scientifically and ethically sound research and to continuous improvement.
As the "gold seal," AAHRPP accreditation offers assurances—to research participants, researchers, sponsors, government regulators, and the general public—that an HRPP is focused first and foremost on excellence.
Investigators request services through the CCTST’s online “Research Central” portal which documented 444 project intakes in 2013. The CCTST website features service descriptions, videos, a searchable database of intramural funding opportunities, news, and a comprehensive AHC events calendar. Faculty, trainees and community/industry representatives can establish free CCTST membership online, required to obtain access to consultation services 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. To date, over 2,500 members have joined the CCTST, including nearly 300 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). Stop by our resource table to learn more about our programs and services!
Chesapeake IRB has been providing central independent IRB services since 1993. Chesapeake IRB, AAHRPP accredited since 2004, has a history of creating innovative and adaptive solutions in response to changing research and regulatory environments. We offer a 21 CFR Part 11 compliant, electronic IRB platform (CIRBI) which streamlines protocol submissions and decreases investigator review turnaround times resulting in faster subject enrollments.
The OCTR functions as a “one-stop” clinical research support center – from concept development to publication. Its mission is to provide clinical investigators and sponsors with comprehensive support services, research tools, experienced research personnel, and facilities to conduct or facilitate pediatric and adult clinical research – from identification and development of research opportunities to phase I through phase IV clinical research trials.
The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami offers customizable, web-based training in Animal Care and Use, Biosafety and Biosecurity, Conflicts of Interest, Export Control, Good Clinical Practice, Human Subjects Research, Information Privacy and Security, and Responsible Conduct of Research. Visit citiprogram.org to learn more.
Compliance Insight, Inc. is a Regulatory Affairs, Quality Assurance and Training services & consulting company. We provide services for the pharmaceutical, medical device, biotechnology and other industries. We support our clients with Regulatory & Quality Assurance project management leadership, virtual quality support and oversight, gap analysis, due diligence support for acquisitions, a range of validation services for facilities, equipment and utilities including computer system validation. Our services also include project oversight, implementation and execution of continuous improvement methodology, quality engineering services, lean and six sigma training, quality data review, and final report assessment. With over 150 years of combined experience in FDA regulated industries, our dedicated team has the knowledge to get your organizations quality systems compliant with industry requirements.
About IRBNetIRBNet, a WIRB-Copernicus Group company, helps more than 2,000 research sites and boards manage the complex federal ethics compliance requirements governing human, animal and recombinant DNA research, and seamlessly powers Enterprise Conflict of Interest, IRB, IACUC, Biosafety, Sponsored Programs, Publication Tracking, Training & Credentials Management and other research functions.
IRBNet's solution enables institutions to comprehensively oversee the research compliance activities of both internal and external review panels. IRBNet's National Research Network members benefit from streamlined process efficiencies, reduced costs, greater process transparency and superior data reporting, and participate in the largest research and compliance oversight network in the country. Members include hundreds of universities hospitals, federal and state agencies.
About WIRB-Copernicus GroupWIRB-Copernicus Group (WCG) is the world’s largest provider of regulatory and ethical review services for human research. With eight individual AAHRPP accredited panels, over 100 experienced board members, and over 60 years of combined experience in protocol and study-related review, WIRB-Copernicus Group brings more expertise to the industry than any other ethical solutions provider.WIRB-Copernicus Group companies include Western Institutional Review Board (WIRB) and Copernicus Group IRB (CGIRB), the nation’s leading independent institutional review boards, and IRBNet, the top software application supporting institutional IRBs. It is the mission of WIRB-Copernicus Group to meet the highest standards of ethics and science, and to ensure the safety and welfare of subjects worldwide.
PRIM&R is a nonprofit organization dedicated to advancing the highest ethical standards in the conduct of research. We accomplish this goal by providing educational programming and professional development services to the full array of individuals and organizations involved in biomedical and social science/behavioral research. Via a variety of conferences and other educational activities, PRIM&R provides balanced, thorough, and accurate information on a range of ethical and regulatory issues affecting research.
Quorum Review IRB is a privately-held independent ethics review board (REB) fully accredited by AAHRPP. Our mission is to safeguard the rights and well-being of research participants while enhancing the clinical research process. We provide sponsors, CROs, institutions and sites with reliable, responsive service to support efficient study start-up and management. With 15 board meetings a week, Quorum Review provides 24-hour site start-up, 36-hour amendment review, same-day site changes, and secure web portal for online submissions, downloads and status. At Quorum Review we are passionate about our work and are committed to high standards of patient protection and regulatory compliance.
For over 30 years, Schulman Associates IRB has been dedicated to protecting human research subjects in the US, Puerto Rico and Canada. Our comprehensive suite of IRB review services includes dedicated review capabilities for all phases of research across all therapeutic areas. Schulman is AAHRPP accredited and has an unparalleled clean audit history with FDA. We are committed to providing high quality, rigorous IRB reviews via streamlined processes, customized technology solutions and responsive customer service.
The UC Health Clinical Trials office is affiliated with the University of Cincinnati and provides comprehensive support services, research tools and resources to both investigators and sponsors in order to facilitate clinical research at UC Health. The University of Cincinnati (UC) has a rich history in medical discovery and innovation. UC is accredited to conduct clinical research by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Researchers routinely conduct industry, investigator-initiated and National Institutes of Health (NIH) sponsored clinical trials (phase I-IV) in nearly all therapeutic areas, conforming to regulatory requirements in an efficient and cost-effective manner. Through our large network of providers and patient databases, we have access to disease-specific subject populations.
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