Atlanta Clinical and Translational Science Institute (ACTSI) Contents SHORT VERSION: ............................................................................................................................................ 2 Details ............................................................................................................................................................... 2 The multi-site Clinical Interaction Network (CIN) ............................................................................................ 2 Clinical and Translational Research Program for Pediatrics, CTRPP ............................................................. 3 The Research Education, Training, & Career Development (RETCD) ............................................................ 3 The Translational Technologies & Resources Program, TTR ......................................................................... 4 The Community Engagement & Research Program (CERP).......................................................................... 4 The Ethics, Regulatory Knowledge, & Support (ERKS) .................................................................................. 4 The ACTSI Pilot and Collaborative Translational and Clinical Studies Program (PiCoTraCS) ........................ 5 The Biostatistics, Epidemiology, & Research Design (BERD) ........................................................................ 5 The Biomedical Informatics Program (BIP) .................................................................................................... 5 ACTSI KL2 CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAM ................................................. 5 1 SHORT VERSION: Atlanta Clinical and Translational Science Institute (ACTSI), an NIH-funded collaborative with Emory School of Medicine, Morehouse School of Medicine and Georgia Institute of Technology was created to increase availability and enhance efficiency of clinical trials for patients. It is an inter-institutional magnet that concentrates basic, translational, and clinical investigators, community clinicians, professional societies, and industry collaborators in dynamic clinical and translational research projects. ACTSI provides research resources including technical support, biostatistical consultation, equipment, laboratory services and nursing support. A clinical interaction network provides support for conducting patient oriented research. Research educational opportunities include a Master of Science in Clinical Research program and KL2 Career Development Award for junior faculty. Community engagement is an important component of ACTSI and promotes effective community participation in clinical trials to build a partnership between researchers and the community in order to reduce health disparities. Other components of ACTSI include ethics and regulatory support; biostatistics, epidemiology, and research design support; a pilot grant program to promote new and multidisciplinary research; a tracking and evaluation unit; and the Clinical and Translational Research Program for Pediatrics that has provided financial support to develop inpatient and outpatient clinical research units in collaboration with CHOA and is becoming a centralized home for clinical research collaborations across the entire Atlanta pediatric community. Details While Emory University has had, for many years, a very active General Clinical Research Center (GCRC), the center has moved up to a new level in 2007 when the university was awarded a Clinical Translational Service Award (CTSA) from the National Institutes of Health. With this award, the Atlanta Clinical and Translational Science Institute (ACTSI) was formed. The ACTSI is an inter-institutional magnet that concentrates basic, translational, and clinical investigators, community clinicians, professional societies, and industry collaborators in dynamic clinical and translational research projects. Emory has engaged two of its close academic partners in metropolitan Atlanta - Morehouse School of Medicine (MSM) and Georgia Institute of Technology (GA Tech)- to form the ACTSI. This partnership, a strategic multi-institutional alliance, offers compelling, unique and synergistic advantages. Emory is a national leader in healthcare and biomedical research as well as outstanding training and education in clinical and translational research; GA Tech is a national leader in biomedical engineering and the application of innovative systems engineering to health care solutions; MSM is a leading black institution that addresses health disparities through successful community engagement programs and serves as a pipeline for training minority investigators. These institutions extend their current partnerships in healthcare, education, and cutting-edge interdisciplinary research to synergize the ACTSI. Strategic translational initiatives of the ACTS I are highlighted by the work of the Yerkes Primate Center, the Neurosciences Center, Winship Cancer Center, Vaccine and Immunology Center, as well as Nanotechnology and Regenerative Medicine. Building on this strategic trans-institutional effort, an innovative pediatric clinical and translational research home with full engagement with Children's is now a key partner in the ACTSI. The mission of the ACTSI is to integrate the multiplicity of our partner institutions' strengths in science and technology with rigor in the social sciences by: Applying new methodologies, e.g., genomics, imaging, nanotechnology, proteomics, metabolomics, glycomics, and informatics to advance clinical and translational research; Promoting and rewarding multi-disciplinary research to provide the most advanced and innovative therapies; Creating and sustaining partnerships to conduct community-based research with, rather than on, Atlanta's disadvantaged communities; Exploiting the capacity of novel approaches, including drug discovery and design, predictive health, regenerative biology, health disparities, computational and life sciences, translational animal models, imaging, and inflammation and vaccines; Accelerating the transfer of new technology, therapeutics and applications into routine use; and Focusing our collective scientific expertise on critical health problems facing our region and country today. The multi-site Clinical Interaction Network (CIN) of the ACTSI formally replaces the Emory General Clinical Research Center (GCRC). The CIN includes sites at Emory University Hospital, Emory Crawford Long Hospital, Grady Memorial Hospital, the Ponce Infectious Diseases Clinic, the Hope Clinic, Wesley Woods 2 Health Center, the Morehouse School of Medicine Clinical Research Center, and Kaiser Permanente of Georgia. Given the dispersed nature of the Atlanta research community and the goal to actively engage the community in bidirectional research translation, the ACTSI has developed a three tier Clinical Interaction Network (CIN) that incorporates hospital-based, medical office-based and community-based clinical interaction sites through integration with the Community Engagement and Research Program. An efficient, flexible and geographically distributed CIN has been created to meet the needs of translational and clinical investigators from Emory, MSM, and GA Tech. The CIN is centralized under the leadership of a single CIN director, Dr. Arlene Chapman of Emory University (letter of support included) and a co-director, Dr. Elizabeth Ofili of MSM. An inter-institutional senior management team is present to streamline administrative efforts and to ensure appropriate city-wide access to resources. Clinical and Translational Research Program for Pediatrics, CTRPP supports and develops pediatric research in part through the excellence in research and teaching present within the Departments of Pediatrics at Emory, Morehouse School of Medicine, and Children's. The relationship between the two schools of medicine and Children’s provides an unprecedented opportunity for growth and expansion in translational and clinical research in child health and disease. The Departments of Pediatrics at Emory, MSM and Children’s worked with Georgia Tech and Kaiser Permanente Georgia to develop an academic home for the conduct of pediatric clinical and translational research that effectively reaches the entire Atlanta pediatric community. The CTRPP provides a coherent and integrated program in pediatric clinical and translational research by enhancing specific elements in research infrastructure including designated inpatient and outpatient clinical interaction sites, trained pediatric navigators and research subject advocates, integration between the Children’s office of clinical research and Institutional Review Boards, integrated clinical informatics, and support for pediatric-based community engagement programs. In addition, the CTRPP, working with the Research, Education, Training and Career Development program, provides training, education, and the opportunity for establishing newly-trained clinical, translational pediatric investigators to meet the goal of rapidly translating available scientific discoveries to the community through hospital and community-based programs. CTRPP, the Clinical Interaction Network (CIN), and CHOA support a Clinical Interaction Site located at Children’s Healthcare of Atlanta at Egleston (Egleston) called the Pediatric Research Center (PRC). The PRC is designed to provide the necessary infrastructure for investigators conducting pediatric clinical research. This four-bed inpatient unit is located on 4 West (Tower 2) and the four-bed outpatient unit is located within the Technology-Dependent Intensive Care Unit (TICU) (Tower 2) of Egleston (1405 Clifton Road NE). The PRC is available to any pediatric investigator with an approved ACTSI protocol or a NIH-funded network study. The pediatric inpatient and outpatient units offer core support facilities and resources, including facilitating tests and procedural visits conducted by research nurses, such as radiological exams, phlebotomy, IV access, medication administration, vital signs, and lab draws, protocol design consultation, research pharmacy support, safety oversight, bionutrition support, basic laboratory procession of human biological samples, preservation and storage of samples, generation of aliquots, scheduling, sample acquisition, and tracking via Laboratory Information Management System (LIMS) and assay consultation. The Research Education, Training, & Career Development (RETCD) program is focused on providing didactic and mentored clinical and translational research training to a wide variety of trainees at Emory University, MSM, and GA Tech who are committed to careers in clinical investigation. The RETCD program provides primarily long-term clinical and translational research training to postdoctoral and pre-doctoral trainees but also provides short-term training opportunities. Available RETCD Resources include: The Emory Master of Science in Clinical Research (MSCR) degree program is open to doctorate or equivalent degree holders (such as physicians and PhD-level scientists) and pre-doctoral (medical or PhD) graduate students (through TL1 program support). The MSCR program includes a Clinical Research Education and Career Development (CRECD) component for under-represented minority scientists and is funded by NCRR. The KL2 Mentored Clinical and Translational Research Scholars program provides training to junior faculty with a doctorate (MD or PhD), at the level of instructor or assistant professor. The TL1 predoctoral Medical Scientist Training program offers MD/MSCR and PhD/MSCR dual degrees and is open to medical students and PhD graduate students at Emory, MSM, and GA Tech as well as other health professionals, pursuing doctorate degrees in public health, biomedical sciences, and nursing. The RETCD also 3 enhances clinical and translational research activities for doctoral and non-doctoral level trainees through short course training, and through a three-month clinical and translational research rotation for pre-doctoral trainees. In addition, RETCD collaborates with the Summer Undergraduate Research at Emory (SURE) program to provide opportunities for clinical and translational research training for undergraduate students. The Translational Technologies & Resources Program, TTR program provides the infrastructure and programmatic foundation to rapidly identify and invest in promising technologies; enhance collaborative opportunities among translational investigators; promote novel methodological development; enhance awareness and support education and training in translational technologies; and provide better access to shared resources, including service centers and core facilities at Emory University, MSM, and Georgia Tech. This program’s relationship with the Office of Technology Transfer will greatly facilitate transactions related to protecting, marketing and negotiating license arrangements for intellectual property. The Community Engagement & Research Program (CERP), connecting existing academic community research programs from MSM and Emory’s Rollins School of Public Health, transforms research from a scientist-subject interaction to an equitable partnership, and trains investigators in principles of communitybase participatory research. To reduce health disparities, CERP, 1) creates a continuous community involvement process to reach communities and practitioners, share findings, and engage communities, 2) generates new research programs, conducts courses and seminars on community-based participatory research and 3) builds community capacity to generate research questions and work toward the improvement of community health. A Steering Board, containing a community representative majority and chair, oversees all CERP activities and includes representatives from each ACTSI academic and community partner. CERP developed a program of courses and seminars to train investigators to work in the community on participatory-based research, conduct clinical and translational studies, and improve access to previously identified patient populations. A semester-long two credit course, Community Engagement in Clinical Research, is an integral part of the training of MD and PhD ACTSI trainees and a requirement in the Emory and MSM MSCR programs. CERP collaborates with the RETCD program to train students in the principles and practice of community-based participatory research. A variety of seminars and workshops provide the opportunity for investigators to learn more about projects underway and current thinking in community-based research. The Ethics, Regulatory Knowledge, & Support (ERKS) program provides ethics and regulatory knowledge infrastructure and support for clinical and translational investigators within the ACTSI. The program has helped to centralize and consolidate research support infrastructure program-wide at Emory University, MSM, and GA Tech, including broadening of the Emory Clinical Trials Office to form an Office of Clinical Research and Research Compliance. In addition, a research ethics resource is available within Emory, titled the Section on Ethics in Research and Participant Advocacy (SERPA). ERKS provides support to ACTSI investigators on major regulatory issues through its integration with the Emory Offices of Clinical Research and MSM Office of Sponsored Research Administration, which provides the infrastructure to integrate and broaden the scope of regulatory support and training, assist the academic growth of clinical investigators, and support the highest level of ethically conducted clinical and translational investigation across institutions. ERKS resources include investigator and protocol support for regulatory affairs, investigator and institutional conflict of interest assistance, complex IRB issue resolution, coordination of multiple committee approvals, intellectual property issues, competing or conflicting institutional policies, safety surveillance and support, financial and research compliance, quality assurance, an adverse event database, IRB reciprocity, Memorandums of Understanding, and Material Transfer Agreements with ACTSI partner institutions and training and education programs for investigative teams. ERKS offers research ethics consultative service, research, and support to ACTSI investigators. The ACTSI Ethical Dilemmas in Scientific Research and Professional Integrity website developed by the Section on Ethics in Research and Patient Advocacy (SERPA) as part of the ERKS program is located at http://www.actsi.org/ethics. This website has been populated with ethical dilemmas in research as well as expert opinions on resolving the dilemmas. Original cases include allocating credit, animal use, authorship, confidentiality, conflict of interest, data interpretation and management, drug trials, intellectual property, 4 mentoring, misconduct, and participant recruitment. Each case on the website is followed by an expert opinion, developed by SERPA personnel. During a typical month, this website receives between 100 to 200 hits, with viewers usually examining multiple cases. (In August 2010, for example, 608 cases were accessed by viewers.) This website continues to be populated with new ethical dilemmas contributed by investigators and students along with expert opinions. This activity will continue in the next grant cycle. The primary value of the website is for students and faculty who desire training and instructional materials on various ethical issues occurring in research. The ACTSI Pilot and Collaborative Translational and Clinical Studies Program (PiCoTraCS) is a catalyst and vehicle for the transformation of clinical and translational science in Atlanta. PiCoTraCS promotes new networks of multidisciplinary and inter-institutional research teams to re-engineer the health sciences enterprise of our city. PiCoTraCS enhances currently available resources from each of our partner institutions by investing in new clinical and translational research paradigms, to encourage young faculty to develop cutting edge science, and to become the glue that cements investigators and projects across the research consortium. Funding is used to support 1-2 year pilot projects consonant with the broad aims and objectives of ACTSI. The Biostatistics, Epidemiology, & Research Design (BERD) program provides essential research design, biostatistics, and epidemiological collaborative/consultative services to ACTSI investigators and fosters the development of new statistical methodology to meet analytic challenges. The program promotes biostatistical and epidemiological education and training opportunities and supports outreach programs in Atlanta and throughout Georgia. BERD personnel are available to support all phases of statistical protocol development, including experimental design, data analysis planning and statistical power/sample size estimation. A key goal of the BERD program is to provide value added assistance to markedly improve the quality of the translational and clinical research of ACTSI investigators. This is accomplished by having highly trained, userfriendly BERD program personnel available to assist investigators in a timely manner. The Biomedical Informatics Program (BIP) enables investigators by offering informatics services and a team of research informaticians. The program offers informatics support to Emory University, MSM, and GA Tech investigators throughout the life cycle of their research protocols. BIP presents investigator-focused support in informatics research, consulting, and key tools to facilitate clinical and translational research. BIP also offers informatics education to Emory, MSM, and GA Tech students and investigators, including training and bioinformatics courses taught by GA Tech and Emory faculty. BIP works with partner institutions to develop innovative infrastructure to support collaborative integrative translational research studies within and between CTSA sites. Furthermore, the program works with the Information Technology Offices of Emory, MSM, GA Tech, Children’s, Atlanta VA Medical Center, and Kaiser Permanente Georgia to support ACTSI investigators, build technology infrastructure, and securely connect the Clinical Interaction Network (CIN) sites across the ACTSI. Available BIP resources include informatics research and development (Translational research informatics, Biomedical informatics, High performance computing, Grid computing, Imaging informatics) Informatics Consulting (Solution design, Data management and reporting, Programming and application development, Web design, Data and information security), and tools (Clinical research information warehouse, Databases and data reporting, High performance clusters, Collaboration environments, Form-based data capture instruments and market surveys, Automation of research laboratories including biorepositories, Research participant scheduling). ACTSI KL2 CLINICAL RESEARCH CAREER DEVELOPMENT PROGRAM FOR JUNIOR FACULTY MEMBERS Junior faculty members at the MD or PhD level from a wide variety of disciplines at Emory University, Morehouse School of Medicine, or Georgia Institute of Technology who are committed to an academic career in clinical and/or translational research and who have excellent potential to become an independent clinical investigator are encouraged to apply to the KL2 – Mentored Clinical and Translational 5 Research Scholars (MCTRS) Program. The KL2 award provides support for didactic and mentored research training for junior faculty members committed to a career in clinical investigation. KL2 award recipients must devote 75% professional effort to the program (surgeons may devote 50% effort). Applicants who are successfully funded will receive salary support (75%), a KL2 technical budget ($25,000 per year) for research costs and tuition, and some salary support for the KL2 scholar’s Lead Mentor. Partial or matching salary support from the applicant’s Division, Department or other non-federal sources is highly encouraged but not required. 6