University of Iowa Institute for Clinical and Translational Science

1. University of Iowa Institute for Clinical and Translational Science

2. What is the Institute for Clinical and Translational Science all about? The Institute for Clinical and Translational Science (“the Institute”),will serve as the University’s overarching, academic structure for all clinical and translational research and training. The Institute will establish a multidisciplinary matrix to facilitate and support all clinical and translational science across the University’s colleges.

3. What are the goals of the Institute? • To serve as the home for all aspects of the CTSA • To remove barriers to clinical and translational research and to stimulate new interactions and multidisciplinary research and training programs • To promote ethnic and gender diversity within all aspects of the Institute • To identify, recruit, and train outstanding scholars from diverse disciplines in the comprehensive principles and techniques of academic, patient-oriented research, including epidemiological and translational research and clinical trials • To provide short-term training to a wide variety of scientists interested in conducting clinical and translational research, including community researchers, study coordinators, and early-career researchers • To develop a network of Iowa communities integral to the Institute’s research and education components

4. What are the goals of the Institute? • To aid in bridging basic and clinical research, and to bring these discoveries to Iowa’s communities and beyond • To carefully monitor the progress of the Institute to ensure optimal use of the CTSA and State of Iowa resources, as well as to ensure the success of the Institute’s research and education training programs • To integrate existing programs for clinical research training—including a variety of established clinical training programs; the University’s NIH-funded K30, K12, and T32 programs; and the Graduate Program in Translational Biomedicine—and to increase collegial interactions among trainees • To integrate functions that support clinical and translational research, including regulatory support and drug development, essential research core support, pilot grants, and information technology • To provide an academic home and supportive environment for University faculty interested in clinical and translational research, including support for career development and promotion • To forge research partnerships with industry

5. Institute Governance

6. Institute Key Functions • Participant and Clinical Interactions Resources • Regulatory Knowledge and Support • Translational Technologies and Resources • Pilot and Collaborative Translational and Clinical Studies • Development of Novel Clinical and Translational Methodologies • Genetics and Genomics • Diversity and Career Development • Research Education, Training and Career Development • Clinical and Translational Research in Pediatrics • Community Engagement • Biomedical Informatics • Design, Biostatistics, and Clinical Research Ethics

7. Participant and Clinical Interactions Resources The Participant and Clinical Interactions Resources (PCIR) Key Function of The University of Iowa Institute for Clinical and Translational Sciencehas been developed to transform the way investigators at The University of Iowa and regional communities interact with research participants. This key function will reinforce our current strengths in providing high quality services to a growing number of research participants and will address current challenges, such as space constraints, aging facilities, and a lack of recruiters and coordinators. The PCIR Key Function will provide the physical facilities and personnel to enhance recruitment and participation of research subjects for translational research at The University of Iowa.

8. Participant and Clinical Interactions Resources Specific Functions • To provide a nodal physical infrastructure for interactions with research participants at The University of Iowa that operates in accordance with the principles of Good Clinical Practice (GCP). Nodes include • A new central Clinical and Translational Research Facility (CTRF) that provides dedicated inpatient and outpatient space for research participants, staffed by nurses and coordinators with extensive training and expertise in clinical research; • Peripheral clinical research nodes to facilitate the recruitment and participation of research subjects who are unable to visit the CTRF. These nodes will be situated in the operating rooms, intensive care units, and dental facilities of The University of Iowa Hospitals and Clinics. • To provide a recruitment core that will offer investigators within and beyond The University of Iowa the opportunity to recruit research study participants, including the recruitment of more diverse study populations; this core will prospectively and continuously examine issues of race/ethnicity, geography, gender, and other factors that are barriers to participation by different groups of populations. • To provide a cadre of experienced clinical research coordinators for young and/or new translational research investigators, and to assist established investigators on a cost-for-service basis.

9. Participant and Clinical Interactions Resources • To widely disseminate the resources available in the PCIR to maximally support new investigators at The University of Iowa or in community and partner institutions in the State of Iowa or elsewhere. • To support early translational studies. • To ensure that all studies in the PCIR meet the highest standards for scientific priority, trial design, statistical power, and research subject safety, through rigorous tracking, auditing, and evaluation. • To provide enhanced support for investigators in early stages of their clinical or translational research, both those in training and those in a transitional phase of their career.

10. Regulatory Knowledge and Support • The Institute Regulatory Knowledge and Support (RKS) Key Function has been developed to help investigators comply institutional and federal regulations and to enhance the safety of research participants. • The Investigator Support Office (ISO) will enhance the efficiency and timeliness of translational research regulatory approvals by proving expertise in clinical research regulation, and assistance with the preparation of regulatory documents. • The Research Safety Office (RSO) will enhance participant safety by monitoring protocol adherence and evaluating protocol safety. • The two main purposes of the RKS Key Function are to 1) provide the highest standards in research participant safety through the activities of the ISO and RSO in investigator support and monitoring, and 2) transform clinical research efficiencies and timeliness by helping investigators comply with institutional and federal regulations.

11. Regulatory Knowledge and Support Functions • Accelerate the process of IRB approval by assisting with the preparation of high quality applications and consent forms • Streamline approvals from other institutional committees (radiation, pharmacy, and others) • Provide a forum for communication and feedback between investigators and The University of Iowa Human Research Protection Program (HRPP) and IRB • Support investigational new drug/investigational device exemption (IND/IDE) submissions to the Food & Drug Administration (FDA) through training and administrative assistance • Help investigators in the preparation of data monitoring and safety plans for their research protocols • Closely monitor the conduct of the consenting process, and of protocols, to ensure the safety of research participants • Track, evaluate, and report adverse events in research studies

12. Translational Technologies and Resources The Institute Translational Technologies and Resources (TTR) Key Function has been developed to transform how investigators utilize and develop expertise in sophisticated, state-of-the-art technologies for clinical and translational research.

13. Translational Technologies and Resources The purpose of the TTR Key Function is to provide advanced translational technologies for clinical trainees and investigators. The specific functions are to: • provide expertise and established methodologies that are needed by our clinical and translational research communities • provide training and expertise in translational technologies to enhance the skills of new clinical and translational investigators • assist investigators in identifying links between components of the basic and clinical technology resources • facilitate the translation of findings and technological tools to the clinical arena in ways that will improve clinical diagnosis and treatment • deploy new technologies in response to scientific developments and investigator needs

14. Pilot and Collaborative Translational and Clinical Studies The overall purpose of the Institute’s Pilot Grant Program is to: • encourage innovation by funding high-risk/high-reward projects before they have enough preliminary data to compete for traditional funding • increase the rate of discovery in patient-oriented research and the translation of basic research into patient-oriented research and practice • foster interdisciplinary and collaborative approaches to clinical and translational research • encourage investigators to commit to careers in clinical and translational research by enhancing the training and development of junior investigators in clinical and translational research and by facilitating innovative clinical and translational research approaches for established investigators developing a translational research emphasis • support the collection of preliminary data that will lead to successful applications for external peer-reviewed funding, particularly data associated with innovative, high-risk/high-reward projects with the potential for significant reward

15. Pilot and Collaborative Translational and Clinical Studies The specific functionsare to: Provide access to pilot funding for - junior investigators (including trainees) who are in the initial phases of their research career - established investigators who are seeking to redirect all or a portion of their research effort toward collaborative translational research • Provide access to pilot funding for proposals that - are particularly innovative and have a high level of risk and potential reward - are hypothesis-generating or designed to develop new methodologies - advance our understanding of the complexities in applying clinical knowledge to practice - seek to improve clinical design, biostatistics, clinical research ethics, informatics, or regulatory pathways • Provide access to both regular-cycle pilot funding and “as needed” pilot funding for time-limited opportunities • Support the generation of preliminary data for submission of an externally funded research grant application • Support acquisition of new technology and expertise in its use

16. Pilot and Collaborative Translational and Clinical Studies • Support pilot award grantees with access to - state-of-the-art resources, technology, methodologies, and expertise available through the Institute - Institute research infrastructure cores, such as assistance in protocol development, regulatory issues, and subject recruitment - assistance in patent applications and interactions with industry • Encourage new collaborations that bring together basic and clinical scientists by identifying such collaborations as an explicit review criterion • Encourage new and expanded interdisciplinary collaborative research by integrating pilot award grantees into the activities and structure of the Institute • Encourage research in specific fields of investigation determined by the Institute’s Executive Committee to present a special opportunity or need • Ensure the highest possible quality research by monitoring the conduct of pilot grant projects in order to assess progress and determine whether projects are meeting objectives • Be a resource for funding of trainees in the following educational tracks: Early Stage Translation, Computational Biology & Genetics, Clinical Research, Epidemiology & Behavioral Health, Community Translation

17. Development of Novel Clinical and Translational Methodologies Purpose and Functions • The purpose of this key function is to strategically enhance development of translational technologies in basic science through the following ways: • Infrastructure: Provide a supportive infrastructure of scientific resources and educational opportunities focused around a core group of investigators working in nanoscience, nanotechnology, and gene therapy (living nanoparticles). • Nanorelationship Collaboration Training Program: Develop a program of strategic matching of junior investigators with advanced training in nanoscience and nanotechnology with more senior clinical scientists (Nanorelationship Collaboration, NC). This program will be matched with an innovative set of assessment metrics to evaluate previous and current academic collaborations and to determine the key set of factors that distinguishes collaborations that are accomplished (what we think of as good) from those that take on a life of their own and transform the investigators, their teams, and the science they do (what we call great collaborations).

18. Development of Novel Clinical and Translational Methodologies Purpose and Functions • Novel Diagnostic, Drug, and Device Applications of Nanotechnology: Assist with the development of innovative diagnostic, drug, device, and gene delivery technologies and preclinical application carrying them though to issues of scale up assessment, analysis, preparation, and submission of investigational new drug (IND) applications prior to initiating Phase I trials in humans • Integration with Industry: Expand our contacts and relationships with industrial partners, focusing mainly on nanotechnology, small biotechnology, and therapeutic device companies with a similar portfolio of research and development services • Personnel: Provide enhanced personnel support for NanoHealth, ie, health-related nanoscience and nanotechnology programs across campus • Engagement: Provide regulatory, policy, and community engagement in areas of translational science application and nanoscience (NanoHealth)

19. Genetics and Genomics • The purpose of the Genetics and Genomics (G&G) Key Function is to enable the translation of basic science findings of the Human Genome Project to directly improve disease diagnosis and risk assessment through gene discovery.

20. Genetics and Genomics The specific functions are to • Perform and provide training for genetic and genomic analyses • Perform and provide training for convergent genomic analysis and mutation screening • Collect, process, store, and distribute biospecimens for genetic and genomic analyses

21. Diversity and Career Development • The purpose of the Diversity and Career Development Key Function is to enhance the training of women and minorities and nurture their development across all stages of the career training pipeline. Importantly, the Key Function will integrate a rich spectrum of diversity programs currently on The University of Iowa campus with the infrastructure of the Institute.

22. Diversity and Career Development The specific functions are • To foster professional development skills in University of Iowa junior and senior undergraduate students and students from communities affiliated with the Institute from underrepresented groups. The purpose of this aim is to familiarize them with successful role models and mentors in translational sciences in order to promote future recruitment into the Institute. • To introduce health professions students underrepresented in the health sciences to translational research for the purpose of fostering diversity within clinical and translational sciences. • To recruit and retain faculty trainees from underrepresented racial/ethnic minority groups. • To equip women and underrepresented minorities with the skills to achieve academic success. • To foster women and underrepresented minorities who have demonstrated academic success with the knowledge and skills necessary to achieve and succeed at leadership roles in academia and healthcare organizations.

23. Research Education, Training and Career Development The Institute for Clinical and Translational Research will train highly motivated clinical research scholars for innovative careers in patient-focused research. The training programs will provide a comprehensive curriculum across a spectrum of clinical research fields, and abundant opportunities for close supervision by mentors from the Colleges of Dentistry, Nursing, Pharmacy, Public Health, Engineering, Liberal Arts and Sciences, and the Carver College of Medicine. Scholars will be selected from a variety of clinical disciplines, including those traditionally underrepresented in clinical research such as radiology, pediatrics, clinical psychology, surgical sub-specialties, anesthesiology, and pharmacy. Training programs will also reach health care providers in the community and nurse research coordinators. The program will include a K12 component, T32 component, year-long certificate program, and a variety of short-term research experiences.

24. Research Education, Training and Career Development The specific functions of the Institute’s training programs are to: • Identify and recruit outstanding scholars from diverse backgrounds and disciplines, inclusive of gender and ethnicity, who wish to obtain an understanding of the principles and techniques of scholarly clinical and translational research • Implement a didactic curriculum in the theories and methods of clinical research, research ethics, and essential career development skills, such as grant writing • Provide multidisciplinary and integrated mentored research experiences that facilitate the development of scholars’ research skills and their broader career development • Support scholars in their training and transition through the Institute from mentee to independent investigator, including recognition of achievement by timely promotion • Increase the pool of well-trained clinical and translational research scholars who will in turn create self-sustaining, innovative, multidisciplinary research and training programs

25. Clinical and Translational Research in Pediatrics The central purpose of the Clinical and Translational Research inPediatrics (Pediatrics) Key Function is to integrate The University of Iowa’s strong foundation in pediatrics into the overall mission of the Institute for Clinical and Translational Science (“the Institute”).

26. Clinical and Translational Research in Pediatrics We have developed four functions to serve this effort: • Outreach Partnerships-To integrate families, school personnel, and primary care providers into partnerships for education, translation of research into practice, and clinical research. • Bench-to-Bedside Collaboratory-To build a digital core facility, the Bench-to-Bedside Collaboratory, for clinical and translational science that will facilitate education and conversations between all of the constituencies involved in this project.

27. Clinical and Translational Research in Pediatrics • Genes and Environment-To study human complex disorders by utilizing large, clinically based populations and biological samples to investigate and confirm relationships between genetic background and environmental exposures. • Perinatal Translational Medicine-To develop a perinatal research enterprise across The University and the State of Iowa by building an infrastructure to support comprehensive epidemiologic and clinical studies.

28. Community Engagement • The Institute will partner with Iowa communities in novel ways that will capitalize on longstanding clinical and health education outreach programs at The University of Iowa, on and on the unique relationship between the University and the people of Iowa. As the largest educational institution in the state, the University has a strong history of providing clinical services and health education in concert with public and private organizations and has a number of senior faculty with extensive experience in working with communities and community leaders.

29. Community Engagement The long-term functions of the Community Engagement Key Function are to: • Foster public trust in and access to health science information and clinical research trials. • Increase the participation of individuals from underrepresented and underserved groups in clinical, behavioral, and health services trials. • Promote Type II research translation and speed adoption of best practices in the community.

30. Biomedical Informatics The purpose of the Biomedical Informatics Key Function is to provide for a new level of information integration, accessing a variety of sources, managed in a flexible and comprehensive manner, and accessed by investigators for the design, conduct, and analysis of clinical research. The specific functions of Biomedical Informatics are to: • Develop a federated infrastructure capable of capturing, archiving, and administering Institute biomedical research outcomes from all classes of units in all their varied forms and media, and of assimilating such data from other institutions. Federation here implies that infrastructure components can interact, but do not relinquish organizational and operational autonomy—components are independent, cooperating entities. • Provide for the secure dissemination of biomedical information to authorized individuals under appropriate data use agreements within the institution, and support its analysis.

31. Biomedical Informatics • Provide for the secure dissemination of biomedical information under appropriate data use agreements to authorized individuals in extramural organizations. • Provide an environment that supports investigator needs relating to collaboration, funding, and awareness. • Participate in the national initiative to integrate our work with that at other institutions, including the standardization of representation and transfer protocols.

32. Design, Biostatistics, and Clinical Research Ethics • The primary purpose of this key function is to provide Institute investigators with access to biostatistical, study design, and ethics expertise within five distinct domains of clinical research: Early Stage Translation, Computational Biology and Genetics, Clinical Research, Epidemiology and Behavioral Health, and Community Translation.

33. Design, Biostatistics, and Clinical Research Ethics The activities of the Design, Biostatistics, and Clinical Research Ethics Key Function are to • help Institute investigators select and implement appropriate research designs and statistical analysis methods for their individual research projects; • increase the integration of principles of bioethics into the design and conduct of clinical and translational research; • develop and evaluate innovative methods in design and analysis of clinical and translational research studies and conduct research on the ethical implications of clinical research design; and • disseminate new methodologies to Institute investigators, such that these methodologies become part of investigators’ scientific repertories.