University of Iowa Institute for Clinical and Translational Science

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University of Iowa Institute for Clinical and
Translational Science
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What is the Institute for Clinical and
Translational Science all about?

• The Institute for Clinical and Translational
  Science (the Institute), will serve as the
  Universitys 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 Universitys
  colleges.

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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 Institutes research and education
  components

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What are the goals of the Institute?

• To aid in bridging basic and clinical research,
  and to bring these discoveries to Iowas
  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 Institutes research and education
  training programs
• To integrate existing programs for clinical
  research trainingincluding a variety of
  established clinical training programs the
  Universitys NIH-funded K30, K12, and T32
  programs and the Graduate Program in
  Translational Biomedicineand 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

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Institute Governance
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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

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Participant and Clinical Interactions Resources

• The Participant and Clinical Interactions
  Resources (PCIR) Key Function of The University
  of Iowa Institute for Clinical and Translational
  Science has 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.

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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.

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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.

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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.

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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

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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.

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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

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Pilot and Collaborative Translational and
Clinical Studies

• The overall purpose of the Institutes 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

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Pilot and Collaborative Translational and
Clinical Studies

• The specific functions are 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

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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 Institutes
  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

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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).

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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)

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Genetics and Genomics

• The purpose of the Genetics and Genomics (GG)
  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.

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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

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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.

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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.

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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.

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Research Education, Training and Career
Development

• The specific functions of the Institutes
  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

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Clinical and Translational Research in Pediatrics

• The central purpose of the Clinical and
  Translational Research in Pediatrics (Pediatrics)
  Key Function is to integrate The University of
  Iowas strong foundation in pediatrics into the
  overall mission of the Institute for Clinical and
  Translational Science (the Institute).

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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.

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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.

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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.

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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.

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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 autonomycomponents
  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.

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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.

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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.

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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.