An Introduction to the Institute of Translational Health Sciences (ITHS)

Cathryn Booth-LaForce, Ph.D.ITHS Director of Membership

ITHS Director of Center for Scientific Review

ITHS is part of the Clinical and Translational Science Awards (CTSA) program

Improve the way biomedical research is conducted across the country

Reduce the time it takes for laboratory discoveries to become treatments for patients

Engage communities in clinical research efforts

Train a new generation of clinical and translational researchers

Led by the National Center for Research Resources,the CTSA program supports a national consortium of medical research institutions that work together and share a common vision to:

A Common Vision

CollaborationBreaking Down Institutional Barriers

Team Science

Connectivity Partnerships

CTSA Philosophy

Guiding Principles of the CTSA Program

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Building a National CTSA Consortium60 CTSA Sites in 30 States and the District of Columbia ($500

million annually)

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PR

= CTSA States= 2006–2010 CTSA Sites= 2011 CTSA Sites

The ITHS is a Working Partnership between Regional Institutions and other CTSAs

Some ITHS Services

• Study Design and Data Management-161 investigators assisted in 2010– Biomedical statistics– EMR data export for research (Amalga)– Cross site data sharing: LC Data QUEST– High throughput data: SNP genotyping data – REDCap: Devise surveys to build own database

• Regulatory and Bioethics-238 investigators assisted in 2010 – Research Coordinator Core– Regulatory compliance auditing – Cross institutional IRB advisory board– Bioethical issues in research

Education and Training—A Few ExamplesLifelong Learning Programs

www.iths.org/training/online

• Interdisciplinary Grand Rounds”Using Genomics to Individualize Drug Therapy: Technical, Clinical and Ethical Challenges”3/14/11 HSB D209 12-1 and webcast

• Clinical Research Education Series“Resolving Ethical Dilemmas in Clinical Research Studies” 5/5/11 T-739 11:45-1:15 and webcast

• Career Development Series“Behind Closed Doors: Secrets of a Study Section” 5/5/11 SLU 4-5 and webcast

ITHS Services• Pre-Clinical Research Development Network-

273 investigators assisted in 2010– Development of innovative products: software, drug delivery systems, drug

formulation, medical devices, etc.– Academic researchers, startups, entrepreneurs

• Community Outreach and Research Translation- 308 investigators assisted in 2010– Community/Practice/Tribe-based research in the WWAMI region– GHRI: Outcomes research, public policy issues– Online training to use plain language in studies: PRISM

Community Outreach & Research Translation Core(www.iths.org/CORT)

• Goals: – To facilitate community-academic research partnerships

that are true collaborations– To increase community involvement in every stage of

research– To promote research that will address priorities and health

outcomes in the communities and practices we work with– To support these communities in becoming more engaged

and savvy about research.

CORT works with…

• Community stakeholders (clinicians, advocates, tribal partners, policymakers)

• Academic researchers who want to integrate community partnerships into their work

CORT offers…..

• Consultation service for tribal research– Provides a resource for tribes and tribal organizations who

have questions about ongoing or proposed research in their communities.

• Research ethics• Institutional Review Board questions• Legal issues• Medical issues• Tribal regulation of research

– With the CORT Tribal Liaison (Abigail Echo-Hawk), CORT attempts to find a scientist specialized in the particular area to answer questions sent by tribal officials or potential research subjects.

CORT offers…..

• Grant-writing assistance (limited basis)– Literature reviews– Grant-writing– Facilitating relationships between tribes and academic

research partners – Identifying potential grants that align with individual

community needs.

CORT offers…..

Developing ProposalsFinding Funding Finding Collaborators Working With Practices and Communities Developing Multi-site Proposals Developing Multi-site Budgets

Starting Up a StudyHandling IRB, Regulatory, and Ethical Issues Setting Up Contracts and Agreements Establishing Multi-site Study Procedures Creating Consent Forms and Study Materials Training Study Staff

Conducting and Managing ProjectsCollecting and Sharing DataObtaining Consent Recruiting Participants Maximizing Participant Retention Overseeing Study Activities Maintaining Collaboration

• Tools and templates for conducting research– PRIMER (Partnership-driven Resources to IMprove and

Enhance Research)—A toolkit for health research in partnership with practices and communities. For example:

CORT offers…..

– LC Data Quest (Locally Controlled Data QUery Extraction Standardization and Translation), which implements a technical infrastructure for sharing electronic medical record data for research while communities retain local control and management of their own data

Contact CORT

• Go to www.iths.org/CORT• Click on “Contact ITHS CORT”

Contact ITHS CORT

ITHS Pilot Fundingwww.iths.org/funding

ITHS offered $1.3 million in funding opportunities in 2010

• Small Pilot Project Grants– Designed to provide preliminary data for larger grant applications

• Ignition Awards-preclinical research– Drug and device development

• Community/Practice/Tribe-based Research Award– Help WWAMI groups develop participatory research capability

Examples of Funded Tribe-based Research Awards

• Roundstone, David Northern Cheyenne (Tsitsistas)Ways of Knowing Gathering: Northern Cheyenne Board of Health

• Smoker, Kenneth Building Translational Research Capacity within the Fort Peck Tribes--Engaging Tribal Youth: Fort Peck Tribes Health Promotion Disease Prevention Program

• Milton, Ann Protecting our Future: Quinault Indian Nation Diabetes & Wellness Program

• Mittelstaedt, Gillian Chronic Respiratory Diseases and Woodstove Use in Tribal Households: A Survey to Understand Awareness, Concerns and Actions Taken: Tulalip Tribes

• Peter, Evon Building Culturally-Responsive Suicide Prevention: Developing Training for Behavioral Health Providers: Maniilaq Association

• Donatuto, Jamie Swinomish Seafood Diet Interview Analyses: Swinomish Indian Tribal Community, La Conner, WA

Membership-Free!www.iths.org/membership

• Benefits to ITHS Members– Eligible for grant funding– Reduced rates for ITHS sponsored resources– Preferred registration for select ITHS events

• Join as Scholar (trainee) or full Member• Clinical, basic and translational researchers, and

tribal/community partners welcome!• All members of research team welcome

(scientists, research coordinators, program managers, administrators)

ITHS Navigator Consult

www.iths.org

Dr. Beth Hackerithsnav@uw.edu

206-616-3875

• Personalized help with translational and clinical research projects • Answer general questions about ITHS services