1. Institutional Development Award (IDeA) Program – Infrastructure for Clinical and Translational Research (IDeA-CTR) J. Rafael Gorospe M.D. Ph.D. Medical Officer NIH/NIGMS/TWD/CBB

2. NIGMS BACKGROUND: C LINICAL R ESEARCH P ROJECTS IN THE ID E A P ROGRAM * INBRECOBRETOTAL Awards2481105 Research Projects 3716941065 Clinical Projects (HS) 3968107 *Data from 2009 APR

3. NIGMS A relatively small proportion of IDeA-funded centers and networks focus on developing clinical and community-based translational research capacity It is critically important to translate the many biomedical research advances from IDeA states into better health outcomes by forging partnerships between basic and clinical scientists in IDeA institutions, supported by programs across NCRR and NIH IDeA-CTR Program: B ACKGROUND AND R ATIONALE

4. NIGMS June 2010: NCRR issued a Request for Information (RFI) titled “Clinical and Translational Research Infrastructure in Institutional Development Award (IDeA) Program Institutions” (NOT-RR-10-010)NOT-RR-10-010 December 2010: NCRR convened an expert Advisory Panel to review RFI responses and discuss next steps at a workshop with NCRR staff in Bethesda January 2011: Concept clearance obtained from NCRR’s Advisory Council to publish FOA June 2011: Funding Opportunity Announcement is published (PAR-11-229).PAR-11-229 IDeA-CTR Program: T IMELINES

5. NIGMS To support the development of infrastructure and human resources required to conduct clinical and translational research in IDeA-eligible states To enhance the ability of IDeA institutions and investigators to develop clinical and translational research programs To foster and sustain collaboration and coordination of clinical and translational activities within and across IDeA institutions/organizations IDeA-CTR Program: G ENERAL O BJECTIVES

6. NIGMS Institutions in IDeA states with active NCRR-funded clinical and translational research centers (CTSAs, RCTRs) cannot be the lead applicant Only one application can be submitted from an eligible IDeA state Institutions with 3 or more active P20 COBRE awards cannot be the lead applicant IDeA-CTR Program: E LIGIBILITY R EQUIREMENTS

7. NIGMS Applicant Institution: Academic Health Center Required Key Component Activities Potential/Optional Key Component Activities U54 Mechanism (Cooperative Agreement) IDeA-CTR Program: G ENERAL O UTLINES

8. NIGMS Partnerships and Collaborations Clinical and Translational Pilot Grants Program Clinical Research Education, Mentoring, and Career Development Core Clinical Research Design, Epidemiology, and Biostatistics Core IDeA-CTR Program: R EQUIRED K EY C OMPONENT A CTIVITIES

9. NIGMS Partnerships  within the state  two or more IDeA states (required)  non-IDeA states (fee-for-service) Facilitation and enhancement of collaborations Define budgetary and administrative arrangements Identify and address hurdles in establishing collaborations Utilization of existing resources and facilities supported by other programs Required Key Component Activities: P ARTNERSHIPS AND C OLLABORATIONS

10. NIGMS Provide plan for soliciting and awarding pilot projects One or more projects funded per year must be ‘clinical’ PIs of pilot projects must hold a faculty appointment or equivalent Do not include plans for individual pilot research projects in the application Required Key Component Activities: C LINICAL & T RANSLATIONAL P ILOT G RANTS P ROGRAM

11. NIGMS Recruitment of Clinical/ Translational Faculty Community Engagement and Outreach Clinical Research Resources and Facilities Biomedical Informatics Resources Ethics, Regulatory Knowledge and Other Technologies and Resources for Core Laboratories Component Activities of IDeA-CTR Program Partnerships and Collaborations within and across IDeA-eligible states Clinical and Translational Pilot Grants Program Clinical Research Education, Mentoring, and Career Development Core Clinical Research Design, Epidemiology, and Biostatistics Core Potential Key Component Activities

12. NIGMS Recruitment of Clinical/Translational Faculty Community Engagement and Outreach Clinical Research Resources and Facilities Biomedical Informatics Resources Ethics, Regulatory Knowledge, and Other Support Activities Technologies and Resources for Core Laboratories Others (up to 3) KCA/Core Directors Commitment: 2.4 person months IDeA-CTR Program: O PTIONAL K EY C OMPONENT A CTIVITIES

13. NIGMS Principal Investigator Established scientist Must have clinical research experience and active peer- reviewed funding Effort: 3.6 to 6.0 person months Program Coordinator (s) Complementary administrative skills and experience Effort: 3.6 to 6.0 person months Administrative Core: L EADERSHIP AND G OVERNANCE P LAN

14. NIGMS Internal Advisory Committee Constituted and named in the application 6-8 members External Advisory Committee Do not provide names of potential EAC members in the application Provide areas of expertise and qualifications of EAC members Administrative Core: A DVISORY C OMMITTEES

15. NIGMS Non- Federal matching funds are not required Letter(s) of commitment*  Lead Institution (required)  Partnering/collaborating institution(s) Examples of institutional commitment:  Financial support  Space  FTEs  Release time agreements  Core consolidation and maintenance IDeA-CTR Program: I NSTITUTIONAL C OMMITMENT

16. NIGMS Internal evaluation plan for monitoring and documenting progress Objective criteria and outcome measures IDeA-CTR Program: E VALUATION P LAN

17. NIGMS Total* costs: $4M per year A&R costs: $300,000 direct cost (one time cost) Project Period: 5 years Anticipated number of awards: 5 awards  2012: 2 awards  2013: 2 awards  2014: 1 award IDeA-CTR Program: A WARD I NFORMATION

18. NIGMS IDeA-CTR Application: I MPORTANT D ATES Letter of Intent Due Dates: August 30 Application Due Date: September 27

19. NIGMS Program Scientific Contact: Dr. J. Rafael Gorospe Phone: 301-435-0832 Email: gorospejr@mail.nih.govgorospejr@mail.nih.gov Review Contact: Dr. Helen Sunshine Phone: 301-594-2881 Email: sunshinh@migms.nih.govsunshinh@migms.nih.gov Financial/Grants Management Contact: Ms. Lori Burge Phone: 301-451-3781 Email: burgel@nigms.nih.govburgel@nigms.nih.gov IDeA-CTR Program: C ONTACTS