Irving Institute for Clinical and Translational Research

1. Irving Institute for Clinical and Translational Research Home for Columbia’s Clinical and Translational Science Award

2. Our Structure: A Comprehensive,Broad Based GCRC • Adult Inpatient • Adult Outpatient • Pediatric Inpatient • Pediatric Outpatient • SLRHC: Inpatientand Outpatient • Core Laboratory • Bionutrition Core • Informatics Core • Biostatistics Resource

3. Support for Research and Training • 75 Investigators and their staffs • 80-100 protocols • 2000-2005: 600 peer reviewed papers, reviews, chapters • K30 Award: MS in Biostatistics: Patient Oriented Research (40 graduates since 1999; 16 active students) • K12 Scholars Award: (4 graduates since 2003; 3 carryover scholars): 75% salary support plus research funds

4. Limitations of the GCRC • Surrounded by walls • Limited core support services • Limited training funds • No mission to affect the way research is conducted

5. Our Mission Train and mentor a new generation of multidisciplinary C/T investigators Expand and optimize the utilization of outstanding new and existing resources at CUMC Support pre-clinical and clinical departments in the recruitment and retention of outstanding C/T investigators at CUMC To change the way people think about and conduct research at CUMC

6. Irving Institute Henry Ginsberg MD Melissa Begg ScD Karina Davidson PhDNancy Green, PhDHarold Pincus, MD Leslie McHale Associate Director Programs Jo-Ann Espaillat Associate Director Finance Regulatory Knowledge And Ethics John Ennever MD Paul Appelbaum MD Ruth Fischbach PhD Translational Technologies Henry Ginsberg MD Community Engagement Rafael Lantigua MD B. Boden-Albala PhD Tracking Evaluation Mark Graham PhD Harold Pincus MD Zoon Naqvi PhD Development of Novel Methods Henry Ginsberg MD Harold Pincus MD Design and Biostats Roger Vaughan DrPH William Friedewald MD Annetine Gelijns PhD Clinical Research Center Karen Marder MD MPH Michael Rosenbaum MD Sudha Kashyap MD Jeanine Albu MD Pilot And Collaborative Study Award Nancy Reame RN PhD Training and Nurturing Scientists for Research That is Multidisciplinary Melissa Begg ScD Karina Davidson PhD Biomarkers Core John O’Connor PhD Botanical Analysis Core Fredi Kronenberg PhD Clinical Genetics Core Angela Christiano PhD Rudolph Leibel MD PhD Imaging Core John Mann MD Organic Synthesis Core Donald Landry MD PhD Research Pharmacy Robert Macarthur PharmD Organizational Chart Biomedical Informatics Stephen Johnson PhD

7. Regulatory Issues • 4 IRBs • CUMC, NYS Psychiatric Institute, WIRB, St. Lukes- Roosevelt • CTSA Advisory Committee Review is not integrated with IRB review • 2 CTSAs (Columbia and Weill Cornell) share 1 hospital New York-Presbyterian

8. Goals for Clinical Research Center • Continue to provide both inpatient and outpatient space and dedicated personnel for patient-oriented research. • Expand support for patient oriented research beyond the confines of the Clinical Research Center (CRC). • Partner with the Community Engagement Resource (CER) to enhance off-site research.

9. Implementation and Oversight: Changing the Culture CUMC 2006: 807 new protocols, 1563 renewals • Pilot survey of inpatient units (Neurology and Pediatric Oncology) • Collaboration between CRC, hospital and School of Nursing to assess staff knowledge, develop and implement research curriculum for nurses, PAs, MDs. • Develop a mechanism to Identify participants in research protocols.

10. Implementation and Oversight: Research in the ICUs and Emergency Departments • New York State has no statute or regulation that clearly identifies a legally authorized representative, and no case law that resolves the issue. • This situation prevents research in critical care units and Emergency Departments. • 18 clinical trials unable to enroll any patients or where enrollment was reduced by 50%. • In collaboration with Dean’s office and University Counsel, we have documented need for change in the New York State Legally Authorized Representative law.

11. Regulatory Knowledge Support And Ethics Resource • Education/Training • Revised Good Clinical Practice requirement – awaiting institutional approval • Bimonthly workshops on regulatory and ethical issues – growing attendance • Research staff and investigators have had little training in legal/ethical theory of informed consent • Provide IRB/HIPAA training • basic (2 hr), advanced (6 wks) – tracking results • Department-specific presentations

12. Adult ED: Research Participation Current Investigators 3/13 (23.1%) MDs 1/22 (4.5%) nurses 0/8 (0%) EMS Past Investigators 8/13 (61.5%) MDs 3/22 (13.6%) nurses 1/8 (12.5%) EMS

13. HIPPA (Research) Certification No Certification in HIPPA for Research 6/13 (46.2%) physicians 19/22 (86.4%) nurses 7/8 (87.5%) EMS ½

14. Challenges • What level of protocol review and data safety monitoring is required for CTSA protocols? • What is the most efficient means to educate MDs, nurses, health professionals and participants? • How do we develop a process to permit clinically important research with adults who lack decisional capacity in NY?