Irving Institute for Clinical and Translational Research

Home for Columbia’s Clinical and Translational Science Award

• Adult Inpatient

• Adult Outpatient

• Pediatric Inpatient

• Pediatric Outpatient

• SLRHC: Inpatientand Outpatient

• Core Laboratory

• Bionutrition Core

• Informatics Core

• Biostatistics Resource

Our Structure: A Comprehensive,Broad Based GCRC

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

Limitations of the GCRC

• Surrounded by walls

• Limited core support services

• Limited training funds

• No mission to affect the way research is conducted

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

Biomedical Informatics

Stephen Johnson PhD

Regulatory KnowledgeAnd Ethics

John Ennever MDPaul Appelbaum MDRuth Fischbach PhD

Translational Technologies

Henry Ginsberg MD

Community Engagement

Rafael Lantigua MDB. Boden-Albala PhD

Pilot And Collaborative Study Award

Nancy Reame RN PhD

Training and NurturingScientists for Research That is Multidisciplinary

Melissa Begg ScDKarina Davidson PhD

Tracking Evaluation

Mark Graham PhDHarold Pincus MDZoon Naqvi PhD

Leslie McHaleAssociate Director

Programs

Jo-Ann EspaillatAssociate Director

Finance

Biomarkers CoreJohn O’Connor PhD

Botanical Analysis CoreFredi Kronenberg PhD

Clinical Genetics CoreAngela Christiano PhD

Rudolph Leibel MD PhD

Imaging CoreJohn Mann MD

Organic Synthesis CoreDonald Landry MD PhD

Research PharmacyRobert Macarthur PharmD

Clinical Research CenterKaren Marder MD MPHMichael Rosenbaum MD

Sudha Kashyap MDJeanine Albu MD

Irving InstituteHenry Ginsberg MDMelissa Begg ScD

Karina Davidson PhDNancy Green, PhDHarold Pincus, MD

Irving InstituteHenry Ginsberg MDMelissa Begg ScD

Karina Davidson PhDNancy Green, PhDHarold Pincus, MD

Design and BiostatsRoger Vaughan DrPHWilliam Friedewald MDAnnetine Gelijns PhD

Development of Novel Methods

Henry Ginsberg MDHarold Pincus MD

Organizational Chart

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

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.

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.

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.

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

Adult ED: Research Participation

Current Investigators

3/13 (23.1%) MDs

1/22 (4.5%) nurses

0/8 (0%) EMS

0

20

40

60

80

100

Physicians Nurses EMS

No

Yes

Not Sure

Past Investigators

8/13 (61.5%) MDs

3/22 (13.6%) nurses

1/8 (12.5%) EMS

0

20

40

60

80

100

Physicians Nurses EMS

No

Yes

Not Sure

HIPPA (Research) Certification

0

20

40

60

80

100

Physicians Nurses EMS

No

Yes

Not Sure

½

No Certification in HIPPA for Research

6/13 (46.2%) physicians

19/22 (86.4%) nurses

7/8 (87.5%) EMS

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?