irving institute for clinical and translational research
DESCRIPTION
Irving Institute for Clinical and Translational Research. Home for Columbia’s Clinical and Translational Science Award. Our Structure: A Comprehensive, Broad Based GCRC. Adult Inpatient Adult Outpatient Pediatric Inpatient Pediatric Outpatient SLRHC: Inpatient and Outpatient. - PowerPoint PPT PresentationTRANSCRIPT
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
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 ParticipationCurrent Investigators
3/13 (23.1%) MDs
1/22 (4.5%) nurses
0/8 (0%) EMS
0
20
40
60
80
100
Physicians Nurses EMS
NoYesNot 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
NoYesNot 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?