© 2007 trustees of the university of pennsylvania how to navigate research resources at penn...
TRANSCRIPT
© 2007 Trustees of the University of Pennsylvania
How to Navigate Research Resources at Penn
Symposium for Early Investigators
Friday, December 11, 2009
© 2007 Trustees of the University of Pennsylvania
Panelists:
• Emma Meagher, MD, Associate Professor of Medicine
• Kurt Barnhart, MD, Associate Professor of Medicine
• Ian Blair, PhD A. N. Richards Professor of Pharmacology, Scientific Director Proteomics and Systems Biology Facility
• Jim Eberwine, PhD, Elmer Holmes Bobst Professor of Pharmacology
© 2007 Trustees of the University of Pennsylvania
© 2007 Trustees of the University of Pennsylvania
Provost
Vice Provost for ResearchSteven J. [email protected]
Center for Technology
TransferMike Cleare
Environmental Health & Radiation
SafetyMatt Finucane
Office of Regulatory
Affairs
Office of Research Services
University Laboratory Animal
ResourcesDiane Gaertner
Research Compliance
Joanne [email protected]
PA Small Business Development
CenterChristian Conroy
IndustryRelations
Vice President for Finance & Treasury
Vice President for Development &
Alumni Relations
Intellectual Property,
Protection & Management
Network-wide Center
Management
Environmental Management
Assistant Program
IACUCTroy Hallman
IRBYvonne Higgins
Clinical & Diagnostic
Services
Facilities & Husbandry
Procurement
Training
Industrial Programs,
Biosafety & Environmental
Programs
Radiation Safety
Training
Corporate Contracts
MTAs
PennERA
Pre-AwardPost-Award
Research Operations &
Cash Management
Research Conflict of
Interest
Responsible Conduct of Research
Research Misconduct
Profiler
CorporateDon Bone
Foundation
November 2009
UNIVERSITY OF PENNSYLVANIAOFFICE OF THE VICE PROVOST FOR RESEARCH
© 2007 Trustees of the University of Pennsylvania
Collaborations
Basic Research
Clinical Research
Research Plan
Research Plan
IACUC
SampleAnalysis
in mice
in humans
Biomedical Lab
Animal Facilities
External Scientific Adviser and Industry
Biochemistry Core LabResearch Nurse Core
Biostatistics Core
InstitutionalReview Board
CTRC Advisory Council
ITMAT Clinical Trials Unit
Food and Drug Administration (IND)
Bioinformatics CoreCRCU Data Management
Center for Clinical Epidemiology and Biostatistics
Investigational Drug Service
Post-Doctoral Researcher
Collaborators# involved: 60# close contact: 9/60 # ‘day-to-day’ contact: 6/60
Kinetics Modeling and Simulation
Clinical Translational Research Center
Bionutritional Research Core
Physician-Scientist
Administration / Office of Human Research
LC-MS/MS Core
Development of unbiased
markers
© 2007 Trustees of the University of Pennsylvania
Central resourceCentral resource
• http://www.med.upenn.edu/research/faculty/index.shtml
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
How do I get students/post-docs onto training grants?
• Find out what training grants exist in your Dept, Grad Group or area of expertise
• You must nominate your student for the training grant
• Training grants have requirements that must be met
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
What research cores are available to me and how do I access them?
• Abramson Cancer Center Proteomics Core: http://www.penncancer.org/shared_resources.cfm
• Center for Cancer Pharmacology Proteomics Core Facility: http://www.med.upenn.edu/ccp/proteomonics/index.shtml
• Center of Excellence in Environmental Toxicology: http://www.med.upenn.edu/ceet/research.shtml#facility_cores
• Institute for Translational Medicine and Therapeutics: http://www.itmat.upenn.edu/cores.shtml
• Penn Genome Frontiers Institute (PGFI): http://www.genomics.upenn.edu/facilities/core-facilities
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
What statistical support is available to me?
• The Biostatistics and Epidemiology Consulting Center (BECC) provides study design and biostatistical consultation and advice to researchers within the health system on matters related to proposal development.
• http://www.cceb.upenn.edu/services/studydesign.php– Biostatistics Analysis Center (BAC)• Short-term consultations (first visit free)• Newly funded federal, foundation and industry-funded projects • Pilot analysis (with limited funding available for select projects)
(<20 hrs)– Biostatistics Epidemiology Center (BECC)
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
What statistical support is available to me?
• http://www.itmat.upenn.edu/ctrc– Study Design and Biostatistics (SDAB)
ITMAT member CTSA supported investigators planning and analytic services, which include study design, sample size estimation, analysis planning, as well as production of statistical reports and graphical displays.
Adult: Andy Cucchiara, PhD: Email: [email protected] Pediatric: Justine Shults, PhD: Email: [email protected]
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
What are some of the internal PENN funding opportunities?
• http://www.med.upenn.edu/research/faculty/grantscontracts.shtml
• Internal Funding for Faculty – OVP Limited Applications – Funding Opportunities - Faculty – McCabe – Pilot and Seed Grants (27 seed program)– SOM Bridge Funding Program – Penn's Global Initiatives Fund – Provost Interdisciplinary Seminar Fund
© 2007 Trustees of the University of Pennsylvania
How do you deal with Conflict of Interest issues related to your work and grant submission?
• Process
• CISC
• Extramural Effort reporting– Honor code
• Deliberative process
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
How do I get a contract approved?
• A contract can be from NIH, a foundation, a public company or a private company
• Contract should be discussed with Dept. Chairman and then ORS. ORS will help negotiate the contract
• All regulatory and COI issues must be appropriately addressed
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
How do I write a budget?
• Key resources important to budget development– A well written protocol
(i.e. not just the science, but also include detailed operational elements)
– Standardized rates for tests/procedures– Your Clinical Research Coordinator– Your departmental Business Administrator– Carefully organized budget spreadsheets
• Additional support– Budget development workshops– Departmental standards– Sign off: Department, ORSS (SOM), OHR (PRA), ORS (Univ)
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
How do I write a budget?
Well-written protocol
Penn Manual for Clinical Research- https://somapps.med.upenn.edu/pennmanual
Protocol Templates (Forms/Templates Library)- Tabbed section of Penn Manual
Standardized rates for tests/procedures
CostFinder- www.med.upenn.edu/apps/my/costfinder
Clinical Research Coordinators (CRC)
Departmental CRCs- CRCs are familiar with the “inner workings” of research
operations, and therefore extremely helpful in budget development
- If you don’t have a CRC for your study, Departmental CRCs are often still able to help you in aspects of budget
development
Business Administrators (BA)
Departmental BAs- Develop a good working relationship with your BA. They
are responsible for finalizing & submitting budgetsOffice of Research Support Services
- www.med.upenn.edu/orss- ORSS has expertise in all aspects of NIH budget
requirements
© 2007 Trustees of the University of Pennsylvania
Clinical and Translational Research CenterClinical and Translational Research Center
• Clinical Space to conduct in pt and out pt studies:
• Research Nursing and support
• Investigational Drug Service
• Biostatistical support prior to submission and upon completion of studies
• Translational Research Laboratory: Centralized facilities for measurements of biomarkers and physiological assessments
• Junior Investigator Pilot Grant (JIPG) Program
• http://www.itmat.upenn.edu/ctrc/index.shtml
© 2007 Trustees of the University of Pennsylvania
Clinical and Translational Research CenterClinical and Translational Research Center
• Clinical research space
• HUP: 1 Dulles inpatient and outpatient
• PMC: Mutch—currently 4th floor outpatient unit
• CHOP: inpatient in Main Bldg, outpatient on Market St
© 2007 Trustees of the University of Pennsylvania
Submission of Protocols to Penn CTRC
• Prepare clinical protocol using OHR or IRB template with adequate justification and detail
• Contact Statistician, Nurse Manager and Administrative Manager prior to submission
• Submit electronically to IRB for IRB-CTRC review
• Protocols reviewed once per month by review committee
• Deadline for submission last business day of every month for review by IRB#3 on the second Thursday of every month
© 2007 Trustees of the University of Pennsylvania
Important CTRC Contacts
• Ronnie Mazzaccaro, MBA Pediatric: BA [email protected]
• Linda McCrae, BA Adult [email protected]
• Michael McNicholas: Adult Nurse Manager
• Audrey L Kamrin Pediatric Nurse Manager [email protected]
© 2007 Trustees of the University of Pennsylvania
How do I navigate the IRB?
• http://www.upenn.edu/regulatoryaffairs
• On line application process
• Types of review
• Process
• Key Personal– [email protected]– [email protected]– [email protected]
© 2007 Trustees of the University of Pennsylvania© 2007 Trustees of the University of Pennsylvania
How do I apply for an IND/IDE?
Office of Human Research• A SOM & ITMAT office providing an array offerings to support clinical research
www.med.upenn.edu/[email protected]
• OHR IND/IDE regulatory support services– IND/IDE consultations– IND exemption determinations– FDA interface facilitation– IND application development & submission support – Regulatory Master File organization– Monitoring plan development– Training of study monitors (and assistance with subcontracting monitors)– Data Safety & Monitory Board organization & set-up– Sponsor SOP maintenance and training (SOP link: www.med.upenn.edu/ohr/secure/sop)
• More Information, Tools, & Templates– Penn Manual for Clinical Research: text search “IND” or “IDE”– Forms & Templates Library: text search “IND” or “IDE”
© 2007 Trustees of the University of Pennsylvania
Is there help available for grant submission?
• No formalized structure for early career development awards
• Business manager in division will help in guidelines
• Central office of Grants management will help direct specific question– Marianne Achenbach
© 2007 Trustees of the University of Pennsylvania
Closing remarks
• The most useful website to which you direct your initial questions
• http://www.med.upenn.edu/research/faculty/index.shtml