Transcript Office of Research Affairs

Contracts
Penn State Research
Penn State Hershey Research
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Dan Notterman, MD
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Vice Dean for Research
Sheila Vrana, PhD
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Associate Dean for Research
Contracts Team
Barb Suchanec
x4196
Lou Porter
Robinn Moyer
Paul Primrose
Stacey Cleary
Who’s my person?
Department
Person
ANYTHING basic science
Lou
Anesthesiology
Biochemistry & Molecular
Biology
Cellular & Molecular
Physiology
Commonwealth of
Pennsylvania
Stacey
Department
Person
Department
Person
Medicine – Endocrinology
Stacey
Neurology
Stacey
Medicine - Infectious Disease
Stacey
Neurosurgery
Stacey
Obstetrics & Gynecology
Stacey
Lou
Medicine - Heart & Vascular
Institute
Lou
Medicine – Gastroenterology
Stacey
Ophthalmology
Stacey
Barb
Medicine - General Internal
Stacey
Orthopedics
Stacey
Comparative Medicine
Lou
Medicine – Nephrology
Stacey
Pathology
Lou
Dean's Office
Lou
Medicine - Pediatric Oncology
Paul
Pediatrics
Paul
Dermatology
Barb
Medicine - Radiation Oncology
Paul
Pharmacology
Lou
Barb
Emergency Medicine
Stacey
Medicine – Pulmonary
Stacey
Psychiatry
Paul
Family & Community
Medicine
Stacey
Medicine – Rheumatology
Stacey
Public Health Sciences
Lou
Humanities
Lou
Microbiology & Immunology
Lou
Radiology
Medicine - Cancer Institute
Paul
Neural & Behavioral Sciences
Lou
Surgery
Stacey
Paul
Where do I start?
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CDA – Jill Wagner, Tech
Development
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Before you can see Sponsor
information, you agree to keep it
confidential
Internal Submission
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ePIAF
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Internal form for approval
Originally developed for grant
applications
Database for reporting
Declare conflicts
Into the queue
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ePIAF generates an OSP#
Email to CTO and ORA
Schedule budget feasibility meeting
Sponsor
Principal
Investigator /
Department
Government,
Industry,
Foundation,
Department
Agreement
Execution/
Office of Research
Affairs
Clinical Trials Office
HSPO/IRB
Office of Technology
Development
Clinical Research Center
Marketing &
Communications
Award
$
Other
Biosafety
Conflict of Interest
COM Controller’s Office
PFS/Finance
Public Health Sciences
Research Quality Assurance
Risk Management
The Contract
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Establish the rules before the game.
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Players
Positions
Protection
Payment
Problems
The Players
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Penn State and the Medical Center
The Investigator
The Sponsor
Maybe a CRO
What does Sponsor want?
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Test a new drug or device
Test a new use of an approved
drug/device
Control cost
Enroll fast
Own and control the data
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Publications
Intellectual Property
What do We Want?
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Help our patients
Participate in research
Publish
Use research data internally
Teach our students
Maybe generate a little margin
Set the rules
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Everyone follows the laws as they
apply to their role
Everyone protects the patient
Everyone gets to publish
Everyone agrees to share
What’s in the Contract
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Relationship of the Parties
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Clearly state that neither party is an
agent or employee
Independent contractors
Notices
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To assure that both parties trust that
communications are received
Where to send
What is acceptable
What’s in the Contract
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Term/Termination
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Effective Date and Expiration
 Sets
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period for budget/fund in IBIS
Early termination
 Breach
 Safety
 Sponsor
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said so
Change in PI
Effective of termination
What’s in the Contract
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Use of Name
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Approval of the other party
 Except
reporting
 Biosketches / grant applications
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Assignment
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Sponsor assigns to CRO
Survival Clauses
Articles in the Contract
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Order of precedence
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Governing Law
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Contract vs Protocol
Pennsylvania or silent
Payment / Invoicing Addresses
Publication
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Usually multi-center publication first
ICMJE and Clinicaltrials.gov both
require study results to be public
Allow sponsor review for confidential
info / patent
Confidentiality
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Mark things confidential
Protect confidential things
Set a term, but within rules for
publication
Intellectual Property
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If something new develops, who
owns it
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Agree to disclose new developments
Applies to PI and all study staff
Indemnity
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“the act of making another “whole”
by covering or guaranteeing any
costs are incurred contractually in a
trial
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Legal process and fees
Expenses required to care for study
subject
Indemnity
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Subject injury
Sponsor’s use of data
Product liability
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Unless…
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Negligent
Don’t follow protocol/instructions
Natural progression of disease
Subject Injury
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Sponsor reimburses charges related
to injury
Institution arranges treatment
Contract provision matches consent
form
AAHRPP
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Voluntary program
Protect the participants
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Data / Safety Monitoring Board
On-site monitoring
 Guest
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Account Access Form
Share adverse event info, during and 2
years after study
The Stars Align!
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Final contract language and budget
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CTO does final congruence
Contract Person assembles papers
PI signs first
Vinnie Falvo signs for COM
Kevin Haley signs for HMC
FULLY EXECUTED AGREEMENT!
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Statement of Award
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Establishes fixed dates for IBIS
Awards a specific dollar amount
Wildcards
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Master Agreements
Amendments
Export Control
Extension Requests
Federal Flow-through
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FDP templates
Sort of like a Master Agreement
Annual project period
Be involved!
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ROAR
RQA Lunch Lectures
IRB workshops
Tech Development Workshops
ACES
Questions?