Transcript Document

Clinical and Corporate
Contract Services Team
- OVERVIEW Esteban Mendoza
Office of Research
Senior Clinical/Corporate Contracts Officer
UNIVERSITY OF PITTSBURGH
INTERNAL USE ONLY
Clinical & Corporate Contract Services Team
WHAT WILL BE COVERED
• Organization Overview
• MyRA - New Intake Process for Non-Financials
• The Basic – CDAs, MTAs / DUAs, Collaborations
• Key Consideration in Contracts
• Tips & Resources / websites
Overview of Research Administration
University of Pittsburgh - Office of Research (OR) Processing Teams
Clinical and Corporate Contract Services Team
Federal Contract
Services Team
Grants Management
Services Team
NON-FINANCIAL
-Research Confidential Disclosure Agreement/Non-disclosure
Agreement (CDA/NDA)
Proposals & Awards
for Federal Contracts
(mainly from RFP and
RFQ submissions)
Grant Proposals &
Awards from federal
sponsors/agencies
(i.e. NIH, NSF, DOE,
DOD, etc.)
-Material Transfer Agreement (MTA): incoming & outgoing
(includes equipment loan agreements, CRADAs, drug supply
agreements)
-Data Use Agreement (DUA)
-Non-Financial Collaboration Agreements
FINANCIAL
-Corporate research agreements (CRAs)- includes investigatorinitiated basic research agreements as well as applicable clinical
trial agreements (CTAs)
-Subawards and contracted services agreements under
corporate funded contracts
-Proposals for corporate funding
Overview of Submission Process
Financial Contracts require submission forms see “Clinical Corporate/Forms”:
http://www.research.pitt.edu/office-research-forms-0
Non-Financial Contracts (MTA/DUA/CDA)
electronically submitted through MyRA:
http://www.research.pitt.edu/myra
TIP: Tutorials on YouTube!:
https://www.youtube.com/channel/UCxKR3YXwBhlgC3KDoeJ-Kaw
Why do any type of agreements?
Working together to ensure:
• In accord with University Principles
• Publication / Academic credit
• Encumbrances & Liability
• Ownership
• Address unique/non-standard situations
University Principles
• Dissemination of results
• Access to research materials
• Consideration of needs of students
• Compliance with funding obligations
• Compliance with laws and regulations
– HIPAA, FDA, NIH, Bayh Dole, OHRP, IRS, PA Laws
Confidentiality / Non-Disclosure Agreements (CDA/NDA)
• Non-financial agreements for Pitt to receive information, disclose
information, or both
• TIP: Usually prior to collaboration discussions and before PI
– discloses unpublished/non-public data, research plans, etc.
– receives confidential information from others
• OTM involvement if it involves an invention disclosure
• Typically, not for exchanging research tools
• CC team handles all CDAs & NIH Certificates of Confidentiality
except for:
– A CDA in connection with a Federal contract (FedCon)
– A CDA that should be handled by UPMC in connection with an
industry-designed clinical trial (OSPARS)
MATERIAL TRANSFER AGREEMENTS,
DATA USE AGREEMENTS,
&
COLLABORATIONS
Research Scenarios
• UPitt PI is providing, receiving, or providing &
receiving clinical data to another entity
• UPitt PI is providing, receiving, or providing &
receiving research tools or primary tissue
samples to another entity
• UPitt PI is exchanging both materials/tools &
clinical data
MTAs are:
• Contracts to acquire research tools from
– Non-profit entities like other universities or repositories
– The government, like the NIH
– The for-profit sector, like a pharmaceutical company
• Research materials/tools: transgenic animals, cell lines,
human biological specimens, compounds/drugs,
research tools, etc.
– TIP: Until summer enhancement to MyRA, for
dual transfer on MyRA fill out one record for
“sending” and one for “receiving” and put a note
they are related to the same project
So when do you need an MTA?
• Sending materials to an investigator working at another
university, the government or a company.
• Receiving materials from an investigator working at
another University, the government or a company.
• Sometimes in a procurement situation.
• Sometimes under a collaboration.
• Only if no other contract exists to address the transfer!
– NOT Needed: Exchanging data/materials with clinical trial sponsor
 instead amend the clinical trial agreement
– Needed: Using materials from a third party (i.e. a company) in an NIH
funded project
Is a DUA the same as an MTA?
• No, DUAs are for exchanging certain protected
clinical data & information (i.e. Limited Data Set)
being shared for research purposes
– Required by HIPAA absent informed consent/HIPAA
authorization
– Only if not already addressed by another agreement (i.e.
clinical trial agreement)
• MTAs are for tangible materials. Any Pitt materials
being sent outside of Pitt need an MTA or other
appropriate form of contract
• TIP – may have a combined MTA/DUA if needed!
DUA/MTA vs COLLABORATION
“Is this a collaboration with recipient?”
DUA/MTA
Collaboration
Slogan
“Use Our Materials/Data”
“Let’s Work Together”
Overview
Sharing of our research materials
/data with the recipient for
recipient’s research project
Involvement by both parties, often
in complementary ways
Pitt’s contribution:
Hands-on research, data analysis,
experimental design
Form of contract
Often streamlined w/ other
universities (i.e. UBMTA / NIH SLA)
More detailed
Publication
Generally only recipient would
publish results
Both parties can publish, often
initial publication of results will be
a joint publication
Share back of research results to
Pitt investigator
Can be included, if desired by Pitt
investigator
Standard for collaborations
Bi-directional transfer of materials
No
Sometimes, depending upon the
project
Key to Success is Meeting the Different
Needs of Academia & Industry
• Cultural differences: open vs closed
• Business differences: educational vs commercial
• Regulatory differences: university vs pharma
• SOLUTIONS
 OPEN DIALOGUE to understand sponsor’s specific needs under the project
 allow for review of manuscripts prior to publication to redact confidential
information & protect potential discoveries
 grant the right to negotiate exclusive licenses to patentable discoveries
from the sponsored research
Key Topics in Recent Agreements
 No Publication Blocks (i.e. “control”/“prior approval”)
 Trade Secrets – high risk, perpetual obligations
 Excessive control or “reach through”
 “Assignment” to all “arising from”
 Giving away “know-how” can prevent investigators from engaging in their
own research in future projects
 Export Control info/materials excludes investigators students from
certain countries from participating in our research; potential fines &
incarceration for any breach of such laws!
 Indemnification
 We gladly share results and data but recipients must be responsible for
their own use.
 PITT can’t be responsible for actions of unrelated third parties
Additional Tips – Budgets and F&A
• Internal Budget vs. Corporate Contract Budget
– In general, industry sponsors only need total or total breakdown
Direct Costs
Indirect Costs
TOTAL
$10,000
$5,900
$15,900
• Contact us if unsure of correct F&A (i.e. research vs. clinical)
– MTCD vs. TDC (clinical)
http://www.research.pitt.edu/dataforproposalpreparation#facilityandadministrativecosts
• If sponsor refuses to pay for full F&A
– Written proof of sponsor’s policy limiting F&A rate, or
– PI can apply for waiver
Additional Tips – Scope of Work
• Scopes of Work
– Scientific description of experiments & materials
– NO contract terms (i.e. cost, ownership, budget)
– May contain estimated timelines for individual
steps
Additional Tips - Amendments
• Amendment vs. New Agreement
– Different PI?
– Different area of research?
– New materials/tools?
– Altering nature of project i.e. in vitro ↔ human?
Who can you contact for more
information?
Office of Research
University Club123 University Place, Lower Lobby
http://www.research.pitt.edu/
Phone 412-624-7419 (Clinical/Corporate)
Phone 412-624-7400 (General)
Fax
412-624-7414
Esteban Mendoza
Phone 412-624-7402
[email protected]
http://www.research.pitt.edu/orgen-stafflist
Questions?