clinical and corporate contract services team - overview - esteban mendoza office of research senior...

Clinical and Corporate Contract Services Team

- OVERVIEW -

Esteban MendozaOffice of ResearchSenior Clinical/Corporate Contracts Officer

UNIVERSITY OF PITTSBURGHINTERNAL 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 AdministrationUniversity 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)

-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 investigator-initiated basic research agreements as well as applicable clinical trial agreements (CTAs)

-Subawards and contracted services agreements under corporate funded contracts

-Proposals for corporate funding

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.)

Overview of Submission ProcessFinancial 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

Working together to ensure:

• In accord with University Principles

• Publication / Academic credit

• Encumbrances & Liability

• Ownership

• Address unique/non-standard situations

Why do any type of agreements?

• 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

University Principles

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

• 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

MTAs are:

• 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

So when do you need 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!

Is a DUA the same as an MTA?

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

DUA/MTA vs COLLABORATION“Is this a collaboration with recipient?”

• 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 to Success is Meeting the Different Needs of Academia & Industry

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

• 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

Direct Costs $10,000Indirect Costs $5,900TOTAL $15,900

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?

Office of Research University Club-123 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

esm34@PITT.eduhttp://www.research.pitt.edu/orgen-stafflist

Who can you contact for more information?

Questions?