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RESEARCH AGREEMENTS

RESEARCH AGREEMENTS. Cecile Del Rosario, ORTA Research Agreements Officer Naval Medical Center Portsmouth. Research agreements. COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) MEMORANDUM OF UNDERSTANDING/AGREEMENT (MOU/MOA) EDUCATIONAL PARTNERSHIP AGREEMENT (EPA)

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RESEARCH AGREEMENTS

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  1. RESEARCH AGREEMENTS Cecile Del Rosario, ORTA Research Agreements Officer Naval Medical Center Portsmouth

  2. Research agreements • COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) • MEMORANDUM OF UNDERSTANDING/AGREEMENT (MOU/MOA) • EDUCATIONAL PARTNERSHIP AGREEMENT (EPA) • NON-DISCLOSURE AGREEMENTS • DATA SHARING AGREEMENTS

  3. CRADA definition - 15 Usc 3710a • A Cooperative Research and Development Agreement (CRADA) means any agreement between one or more federal laboratories and one or more non-federal parties under which the Government, through its laboratories, provides personnel, services, facilities, equipment, intellectual property, or other resources with or without reimbursement (but not funds to non-federal parties) and the non-federal parties provide funds, personnel, services, facilities, equipment, intellectual property or other resources toward the conduct of specified research or development efforts which are consistent with the missions of the laboratory…

  4. Why a crada? It’s the LAW!!! • Federal Legislation (15 USC 3710 – 3716) • Describes the general authority, enumerated authority and contract considerations for CRADAs and provides themes that should be covered • DoD Directive 5535.3/DoD Instruction 5535.8 • Implements policy, assigns responsibilities and prescribes procedures for implementation of Technology Transfer (T2) program • SECNAVINT 5700.17 • Delegates CRADA authority to Navy laboratories by the Secretary of the Navy

  5. Benefits of Collaboration • Access to outside expertise, facilities, equipment, personnel and/or services • Need for high quality, timely and integrated products • Both DoN and collaborator can leverage scarce funds, personnel and facilities • Solve technical and industrial problems that support the Warrior • Sustain a critical technology capability that would otherwise be lost or continue to erode

  6. Some technology transfer examples • Lasers • GPS • Light Sticks (developed by Naval Air Warfare Center Weapons Division (NAWCWD) China Lake • Enhanced digital image technology used to detect mines underwater, also used for early detection of breast cancer cells (developed by Naval Undersea Warfare Center (NUWC), Newport Division

  7. Types of CRADAs • FULL CRADA (Standard/Non-Standard) • Collaboration between 2 or more parties • Defines topic of research • Involves a Statement of Work (SOW) • Funded or Not Funded by the outside party • Limited Purpose (LP) CRADA • Not a collaboration • Transfer of Equipment/Material or Information • No Statement of Work (SOW)

  8. Possible CRADA Collaborators

  9. Funding Rules EITHER The non-DoN collaborator provides funds Non-DoN Collaborator DoN Collaborator OR Each collaborator funds its own efforts

  10. What may be funded? • Labor • Research personnel, e.g., nurse, assistant/coordinator • Travel • training • Materials • Supplies • Subject Remuneration • Per patient cost/visit • Start-up fee • CRADA fee - $1.5K • IRB fee - $2K

  11. Funding Rules • Anti-Deficiency Actprohibits federal employees from • making or authorizing an expenditure from, or creating or authorizing an obligation under, any appropriation or fund in excess of the amount available in the appropriation or fund unless authorized by law. 31 U.S.C. § 1341(a)(1)(A) • involving the government in any obligation to pay money before funds have been appropriated for that purpose, unless otherwise allowed by law. 31 U.S.C. § 1341(a)(1)(B).

  12. How are crada funds managed? • Comptroller/ Budget • CID - Grants Manager • Studies with subject compensation • Subject’s information • Name, address and date completed visit/procedure • Study title and IRB approval date

  13. CRADA Rules – Foreign Partners • Foreign partners: Okay if allowed by their country • Seek permission from the Office of U.S. Trade Representative prior to start of negotiations • Some controlled materials or information may require an export control license

  14. How ip rights are allocated under a crada? • Each collaborator owns background/pre-existing IP that it brings to the CRADA • IP developed under the CRADA is shared by both collaborators • Each collaborator granted non-exclusive license in shared data • Option available to receive an exclusive license for inventions made under a CRADA

  15. What do you need to start a CRADA? • An information sheet • Names of collaborators • POCs • Third Party, if any • Objective of the collaborative effort • Benefit to the Navy • Funding • Budget page/Schedule of Payment • Statement of Work • Research Protocol – IRBNet

  16. Important to know (CRADAs) • Article 2, Objective • Article 5, Funding • Article 6, Final Report • Article 7, Marking of Data • Appendix A, Statement of Work • Appendix D, Budget

  17. CRADAs take time Negotiations start immediately after partner’s legal review and ends upon all parties reaching an agreement. Processing time starts from receipt of information sheet to final signature. Some steps are not reflected in table, e.g., time it takes to develop a draft, and therefore Processing Time in days is not the sum of the numbers in the table.

  18. Why so much time? PI and Non-Navy Collaborator completes information sheet ORTA prepares draft CRADA PI and Non-Navy Collaborator review draft ORTA prepares final document Lab Legal Team reviews CRADA accepted and entered into DON DTTIS database ORTA sends CRADA to Non-Navy Collaborator for review and signature Lab CO signs the CRADA ORTA forwards signed CRADA to DON T2 PM DON T2 PM reviews CRADA package for completeness

  19. Memorandum of Understanding/agreement • An agreement between federal agencies • Sharing of resources • Describes tasks for each party • Funded or non-funded. If funded = ISSA (Inter-Service Support Agreement)

  20. MEMORANDUM OF UNDERSTANDING/AGREEMENT (MOU/MOA) • BUMEDINST 7050.1B • Promotes sharing of health care and other resources and define management responsibilities and procedures for administering support agreements • Program under Director of Resource Management

  21. MOUs take time

  22. MOU Process RAO prepares draft Principal investigators review draft RAO submits draft to MOU coordinator Legal Review at each command MOU coordinator sends to collaborators for review and signature MOU coordinator notifies RAO of executed agreement MOU coordinator sends to BUMED review NMCP CO signs

  23. CRADA vs. MOU CRADA • Navy Collaborator and a Non-Navy Collaborator • 15 USC 3710a and SECNAVINST 5700.17 • Good for three to five years MOU • Military to military or other federal agency • BUMEDINST 7050.1a • Good for five years

  24. A CRADA is not a Contract CONTRACT: • Not a collaboration; a binding agreement to have work done for the Navy • Competitive – Request for Proposal (RFP) • Intellectual property: Contractor can elect to retain title to subject invention CRADA: • Collaboration between Navy and Civilian • Noncompetitive - work directly with non-federal lab to negotiate agreement • Intellectual Property: Title to subject invention depends on whomever the inventors are: company, government or jointly-owned

  25. Educational partnership agreement (EPA) • 10 USC 2194 (b)(5) • Lab equipment loans • Transfer of surplus property • Lab personnel available to teach science course • Involving faculty and students of the institution in defense lab research projects • Cooperating with the institution in developing a program under which students may be given academic credit for work on defense lab research projects • Providing academic and career advice and assistance to students of the institutions • Duty Under Instructions (DUINS) students

  26. Non-Disclosure Agreements • Non-Disclosure Agreements or Confidentiality Disclosure Agreements • 18 USC 1905 – Disclosure of Confidential Information • Protects proprietary data • Only CO may sign

  27. Data sharing agreement (DSA) • DSA is a legally binding agreement between a Federal agency and an external entity (e.g., contractor, private industry, academic institution, other Federal government agency, or state agency) that clearly documents what data are being shared and how the data can be used. DSAs ensure uses and disclosures of MHS data meet the requirements for both Federal laws and Department of Defense (DoD) regulations.

  28. DATA SHARING AGREEMENT (CON’T) • TMA/BUMED required when • Sharing PHI/PII • Using the MHS system data • Usually requested by the Business Associate (BA) • TMA POC – Ms. Barbara Hazzard • Director, TMA Privacy Office is the final approval authority • DSAA approval occurs after CRADA and IRB approval

  29. Research agreements Plan ahead. They take a lot of time. QUESTIONS??? Cecile.delrosario@med.navy.mil 757-953-5939

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