cecile del rosario, orta research agreements officer naval medical center portsmouth
DESCRIPTION
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…TRANSCRIPT
Cecile Del Rosario, ORTAResearch Agreements Officer
Naval Medical Center Portsmouth
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA)
MEMORANDUM OF UNDERSTANDING/AGREEMENT (MOU/MOA)
EDUCATIONAL PARTNERSHIP AGREEMENT (EPA)
NON-DISCLOSURE AGREEMENTS
DATA SHARING AGREEMENTS
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…
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
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
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
FULL CRADA (Standard/Non-Standard)Collaboration between 2 or more partiesDefines topic of research Involves a Statement of Work (SOW)Funded or Not Funded by the outside party
Limited Purpose (LP) CRADA Not a collaborationTransfer of Equipment/Material or
InformationNo Statement of Work (SOW)
EITHERThe non-DoN collaborator provides funds
Non-DoN Collaborator
DoN Collaborator
OREach collaborator funds its own efforts
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
Anti-Deficiency Act prohibits 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).
Comptroller/ Budget CID - Grants Manager
Studies with subject compensationSubject’s information
Name, address and date completed visit/procedure
Study title and IRB approval date
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
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
An information sheetNames of collaborators POCsThird Party, if anyObjective of the collaborative effortBenefit to the NavyFunding
Budget page/Schedule of PaymentStatement of Work
Research Protocol – IRBNet
Article 2, Objective
Article 5, Funding
Article 6, Final Report
Article 7, Marking of Data
Appendix A, Statement of Work
Appendix D, Budget
CRADA No. 12-209 (ODURF) 12-175 (UNC and OSU)
PI Review 30 4 - UNC14 – OSU
Partner Legal Review 27 107 –UNC98 - OSU
Negotiations to Approval
99 267
*NMCP Legal Review 1 1
*Comptroller Review n/a n/a
*NMRC IP Review 45 269
Signatures 9 50
Processing Time in days
142 452
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.
ORTA prepares draft
CRADA
PI and Non-Navy
Collaborator review draft
PI and Non-Navy Collaborator completes information
sheet
ORTA prepares final
document
Lab Legal Team reviews
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 completene
ss
CRADA accepted
and entered into DON
DTTIS database
An agreement between federal agencies Sharing of resources Describes tasks for each party Funded or non-funded. If funded = ISSA
(Inter-Service Support Agreement)
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
OT-244(NMCP-NMCPHC)
OT-255 (NMCP-NHB-
MCRD)PI REVIEW 1 20
NMCP LEGAL REVIEW
14 286
no data(NMCPH Legal
Review)
317 (NHB Legal
Review)91
(MCRD LEGAL REVIEW)
BUMED REVIEW 42 45SIGNATURES 146 84PROCESSING TIME IN CALENDAR DAYS
298 417
RAO prepares
draft
Principal investigator
s review draft
RAO submits draft to MOU coordinator
Legal Review at each
command
MOU coordinator
sends to BUMED review
MOU coordinator
sends to collaborators
for review and signature
NMCP CO signs
MOU coordinator
notifies RAO of
executed agreement
CRADA1. Navy Collaborator
and a Non-Navy Collaborator
2. 15 USC 3710a and SECNAVINST 5700.17
3. Good for three to five years
MOU1. Military to military
or other federal agency
2. BUMEDINST 7050.1a
3. Good for five years
CONTRACT:1. Not a collaboration;
a binding agreement to have work done for the Navy
2. Competitive – Request for Proposal (RFP)
3. Intellectual property: Contractor can elect to retain title to subject invention
CRADA:1. Collaboration between
Navy and Civilian
2. Noncompetitive - work directly with non-federal lab to negotiate agreement
3. Intellectual Property: Title to subject invention depends on whomever the inventors are: company, government or jointly-owned
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
Non-Disclosure Agreements or Confidentiality Disclosure Agreements18 USC 1905 – Disclosure of
Confidential InformationProtects proprietary data Only CO may sign
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.
TMA/BUMED required whenSharing 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
