How and When to Use a CRADA
Important Basic CRADA Information
- What Is A CRADA?
- The Purpose of CRADAs
- When To Use A CRADA
- When To Use A Materials CRADA
- Finding A CRADA Partner
- Negotiating A CRADA
- The Model PHS CRADA
- Clinical Trial CRADAs
- Other Investigator Information
- Signing Off: Getting CRADA Approval
- CRADA Signatures
- CRADA Term Length
- "Jump-starting" A CRADA: Letters of Intent
What Is A CRADA?
CRADAs are formal research and development agreements of limited duration and scope between PHS investigators and their colleagues from industry, academia, and elsewhere (for example, from other Federal agencies, State and local governments, and non-profit and not-for-profit institutions.)
In order to meet the standards of a CRADA, there must be an intellectual contribution from all parties to the agreement. This contribution can take the form of sole-source materials or instrumentation, as well as so-called "know-how," itself. CRADAs are a primary mechanism by which Government scientists can leverage their own research resources. In turn, their partners may do likewise, while collaborating in state-of-the-art PHS research.
The Purpose of CRADAs
The purpose of a CRADA is to make available Government facilities, intellectual property, and expertise for collaborative interactions that lead to useful, marketable products that benefit public health. Under a fully executed CRADA, the NIMH investigator's laboratory can receive a variety of benefits in addition to intellectual collaboration. Specifically, the collaborator may provide monies, materials, equipment, and personnel to the investigator's laboratory. In turn, the investigator's laboratory may provide materials and personnel to the collaboration, but cannot provide funding to the collaborator. The largest benefit to the collaborator is that it may obtain a first option for licensing of patents which result from the CRADA.
When To Use A CRADA
Because CRADAs involve patent rights, these rights must properly be considered before any outside collaborations and/or exchange of materials between NIMH and other parties are undertaken.
To protect these rights, the NIMH Technology Transfer Office should also be consulted at an early stage of collaboration by the NIMH investigator to assist in identifying and developing the proper documents and obtaining the required approvals for research to proceed.
A CRADA is used when the following circumstances obtain:
- A cooperative research and development project between a Government scientist and a scientist from the private sector is contemplated.
- The exchange of material and/or research and development collaboration takes place over a substantial period of time.
- Staff or equipment is to be supplied by one or more parties; or,
- Non-Federal partner contributes funding or requests the granting of intellectual property rights.
When To Use A Materials CRADA
A CRADA may also be necessary in instances where, for example, a company is providing an otherwise non-available material and requests an option to exclusively license intellectual property arising from the research. The PHS Model Materials CRADA, available elsewhere on this web site, specifically addresses this issue. A Materials CRADA is limited in its term and scope and does not permit the provision of personnel to carry out the subject research project in the Federal laboratory.
Finding A CRADA Partner
To begin a CRADA, a potential partner may first contact a NIMH scientist with whom it would like to collaborate. Alternatively, a Government scientist may choose a CRADA collaborator. In this instance, a competitive process is generally not required, except under limited circumstances pursuant to PHS "fair access" guidelines. NIMH may, however, choose to compete a CRADA when interested parties are unknown or the technology/project is such that competition is in the Government's and public's best interests. An announcement may be placed in the Federal Register or Commerce Business Daily with a selection made known to the responding parties. If appropriate, the Institute may establish an ad hoc evaluation committee to review submissions.
Negotiating A CRADA
A full CRADA requires two types of negotiations, the Research Plan and the "boilerplate." The Research Plan is a detailed description of the research to be performed. The reagents to be used, the methods to be used, the problem to be solved, and the relative contributions of the parties need to be set forth in great detail. The Principal Investigators on both sides of the CRADA work together to sculpt a proper Research Plan. The NIMH Technology Transfer Office assists them, by providing guidance with regard to the format required for NIH review of the CRADA. As appropriate, the "boilerplate" may be modified by the parties, subject to conformance to applicable law and policy. As soon as both participating scientists negotiate the Research Plan (namely, the written description of the research and development project, including each party's contribution to the planned research and development), a written CRADA should be developed. NIH has a model CRADA, available elsewhere on this web site, which is required and used as the basis for all negotiations with outside parties.
The Model PHS CRADA
The model CRADA contains three appendices:
- Appendix A: The Research Plan
- Appendix B: Financial and Staffing Contributions, and
- Appendix C: Modification to Agreement Provisions.
Additional appendices addressing reporting requirements or issues specific to the research project may also be included.
Clinical Trial CRADAs
CRADAs are appropriate for both basic research projects and for projects involving clinical trials. The same PHS model CRADA agreement is used for both types of research; however, a Clinical Trial CRADA (CTC) has additional terms added to Appendix C which address such issues as INDs, protection of human subjects, adverse reactions, etc. (Click here to view the Appendix C modifications for Intramural or Extramural Clinical Trial CRADAs.)
Other Investigator Information
NIMH Principal Investigators (PIs) pursuing CRADAs are required by law to fill out and attach a Conflict of Interest and Fair Access Survey form. The purpose of this form is to assure that any PI collaborating with a company in a CRADA situation does not have a financial interest in the company, thus raising a conflict of interest. The NIMH Technology Transfer Office is available to help scientists draft an acceptable CRADA and related Appendices and to proffer advice in the development of the overall agreement. The Office will also negotiate the CRADA and Appendices in conjunction with the appropriate company representative.
Signing Off: Getting CRADA Approval
In addition to the originating scientist, the negotiated CRADA must be approved by his or her Laboratory or Branch Chief, the NIMH Technology Advisory Committee (TAC), and the Scientific Director for the intramural research program. It is then reviewed by both the NIH OTT and Office of General (OGC) before being forwarded to the NIH CRADA Subcommittee. After addressing any changes recommended by the CRADA Subcommittee, it is then returned to the OTT and OGC as a prelude to final approval recommendation to the Deputy Director for Intramural Research, NIH. Each of these parties must sign off on an internal CRADA Clearance Form.
By law, a 30-day period exists in which to disapprove or modify a CRADA after its finalization by NIMH. When no changes are required, the CRADA is signed and returned to the NIMH Technology Transfer Office to obtain the proper signatures required for execution, namely signatures by the NIMH Director and by the collaborator. The date of the last signature may be specified as the execution date for the CRADA.
CRADA Term Length
CRADA agreements have no mandatory term length, but are often designated for a one- to four-year term. If there is no substantial change in the Research Plan and a CRADA has been in existence for less than 4 years, it can be extended for a minimal period of time by the parties' mutual agreement. Because scientific objectives and circumstances change over time, however, any substantial changes to the Research Plan must be reviewed by the NIH CRADA Subcommittee or its chairman, as appropriate. Accordingly, while a fully signed CRADA may be amended as research progresses, all amendments must be made through the NIMH Technology Transfer Office. Informal amendments made between the investigators cannot be assumed to be valid.
"Jump-starting" A CRADA: Letters of Intent
n order to expedite the commencement of the Research Plan, prior to final execution of the CRADA, the NIMH Technology Transfer Office can assist you in executing an interim Letter of Intent (LOI) with a CRADA partner.