DoD Neurofibromatosis Exploration-Hypothesis Development

The NFRP Exploration - Hypothesis Development Award supports the initial exploration of innovative, high-risk, high-gain, and potentially groundbreaking concepts in NF research. Studies supported by this award mechanism are expected to lay the groundwork for future avenues of scientific investigation. The proposed research project should include a well-formulated, testable hypothesis based on strong scientific rationale and study design. The presentation of preliminary and/or published data is not required.

Participants will share data following the FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles for reproducible science found in “The FAIR Guiding Principles for scientific data management and stewardship” (https://www.nature.com/articles/sdata201618). Refer to the Data and Research Resources Sharing Plan document in Attachment 8.

The proposed research project should be innovative. Innovative research may introduce a novel paradigm, challenge existing paradigms, examine existing problems from novel perspectives, or exhibit other highly creative qualities. Research that is an incremental advance upon published data is not considered innovative and is not consistent with the intent of this award mechanism. It is the responsibility of the Principal Investigator (PI) to clearly and explicitly articulate how the proposed research project is innovative in the field of NF.

Investigators must review their institutional requirements and guidelines for filing with the Institutional Review Board (IRB) for exempt or expedited status. Information can be found in the Code of Federal Regulations, Title 32, Section 219.104(d) (32 CFR 219.104[d]) for exempt status or 21 CFR 56.110 for expedited status. Studies that do not qualify for exempt or expedited status will be administratively withdrawn.

The types of awards made under the program announcement will be assistance agreements. An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. The level of involvement on the part of the Department of Defense (DOD) during project performance is the key factor in determining whether to award a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement. Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award. The award type, along with the start date, will be determined during the negotiation process.