The DoD Offers a Lung Cancer Concept Award for High-Risk, Innovative Research

Presentation of preliminary data is not consistent with the intent of the Concept Award mechanism. While the inclusion of preliminary data is not prohibited, the strength of the application should not rely on preliminary data.

The anticipated direct costs budgeted for the entire period of performance for an FY17 LCRP Concept Award will not exceed $100,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Military Relevance: The LCRP seeks to support research that is relevant to the healthcare needs of military Service members, Veterans, and their families. Military relevance will be considered in determining relevance to the mission of the DHP and FY17 LCRP during programmatic review. Investigators are strongly encouraged to consider the following characteristics as examples of how a project may demonstrate military relevance:

• Use of military or Veteran populations, biospecimens, data/databases, or programs in the proposed research.

• Collaboration with Department of Defense (DoD) or VA investigators.

• Involvement of military consultants (Army, Air Force) or specialty leaders (Navy, Marine Corps) to the Surgeons General in a relevant specialty area.

• Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to address a military need that also benefits the civilian population.

• Explanation of how the project addresses an aspect of lung cancer that has direct relevance to military Service members, Veterans, or other military health system beneficiaries, including environmental exposures other than tobacco.

Use of Active Duty Military and VA Populations: If the proposed research plan involves access to active duty military and/or VA patient populations or resources, the PI is responsible for establishing and demonstrating such access. If possible, access to target active duty military DoD FY17 Lung Cancer Concept Award and/or VA patient populations/resources should be confirmed at the time of application submission by inclusion of a letter of support, signed by the lowest ranking person with approval authority, for studies involving active duty military Service members, Veterans, military and/or VA-controlled study materials, and military and/or VA databases. If access cannot be confirmed at the time of application submission, the Government reserves the right to withhold or revoke funding until the applicant has demonstrated support for and access to the relevant population(s) and/or resources. Note that access to a Veteran population for clinical studies may only be obtained by either collaboration with a VA investigator where the VA investigator has a substantial role in the research or by advertising to the general public.

Because the Concept Award is designed for preliminary investigations, projects involving human subjects or specimens must be either exempt under Title 32, Code of Federal Regulations (CFR), Part 219, Section 101(b) (32 CFR 219.101[b]) or eligible for expedited review (32 CFR 219.110 or 21 CFR 56.110). Clinical trials are not allowed under this Program Announcement. Studies that do not qualify for either exempt or expedited review status will be administratively withdrawn. For additional information on clinical research, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Investigators wishing to apply for funding to support a clinical trial should consider submitting an application to the FY17 LCRP Translational Research Partnership Award mechanism (Funding Opportunity Number: W81XWH-17-LCRP-TRPA).