DoD Kidney Cancer, Academy of Kidney Cancer Investigators – Early-Career Scholar Award

Academy of Kidney Cancer Investigators (AKCI) is a virtual career development and research mentoring platform that consists of Early-Career Scholar (ECS)/Designated Mentor pairs from different institutions, and an Academy Dean. The KCRP AKCIECSA is not a traditional career development award; the ECS is expected to conduct research, participate in monthly webinars, and annual workshops and to communicate and collaborate with other members of the Academy (other Early-Career Scholars, mentors, Dean) as well as with the kidney cancer advocacy community.

The KCRP Academy of Kidney Cancer Investigators – Early-Career Scholar Award supports a unique, interactive virtual academy providing intensive mentoring, national networking, collaborations, and a peer group for junior faculty emerging as potential leaders of kidney cancer research. The overarching goal of the AKCI is to advance kidney cancer research through development of highly productive kidney cancer researchers in a collaborative research and career development environment.

The Academy Dean, selected in FY19, serves as a resource for the ECS and mentors, assessing the progress of the ECS, and facilitating communication and collaboration among all of the Early-Career Scholars and mentors, as well as with research and advocacy communities. In addition to fostering ECS scientific development, the AKCI, through its leadership by the Academy Dean, provides professional and leadership development of the ECS to include skills and competencies needed to fund and manage a productive laboratory or research team.

This FY22 program announcement is soliciting Early-Career Scholars and Designated Mentors to join the existing Academy of Kidney Cancer Investigators. This award mechanism enables the ECS (the Scholar named as the Principal Investigator [PI] on the application) to pursue a kidney cancer project that may be basic, translational, and/or clinical research. The Designated Mentor is not required to be at the same institution as the ECS.

The KCRP encourages applications from Early-Career Scholars whose ability to commit to conducting kidney cancer research is limited by minimal resources or a lack of resources, such as a qualified Designated Mentor at their institution, access to kidney cancer research tools, opportunities for establishing collaborations, or other obstacles, which should be identified in the application.

Preliminary data to support the feasibility of the research applications and approaches are required; however, this data does not necessarily need to be derived from the kidney cancer research field.

The ECS must be in the early-career stage. This award provides the ECS with funding, networking, and collaborative opportunities, and research experience necessary to develop and sustain a successful, independent career at the forefront of kidney cancer research. This award also provides support and protected time for the ECS for 4 years of intensive research under the guidance of a Designated Mentor experienced in kidney cancer research. Although the AKCI will serve as a conduit to share knowledge and research experience among all Academy members, the ECS and Designated Mentor will be responsible for developing the career development plans of the ECS and for designing and executing the proposed research. The ECS must clearly articulate their commitment to a career as a kidney cancer researcher and to participating in and contributing to the growth of the AKCI.

The Designated Mentor must have a strong record of mentoring and training early-career investigators. With the goal to expand and enrich mentorship capacity within the Academy, a Designated Mentor must agree to also serve as a Secondary Mentor to another ECS in the Academy. The Designated Mentor will be limited to one Primary (applicant ECS/mentor pair) and one Secondary Mentorship. Applicants are not permitted to list the Dean of the Academy as a Designated Mentor. The ECS and Designated Mentor are required to attend a biennial multi-day Department of Defense (DOD) KCRP AKCI Workshop and, in alternate years, a 1-day DOD KCRP AKCI Workshop.

The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

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 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.

A congressionally mandated Metastatic Cancer Task Force was formed with the purpose of identifying ways to help accelerate clinical and translational research aimed at extending the lives of advanced state and recurrent patients. As a member of the Metastatic Cancer Task Force, CDMRP encourages applicants to review the recommendations (https://health.mil/Reference-Center/Congressional-Testimonies/2018/05/03/Metastatic-Cancer-Research) and submit research ideas to address these recommendations provided they are within the limitations of this funding opportunity and fit within the FY22 KCRP priorities.

Collaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the partners bring to the research effort, ultimately advancing cancer research that is of significance to the Warfighter, military families, and the American public. The anticipated direct costs budgeted for the entire period of performance for an FY22 KCRP AKCIECSA will not exceed $725,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards will be made no later than September 30, 2023. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $3.48M to fund approximately three Academy of Kidney Cancer Investigators – Early-Career Scholar Award applications. Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 2028.

Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Research Protections (ORP), Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. Allow up to 3 months to complete the HRPO regulatory review and approval process following submission of all required and complete documents to the HRPO. Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.

If the proposed research involves more than one institution a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation. The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.

Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies that meet the requirements for Institutional Review Board (IRB) Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available. Clinical trials are not allowed. A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Application Instructions, Appendix 1, for additional information.

Research Involving Animals: All research funded by the FY22 KCRP AKCIECSA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC ORP Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.

Guidelines for Animal Research: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of preclinical research. The standards are described in Landis, SC, et al. A call for transparent reporting to optimize the predictive value of preclinical research, Nature 2012, 490:187-191 (www.nature.com/nature/journal/v490/n7419/full/nature11556.html). While these standards are written for preclinical studies, the basic principles of randomization, blinding, sample-size estimation, and data handling derive from well-established best practices in clinical studies. Applicants should consult the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines 2.0 to ensure relevant aspects of rigorous animal research are adequately planned for and, ultimately, reported. The ARRIVE guidelines 2.0 can be found at https://arriveguidelines.org/arrive-guidelines.