Eligible Applicants: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

Agency Name: Jennifer Shankle Grantor

Description:

The Academy of Kidney Cancer Investigators (AKCI) is a virtual research capacity building and research mentoring platform that consists of Early-Career Scholar (ECS)/Designated Mentor pairs from different institutions and an Academy Leadership Team. 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 communicate and collaborate with other members of the Academy (other Early-Career Scholars, mentors, Academy Leadership Team) 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 Leadership Team, consisting of Academy Director and Deputy Director, 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 Designated Mentors, as well as with research and advocacy communities. In addition to fostering ECS scientific development, the AKCI, through its leadership by the Academy Leadership Team, 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 FY24 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.

Organizational-Level Emphasis: The following areas of emphasis are broadly applicable to many CDMRP programs, not just the KCRP. Investigators are encouraged to consider addressing these areas in their applications if doing so is appropriate for their line of research, addresses the FY24 KCRP Overarching Strategic Goals and Focus Areas described in Sections II.A.1 and II.A.2, and meets the intent of the AKCIECSA.

Nuclear Medicine: Innovative research involving nuclear medicine and related techniques to support early diagnosis, more effective treatment, and improved health outcomes of active-duty Service Members and their Families is encouraged. Such research could improve diagnostic and targeted treatment capabilities through noninvasive techniques and may drive the development of precision imaging and advanced targeted therapies.

Women’s Health: The CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.

Metastatic Cancer Task Force: 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, the 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 FY24 KCRP priorities.

Rigorous Study Design: All projects should adhere to a core set of standards for rigorous study design and reporting to maximize the reproducibility and translational potential of clinical and preclinical research. The standards are described in SC Landis et al., 2012, A call for transparent reporting to optimize the predictive value of preclinical research, Nature 490:187-191 (https://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.

Military Service Involvement: Applications from investigators within the military services and applications involving multidisciplinary collaborations among academia, industry, the military services, the U.S. Department of Veterans Affairs (VA), and other federal government agencies are highly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique clinical populations that the collaborators bring to the research effort, ultimately advancing research that is of significance to Service Members, Veterans, and/or the American public. If the proposed research relies on access to unique 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.

Research involving human subjects and human anatomical substances is permitted; however, clinical trials are not allowed under this funding opportunity.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Studies that do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.

For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies.

(2) Epidemiologic and behavioral studies that do not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention.

(3) Outcomes research and health services research that do not fit under the definition of clinical trial.

Excluded from the definition of clinical research are in vitro studies that utilize human data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

The funding instrument for awards made under the program announcement will be grants (31 USC 6304).

The anticipated direct costs budgeted for the entire period of performance for an FY24 KCRP AKCIECSA should not exceed $725,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.

Awards supported with FY24 funds will be made no later than September 30, 2025.

The CDMRP expects to allot approximately $2.32M to fund approximately two 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, the number of applications received, the quality and merit of the applications as evaluated by peer 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 FY24 funding opportunity will be funded with FY24 funds, which will expire for use on September 30, 2030.

Grantor Contact Information: CDMRP Help Desk Phone: 301-682-5507 Email: help@eBRAP.org