The Academy of Kidney Cancer Investigators (AKCI) is a unique, interactive virtual academy that provides, intensive mentoring, national networking, and a peer group for scientist and clinician junior faculty.

The KCRP created the Academy of Kidney Cancer Investigators in FY19 to align with several

credit: Cancer Research UK

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program priorities, which include to build research capacity in kidney cancer; increase collaborations to advance kidney cancer research, and support innovative research conducted by the next generation of kidney cancer scientists and clinicians.

The overarching goal of the AKCI is to increase research capacity in kidney cancer through the development of successful, highly productive kidney cancer researchers in a collaborative research and training environment.

The AKCI is a virtual career development and research training platform that currently consists of 11 Early-Career Scholars (ECS)/Designated Mentor pairs from different institutions, and one Academy Director.

It is expected that six Early-Career Scholars will graduate by the fall of 2025 and four FY23 AKCI – Early-Career Scholars/Designated Mentor awards will be made by September 202 4. In addition, Academy graduates will continue to participate in the annual Academy meetings.

Information about the Academy is available on the KCRP webpage and in the Kidney Cancer Program Booklet at https://cdmrp.health.mil/kcrp.

The AKCI leadership team will identify opportunities for engagement with KCRP AKCI Scholars-Designated Mentors and KCRP FY25 (and subsequent year awardees) Postdoctoral and Clinical Fellowship Awardees.

The Academy Director and Deputy Director catalyze the growth and professional development of the Early-Career Scholars in collaboration with their Designated Mentors, assess the progress of the ECSs, and facilitate communication and collaboration among all of the Academy members.

The AKCI leadership team will also identify and offer opportunities for engagement (e.g., invitations to seminar series and in-person meetings) with FY24 Postdoctoral and Clinical Fellowship Awardees with FY24 KCRP AKCI-ECS-Designated Mentors (and subsequent year awardees).

This FY24 funding opportunity is soliciting applications for an Academy Director (Principal Investigator [PI]) and Deputy Director (Partnering PI) to lead the AKCI.

The newly selected FY24 Academy Director and Deputy Director will initiate their responsibilities no later than October 202 5. The Academy Director and Deputy Director (hereafter referred to as Academy Leadership) must be established kidney cancer researchers and can be at different institutions.

The Academy Leadership must demonstrate a strong record of mentoring and training early career investigators, a commitment to leadership, the ability to articulate methods toward research collaborations, and the ability to objectively assess the progress of all Scholars with their Designated Mentors in the AKCI.

Other objectives will include execution of research that will engage AKCI FY24 Scholars (including subsequent-year Scholars), develop tools for Scholars to enable success, and provide opportunities to broaden their knowledge in kidney and renal pelvis cancers.

The leadership team will identify and offer occasion(s) for the AKCI to network with KCRP FY24 Postdoctoral and Clinical Fellowship Awardees (and subsequent year awardees).

Designated Mentors on FY24 KCRP AKCI – Early-Career Scholar Award applications and Designated Mentors on open FY19 through FY23 KCRP AKCI – Early-Career Scholar Awards (with the exception of those graduating in 2024) are not eligible to apply for this award.

Note:
An invited oral presentation is a requirement for application review of the KCRP AKCI – LA, as described in Section II.D.

2. b.iv, Additional Application Components.

Responsibilities of the Academy Leadership include, but are not limited to:
• Act as a resource for all Scholars and Designated Mentors in the Academy over the Scholars’ 4-year period of performance.

• Facilitate communication and collaboration among all Scholars and Designated Mentors (including periodic interactive communication among all Academy members).

• Develop assessment criteria to evaluate the research progress made by all Scholars, as well as their career progression and sustainment as independent investigators in kidney cancer research.

• Conduct collaborative kidney cancer pilot project(s) that include Academy Scholars.

These pilot projects should have the potential to improve collaboration within the Academy, as well as impact kidney cancer research and/or kidney cancer patients/survivors.

o Examples of pilot research projects may include but are not limited to (a) funding an extended statistical or bioinformatics analysis with AKCI Scholars, (b) performing a large-scale meta-analysis of human or animal datasets with AKCI scholars, (c) provide access to critical biorepositories or animal models to expand AKCI investigator analyses or increase study rigor.

• Provide constructive critiques with the goal of advancing the research and professional careers of the Scholars and strengthening the mentorship of the Designated Mentors.

• Provide avenues to increase the promotion of the Academy and visibility of Scholars within kidney cancer research and advocacy communities (e.g., peer review, conferences, editorial boards).

• Support the professional development, to include laboratory management skills, of the Scholars into leading researchers through invited presentations by experts outside of the AKCI – LA.

• Plan and host an annual 1-day workshop and, biennially, a multi-day workshop for all Scholars/Designated Mentor pairs as well as Academy graduates to present their research, share knowledge, and develop collaborative efforts within the AKCI.

Scholars will be responsible for their own travel costs to in-person Academy meetings.

• Include KCRP FY24 Postdoctoral and Clinical Fellowship Awardees in at least one meeting of the FY24 AKCI.

These investigators will be responsible for their own travel costs, funds for which are included in their research awards.

• Establish a panel of patient advocates and Veteran(s) (i.e., the Patient Advocacy Panel) to inform the AKCI on the needs of the patient community.

• Establish the Designated Mentor Panel to facilitate collaborations among the AKCI participants including the Scholars, Academy Director/Deputy Director, and the Designated Mentors.

The Academy of Kidney Cancer Investigators – Leadership Award is structured to support two PIs.

The Academy Director will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission.

The Deputy Director will be identified as the Partnering PI.

The collaboration between the Academy Director and the Deputy Director should be supported by complementary expertise and experience.

Initiating and Partnering PIs each have different submission requirements, as described in Section II.D.2, Content and Form of the Application Submission; however, both PIs should contribute significantly to the development of the proposed research project.

The application should clearly demonstrate that both PIs have equal levels of input on the proposed Academy Leadership and clearly define the components to be addressed by each to support the success of the Scholars.

While it is up to the Academy Director and the Deputy Director to define their roles, both Academy Leaders should have interactions with each Scholar-Designated Mentor pair, (and the Scholars’ Designated Mentors); acting as administrative support does not fulfill the intent of the Director and Deputy Director.

If recommended for funding, each PI will be named on separate awards to the recipient organization(s).

Each award will be subject to separate reporting, regulatory, and administrative requirements.

For individual submission requirements for the Initiating and Partnering PI(s), refer to Section II.D.2, Content and Form of the Application Submission.

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 strategic priorities and/focus areas described in Section II.A.1 and Section II.A.

2. 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:
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, 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/nature1155 6. 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 their Families.

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.

Clinical trials are not allowed under this funding opportunity.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 4 6. 102 (45 CFR 4 6. 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 §4 6. 104(d)(4) of the Common Rule.

The funding instrument for awards made under the program announcement will be cooperative agreements (31 USC 6305).

Substantial CDMRP programmatic involvement with recipients is anticipated during the performance of award activities.

Substantial involvement means that, after award, CDMRP staff will assist, guide, coordinate, or participate in project activities including but not limited to:
• Participating in the Steering Committee that oversees study conduct.

• Make recommendations for continued funding based on (a) overall study progress, including sufficient patient and/or data accrual; (b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or (c) maintenance of a high quality of research.

The anticipated combined direct costs budgeted for the entire period of performance for a FY24 KCRP AKCI – LA should not exceed $1,500,00 0. 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, 202 5. The CDMRP expects to allot approximately $ 2. 4M to fund approximately one KCRP Academy of Kidney Cancer Investigator Leadership Award application (consisting of an Initiating PI application and a Partnering PI application).

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 and FY26 funds, which will expire for use on September 30, 2030, and September 30, 2032, respectively.