DoD Kidney Cancer, Nurse Initiated Research Award

The FY23 KCRP Nurse-Initiated Research Award supports innovative, high-impact kidney cancer research, conducted by nurses working in clinical practice and/or an academic environment (DNP or PhD), to advance ideas or clinical care. Proposed research must demonstrate potential to have a major impact in kidney cancer, ideally in a multi-disciplinary manner led by a nurse. Applications are strongly encouraged to address one of the FY23 KCRP Focus Areas or must provide justification that the proposed research addresses a critical problem, question, or need in kidney cancer.Nurses make up the largest group of health professionals within the health system and nursing is the largest profession in the United States. Nurses engage in more regular interactions with patients and their families, relative to other health professionals. Nurses who have earned advanced degrees (PhD in particular) are being recognized more frequently for their contributions in bridging clinical practices and patient care experiences to nurse-initiated research. Their evidence-based investigations have resulted in advancements to health care delivery and the growing field of nurse scientist-led investigations. Please refer to Appendix 2 for further reference. This award enables the nurse-scientist(s) to compete for research funding that will help determine the best practices to both inform and improve kidney cancer patient care. Although the project should address an important question in kidney cancer patient care, studies may also seek to investigate topics associated with access to care, health equity/health disparities, communication/patient education, quality of life, or patient support systems (not all-inclusive).Research Approach: The proposal must pursue a kidney cancer project and should have high potential to lead to, or make breakthroughs in, kidney cancer patient care, survivorship, and outcomes research (not all-inclusive). The feasibility of the research design and methods should be well-defined, and a clear plan should be articulated as to how the proposed goals of the project can be achieved. Below are some examples of projects that this award is intended to support (not all-inclusive):• Projects that develop best practice models for support of nurses and patient care• Evaluating the effects (short-term and long-term) of interventions on patients and/or patient care• Investigating psychosocial issues relevant to people living with kidney cancer, their families, and/or their care-partners• Conducting nurse practice for kidney cancer patients during a period of medical crisis (e.g., COVID-19, nurse shortages, access to therapies)Preliminary Data: The inclusion of preliminary data relevant to kidney cancer and the proposed project is encouraged but not required. All research projects must include a well-formulated, testable hypothesis based on strong scientific rationale. Any preliminary data provided should be from the Principal Investigator (PI) and/or collaborating investigator(s); additionally, required resources should be identified and supported through documentation. At minimum, the PI or one collaborating investigator must have experience with kidney cancer research.Impact: Research supported by the Nurse-Initiated Research Award will have the potential to improve patient care for those living with kidney cancer. The impact may be short term or long term but must move beyond an incremental advance. Applications are expected to identify the kidney cancer patients or at-risk individuals who would ultimately benefit from the proposed research. At least the PI or one collaborating investigator must have experience with kidney cancer patient care.Qualified Collaboration Option: In FY19, the KCRP awarded a Clinical Consortium Award to create a network of institutions focused on designing and executing phase 1 and 2 clinical trials. The Kidney Cancer Research Consortium (KCRC) has now been established to investigate promising therapeutics for kidney cancer. Applicants to the FY23 Nurse-Initiated Research Award are encouraged to make use of the established infrastructure of the KCRC, such as recruitment networks, existing protocols, Common Data Elements (CDEs), and data management procedures. A letter of collaboration from the KCRC is required, outlining the services that will be shared to bring value to the government.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.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 FY23 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 FY23 KCRP Nurse-Initiated Research Award should not exceed $300,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $0.48M to fund approximately one Nurse-Initiated Research Award application. Funding of the award is contingent upon the availability of federal funds for this program as well as the quality and merit of the application 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 FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.Research Involving Human Data, Human Anatomical Substances, Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), 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 application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/collaborate/research_protections/hrpo for additional information.As of January 20, 2020, U.S. institutions engaged in non-exempt cooperative research must rely on a single IRB to review and approve the portion of the research conducted at domestic sites in accordance with Code of Federal Regulations, Title 45, Part 46.114(b) (45 CFR 46.114[b]). If the proposed, non-exempt research involves more than one U.S.-based 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.Funding for clinical trials is 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 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.The Nurse-Initiated Research Award will not directly support intervention clinical trial costs; however, correlative studies and other research projects that run in parallel to a clinical trial are permissible.Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research 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 study 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 tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military and/or VA 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 FY23 KCRP Nurse-Initiated Research Award involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO 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.
Categories: Science and Technology and other Research and Development.