DoD Kidney Cancer, Clinical Research Nurse Development Award

Organization
DOD
Type
DOD
Application or LOI Due Date
11-03-2020
Number
W81XWH-20-KCRP-CRNDA
Brief Description

The inclusion of clinical trial research nurses on a multi-disciplinary clinical research team is thought to be a valuable asset in executing the day-to-day management of a clinical trial. Clinical research nurses (CRNs) perform an essential role to ensure that the integrity and quality of clinical trials are maintained while also safeguarding the welfare of clinical research and/or trial participants. CRNs are involved in all aspects of the clinical trial continuum from the initial development of a trial protocol through post study patient care, trial closeout, and the dissemination of research findings (please refer to Appendix 2 and Appendix 3 for references regarding CRNs). During the past 20 years there has been an increase in the number of CRNs as well as a rise in training and certification programs for this specialty, albeit the overall number of nurses with clinical trial research expertise remains low (Poston, 2010). Some factors that have impeded a more significant increase in CRNs are lack of educational resources, limited financial support, and ability to access hands-on training by experienced CRNs and in research settings. The intent of the Clinical Research Nurse Development Award is to support research that allows the preparation of nurses for the kidney cancer CRN specialization through a mentored research training approach.

Clinical research requires a team of collaborating members and is most productive in settings where all team members are experienced and striving to work at the top of their capacity to advance novel therapeutics or the medical treatment field. Developing a workforce of highly skilled and knowledgeable CRNs requires a comprehensive, interdisciplinary clinical research experience to foster active roles in clinical trial management, protocol adherence, industry/institution and regulatory collaborations, and patient education. The FY20 KCRP Clinical Research Nurse Development Award funds research that is supported by mentoring partnerships between a clinician (i.e., physician, physician scientist, or equivalent) and a CRN coordinator (or equivalent) to pilot a CRN fellowship program that will enable the advancement of credentialed nurses to pursue dynamic careers in collaborative kidney cancer clinical research.

The Clinical Research Nurse Development Award requires more than one Principal Investigator (PI).  One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as a Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, Statement of Work (SOW), and other required components. If recommended for funding, each PI will be named to an individual award within the recipient organization. For individual submission requirements for the Initiating and Partnering PIs, refer to Section II.D.2, Content and Form of the Application Submission. Key components of this award mechanism are as follows: Research Approach: The proposed research project must have high potential to lead to or make breakthroughs in kidney cancer. The proposal must pursue a kidney cancer project and explicitly state the involvement of the CRN trainees in conducting and assessing the clinical trial research project with sufficient detail to be evaluated in the context of the complete training program. 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. The inclusion of preliminary data relevant to kidney cancer and the proposed project is encouraged but not required.  Any preliminary data provided should be from the PI and Partnering PI; additionally, required resources should be identified and supported through documentation. Impact: Research supported by the Clinical Research Nurse Development Award will have the potential for a major impact and accelerate progress toward ending kidney cancer and/or improving patient care for those participating in kidney cancer clinical trials. 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.

Principal Investigators (PIs): Each application must include one pair of PIs, an equal partnership between a clinician and a CRN coordinator (or equivalent). The two PIs of the KCRP Clinical Research Nurse Development Award are the mentors of the proposed research nurse development program. The clinician PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The CRN coordinator (or equivalent) PI will be identified as the Partnering PI. The clinician PI must be the PI, co-PI, or lead of active clinical trials and/or research. The CRN coordinator (or equivalent) must have at least 2 years of cancer or oncology clinical trial research nurse experience. At least one of the PIs in this partnership must demonstrate clinical research experience in kidney cancer. Both PIs should be involved in writing the project narrative, the program’s development plan for future research nurse trainees, and other application components.  The PIs do not need to be from the same institution, although an established collaboration must be clearly detailed, and at least one of the PIs must be at the same institution of (prospective) CRN trainees. The proposed research project and career development plan must focus on kidney cancer.  Applications must emphasize both PIs’ potential for success in developing two or more kidney cancer clinical trial research nurses based on their prior track record as mentors, prior experience in developing research training programs, and/or prior experience in kidney cancer clinical research. Mentors/PIs: The mentors (clinician and CRN coordinator) must possess the appropriate expertise and experience in kidney cancer clinical research, clinical trial research, and/or patient care, to include recent publications, active peer-reviewed kidney cancer funding, and clear demonstration of a commitment to guiding the trainees’ development into kidney cancer clinical trial research nurses. The mentors must provide a plan that ensures trainees will have access to clinical trial patients in order to gain hands-on research experience and training (e.g., evidence of an active clinical trial). The application must show how the combined experiences of the mentors will support the KCRP Clinical Research Nurse Development Award intent of preparing nurses for kidney cancer research and CRN specialization. Mentorship by an investigator without an established record of mentoring clinical trial nurses may be offset by the overall strength of the career development plan. The mentors should showcase how they intend to dedicate time to this significant effort to directly train and advance trainees to become clinical trial research nurses. Training Environment: The institution where the research and training will occur will be evaluated to determine the presence of strong programs in interdisciplinary kidney cancer research.  Successful applicants must have mechanisms in place to ensure that the clinical trial research nurse trainees will have exposure to kidney cancer scientists and clinicians, other trainees, and research teams on an ongoing basis (e.g., through journal clubs and seminars). Applications must demonstrate the training institution has a substantial history of conducting clinical trials and research in kidney cancer. Additionally, applications must demonstrate that there are active and open kidney cancer clinical trials and research at the institution and/or that new kidney cancer clinical trials will be opened and that kidney cancer patients are being recruited at the institution during the proposed period of performance for the training program. Institutions must also demonstrate commitment to retain the trainees or provide evidence of plans to integrate trainees into collaborating institutions following the period of training. This award is intended to support kidney cancer research and the career development of kidney cancer clinical trial research nurses. Career Development Plan: Applications must provide details on the kidney cancer research-focused career development plan, and describe how it will facilitate the trainee’s career development as kidney cancer clinical trial research nurses, enabling trainees to conduct impactful research. The suitability of the career development plan for attaining the goals of this award mechanism will be a critical component of the evaluation. Applications should provide details on the expected qualities of the planned trainees, evidence of qualified candidates, the selection criteria and process for trainees, and training and research curriculum planned over the period of performance. The research and training curriculum should include a combination of hands-on approaches with both mentors (e.g., shadowing the mentors, shadowing clinicians and patients, attending laboratory meetings, learning laboratory research techniques, interacting with patients under supervision) and self-learning curriculums to be performed by the trainee (e.g., attending and participating in conferences, seminars, journal clubs, department-wide didactic meetings). If trainees have been identified, detailed biographical sketches should be included. Career development planning should include the duration of mentored research effort, planned interactions with the PIs and possibly other research and clinical staff, opportunities to gain tangible certifications or degrees (such as the Society of Clinical Research Associates’ international certification program, Certified Clinical Research Professionals), opportunities to gain independence in clinical trial research performance and/or to exercise skills in program leadership, team development, or project design. Consideration of the development of communications, networking, finance, regulatory, data management, or other business skills will also be evaluated. A multidisciplinary research approach to kidney cancer is highly encouraged but not required; however, if there are multidisciplinary aspects, they should be clearly outlined in the application.

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

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 FY20 KCRP priorities.

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.

The anticipated direct costs budgeted for the entire period of performance for an FY20 KCRP Clinical Research Nurse Development Award will 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, 2021. For additional information refer to Section II.F.1, Federal Award Notices.

The CDMRP expects to allot approximately $0.96M to fund approximately two Clinical Research Nurse Development 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 FY20 funding opportunity will be funded with FY20 funds, which will expire for use on September 30, 2026.

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 U.S. Army Medical Research and Development Command (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 a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource 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 is cooperative (i.e., involving 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 trial costs will not be supported by this award, but correlative studies to clinical trials may be supported. 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 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.