The FY21 PCRP Health Equity Research and Outcomes Improvement Consortium (HEROIC) Award supports a synergistic, multi-institutional collaboration incorporating innovative and translational approaches that have the potential to make a major impact on specific FY21 PCRP Overarching Challenges.

Therefore,

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all applications are required to address one or both of the following FY21 PCRP Overarching Challenges:• Improve quality of life to enhance outcomes and overall health and wellness for those impacted by prostate cancerApplications should aim to understand the impact of prostate cancer on quality of life for the cancer survivor, their family, caregivers, and their community with the goal of improving and enhancing quality of life and overall health and wellness.

Studies should consider both short- and long-term quality of life outcomes.

Areas of particular interest include:o The mental and emotional health of patients and their families/caregiverso Impact of quality of life considerations on decision-making after diagnosis and/or treatmento Identification of vulnerable groups of men and their families at great risk of quality of life detrimentso Translation of factors or interventions that improve quality of life outcomes and overall health and wellness• Advance Health Equity and Reduce Disparities in Prostate CancerApplications must be directly relevant to the better understanding and/or reduction of inequities and disparities that impact a person, their family, or their caregiver's ability to prevent, detect, manage, and survive prostate cancer.Inequities may arise from socioeconomic status, race or ethnicity, geography, environment, lifestyle, sexual and/or gender identification, access to care (in rural or urban settings), or other factors.Health inequities may include physical, mental, or emotional health differences, as well as social and financial differences experienced primarily in high-risk or underserved prostate cancer patients.High-risk populations include, but are not limited to, people of African descent (including Caribbean), genetically predisposed populations, Service Members, and Veterans.Underserved populations include, but are not limited to, men with limited access to clinical care and resources (in rural or urban settings), and sexual and/or gender minorities.Each application must outline and identify all key members of the consortium, which must include four to six Research Teams total; one Research Team will be led by a Consortium Director, and the remaining three to five Research Teams will be led by Research Team Principal Investigators (PIs).

A minimum of three institutions must be represented.

The consortium must include leading scientists and/or clinicians who have specific expertise related to prostate cancer, health disparities, and/or survivorship research or other areas of expertise related to addressing the overarching theme of the proposal.

All consortia must include at least one prostate cancer consumer advocate that has an active role in every aspect of the proposed consortium’s work.Consortia funding will be offered in two phases.

Phase 1 of the HEROIC Award will enable the consortium to lay the groundwork for the research effort, including the conduct of preliminary research projects to demonstrate proof of concept of the proposed central hypothesis.

Phase 2 of the HEROIC Award will enable the execution of the full research effort, including multiple, parallel projects supported by the preliminary data generated in phase 1, which approach the research problem from a variety of perspectives.

Phase 1 awardees will be eligible to compete for phase 2 funding in FY23 pending availability of funds.

It is the program’s intent that all phase 1 recipients will receive phase 2 funding pending successful achievement of phase 1 goals.Phase 1 HEROIC Award:
The first phase of funding is intended to provide the initial support necessary to establish the infrastructure of the consortium and conduct pilot studies that will generate preliminary data and demonstrate feasibility for achieving the aims of the completed project in phase 2. Key aspects of phase 1 HEROIC Award applications include the following:• Personnel:
The HEROIC Award mechanism requires a multi-PI partnership between one Consortium Director and three to five Research Team PIs.

The Consortium Director will be responsible for the majority of the administrative tasks associated with application submission.

All 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 Consortium Director and Research Team PIs, refer to II.D.

2. b.i Step 2:
Full Application GuidelinesThe Consortium Director is expected to have experience in successfully leading the design, administration, and management of multi-institutional research projects.

The Consortium Director should create an environment that facilitates the advancement of translational research efforts while also fostering and supporting innovation and creativity, with consistent, intensive interaction with the Research Teams in a way that engages all members of the consortium in all aspects of the research projects.

Research Teams in this consortium should be comprised of scientists and/or clinicians who have made significant contributions to the field of prostate cancer or who have specific expertise related to health disparities or survivorship or other areas of expertise related to the research project.

All team members should be integrally involved throughout the planning and implementation of the research project.This award encourages the establishment of new collaborations.

If support for a pre-existing consortium is proposed, then it should be apparent why the Research Teams collectively represent the best group to address the proposed research question.

Each Research Team is encouraged to consider including promising Early-Career Investigators (within 5 years of their last postdoctoral research position [Ph.D.], clinical fellowship [M.D.], or equivalent), scientists from nontraditional disciplines, and/or Epidemiologists/Public Health Experts, where appropriate, to enhance the consortium’s efforts.• Consumer advocate involvement:
The consortium must include at least one prostate cancer consumer advocate.

The consumer advocate(s) are expected to represent the perspective of the patient population(s) that are most relevant to the consortium’s proposed research, and therefore should be from a recognized advocacy organization or have demonstrated prior contributions toward efforts to address prostate cancer issues in the populations of interest.

The prostate cancer consumer advocate(s) must have an active role in every aspect of the proposed consortium’s work, including consortium conception and design, ongoing discussion, decisions and oversight, program evaluation, and dissemination of information to the public.

The consumer advocate(s) must be integrated into and play an active role in the leadership and decision-making committees for the consortium.

Examples of appropriate integration include membership on advisory board(s) and steering committee(s), participation in project/aim teams, and attendance at all consortium-related meetings.• Infrastructure development:
Support must be utilized to develop key infrastructure elements necessary for successful conduct of collaborative, multi-institutional projects by the end of phase 1, including but not limited to:o Develop the infrastructure of the consortium (e.g., building appropriate collaborations, outlining an administrative and management plan, developing a research and communication plan, and devising an intellectual property plan) and a multi-institutional research team inclusive of scientists, clinicians, and prostate cancer consumer advocate(s).o Acquire research resources, patient cohorts, and/or datasets that will be needed for current or future consortium projects.o Develop a plan to disseminate information regarding the procurement and distribution of data and/or biospecimens to the non-consortium prostate cancer research community.o Prepare documents for obtaining approvals from local Institutional Review Boards (IRBs), as applicable.o Develop informed consent forms, as applicable.• Pilot projects:
Applications must outline and describe the pilot projects that will be conducted during the phase 1 award.

Proposed pilot projects are intended to demonstrate proof of concept and provide preliminary data that will demonstrate the feasibility of achieving the aims that are planned for phase 2 funding.

Additional pilot projects to explore innovative approaches to address the hypothesis may also be included.

Preliminary data to support the feasibility of the research hypotheses and research approaches and/or the clinical relevance of the idea may be included, but are not required.

Clinical trials are not allowed.

Applicants must submit a statistical plan that includes a preliminary power analysis that reflects sample size projections that will answer the hypothesis and/or objectives of the proposed project (if applicable).

It is expected that the research and statistical plan and power analysis will be updated based on the pilot study data for the FY23 phase 2 HEROIC Award application.Note:
An invited oral presentation is a requirement for review of phase 1 HEROIC Award applications at the programmatic review level, as described in Section II.D, Full Application Submission Content.Phase 2 HEROIC Award:
The following is an initial description of the scope and intent of the planned phase 2 HEROIC Award, which may be offered by the PCRP in FY23 to further support these research efforts.

The information provided here is based on anticipated FY23 appropriations; funding opportunity details may need to be adjusted should program characteristics and/or requirements change (e.g., actual FY23 appropriation amount, congressional language).

The following description of the scope and intent of the phase 2 award is provided at this time for transparency and to assist investigators in preparing applications for phase 1. Only the recipients of the FY21 PCRP phase 1 HEROIC Award will be eligible to compete for phase 2 funding.

It is the program’s intent that all phase 1 recipients will receive phase 2 funding pending successful achievement of phase 1 goals.• Funding amount:
The anticipated combined direct costs budgeted for an FY23 phase 2 HEROIC Award for the entire 4-year period of performance for the Consortium Director’s and each Research Team PI’s applications will not exceed $10M.

Due to the annual appropriations for this program, there is no guarantee that funds will be available in FY23 to implement phase 2 of this HEROIC Award.• Research project:
Phase 2 HEROIC Awards are expected to support research efforts including multiple, parallel projects that will build off of the preliminary data generated by the pilot projects from phase 1 and have the potential to make a major impact on advancing health equities, reducing disparities, and/or improving quality of life and overall health and wellness for those impacted by prostate cancer.

Proposed research efforts in phase 2 should emphasize translational research approaches spanning preclinical to clinical studies, with a focus on efforts that will readily translate to direct patient benefit.

Consortia are encouraged to include additional pilot projects that incorporate innovative approaches or ideas not included in the phase 1 pilot projects; phase 2 pilot projects are intended to generate new ideas integral to the central research hypothesis with clear potential for translation.

Multi-disciplinary approaches are strongly encouraged.• Personnel:
It is expected that the same research sites, investigators, and prostate cancer consumer advocate(s) named in the phase 1 HEROIC Award will be named in the phase 2 award.

Any changes to key personnel should be fully justified.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, 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 FY21 PCRP priorities.The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public.

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 CDMRP intends that information, data, and research resources generated under awards funded by this program announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and the public at large.

For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.The anticipated combined direct costs budgeted for the entire period of performance for an FY21 phase 1 HEROIC Award will not exceed $ 2. 70M.

Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 202 2. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $1 2. 96M to fund approximately three phase 1 HEROIC 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 202 7. 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 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 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.