OpportunityTitle: DoD Ovarian Cancer, Omics Consortium Development Award
Description: The FY18 OCRP Omics Consortium Development Award supports a multi-institutional research effort conducted by leading ovarian cancer researchers and consumer advocates that specifically focuses on the compilation of new and/or use of existing large datasets to study the origin of ovarian cancer disease with an emphasis on early detection and screening. This effort will be executed through a two-stage approach using two separate award mechanisms: the first is the current funding opportunity, the FY18 Omics Consortium Development Award, which will enable the consortium to lay the groundwork for the research project, including a proof of concept preliminary research project; and the second is an FY20 Omics Consortium Award, which will support the execution of the full research project. Research projects proposed under the Omics Consortium Development Award must use large datasets (genomics, proteomics, metabolomics, other &#8216;omics) to focus on origin of disease. The long-term goal of the Omics Consortium is to facilitate improvements in early detection and screening of ovarian cancer, although immediate benefits of the consortium will be in initial diagnosis and therapy. With this in mind, applicants are encouraged to include rare subsets and putative pre-malignant lesions, as well as linkage to relevant interventional clinical trials, to be included in the data gathered by the Omics Consortium Development Award. Applications for the first stage, the Omics Consortium Development Award, are being requested in this funding opportunity. The Omics Consortium Development Award provides support to: &#8226; 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 ovarian cancer consumer advocates; &#8226; Acquire research resources; &#8226; Develop a plan to disseminate information regarding the procurement and distribution of data and/or biospecimens to the non-consortium ovarian cancer research community; &#8226; Develop a detailed statistical plan with refined power analysis; &#8226; Conduct a preliminary research project to demonstrate proof of concept; &#8226; Prepare documents for obtaining approvals from local Institutional Review Boards (IRBs); and &#8226; Develop informed consent forms, as applicable. The Principal Investigator (PI), as the Consortium Director, is expected to have experience in successfully leading the design, administration, and management of multi-institutional research projects. The PI should create an environment that fosters and supports innovation and creativity, with consistent, intensive interaction within the research team in a way that engages all members of the consortium in all aspects of the research project. Research sites in this consortium should be scientists and/or clinicians who have made significant contributions to the field of ovarian cancer or who have specific expertise related to the research project. This award is meant to facilitate new collaborations. If support for a pre-existing consortium is proposed, then evidence of new collaborations must be apparent within the application. The research team must include (1) at least one Early-Career Investigator who is within 5 years of his/her last postdoctoral research position (Ph.D.), clinical fellowship (M.D.), or equivalent, (2) at least one ovarian cancer consumer advocate, and (3) at least one Epidemiologist/Public Health Expert, all of whom should be integrally involved throughout the planning and implementation of the research project. As lay representatives, the consumer advocates must be individuals who have been diagnosed with ovarian cancer and who belong to an ovarian cancer advocacy organization. They must have a high level of familiarity and training involving current issues in ovarian cancer research, or a plan for such training should be included in the proposal. Consumer advocates should be involved in the project design, recruitment, and evaluation, as well as other significant aspects of the proposed project. Interactions with other consortium members should be well-integrated, ongoing, and not limited to attending seminars and semi-annual meetings. In addition to developing infrastructure and acquiring research resources, the FY18 Omics Consortium Development Award provides funding for conducting a pilot project to demonstrate proof of concept. 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. Preliminary data from the pilot study should demonstrate feasibility for achieving the aims of the completed project. It is expected that the research and statistical plan and power analysis will be updated based on the pilot study data for the FY20 Consortium Award application. The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public. Only the recipients of the FY18 OCRP Omics Consortium Development Award will be eligible to compete for the Consortium Award, which may be offered by the OCRP in FY20 to further support these research efforts. Due to the annual appropriations for this program, there is no guarantee that funds will be available to implement this FY20 Consortium Award. The OCRP expects to fund three FY18 Omics Consortium Development Awards, depending on the number and the quality of applications received. If this goal is not met, the OCRP then reserves the right to re-release the Omics Consortium Development Award funding opportunity or open the FY20 Omics Consortium Award to all applicants meeting the eligibility requirements. FY20 OCRP Omics Consortium Award Description: A description of the scope and intent of the FY20 Omics Consortium Award is provided at this time to assist investigators in preparing applications for the FY18 Omics Consortium Development Award. The FY20 Omics Consortium Award will support research focused only on the use of large datasets to study the origin of disease with an emphasis on early detection and screening. The scope of this research effort may include a broad spectrum of research spanning preclinical to clinical studies. Datasets may be newly generated or culled from existing resources. The research effort will provide immediate benefits for ovarian cancer patients in initial diagnosis and therapy and the end result will lead to improvements in early detection and screening detection of ovarian cancer. The consortium should comprise a multi-institutional research team made up of scientists and/or clinicians who have made significant contributions in the field of ovarian cancer, at least one Early-Career Investigator, at least one consumer advocate associated with an ovarian cancer consumer advocacy organization(s), and at least one Epidemiologist/Public Health Expert. It is expected that the same research sites, Early-Career Investigator(s), ovarian cancer consumer advocate(s), and Epidemiologist(s) named in the Omics Consortium Development Award application will be included in the Omics Consortium Award application. Any changes from the Omics Consortium Development Award should be fully justified. The FY20 Omics Consortium Award expects the collaborations established through the consortium to be synergistic. The Consortium should maximize the use of resources and minimize unnecessary duplication among consortium members by sharing resources among all consortium members. The consortium should develop and execute a plan to establish financial independence from DoD funding by the end of the Omics Consortium Award period of performance. The OCRP Programmatic Panel and CDMRP staff members will serve as an external advisory board for the consortium. The anticipated direct costs budgeted for the entire period of performance for an FY18 OCRP Omics Consortium Development Award will not exceed $400,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. Extramural Organizations: An assistance agreement (grant or cooperative agreement) is appropriate when the Federal Government transfers a &#8220;thing of value&#8221; to a &#8220;state, local government,&#8221; or &#8220;other recipient&#8221; 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. If &#8220;no substantial involvement&#8221; 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 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. 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 Materiel Command (USAMRMC) 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. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application. Submission to HRPO of protocols covering more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol as DoD-supported research and may include extensive modifications to meet DoD human subjects protection requirements. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource Document available on the electronic Biomedical Research Application Portal (eBRAP) &#8220;Funding Opportunities &amp; Forms&#8221; web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information. Use of DoD or VA Resources: If the proposed research involves access to active duty military patient populations and/or DoD resources or databases, the PI is responsible for demonstrating such access at the time of application submission and should develop a plan for maintaining access as needed throughout the proposed research. Access to target active duty military patient population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research involves access to VA patient populations, VA study resources and databases, and/or VA research space and equipment, VA PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&amp;D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the funds, the application should include a letter from the VA ACOS/R&amp;D confirming this arrangement and identifying the institution that will administer the funds associated with the proposed research. Access to certain DoD or VA patient populations, resources, or databases may only be obtained by collaboration with a DoD or VA investigator who has a substantial role in the research and may not be available to a non-DoD or non-VA investigator if the resource is restricted to DoD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DoD or non-VA investigator collaborating with the DoD and/or VA. If access cannot be confirmed at the time of application submission, the Government reserves the right to withdraw or revoke funding until the PI has demonstrated support for and access to the relevant population(s) and/or resource(s). 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 to the public at large. For additional guidance, refer to the General Application Instructions, Appendix 2, Section K. Awards will be made no later than September 30, 2019. For additional information refer to Section II.F.1, Federal Award Notices.
GrantorContactEmailDescription: CDMRP Help Desk
GrantorContactText: CDMRP Help Desk &lt;br/&gt;Phone: 301-682-5507 &lt;br/&gt;Email: help@eBRAP.org