Notice Number: NOT-NS-18-083

Key Dates

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for Exploratory Grants for NINDS Morris K. Udall Parkinson's Disease Research Center Without Walls.

The purpose of this FOA for Exploratory Grant (P20) applications is to support the formation of new, highly skilled research consortia to address urgent and emergent challenges posed by the inherent complexity of Parkinson's Disease (PD). Resolution of some particularly difficult challenges requires a transdisciplinary "Center without Walls (CWOW)" approach, in which a specialized research consortium works seamlessly across institutional, geographic and research boundaries using a goal-driven approach to resolve an essential question or controversy in PD. Development of an effective research consortium, identification of an optimal strategy and planning of comprehensive efforts to address fundamental challenges in PD research require dedicated time and resources. Therefore, this NINDS initiative will provide up to two years of support for new collaborative teams to initiate planning, develop organizational structure, perform research feasibility studies and obtain preliminary data that will lead directly to the submission of a competitive NINDS Morris K. Udall Center without Walls for PD Research (Udall PD CWOW) application. The Exploratory Grant mechanism provides each applicant consortium with flexibility in choice of PD research challenge and project design. That stated, the consortium will select and justify a timely, relatively implementation-ready challenge, such that the team can effectively mobilize required data, skills and resources within a two-year period. Because a goal of this initiative is to establish new research consortia, preliminary data is not required for proposed research feasibility projects. The components required to form effective partnerships and develop a rigorous evidence base will involve a range of research expertise, multiple sites and institutional resources. All activities will be directed toward development and submission of a subsequent NINDS Udall PD CWOW application. Udall PD CWOW applications are expected to transform PD research and treatment through transdisciplinary, synergistic and timely resolution of an identified critical challenge in PD research. The anticipated scope of the ensuing Udall PD CWOW applications will include the optimal combination of preclinical and clinical reseaserch necessary to address the identified challenge and to meet stated goals within a five-year project period.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Autumn 2018 with an expected application due date in Winter 2018.

This FOA will utilize the P20 Exploratory Grant activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into Parkinson's Disease to begin to consider applying for this new FOA.

Among the areas of research encouraged in this initiative are transdisciplinary, consortium-based exploratory research efforts to resolve a critical challenge in Parkinson's Disease (PD) research.

The goal of this FOA is to convene new transdisciplinary research consortia and formalize the multi-institutional organizational and investigational structure necessary to resolve an essential challenge in Parkinson's disease (PD) through a subsequent NINDS Udall PD Center without Walls (CWOW) approach. The most compelling applications will: (i) identify a fundamental PD research priority; (ii) build an exemplary research consortium; (iii) gather supportive preliminary data; and (iv) demonstrate exceptional potential to pursue a targeted strategy to remove a critical impediment blocking advancement of the understanding and treatment of PD. The stated challenge and related research feasibility projects will inform the etiology, pathogenesis or treatment of PD; investigations on related synucleinopathies may be included if such studies directly address the central PD research challenge. To foster the development of innovative research collaborations, this FOA will provide support for new research consortia only; continuation of established projects and teams will not be supported.

To be considered "new," the consortium must represent a novel collaboration among independent investigators who have not co-authored primary research publications within the past two years. The consortium must also include transdiciplinary expertise as demonstrated by primary training, professional affiliation and research expertise of its members. Consortium novelty is also defined by the combination of research methodologies, expertise and significance of the challenge selected and the optimal combination of specialized expertise required to resolve the stated challenge using a goal-driven approach.

The Program Director/Principal Investigator (PD/PI) must be eminently qualified to provide visionary scientific leadership and effective oversight of consortium administrative activities. Participating investigators should be recognized as world-class experts in their fields. Teams must be anchored by at least one PD researcher. To maximize potential for new insights and incorporation of cutting-edge approaches, consortia will actively integrate at least one investigator with primary expertise in another, complementary research area. The applicant institution must demonstrate ability to lead and coordinate research and administrative activities of the consortium. Participating sites must demonstrate leadership in their area of scientific expertise, as well as propensity to leverage existing resources and technologies to meet stated goals. Proposals that include established consortia, interventional clinical trials or that seek to establish research infrastructure are not responsive to this opportunity. Applications should highlight expected end products of exploratory activities as well as significance of a subsequent PD CWOW effort. Successful exploratory efforts will lead directly to an application for support of an NINDS Morris K. Udall Center without Walls for Parkinson’s Disease Research (Udall PD CWOW; U54). Synergistic Udall PD CWOW efforts are expected to transform PD research and treatment through transdisciplinary, goal-driven and timely resolution of an identified essential challenge in PD research.

The PD CWOW FOA is anticipated in fiscal year (FY) 2021 and will utilize the NIH Specialized Center Cooperative Agreement (U54) mechanism. The U54 is a milestone-driven mechanism, the continuation of which is dependent upon the achievement of quantifiable steps within a clearly defined timeframe. Udall PD CWOW milestones will describe the research goal as well as provide objective and quantitative outcomes by which to justify advancing the project, i.e. measures that would be recognizable as appropriate endpoints in the specific scientific area. Synergy must be evident among PD CWOW research projects and cores such that successful completion of proposed milestones could not be accomplished without the CWOW consortium structure. Interventional clinical trials and advanced therapeutic development approaches will be beyond the scope of NINDS Udall PD CWOW efforts; in addition, applications proposing incremental expansion (rather than transformative advancement) of knowledge, data, resources or technologies will not be considered responsive.

The following information is provided to facilitate the development of an Exploratory Grant application.

• Required components for a future Udall PD CWOW application are expected to include:

  • An Overall Section, including but not limited to:

  • Statement of and justification for the selected PD challenge.

  • Expected impact of the proposed solution.

  • Description of synergistic research activities, including:

    • Transdisciplinary pursuit of the defined research challenge.

    • Harmonization of methodologies, technologies, and approaches.

    • Standardization of data and biospecimen collection.

  • Justification for the proposed consortium, including unique investigative skills, emergent methodologies, cutting-edge technologies and readily available resources.

  • Well-defined milestones.

  • A timeline for key CWOW events.

• A minimum of three milestone-driven Research Projects.

• An Administrative Core.

• A minimum of one Scientific Core; each Core must support at least two Research Projects.

• A Clinical Core to support human subjects-focused research (if proposed).

• A Resource Sharing Core.

• Scientific Governance structure, including but not limited to:

  • Internal Executive Committee.

  • External Steering Committee (to be assembled only subsequent to a successful U54 application).

  • Other coordinating committees required for optimal Udall PD CWOW function, e.g.

    • Data coordination/access.

    • Resource coordination/access.

    • Clinical research oversight.

• A dedicated website to provide information to the research community.

Proposed consortia must include the optimal combination of specialized expertise required to resolve the stated challenge using a goal-driven approach. The Program Director/Principal Investigator (PD/PI) must be eminently qualified to provide visionary scientific leadership and effective oversight of consortium administrative activities. The PD/PI must lead the Administrative Core and may lead no more than one other component. Participating investigators should be recognized as world-class experts in their fields, with excellent research productivity and/or the stewardship of multi-site clinical research studies. Teams must be anchored by at least one PD researcher/clinician. To maximize potential for new insights and incorporation of cutting-edge approaches, consortia will actively integrate at least one investigator with primary expertise in another, complementary research area. Inclusion of international collaborators with critical expertise for reaching proposed goals is encouraged. This team structure is intended to enrich the perspectives and methodologies brought to bear on resolution of key issues in PD research. Effort dedicated by the PD/PI and investigators must be commensurate with the goals and timeline of the PD CWOW. The applicant institution must demonstrate ability to lead and coordinate research and administrative activities of the consortium. Participating sites must demonstrate leadership in their area of scientific expertise, as well as propensity to leverage existing resources and technologies to meet stated goals.

All projects should be supported by a timeline and yearly milestones for completion. Milestones are goals that create go/no-go decision points in the project and must include clear and quantitative criteria for success. Achievement of milestones will be evaluated by NINDS, and funding of non-competing award years will depend on milestone accomplishment. Note that the NINDS Udall PD CWOW awards will be managed as cooperative agreements; therefore, projects that do not comply with terms, conditions, and established milestones of the award and of this program may be terminated.

By design, Udall PD CWOW are expected to include larger-scale research collaborations, in terms of numbers of investigators and research projects, geographic and institutional diversity of multiple (= 3) research site locations, and dedicated resources, than current Udall Centers (P50). Udall PD CWOW consortia will also be focused on resolution of the identified PD research challenge within a 5-year project period. Due to the goal-driven focus of the planned U54 FOA and inherent differences from aims-driven investigative approach of the P50 Udall Centers, the Udall PD CWOW will not include career development/research training or formal community outreach activities. However, Udall PD CWOW consortia will be encouraged to include a person with Parkinson's or a caregiver on the Steering Committee to provide important perspective. Based on common goals for advancement of PD research, Udall PD CWOW Program Directors/Principal Investigators will become part of the overall NINDS Udall Centers program and will be required to participate in annual meetings to exchange information and ideas. An NINDS PD CWOW will be expected to leverage existing infrastructure and share developed resources, including knowledge, data and reagents, broadly with the research community, consistent with achieving the goals of the Udall Centers program.

A P20 Exploratory Grant Award is not a prerequisite for submission of a Udall PD CWOW U54 application.

Funding Information

Estimated Total Funding $1,000,000 direct costs
Expected Number of Awards The NINDS intends to fund up to 4 awards.
Estimated Award Ceiling $250,000 direct costs
Primary CFDA Numbers 93.853

Anticipated Eligible Organizations

Inquiries

Please direct all inquiries to: