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Frequently Asked Questions
Which NIH Institutes and Centers (IC) are participating in the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndrome) project?
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Advancing Translational Sciences (NCATS)
National Center for Complementary and Integrative Health (NCCIH)
Office of the Director/Office of Research Infrastructure Programs (ORIP)
Office of the Director/Office of Strategic Coordination (Common Fund)
Whom should I contact if I have a specific question about an IC’s scientific priorities?
Concepcion (Marie) Nierras, PhD
Office of Strategic Coordination (Common Fund)
How many awards does NIH intend to fund under the INCLUDE project for fiscal year 2019 (FY19)?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. NIH anticipates funding several new awards in FY2019, under the auspices of four separate Requests for Applications (RFAs). See NOT-OD-19-051 for details of these RFAs.
What are the mechanisms available for INCLUDE funding in fiscal FY19?
There are three different RFAs and one Notice of Availability of Funds for Competitive Revisions undergoing competition in FY19. Each of these meet criteria from one of the three components of the INCLUDE Project, outlined in the INCLUDE Project Research Plan.
Information about these opportunities are below along with the indicated mechanisms, from NOT-OD-19-051:
- INCLUDE Project Transformative Research Award
This initiative will focus on research in the targeted, high risk, high reward basic science domain (component 1) and will support unusually innovative research projects, which, if successful, would have a major impact in understanding the biology of Down syndrome (DS) or potential to lead to the development of new treatments for health conditions experienced by individuals with DS. Projects may be considered transformative if they address or overturn fundamental scientific paradigms through novel approaches, transform the way research is conducted through the development of novel tools or technologies, or lead to major improvements in health through the development of highly innovative therapies, diagnostic tools, or preventive strategies. This RFA will utilize the Transformative Research Award (R01 – Clinical Trial Not Allowed) activity code.
- INCLUDE Project Clinical Trial Readiness Award
This initiative will support clinical projects that address critical needs for clinical trial readiness in DS (component 3). Projects may facilitate DS research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for DS and its co-occurring conditions, or may increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with DS to enable the design of future clinical trials. This RFA will utilize the Exploratory/Developmental Research Grant Award (R21 - Clinical Trial Not Allowed) activity code.
- INCLUDE Project Clinical Trials for Co-Occurring Conditions in Down Syndrome
This initiative will support development of clinical trials to treat critical and co-occurring health conditions in individuals with DS (component 3). Research is needed to develop or test new and innovative adaptations of current drugs, interventions, and therapies for the treatment and management of co-occurring conditions in DS. Projects will be encouraged that focus on delivering better healthcare outcomes and should seek solutions that are effective, deliverable, and sustainable in clinical settings beyond the research environment. Projects may address a particular co-occurring condition at a particular stage of development or across the lifespan in people with DS. Outcomes research and health services research related to DS will also be encouraged in addition to testing new, enhanced, or tailored therapies for treating DS. Because some aspects of this research area may be new for the trans-NIH scientific community, there will likely be a need to obtain preliminary data or conduct early-stage clinical trial preparatory activities before moving to a full-scale project in this domain. This RFA will utilize the R61/R33 Phased Exploratory/Developmental Grant Award (R61/R33 - Clinical Trial Required) activity code.
- INCLUDE Project Competitive Supplements for Research in Down Syndrome
This initiative will encompass research on all three components of INCLUDE and will support competitive supplement applications to existing funded NIH projects that propose to add a new component related to the goals of the INCLUDE project. The goal is to support new but related projects or aims that will add a DS element in order to accelerate scientific progress on the INCLUDE project. This notice will utilize the Competitive Revision (Supplement) mechanism to an existing funded award, and supplements will be limited to no more than two years of support, depending on the duration of the funded “parent” award.
Is each participating IC signed on to all four FY19 funding opportunities?
No, each participating IC may be signed on to all or a subset of the four Funding Opportunity Announcements (FOA). To see if an IC is participating in a particular FOA, see the box with “Components of Participating Organizations” listed in Part I at the beginning of each funding opportunity.
Is there an award ceiling?
The cap on awards is determined by the mechanism of the initiative.
Note that for Competitive Supplements, budget requests are not capped. However, budget requests greater than the annual total direct costs of the parent award in the current year, exclusive of Facilities and Administrative costs on subcontracts, must be highly justified. Application budgets must reflect the actual needs of the proposed project. Supplement budget requests that exceed $500,000 in direct costs (exclusive of Facilities and Administrative costs on sub-contracts), must receive prior written permission from the program officer for the parent award and IC Contact listed prior to submission. In addition, competitive supplement budget requests are limited to up to 2 years of funding, and projects cannot be dependent on a no cost extension of the parent award to complete the proposed project.
Are applications from multiple PIs permitted?
Yes, multiple PIs are allowed.
Can a PI apply to multiple funding opportunities?
Are foreign institutions eligible to apply for INCLUDE funding?
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Is a resource sharing plan required for my INCLUDE project?
Yes. All applications, regardless of the amount of direct costs requested for any one year, should include a Data Sharing Plan. The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.It is expected that the results of INCLUDE-funded research will be shared with the wider scientific community in a timely manner. NIH intends to maximize the availability of publications and the sharing of underlying data and biospecimens for INCLUDE-supported supplements and projects.
Under the goals of INCLUDE, recipients are required to develop a Public Access and Data Sharing and Management Plan that (1) describes their proposed process for making resulting publications and biospecimens, and to the extent possible, the underlying primary data immediately and broadly available to the public; (2) if applicable, provides a justification to NIH if such sharing is not possible. Underlying primary data should be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Additional instructions are provided in the Resource Sharing Plan section of each RFA.
Where can I find assistance in recruiting a cohort of individuals with Down syndrome and/or planning a clinical trial for a co-occurring condition in Down syndrome?
Investigators responding to components 2 or 3 may need some assistance in developing a cohort of subjects with Down syndrome to achieve their study goals, or in clinical trial design and planning. Several resources exist to help with clinical and translational research. The National Center for Advancing Translational Sciences (NCATS) supports the Recruitment Innovation Center (RIC), the Trial Innovation Centers (TICs), and the to facilitate clinical research, clinical trials, and subject recruitment and engagement. Investigators can also propose to use DS-Connect®: The Down Syndrome Registry () to help with recruitment for their projects; to do so, register a professional account with DS-Connect and/or contact the registry coordinator at . In addition, applications addressing components 2 or 3 should strongly encourage participants with Down syndrome or their caregivers to register in DS-Connect.
Where can I find more information about review?
Please refer to Section IV (Application Review Information) in the Request for Application of the funding opportunity of interest for review criteria are specified.
In addition, NIH’s Office of Extramural Research webpage, https://grants.nih.gov/policy/peer/index.htm, provides a variety of resources on the policies and practices of peer review.
Will INCLUDE applications be reviewed by a standing study section or a Special Emphasis Panel (SEP)?
All the INCLUDE applications will be reviewed by Special Emphasis Panel(s) within NIH in order to ensure appropriate expertise. Please refer to each RFA separately for specific review criteria.
Will there be similar announcements in fiscal year 2020 (FY20)?
The mechanism of funding has not been finalized for FY20.
Will administrative supplements be solicited in FY19?
Plans to solicit administrative supplements in FY19 may be indiciated in a future Notice of Availability of Funds in the NIH Guide.
Who do I contact if I have questions?
If you have questions that are not included in the FAQ, please email: firstname.lastname@example.org.
This page last reviewed on June 26, 2019