June 28, 2021
PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
Office of The Director, National Institutes of Health (OD)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
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 Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
The last decade has seen an explosion of new technologies aimed at assessing and improving health. Examples include wearable devices, communication aids, robotics and e-textiles, just to name a few. During this period, there have also been enormous advances in technologies that were not created for health-related purposes, but that have potential applicability to health assessments and interventions, including mobile device applications (“apps”) and social media platforms.
However, most of these technologies were originally developed for use in adults with typical cognitive and motor function. As a result, there is currently a relative paucity of valid and reliable technological tools for children and adults with intellectual and developmental disabilities (IDD) with a focus on Down syndrome (DS).
This Notice therefore invites applications specifically aimed at developing or building upon existing technological tools to improve diagnosis, assessments, interventions, management, and outcomes for infants, children, adolescents and adults with DS.
The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018, 2019, and 2020 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on DS and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded from 2018 through 2020, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.
The purpose of this Notice of Special Interest (NOSI) is to support exploratory and developmental research project grant (R21) applications focused on digital technologies and/or mHealth that meet programmatic objectives for the INCLUDE Project. Sharing of resources and effective communication of outputs of appropriate interest to broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3,NIH Strategic Plan For Data Science).
Applications in response to this NOSI should be aligned with the INCLUDE Project Research Plan, which consists of three components, two of which apply to this Notice:
Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH,DS-Connect®. For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use biorepositories designated by INCLUDE staff that meet requirements for broad sharing. An NIH resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing. For those applications that generate clinical data, it is expected that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC).
The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018, 2019, and 2020 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on DS and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded from 2018-2020, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.
Individuals with DS face significant and changing health challenges but have often been excluded from participation in research that could improve their health outcomes and quality of life. This population is understudied even though DS is the most common genetic cause of intellectual and developmental disabilities (IDD) and, in the past 25 years, the average lifespan has doubled from 30 to 60 years. In addition to intellectual disability, DS is associated with an increased prevalence of autism and epilepsy. About 75% of individuals with DS experience cognitive decline in a syndrome that resembles Alzheimer’s disease, but with onset a decade or two earlier than typical Alzheimer’s disease. Individuals with DS also have high rates of hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, and other autoimmune or immune dysregulation disorders including celiac disease. However, people with DS infrequently develop solid tumors such as breast or prostate cancer. Despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, people with DS rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with DS and for individuals who do not have DS but who share these co-occurring conditions.
Applications responsive to this Notice will address tools and/or technologies and target populations of interest. Proposals must address one or more target populations of interest: infants, children, adolescents, and adults with DS.
Applications proposing tools and/or technologies may include, but are not limited to, home monitors, point-of-care diagnostic technologies, mobile devices, mobile device apps (including social media apps), and wearable sensors and monitors. They may also include tools that help share information between caregivers, or between families and clinicians, including tools that interface with electronic health record (EHR) platforms.
Technological areas of interest include, but are not limited to:
Specific examples of tools and technologies that could be applied to individuals with DS include but are not limited to the following:
Priorities by Institute and Center
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The National Institute on Deafness and Other Communication Disorders (NIDCD)
Resource Sharing Plan:
NIH intends to maximize the impact of INCLUDE-supported projects through broad and rapid data sharing. Consistent with the new NIH Policy for Data Management and Sharing (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-21-013.html), all applications, regardless of the amount of direct costs requested for any one year, are required to include a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared, regardless of whether the data are used to support scholarly publication. The plan should describe data types, file formats, submission timelines, and standards used in collecting or processing the data. It is expected that all de-identified human data generated by INCLUDE-funded projects will be submitted to NIH-designated repositories in coordination with the INCLUDE Data Coordinating Center (DCC). All applications generating human genomic data should include, as an attachment, an Institutional Certification (https://osp.od.nih.gov/scientific-sharing/institutional-certifications/) which indicates the data use limitations and/or modifiers stating how individual level sequence data can be shared with and used by secondary users, under the guidance of the NIH Genomic Data Sharing Policy http://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html. For more information regarding INCLUDE data sharing, visit https://www.nih.gov/include-project/frequently-asked-questions.
To maximize comparisons across datasets or studies, and facilitate data integration and collaboration, applications submitted in response to this NOSI are strongly encouraged to incorporate the following standards and resources (where applicable):
Additional Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Recruitment Plan to Enhance Diversity
Peer reviewers will separately evaluate the recruitment plan (when applicable) to enhance diversity after the overall score has been determined. Reviewers will examine the strategies to be used to recruit a diverse pool of potential candidates that includes individuals from underrepresented groups. The overall plan will be rated as ACCEPTABLE only if the recruitment strategies for all of the relevant groups identified in the Notice of NIH's Interest in Diversity are viewed by the review panel as acceptable, otherwise the plan will be rated as UNACCEPTABLE. The consensus of the review committee will be included in an administrative note in the summary statement.
PA-20-195 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
Application and Submission Information
This notice applies to standard submission dates.
Submit applications for this initiative using the following funding opportunity announcement (FOA) or any reissue of this announcement through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)