Key Dates

Related Announcements

• September 22, 2021 - Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Postdoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed). See NOFO PAR-21-338.
• September 22, 2021 - Limited Competition: Ruth L. Kirschstein National Research Service Award (NRSA) Predoctoral Research Training Grant for the Clinical and Translational Science Awards (CTSA) Program (T32 Clinical Trial Not Allowed). See NOFO PAR-21-337.
• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.
• September 27, 2018 - Clinical and Translational Science Award (U54 Clinical Trial Optional). See NOFO PAR-18-940.
• December 5, 2017 - Clinical and Translational Science Award (U54 Clinical Trial Optional). See NOFO PAR-18-464.

Issued by

National Center for Advancing Translational Sciences (NCATS)
Office of the Director, National Institutes of Health (OD)

Purpose

This Notice of Special Interest (NOSI) announces NIH support for the professional development of trainees aiming to establish a career in Down syndrome (DS)-related research. By providing these scientists with research experiences, resources, and mentorship, the NIH intends to foster a pathway of investigators in DS who will not only lead future research to improve the understanding of the biology of DS, but also support the development of new treatments for health conditions experienced by those with DS. 

This program offers additional trainee research slots to a CTSA T32 or TL1 award. More specifically, NCATS administratively funds supplemental slots designated specifically for a selected trainee - either predoctoral or postdoctoral - to an existing T32 or TL1 award. That position remains a part of the T32 or TL1 for as long as the named individual is a member of the training program. When the individual no longer receives support from the T32 or TL1, the funds for the position are removed from the grant. 

Background 

Down syndrome is the most common genetic cause of intellectual disability, the most common autosomal trisomy, and one of the most visible and universally recognized genetic syndromes. Each year there are approximately 5300 babies born in the United States with Down syndrome. Within the past 25 years, the average lifespan for a person with Down syndrome has doubled, from 30 to 60 years. Despite this increase in lifespan, individuals with Down syndrome and their families face significant and changing health challenges with age, and they have often been excluded from participation in research that could improve their health outcomes and quality of life. While all people with Down syndrome are connected by the common feature of a complete or partial copy of chromosome 21 (trisomy 21), there are significant physical and cognitive differences among them, indicating that inter-individual variability exists. 

Down syndrome is associated with an increased prevalence of autism and epilepsy. About 75% of individuals experience cognitive decline in a syndrome that resembles Alzheimer’s disease but has its onset a decade or two earlier than typical Alzheimer’s disease. Individuals with Down syndrome 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 Down syndrome infrequently develop solid tumors such as breast or prostate cancer, and despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, they rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with Down syndrome, and for individuals who do not have Down syndrome but share these co-occurring conditions. 

This NOSI is one of several trans-NIH research initiatives created in response to Fiscal Year 2018, 2019, 2020, 2021, 2022, and 2023 Omnibus Appropriations Reports, which encourage NIH to expand its current efforts on Down syndrome and common co-occurring conditions also seen in the general population, while increasing the number of Down syndrome investigators entering the research pathway. Together, the initiatives are called the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE). Information about projects that were funded in prior years, as well as the NIH INCLUDE Down Syndrome Research Plan, are available on the INCLUDE Project website at https://www.nih.gov/include-project/.  

The INCLUDE Project has three components, which span the translational science spectrum: 

• Component 1: Targeted high risk - high reward basic science studies in areas highly relevant to Down syndrome 
• Component 2: Assembly of a large cohort of individuals with Down syndrome across the lifespan to perform deep phenotyping and study co-existing conditions 
• Component 3: Inclusive clinical trials of existing and future treatments and interventions for co-occurring conditions in individuals with Down syndrome 

The NCATS Clinical and Translational Science Awards (CTSA) Program is designed to develop innovative solutions that improve the efficiency, quality and impact of translational research by supporting research, infrastructure, training, and career development in translational science. With the shared interest of supporting all phases of translational science and the CTSA goal of increasing the speed of translational research, the INCLUDE-CTSA funding opportunities are complimentary and are expected to operate synergistically.      

Projects that propose to recruit subjects with Down syndrome are encouraged to promote enrollment of research subjects in the Down syndrome patient registry supported by NIH, DS-Connect®. For biospecimens collected 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 to facilitate broad data sharing. For those applications that generate clinical data, it is encouraged that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC). 

Eligibility 

Applicants must have an active NCATS-funded institutional training (T32/TL1) award. 

Individuals supported under this program must meet the administrative requirements for any trainee supported by a T32 or TL1 award (e.g., citizenship/permanent residency requirements, payback obligation) and must meet all the requirements for prior training, experience, and commitment to research expected of any other trainee in the particular T32 or TL1 program wishing to support them. 

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) - Applications may be submitted at any time prior to the NOSI expiration date but should be received at least 4 months prior to the requested start date. 
• For funding consideration, applicants must include “NOT-OD-24-017” (without quotation marks) in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will be considered incomplete and will not be considered for this initiative. 
• Only existing award recipients of T32 (PAR-21-338, PAR-21-337) / TL1 (award funded previously under PAR-18-940 or PAR-18-464) active awards are eligible to apply. The supplement must comply with all of the parent NOFO requirements of T32/TL1 programs, respectively. 
• To be eligible, the parent award must be active (i.e., not be in an extension period), and the activities proposed for the supplement must be accomplished within the remaining active project period. A grant must have at least two years remaining from the requested start date to be eligible for this funding opportunity to provide an optimal research training experience for the candidate. 
• Award Project Period- Requests are normally made in 12-month increments, and no trainee may be appointed for less than 9 months during the initial period of appointment, except with prior approval of the awarding unit, or when trainees are appointed to approved, short-term training positions (depending on the eligibility of the parent award). 
• Trainee appointment(s) must be able to be fulfilled within the active project period. 
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to NOT-OD-24-017 in order to facilitate efficient processing of the request. 
• Applicant organizations may submit more than one application to this NOSI. Each application should include only one named candidate for the supplement. Use unique project titles for each application to ensure that each application is treated as a distinct submission. 
• R&R Budget, PHS 398 Training Budget. Application budgets must reflect the actual needs of the proposed project with the following limitations. 
  • Predoctoral and Postdoctoral Trainees: 
    • NIH will contribute to the combined cost of tuition and fees at the rate in place at the time of award. Stipend levels, as well as funding amounts for tuition and fees and the institutional allowance are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage. 
    • Trainee Travel: NIH will provide up to $1,500 per trainee to travel to scientific meetings. Trainee travel to attend scientific meetings and workshops that the institution determines to be necessary for the individual’s research training experience is an allowable trainee expense for predoctoral trainees. 
    • Training Related Expenses: NIH will provide funds to help defray other research training expenses, such as health insurance, staff salaries, consultant costs, equipment, research supplies, and faculty/staff travel directly related to the research training program. In accordance with NIH policy, applicants may request additional costs for reasonable accommodation if explained in detail and justified in the application. The most recent levels of training related expenses are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L. Kirschstein National Research Service Award (NRSA) webpage. 
    • Indirect Costs: Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, consortium costs in excess of $25,000, and expenditures for equipment), rather than on the basis of a negotiated rate agreement. 

Instructions for Electronic Application Submission through Grants.gov: Use the “Apply” button(s) in Part I of the PA-20-272 program announcement to access the application forms package posted at Grants.gov. 

Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance: 

Program Plan:(may not exceed 12 pages) 

• Background: Include a summary or abstract of the funded parent award project. Provide rationale for the proposed supplement program and its alignment with the main goals of the INCLUDE Project (to accelerate the development of new therapies, while simultaneously bringing promising agents already in development to individuals with DS as quickly as possible). 
• Research Program Plan: The proposed plan should align with the missions of the INCLUDE Project and the NCATS CTSA Program. Describe how the proposed project will contribute to the trainee's career goals and path to independence. Present a timeline for career development activities and potential publications and grant applications for future support. 
• Career Development Plan: Describe key activities of the candidate trainee during the supplement, included mentored team science activities, didactic coursework (including formal degree programs if appropriate), and other activities. Describe how the proposed career development activities experiences will enhance the candidate's clinical and translational science skills and prepare them to transition into independence. 
• Mentoring Faculty: Provide information about the program faculty who will be involved in the supplement activities, including the complementary expertise and experiences, active research and other scholarly activities in which the faculty are engaged, as well as experience mentoring individuals at the proposed career stages. If any co-mentor is not located at the sponsoring institution, describe the frequency and type of communication that will be used to engage the trainee. 

Letters of Support: Attach appropriate letters from all individuals confirming their roles in the proposed supplement program. Include a signed letter, on institutional letterhead, that describes the applicant institution’s commitment to the planned proposed research project. The letter should confirm that the trainee will be supported by the T32/TL1 if the supplement is funded. The letter should also identify the laboratories, centers, and other specialized institutional facilities that will be made available to the trainee for the research project. 

Project/Performance Site Location form: Include the primary site where the proposed supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided. 

Senior/Key Person form: 

• List the PD/PI as the first person (regardless of their role on the supplement activities). 
• List Senior/Key Personnel who will be serving as members of the trainee's mentoring team. 
• List the trainee proposed to be added through this supplement. Trainees for this supplement support must have an eRA Commons account, and the trainee's Commons Username must be entered in the Credential field. 
• Biographical sketch, Senior/Key Personnel: Include a biographical sketch of the T32/TL1 PD/PI(s) and of each of the individuals who will compose the trainee's mentoring team. The personal statement of each individual who will serve on the trainee's mentoring team should include a description of his/her specific role in mentoring the trainee, how the mentoring will occur (e.g., frequency and mode), and how the trainee's progress will be monitored during the supplement award period. 
• Biographical sketch, Trainee: The personal statement of the trainee's biographical sketch should include a description of his/her research objectives and career goals, and why their experience and qualifications make them particularly well-suited to receive an INCLUDE / NCATS CTSA Program T32/TL1 supplement award. Relevant factors include previous training and research accomplishments in clinical and translational science research and any source(s) of current funding.   

Budget forms: Using the R&R budget form only include funds requested for the additional supplement activities. 

R&R Other Project Information form, Facilities and Other Resources attachment: Describe how the scientific environment in which the career development activities will be done contributes to the probability of the trainee’s success (e.g., institutional support, physical resources, and intellectual rapport). For CTSA Program hub Training Resources, describe the training resources that are available to the trainee. 

PHS Human Subjects and Clinical Trials Information form: Clinical trials are not allowed. 

Inquiries

Please direct all inquiries to:

Jamie Mihoko Doyle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-402-0403
Email: [email protected]