Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. The purpose of this NOFO is to seek applications in a limited competition for the Eunice Kennedy Shriver Intellectual and Developmental Disabilities Research Centers (IDDRCs). This NOFO invites applications to undergo peer review for research center grants designed to advance the diagnosis, prevention, treatment, and amelioration of intellectual and developmental disabilities (IDD) and is limited to IDDRCs funded under RFA-HD-20-016 or RFA-HD-21-009. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.  This NOFO seeks applications from institutions that meet the qualifications for a multidisciplinary program of IDD research that will include: 1) 3-4 total Cores that facilitate interdisciplinary and translational research in IDD and its dissemination, and that support IDD-related projects funded by other sources; and 2) at least two and no more than three specific research projects related to one of several areas identified as areas of research need in IDD. Collaborative investigations combining expertise in translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, and therapeutic development will be encouraged. Funds for the majority of outside research projects using these core facilities will come from independent sources including Federal, State, and private organizations. In addition, the Center should include plans for outreach, engagement, and dissemination to the community, including persons with lived experience (PWLE) of disabilities. The duration of these Centers will be 3 years in total. 

Background

For 50 years, discoveries made by investigators within the IDDRCs have increased the basic understanding of many forms of IDD and moved the field forward appreciably. Historically, the IDDRC program was funded via Center Core (P30) grants that facilitated program coordination and supported central research facilities, administration, and a limited number of new development projects. Over the years, Core services have evolved to include state-of-the-art infrastructure in areas such as developmental neurobiology, genomics, proteomics, neuroimaging, epidemiology, biostatistics, behavioral science, and clinical translational research. The prior round of competitions, held in FY2020 and FY2021, has supported IDDRCs through the P50 (Specialized Center) mechanism. This mechanism allows the research community to continue to respond to emerging needs within the IDD field through a combination of Core services and Specific Research Project(s). NICHD has encouraged cooperation among the Centers, including their integration into a virtual network that has facilitated development of larger, cross-cutting research programs and advances in the field. This NOFO represents the next step in the evolution of the IDDRC program toward more project-focused and translational approaches to IDD research. Research focus areas have been identified in the realms of translational science, biomarker assessment, outcome measure development, tool validation, bioinformatics, artificial intelligence (AI), and therapeutic development that will inform the Specific Research Projects proposed in response to this NOFO.

It is the intent of the NICHD to support individual IDDRCs using the current P50 award format for a final cycle of competition in FY2027. The duration of each proposed IDDRC will be 3 years maximum. The program in its current format will be transitioned in FY2030 to emphasize clinical trial readiness needs that will move the field of IDD research into areas of translational research. 

Consistent with the NIH unified strategy, this NOFO encourages:

• Support of graduate students, postdoctoral researchers, junior investigators, and investigators in the IDD field through access to Core services, thereby fostering the next generation of biomedical scientists.
• Translation of basic research observations into subject oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans and to develop new approaches for prevention, diagnosis, and treatment.
• The option to focus on rigorous replication and reproducibility research, aligning with NIH’s priority to expand support for replication studies and to ensure gold standard science.

Specific Objectives of the Research Program

A major goal of the NICHD IDDRC Program is to support research that leads to the prevention and/or amelioration of IDD. The intent of the IDDRC Specialized Center program is to bring together scientists from various disciplines to work within a Center on the most pressing issues related to IDD. Each IDDRC typically supports investigators studying a range of topics in basic and clinical or applied research. This NOFO also encourages support of graduate students, postdoctoral researchers, junior investigators, and investigators in the IDD field through their access to Core services, in order to attract scientists to IDD research. NICHD strongly encourages translation of basic research observations into subject-oriented protocols whose ultimate aims are to validate the mechanistic basis of IDD in humans and to develop new approaches for the prevention, diagnosis and treatment of IDD. In addition, for the purposes of this NOFO, it is essential that scientific personnel and institutional resources capable of providing a strong research base in the IDD field are available. 

Minimal Structural Requirements

Applications responding to this NOFO must propose a multi-disciplinary program of IDD research that includes Core Components and Specific Research Project Components. Requirements for these components are described in the following sections. 

Cores

Each P50 Center can propose a minimum of three and a maximum of four Cores, with a required Administrative Core and a required Clinical Translational Core as two of the required Cores. Core components must facilitate interdisciplinary and translational research in IDD, and support IDD-related projects funded by other sources.

Each Core must fulfill the following requirements:

• Provide essential facilities or services for at least five, "outside," federally-funded, peer-reviewed research projects in addition to the Specific Research Projects funded directly through this P50 award.
• Have satisfactory quality-control systems documented for its services or facilities.
• Be cost-effective, i.e., the centralization should result in a lower cost than would be incurred if the same facilities or services were supported by the individual research grant budgets.
• Increase the quality and productivity of research projects receiving Core support.
• In general, contract-supported projects may not be counted as qualifying a Core to meet its five research project minimum requirement. Use of Core facilities by projects funded by research and development contracts will be evaluated on an individual basis. Any use of Core facilities by contracts must be paid for in full from contract funds, not from NICHD Center funds.
• Use of Core facilities by projects located at other institutions is allowable with prior NICHD approval. The sharing of unique Core resources among IDDRCs is permitted and encouraged, provided that an appropriate cost-recovery mechanism is developed.
• Use of Core facilities by graduate students or postdoctoral researchers supported by Institutional National Research Service Awards (T32) or other fellowships or career development awards (such as F and K awards) is allowable and encouraged. 

Administrative Core

The Administrative Core should provide for the integration and management of activities within the IDDRC. Each Center should form an External Advisory Committee (EAC) composed of at least five members, with scientific, clinical and patient advocate representation, to ensure the perspectives of persons with lived experience (PWLE) in intellectual disabilities. The EAC should meet in-person or virtually approximately once a year. Funded IDDRCs must utilize the Administrative Core to establish and maintain a website to communicate the Center missions and the availability of Core services. When multiple geographic sites are involved in the IDDRC, the Administrative Core should provide the leadership and communication needed to manage the multiple sites. Any educational elements should be organized and coordinated within the Administrative Core. 

In addition, the Administrative Core will provide dissemination services in order to promulgate information and promote communication about the research supported by the Center to other scientists, educators, the government, and the public, including those with IDD conditions and their families (PWLE). The Center should serve as a communication liaison between investigators conducting state-of-the-art research and the public, and where appropriate, the information should be structured so that it can effectively reach a large segment of the population, including non-English-speaking people. 

Clinical Translational Core

The Clinical Translational Core must have a translational science focus that supports research allowing application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. Examples of activities that might be considered as part of a clinical translational core include but are not limited to:

• Services related to patient recruitment or natural history studies;
• Clinical services in subject assessment, phenotyping, evaluation, or treatment;
• Provision of clinical navigator services to assist investigators with translational resources available at the Center;
• Utilization of biomarkers or validated outcome measures;
• Bioinformatics/biostatistics expertise to design clinical trials or provide clinical trial information management;
• Manufacturing services that incorporate Good Manufacturing Practices (GMP) for chemical or compound formulation for drug development;
• High-throughput screening to enhance identification of compounds for treatment of IDD;
• Collection of human samples from individuals with IDD for biobanking purposes. 

Specific Research Projects

Applications must include at least two and no more than three Specific Research Projects that address one or more of the focus themes identified below. These are recognized as potentially exploratory, discovery-based, and/or high-risk projects, with the goal of yielding interpretable results that will either prove or disprove the proposed hypothesis within a 3-year time frame.

Each Specific Research Project must utilize at least two cores of the IDDRC, which may include the Administrative Core and/or the Clinical Translational Core. Primary funding must be through this P50 mechanism, but other sources of funding are allowed (federal grant, philanthropic, or foundational support). The project can address a broad array of intellectual disorders, including new, recently characterized, or under-researched areas such as comorbid mental health conditions in IDD. In addition, because of delays in completing the Specific Research Project by many of the currently funded IDDRCs due to the COVID pandemic, investigators are allowed to choose one of these Projects to be a completion, continuation, and/or extension of a currently supported Project. The focus areas include, but are not limited to:

• -Omics approaches (e.g., genomic, transcriptomic, epigenomic, proteomic, metabolomic) to increase our understanding of IDD conditions that will improve diagnosis, management, and potentially, treatment.
• Development and/or validation of a biomarker, clinical outcome assessment, or measurement for one or more IDD conditions in one or more species.
• Development of real-world data to inform real-world evidence.
• Development of clinical outcome measures or biomarkers for the cognitive and/or behavioral phenotypes of IDD that could be used to demonstrate a change in response to intervention or treatment (“clinical trial readiness” approaches).
• Development of bi- or multi-modal treatment approaches for a single IDD condition or a group of IDD conditions to demonstrate combinatorial effects to ameliorate a cognitive or behavioral symptom(s) of the condition(s).
• Strategies or treatments to prevent and mitigate the impact of exposures that cause IDD, including many types of medications, substances of abuse, infectious agents, environmental exposures, toxins, or others.
• Interventions and approaches to manage co-occurring mental health conditions, including depression, anxiety, aggression, suicidal ideation, attention deficit hyperactivity disorder (ADHD), bipolar disorder, or psychotic disorders, in those with IDD.
• Innovative technologies to improve assessments, interventions, and outcomes for individuals with IDD, including wearable devices, communication aids, robotics, e-textiles, mobile device applications (apps), electrophysiological or other measures.
• Applications of artificial intelligence (AI)/machine learning (ML) for diagnosis and management of IDD conditions based on ethical and unbiased approaches.
• AI/ML for early detection, risk stratification, or predictive modeling of IDD.
• Validation of tools and technologies that can be implemented in the IDD community and engage PWLE of IDD, such as digital phenotyping or eye tracking software using a mobile device.
• Use of implementation science to improve outcomes for people with IDD and their caregivers. 

Leadership

The Center Director(s) (PD(s)/PI(s)) are responsible for developing and maintaining a Center environment that fosters traditional and novel approaches to multi-disciplinary research collaborations and educational activities. 

Educational Activities

As national resources for IDD research, the IDDRCs play leadership roles in the education of new investigators for the IDD research field and in educating the patient and lay communities regarding educational and research activities. Each Center should establish and maintain a strong mentoring environment for predoctoral and postdoctoral investigators in IDD research, as well as new and early-stage investigators. The Center may include, as examples, education on manuscript writing and reviewing, grantsmanship, team science approaches and lab management, as well as the ethical conduct of research. Other features of the environment may include a seminar program, retreats for presentation of research, journal clubs, or other activities that contribute to the preparation and mentorship of new and junior investigators for careers in IDD research. Education and outreach activities for the lay public may include seminar series, newsletters, public presentations, town hall meetings, social media posts, or other events to disseminate the goals and accomplishments of the Center. Educational and dissemination activities should be organized within the Administrative Core. 

Institutional Support

Scientific personnel and institutional resources capable of providing a strong research base in the IDD field must be available. A strong institutional commitment is essential. For example, the commitment may take the form of faculty appointments and/or partial salary support for investigators, purchase of research equipment and/or service contracts, and/or assignment of research space to facilitate collaborative research and interdisciplinary interaction. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective outside research projects. However, all activities using IDDRC Center funds must be relevant to the mission of NICHD's IDDRC program.

Administrative and scientific organization within a Center and across the network of IDDRCs should enhance opportunities for major discoveries and acquisition of scientific knowledge that will help prevent, diagnose, and ameliorate or treat IDD. NICHD encourages investigators within the Centers to apply for a variety of other grants, including clinical trials grants (e.g., R34, R01, and U01). 

The IDDRC Network

Recipients of IDDRC awards will become part of a national program in IDD research and will be expected to participate in IDDRC network activities, including monthly leadership calls, shared and coordinated activities and projects when appropriate, and an annual meeting of the IDDRC Leadership Committee (composed of IDDRC Directors, NIH program staff, and other relevant parties), that is held in the Washington, DC area, rotated among the IDDRC sites, or held virtually. 

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

This competition is limited to applicants that are recipients of IDDRC P50 awards under RFA-HD-20-016 or RFA-HD-21-009. Please refer to Section 1. Notice of Funding Opportunity Information for more details.

Foreign Organizations/International Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organization) 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 not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help. 

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. 

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

The PD(s)/PI(s) (known as the IDDRC Center Director(s)) should be a scientist or science administrator who can provide effective scientific and administrative leadership. The PD(s)/PI(s) of the IDDRC should be a recognized scientific leader(s) experienced in the field of IDD research and must be able to coordinate, integrate, and provide guidance in the establishment of research programs. The Director(s) will be responsible for the organization and operation of the IDDRC and for communication with the NICHD on scientific and operational matters. The Director(s) should be able to integrate and synthesize the proposed research, and, thereby, serve as an example to other investigators. The Center Director(s) should have a minimum total combined commitment of 2.4 person-months to the IDDRC. The Center Director(s) may also serve as the Director(s) on a Specific Research Project component or a Core of the IDDRC, although their total level of effort will need to increase accordingly. The Center Director(s) cannot serve as a Specific Research Project PD/PI on another active IDDRC award.  

Only recipients funded under RFA-HD-20-016 or RFA-HD-21-009 are eligible to apply. 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique entity identifier (UEI) number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type ‘Overall’.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Follow standard instructions.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Facilities and Other Resources: Describe the institutional support and commitment to the IDDRC. A strong institutional commitment is essential. The commitment may include faculty appointments and/or partial salary support for investigators, purchase of research equipment, or assignment of research space to facilitate collaborative research and interdisciplinary interaction. Scientists may have access to the Center's centralized facilities and participate in its activities while retaining independent control of their respective research projects. However, all activities using IDDRC Center funds must be relevant to the mission of NICHD's IDDRC program. 

Other Attachments:

Applicants must provide a table listing the outside research projects with other sources of funding that are proposed for core usage. Name the table "Research Projects Proposed for Core usage". Projects should be listed in alphabetical order by PD/PI surname. Research Projects must be either currently funded or pending award (status = to be paid in eRA Commons or IMPACII). 

For each outside funded research project proposed to access the IDDRC Research Center, provide the following information in tabular format: 

• PD/PI and level of effort (person-months)
• Title of project
• Source of support (including grant number and project designation, such as 5 R01 HG 12345 (P.I. - Smith), Project III (P.I.- Jones))
• Indication of funding status (funded or pending)
• Period of support
• Total first year or current 12-month budget
• Total project period budget
• Brief description of project (no more than 2 sentences)
• Brief relevance of the project to the center mission and IDD research (no more than 2 sentences)
• Brief justification for use of IDDRC core resources (no more than 2 sentences)

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission. 

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Include Specific Aims for the overall Center.

Research Strategy: Describe the major themes of the Center, its goals and objectives, background information and the overall importance of the research to advancing the diagnosis, prevention, treatment, and amelioration of IDD. Explain the strategy for achieving the goals defined for the overall program and how each Core and Specific Research Project relate to that strategy. Explain how the different aspects of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create a Center that is more than the sum of its parts. Include all necessary tables, graphs, figures, diagrams and charts in this section. In addition, provide the following information:

• Purpose and Objectives of the Center: Discuss the philosophy and objectives of the IDDRC and general plans for the proposed grant period. This section can emphasize information that demonstrates the Center’s past success in realizing its objectives.
• Administration, Organization, and Operation of the Center: Include information on the authority of the Center Director(s), the dissemination and communication plan, the use of internal user or Executive Committees and External Advisory Committees, and the method of determining Core access and space assignment. Describe the organizational framework and provide an organizational chart.
• Cost-Effectiveness and Quality Control: Describe procedures used to lower costs and assure quality of Center administrative and research activities.
• Connections between the proposed Center and other organizations such as patient advocacy groups, industry partners, or other Centers or IDDRCs.
• Accomplishments not previously cited: Describe any other experience the applicants have had with research centers/programs or core resources, which may include:
  • Use of center/program/core administrative funds for activities such as consultant services, scientific seminars, renovations, or travel;
  • Educational activities for graduate students, postdoctoral fellows, junior investigators, or members of the lay public that contributed to the center/program/core environment;
  • Investigators attracted to the field by the center/program and its core facilities, including trainees, new investigators and visiting investigators;
  • Impact of the center/program/core on the institution and community, including documentation of past successes in advancing IDD knowledge and research as well as outreach and dissemination activities and engagement of PWLE;
  • Role of the center/program/core in facilitating IDD research, assisting young investigators, attracting other research funds, and enhancing collaboration and interdisciplinary research; and
  • Other accomplishments. 

Letters of Support: Provide letters of support from institutional officials and letters of assurance/agreement for any collaborative and cooperative endeavors or subcontracts. Include letters of agreement from consultants. For projects to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application. Please compile all letters of support for the entire Center together in one section.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

When preparing your application, use Component Type ‘Admin Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Admin Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Admin Core)

Follow standard instructions.

Research & Related Other Project Information (Admin Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Admin Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Admin Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Admin Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Admin Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Describe the specific functions of key scientific and technical personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as equipment purchase or alterations and renovations. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. No recurring annual escalations in costs are allowed.

Allowable costs for the Administrative Core may include:

• Salaries for the Center Director(s) (PD(s)/PI(s)) specifying a minimum total combined commitment of 2.4 person-months (20 percent) effort to the IDDRC;
• Salaries and support for a limited number of administrative and clerical personnel, such as a Center Administrator, secretaries, and clerical support staff;
• Administrative support services, including supplies, duplication, telephone, and maintenance contracts for equipment when not covered by institutional F & A charges;
• Costs related to dissemination and communication of research results to investigators, the scientific community and lay public;
• Costs related to seminars or meetings designed to promote interdisciplinary interaction, education, or Center cohesiveness;
• Costs related to External Advisory Committee meetings;
• Costs of minor renovation for Cores may be included within the IDDRC budget; NICHD provides no funds for new construction;
• Travel of Center investigators to other IDDRCs or other collaborative sites to exchange scientific ideas, to plan multi-Center research projects, or to learn specialized techniques; and
• Travel for 2-4 IDDRC staff and trainees to annual meeting of the IDDRC Steering Committee (composed of IDDRC Directors, NIH program staff, and other relevant parties), to confer with other NICHD IDDRC Directors and program staff and promote scientific interaction among the Centers. This is held in the Washington, DC area, rotated among the IDDRC sites, or held virtually.

PHS 398 Research Plan (Admin Core)

Specific Aims: Include Specific Aims for the Administrative Core.

Research Strategy: The Administrative Core will be responsible for the management and administration of the overall IDDRC. This section of the application should describe the strategies and processes that will be used to manage the Center and achieve its goals. This Core, led by the Center Director(s), will provide oversight for the Cores and research project(s), and will promote coordination and collaboration within the Center and with investigators and organizations outside the Center. The Research Strategy should describe the planning and coordination of research activities; the integration of cross-disciplinary research; the oversight of fiscal and resource management; the dissemination and communication plan; the plans to incorporate the experiences of persons with lived experience (PWLE) into its activities; and the maintenance of ongoing communication internally and externally. Indicate who will be responsible for each of these activities. To assure active collaboration with other Centers, the IDDRC Director(s) should participate in monthly leadership calls, develop shared and coordinated activities and projects when appropriate, help to refine and standardize operating procedures among the Centers, and attend an annual meeting of the IDDRC Network, contribute to the coordination of effort, and/or help to refine and standardize operating procedures among the Centers. The application should provide the following information about the Administrative Core:

• Objectives of the Core
• Organizational Chart
• Staffing: Description of administrative/business management staff and oversight mechanisms by the Center Director (PD/PI), Center Co-Director (if applicable), and a local Executive Committee.
• Services Provided: Description of current and projected services to other Core and Research Projects, as well as the process for prioritizing requests for use of Core facilities by the various research projects. Include a description of past services provided by the Administrative Core personnel, new technologies developed, changes in protocols or Core administration, dissemination and community activities, and other significant accomplishments. The Administrative Core should establish and maintain a website to communicate the Center's mission and the availability of Core services. When multiple geographic sites are involved in the IDDRC, the Administrative Core should provide the leadership and communication needed to manage the multiple sites.
• Education: Include plans to establish and maintain an educational environment for predoctoral and postdoctoral investigators in IDD research, as well as new and early-stage investigators, and to engage the patient and lay community in educational and research activities. Utilization and adaptation of existing training programs are expected. The educational activities for the center may include, as examples: manuscript writing and reviewing, grantsmanship, team science approaches and lab management, as well as the ethical conduct of research. Other features of the educational environment may include a seminar program, retreats for presentation of research, journal clubs, or other activities that contribute to the preparation and/or mentorship of new faculty members or junior investigators for careers in IDD research.
• Dissemination and communication plan: Include a plan to promote communication about the research supported by the Center to other scientists, educators, the government, and the public, including those with IDD conditions and their families. The Center should serve as a communication liaison between investigators conducting state-of-the-art research and the public, and where appropriate, the information should be structured so that it can effectively reach representative populations. This Core should establish meaningful partnerships with the community, including PWLE of disabilities. The IDDRC should incorporate the experiences, perspectives, needs, and priorities of stakeholders, including those with IDD, into its decisions and activities. Education and outreach activities for the public may include websites, seminar series, newsletters, public presentations, social media postings, town hall meetings, or other events to disseminate the goals and accomplishments of the center.
• Executive Committee and External Advisory Committee: The Administrative Core should establish a local Executive Committee, composed of members of the Center, and an External Advisory Committee, composed of members outside the Center. Describe the general composition of the EAC and provide names of existing EAC members . Describe how the External Advisory Committee will contribute to oversight of the Core facilities and specific research project(s), as well as the educational environment of the Center. The External Advisory Committee should meet approximately once a year virtually or in person, and brief reports of the proceedings of the meeting and recommendations of the committee should be included in the annual progress reports of the Center.
• IDDRC Steering Committee: The Center Director(s) is expected to participate in a steering committee of the entire IDDRC network composed of IDDRC Directors, NIH program staff, and other relevant parties. This committee will hold monthly conference calls and at least 1 annual IDDRC network meeting.
• Cost-effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost-effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services in order to ensure the quality and value of the Core services broadly and the center as a whole.
• User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost-effectiveness, and other means to assess quality and value of services to investigators.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Admin Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed. 

Clinical Translational Core

When preparing your application, use Component Type ‘Clin Transl Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clin Transl Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Clin Transl Core)

Follow standard instructions.

Research & Related Other Project Information (Clin Transl Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. 

Project /Performance Site Location(s) (Clin Transl Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries. 

Research & Related Senior/Key Person Profile (Clin Transl Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Clin Transl Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

Budget (Clin Transl Core)

Describe the specific functions of key scientific and technical personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as significant equipment purchases. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. No recurring annual escalations in costs are allowed.

Allowable costs for the Clinical Translational Core may include:

• Salaries and support for Core Director(s)/core staff
• Supplies (including animals);
• Scientific equipment;
• Computer facilities and services;
• Travel for technical or administrative staff for technical training or to maintain operation of the core unit;
• Consultant services. 

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply. 

PHS 398 Research Plan (Clin Transl Core)

Specific Aims: Include Specific Aims for the Clinical Translational Core. 

Research Strategy: The Clinical Translational Core will be critical for supporting research that allows application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. This section of the application should describe the strategies and processes that will be used to promote the clinical and translational goals of the Center. This Core, led by the Core Director(s), will provide oversight for translational services provided by the Core. The Research Strategy should describe the planning and coordination of translational research activities; the integration of cross-disciplinary translational research supports; and the maintenance of ongoing communication between Core staff and investigators. The application should provide the following information about the Clinical Translational Core: 

• Objective of the Core
• Staffing: Brief description of scientific, technical, and support staff functions.
• Services Provided: Description of current and projected services available to Specific Research Project(s) of the Center and Projects Proposed for Core Use, as applicable, as well as the process for prioritizing requests for use of Core facilities by the various research projects. Include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant accomplishments.
• Administration: Description of overall management of the Core.
• Justification: Description of services provided and their bearing on productivity and quality. Describe how the service(s) provided will support research that allows application of basic science discoveries to the clinical setting, treatment development, and/or clinical trials. Explain how this Core will advance the diagnosis, prevention, treatment, and amelioration of IDD in individuals with these conditions.
• Utilization of Core: For Research Projects proposed to utilize the Core, provide a list or table of projected usage of Core services (e.g., assays performed, animals supplied, etc.). Sort the list/table in alphabetical order by last name of PD/PI, and include the grant number for each relevant project. Compile a summary of usage data across all projects for each category of services.
• Cost-effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost-effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services, including service contracts, maintenance schedules, and technical monitoring of services provided in order to ensure the quality and value of the Core services.
• User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost-effectiveness, and other means to assess quality and value of services to investigators. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Clin Transl Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed. 

Other Core(s)

When preparing your application, use Component Type ‘Core.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Other Core(s))

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates 

PHS 398 Cover Page Supplement (Other Core(s))

Follow standard instructions.

Research & Related Other Project Information (Other Core(s))

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. 

Project /Performance Site Location(s) (Other Core(s))

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Other Core(s))

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘[Name of] Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

Budget (Other Core(s))

Budget forms appropriate for the specific component will be included in the application package. 

For any Other Cores, describe the specific functions of key scientific and technical personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as significant equipment purchases. For additional years of support requested, justify any significant increases in any category over the first 12-month budget period. No recurring annual escalations in costs are allowed.

Allowable costs for Other Core(s) may include:

• Salaries and support for Core Director(s)/core staff;
• Supplies (including animals);
• Scientific equipment;
• Computer facilities and services;
• Travel for technical or administrative staff for technical training or to maintain operation of the core unit;
• Consultant services. 

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply. 

PHS 398 Research Plan (Other Core(s)) 

Specific Aims: Include Specific Aims for the Core. 

Research Strategy: Provide the following information: 

• Objective of the Core
• Staffing: Brief description of scientific, technical, and support staff functions.
• Services Provided: Description of current and projected services to Research Projects and Projects Proposed for Core Use, as applicable, as well as the process for prioritizing requests for use of Core facilities by the various research projects. If this Core already exists, include a description of past services provided, new technologies developed, changes in protocols or Core administration, and other significant accomplishments.
• Administration: Description of overall management of the Core.
• Justification: Description of services provided and their bearing on productivity and quality. Explain how this Core will advance the diagnosis, prevention, treatment, and amelioration of IDD in individuals with these conditions.
• Utilization of Core: For Research Projects proposed to utilize the Core, provide a list or table of projected usage of Core services (e.g., assays performed, animals supplied, etc.). Sort the list/table in alphabetical order by last name of PD/PI, and include the grant number for each relevant project. Compile a summary of usage data across all projects for each category of services.
• Cost-effectiveness and plans for quality control: Describe any cost structures such as fee-for-service, in-kind, charge-back systems, or other methods used to establish cost-effectiveness of the Core services. Describe quality controls systems in place to measure the accuracy, reproducibility, and reliability of equipment, assays or services, including service contracts, maintenance schedules, and technical monitoring of services provided in order to ensure the quality and value of the Core services broadly and the center as a whole.
• User satisfaction surveys: Describe frequency and content of user satisfaction surveys, evaluation of cost-effectiveness, and other means to assess quality and value of services to investigators. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions. 

PHS Human Subjects and Clinical Trials Information (Other Core(s))

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed. 

Specific Research Projects

When preparing your application, use Component Type ‘Project.’

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Project Name)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project Name)

Follow standard instructions.

Research & Related Other Project Information (Project Name)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components. 

Project /Performance Site Location(s) (Project Name)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project Name)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Name Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 

Budget (Project name)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply. 

PHS 398 Research Plan (Project Name) 

Specific Aims: Include Specific Aims for the Specific Research Project, clearly stating the overall objective of the project and indicate which of the focus areas it addresses, as well as its relevance to the focus area chosen. One of the Center’s Specific Research Projects is allowed to be a completion, continuation, and/or extension of a currently supported Project in an existing IDDRC. 

Research Strategy: For any Specific Research Project that involves preclinical research, adequate rigor is expected with regard to experimental design, minimizing bias, interpretation of results, and transparency of reporting. There is awareness among neurological disease communities that to assess the predictive value of preclinical research, sufficient information must be available about study design, execution, and analysis. NICHD urges applicants to the IDDRC program to consider the rationale for the chosen animal model(s) and endpoints, adequacy of controls, route and timing of therapeutic dosing, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results when describing preclinical studies and designing the Specific Research Project. 

A minimum of two Cores (which may include the Administrative and/or Clinical Translational Core) of the Center must be utilized by each Specific Research Project and should be identified.

Organize the Research Strategy as described in the SF424 Application Guide and use the instructions provided below. Start each section with the appropriate section heading Significance, Innovation, Approach. In the application, an explanation should be included describing how the Project relates to and both complements and is enhanced by the research goals and Cores of the Center. Specify the overall biomedical significance of the work proposed and why the project is best suited to be carried out in the Center environment. As part of the Research Strategy, include information on preliminary studies, data, and/or prior experience pertinent to this application, including progress made during the past period of performance if proposing a completion, continuation, and/or extension of an already funded Specific Research Project within a current IDDRC. Because the focus areas represent challenging scientific questions that may require overcoming critical barriers in the field, NICHD recognizes that applications may include Specific Research Projects that are exploratory, discovery-based and/or higher risk in nature. For example, if proposing a novel hypothesis, the investigators should be able to prove or disprove that hypothesis by the end of the funding period; if proposing an exceptionally innovative methodology or technology, the investigators should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible. If external sources of funding are available for the project, these must be clearly stated, including source, amount, and duration of support. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Do not include a Resource Sharing Plan for this Component. Any resources to be developed under this component should be included with the Resource Sharing Plan for the Overall Component. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Do not include a Data Management and Sharing (DMS) Plan within this Component. If a DMS Plan is required for this NOFO, it must be included within the Overall Component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project Name)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the How to Apply- Application Guide must be followed. 

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, the overall score for applications will emphasize the following:

• Overall effectiveness and adequacy of Core resources and facilities;
• Scientific merit and potential to advance the IDD field of the Specific Research Projects responding to one of the focus areas for this NOFO;
• Scientific merit and relevance to IDD of the research projects proposed for Core usage;
• Quality of the plans for management and oversight of the Center;
• Quality of the plan for dissemination and communication of findings to its constituents;
• Effectiveness of the Center in facilitating integrative IDD research, assisting young investigators, and enhancing collaboration and interdisciplinary research;
• Accomplishments of the Center in past cycle(s); and
• Synergy among the components of the Center.

The review will evaluate the potential for the Center as a whole to have a significant impact on the field during the terms of the award, weighing the balance of more conventional approaches with highly innovative components or projects in which success is not guaranteed. The overall score for the center application may be higher or lower than the average of the individual components based on the assessment of whether the whole is greater than the sum of its parts.

In addition, for applications involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation. 

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: Are the arrangements for internal quality control of ongoing research, allocation of funds, day-to-day management, contractual agreements, internal communication, external review, and cooperation among the investigators in the program well delineated and appropriate? Is there a track record of success in advancing progress in IDD-related research? Is the Center organized to support activities, projects, or clinical trials across the virtual IDDRC network?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Integration of the Overall Center

A major emphasis in evaluating the IDDRC is the integration or centeredness of the overall program. The IDDRC will be evaluated as an integrated collection of Core and Specific Research Components. The reviewers will evaluate the following:

• Does the program function as a true Center rather than a collection of unrelated support services and research projects with the sum of the parts being greater than the individual components?
• Is value added by having the proposed Cores and Specific Research Projects comprise a Center that allows the Center to leverage additional resources that would not have been possible without an integrated Center structure?
• Is the Center multidisciplinary in scope and do the breadth and overall quality of the Center's program, the Core Components, the Specific Research Projects, and projects proposed for Core usage have the ability to catalyze significant translational research advances in IDD?

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Human Subjects Policies

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals (as applicable), the committee will consider the progress made in the last funding period.

Revisions

For Revisions (as applicable), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations - Overall

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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Specific Aims

Reviewers will consider whether the applicant has certified the completion of specific aims from previously funded project proposals. 

Review Criteria for Core Components

Reviewers will assign an impact score based on the assessment of each Core Component in terms of the following review criteria. Separate criterion scores will not be assigned for Cores.

Administrative Core

Reviewers will evaluate the following:

• Core Director’s experience in research administration;
• Appropriateness of administrative structures and day-to-day management of the program;
• Decision-making process within the proposed center for the evaluation of research productivity, allocation of funds, and management of resources;
• Process for prioritizing use of Core facilities by the various research projects;
• Process for evaluating research projects and investigators for membership in the Center and access to the Cores;
• Mechanisms proposed for regular communication and coordination among investigators in the program;
• Plan for program evaluation, including the use of an internal Executive Committee and External Advisory Committee;
• Plan for dissemination of research findings to a broad spectrum of constituents; and
• Plan for establishing and evaluating partnerships with the community, including PWLE, that incorporates the experiences, perspectives, needs, and priorities of stakeholders, including those with IDD, into its decisions and activities.

Clinical Translational Core

Reviewers will evaluate the following:

• Experience of the Core Director in directing translational science;
• Likelihood that the service(s) provided will support translational science in IDD;
• Promotion of projects that will lead to treatment development and/or clinical trials;
• Responsiveness of the Core to Human Subjects issues that may arise; and
• Cost-effectiveness and quality control of the Core.

Other Core(s)

Reviewers will evaluate the following:

• Qualifications, experience, and commitment of the Core Director(s) and other Core personnel;
• Quality of the services provided;
• Cost-effectiveness and quality control of the Core;
• If Core already exists, the effectiveness and relevance of provided services and development of new technologies or other significant advances; and
• Utility of the Core to the program.

Review Criteria for Specific Research Projects

Reviewers will assign an impact score based on the likelihood of success for each Specific Research Project responding to one of the focus areas. Since the focus areas represent difficult, challenging scientific questions that may require overcoming critical barriers in the field, NICHD recognizes that applications may include Specific Research Projects that are exploratory, discovery-based and/or higher risk in nature. Reviewers are asked to evaluate the likelihood that interpretable results will be obtained from such studies within the time frame available. In evaluating higher risk components or exploratory projects with limited preliminary data, the reviewers are asked to weigh the potential to achieve transformative, paradigm-shifting advances against the risks. For example, if proposing a novel hypothesis, the investigators should be able to prove or disprove that hypothesis by the end of the funding period; if proposing an exceptionally innovative methodology or technology, the investigators should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.

Overall Impact – Specific Research Projects

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Specific Research Project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria.

Scored Review Criteria – Specific Research Projects

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Specific Research Project that by its nature is not innovative may be essential to advance a field.

Significance

Does the Specific Research Project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Specific Research Project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the Center structure facilitate the Specific Research Project's ability to make substantive advances in at least one of the focus areas listed in Section I? If high-risk or exploratory, does the Specific Research Project have the potential to achieve transformative, paradigm-shifting advances in the field?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well-supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the Specific Research Project Director(s), collaborators, and other researchers well suited to the Specific Research Project? If Early-Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise? Are their leadership approach, governance and organizational structure appropriate for the Specific Research Project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the Specific Research Project challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Specific Research Project? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed Specific Research Project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Specific Research Project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Have the investigators addressed applicable federal regulations and NIH policies for the protection of human research participants, including the evaluation of risks and protections in project proposals, appropriate ethical oversight of funded projects, and plans for monitoring data and safety in clinical research projects? If the Specific Research Project is high-risk or exploratory, will interpretable results be obtained? If proposing a completion, continuation, and/or extension of an already funded Specific Research Project within a current IDDRC, is progress adequate during the past period of performance, and can the project be completed within the time frame available?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Specific Research Project proposed? Will the Specific Research Project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the Specific Research Project well integrated into the Center as a whole?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria – Specific Research Projects

As applicable for the Specific Research Project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. 

Inclusion of Human Subjects Policies

When the proposed Center as a whole or a Specific Research Project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research. 

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. 

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations – Specific Research Projects

As applicable for the Specific Research Project, 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.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Specific Aims

Reviewers will consider whether the applicant has certified the completion of specific aims from previously funded project proposals. 

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons. 

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient organizations must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.

Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.” 

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

• ongoing and consistent access to HHS owned or operated information or operational technology systems; and
• receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Cybersecurity plans and procedures must at minimum include the following:

• Develop cybersecurity plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data:
  • Identify:
    • Develop an inventory of all assets and accounts with access to HHS owned and operated information or operational technology systems or which obtain PII or PHI for the purposes of the award.
  • Protect:
    • Limit access to HHS owned and operated systems to only those in need of access to complete reward activities.
    • Require all staff to complete annual cybersecurity and privacy awareness training. Visit 405(d): Knowledge on Demand (hhs.gov) to obtain free trainings, if needed.
    • Enable multifactor authentication for all employees, subrecipients, and third-party entities to access HHS owned and operated information or operational technology systems.
    • Regularly backup sensitive data and test backups.
  • Detect:
    • Install anti-virus or anti-malware software on all devices, servers, and accounts used to connect to HHS owned and operated systems.
  • Respond:
    • Develop an incident response plan. See Incident-Response-Plan-Basics_508c.pdf (cisa.gov) to learn about developing incident response plans.
    • Have cybersecurity incident reporting procedures that ensure the relevant HHS awarding agencies are notified of a cybersecurity incident within 48 hours of discovery. A cybersecurity incident is defined as an unplanned interruption to a technology service or reduction in the quality of a technology service, or an occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits.
  • Recover:
    • Investigate incidents and plug any security gaps identified. 

All activities proposed in your application and budget narrative must align with applicable law, including but not limited to statutes, executive orders, federal regulations and applicable judicial holdings.  Accordingly, discretionary awards shall not be used to fund, promote, encourage, subsidize, or facilitate; racial preferences or other forms of racial discrimination by the recipient, including activities where race or intentional proxies for race will be used as a selection criterion for employment or program participation; denial by the recipient of the sex binary in humans, or the belief that sex is a chosen or mutable characteristic; illegal immigration; or any other initiatives that compromise public safety.  If an application does not align, the application will not receive funding to the extent permitted by law and applicable court orders.

For applications involving substance abuse, the application must not support harm reduction. Please see Updated Funding Guidance for Recipients on Supplies and Services.

As of October 1, 2025, HHS has adopted 2 CFR Part 200, with some modifications included in 2 CFR Part 300. These regulations replace those in 45 CFR Part 75. However, for NIH, under the Consolidated Appropriations Act for FY 2026, (P.L. 119-75, Division B, Title II, Sec. 224), the provisions relating to indirect costs in 45 CFR 75 continue to apply to NIH awards. Consistent with the statute, NIH will not apply updated thresholds outlined within 2 CFR Part 200, at this time.

Not Applicable

3. Data Management and Sharing

A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.

Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NichdIDDRCProgram@nih.gov 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
nichdgrantsmanagement@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.