Research on the Impact of Ableism on Health Outcomes (RFA-HD-24-007)

Research on the Impact of Ableism on Health Outcomes (RFA-HD-24-007) is sponsored by National Institutes of Health (NIH). This funding opportunity encourages research to understand the impact of ableism on health outcomes for persons with disabilities (PWD), including underlying mechanisms and interventions at community or health systems levels.

Expired RFA-HD-24-007: Understanding and Mitigating Health Disparities experienced by People with Disabilities caused by Ableism (R01 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Eye Institute ( NEI ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) National Cancer Institute ( NCI ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Understanding and Mitigating Health Disparities experienced by People with Disabilities caused by Ableism (R01 Clinical Trial Optional) R01 Research Project Grant November 6, 2023 - Notice of Technical Assistance Webinar and FAQs for RFA-HD-24-007.

See Notice NOT-HD-23-034 September 14, 2023 - Notice of Correction to RFA-HD-24-007, Understanding and Mitigating Health Disparities experienced by People with Disabilities caused by Ableism (R01 Clinical Trial Optional)". See Notice NOT-CA-23-088 August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 .

August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189 . Notice of Funding Opportunity (NOFO) Number Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility. Assistance Listing Number(s) 93.

865, 93. 399, 93. 867, 93.

286 Funding Opportunity Purpose The goal of this NOFO is to encourage research to understand the impact of ableism on health outcomes. Research on the underlying mechanisms by which ableism adversely influences the health of persons with disabilities (PWD), as well as developing and/or testing interventions at a community or health systems level to mitigate adverse health effects of ableism are high priority.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to application due date Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description The CDC and US Census Bureau estimate about 61 million adults and 3 million children in the US have some type of functional limitation or disability. There is strong evidence that people with disability experience health disparities independent of other factors such as race/ethnicity, geography, and socioeconomic status.

People with disabilities (PWD) often face barriers to accessing healthcare, such as physical barriers that prevent them from entering medical facilities, inaccessible medical equipment, or a lack of transportation to medical appointments. Communication barriers also prevent effective interaction with healthcare providers. PWD are more likely to experience chronic health conditions, such as obesity, diabetes, and cardiovascular disease.

Moreover, PWDs are less likely to be up-to-date on routine preventive care, such as cancer screenings and have less access to physical activity equipment and adequate nutrition. There is a long history of overt and implicit discrimination towards PWD by the biomedical research community.

Recent studies have revealed that over 80% of physicians believe people with significant disabilities experience a worse quality of life than non-disabled people and only half of physicians surveyed strongly welcomed people with disabilities into their practices. Moreover, many physicians are unaware of their legal responsibilities under the Americans with Disabilities Act to provide reasonable accommodations to PWDs.

In healthcare settings, ableist beliefs often result in inequitable access to a wide array of healthcare services for PWD, whether due to physical environmental barriers, such as inaccessible medical offices and equipment, or biased medical decision-making, leading healthcare providers to limit services available to PWD, especially preventive care.

Ableism may lead healthcare providers to offer less aggressive treatment options to PWD or refuse outright to provide certain types of medical care.

During the COVID-19 pandemic, the US HHS Office of Civil Rights issued a bulletin reaffirming that persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative worth based on the presence or absence of disabilities...

This bulletin was issued following reports that some states and community hospital-based triage protocols, particularly the allocation of ventilators, were discriminatory towards PWD. Ableism is often an extension to the medical model of disability, which views a person’s impairment is a problem to be fixed and any loss of function is attributed to the individual.

In this context, disability may also be viewed as a failure of medicine and a trait to be eliminated. This NOFO encourages the use of the social model of disability. In this framework, disability is a consequence of environmental, social, and attitudinal barriers that may prevent people from fully participating in society, including receiving health care.

To further examine the impact of ableism on the health of PWD, NIH hosted a two-day virtual workshop in April 2023 titled Ableism in Medicine and Clinical Research. The workshop had two goals: 1) To raise awareness of the concept of ableism and 2) To identify research gaps and opportunities to understand and mitigate the health impacts of ableism on disabled people.

The workshops were recorded and are available for viewing on the NIH videocast: https://videocast. nih. gov/watch=49317 and https://videocast.

nih. gov/watch=49319 . Definitions relevant to this NOFO Ableism - Discrimination and social prejudice against people with disabilities.

Ableism characterizes people as defined by their disabilities and classifies disabled people as inferior to non-disabled people. Ableism may manifest in the physical environment (e.g., inaccessible medical facilities and equipment) or behaviors (e.g., failing to discuss reproductive health based on assumptions of the inability to get pregnant).

Structural ableism entails a complex system of hierarchical and discriminatory processes, policies, and institutions that privilege and prefer able-bodied people, fail to represent or meaningfully include disabled persons voices, and are grounded in a network of ableist beliefs and practices that maintain and reproduce unequal outcomes for disabled people and benefit able-bodied people.

(Keefe ES, 2022) Both ableism and structural ableism are included in this NOFO. Disability For the purposes of this NOFO, disability is a demographic characteristic, not an outcome measure. The term "people with a disability" is used throughout this NOFO for consistency, but we acknowledge that disabled person is the preferred term for some disability communities.

Both are inclusive of this NOFO. The purpose of this NOFO is to encourage research to understand how ableism contributes to health disparities for PWD and/or to develop systems level interventions to combat the negative health impacts of ableism. The types of applications anticipated through this solicitation include both observational and interventional studies.

Observational studies : Projects may (1) examine the impact of ableism on health, and/or (2) evaluate the impact that existing efforts to address ableism (e.g., laws, policies, programs, organizational practices and procedures) have on the health of individuals, families, and communities. Projects may involve collection of primary data/and or analysis of existing data and may involve quantitative or mixed methods approaches.

Projects must be exclusively conducted at domestic locations, including U.S. territories. Systems level intervention studies : Interventions may focus primarily on addressing ableism to improve health outcomes, or ableism may be included as one of several determinants of health addressed to improve health outcomes.

For both types of intervention approaches, interventions must directly address the cause or mechanism of action of the ableism, not just help individuals or populations with disability to cope with ableism. To this end, it is expected that investigators will collaborate with leadership from organizations, agencies, or programs from which the ableism is originating or being sustained.

It is also expected that interventions will engage other relevant actors within the setting (e.g., teachers, clinicians, co-workers, bystanders) as appropriate to enact changes to combat ableist practices and policies. Interventions should not only target people with disabilities who are directly experiencing ableism.

Research designs should allow for the assessment of mechanisms through which the intervention modifies ableism and how these changes result in improvement in the targeted health outcomes of people PWD. Mechanisms of interest related to ableism include changes to behaviors, environments, or policies at the interpersonal, organizational, neighborhood/community, or societal level.

The general interests of the participating NIH Institutes, Centers, and Offices are outlined below: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) NICHD is interested in projects that focus on ableism towards disability broadly.

Examples of studies responsive to this NOFO include but are not limited to: Development and validation of measures of ableism appropriate across a wide range of ages, levels of functioning, and categories of disabilities. Interventions to combat ableism at the health systems level, including those that reduce diagnostic overshadowing.

Studies of exposure to ableism among parents, family and/or other care partners on health outcomes for the people with disabilities. Interventions to reduce the effect of ableism on access and referral to routine preventive care such as contraceptive use; cancer screening; smoking cessation; vaccinations; or promotion of physical activity.

Interventions to reduce the effect of ableism on the access and referral for diagnosis and treatment of health problems experienced by PWD unrelated to their disabling condition. Studies of how ableism affects risk of exposure to violence and the management of the sequelae of violence. The effect of ableism on health literacy and personal agency for health care decisions for PWD.

Effect of ableism on self-determination related to reproduction and reproductive health. Adaptations or technologies to increase the accessibility of medical equipment for people with disabilities, especially imaging technology. Topics that are not responsive to this announcement include: Projects focused on reducing disability.

Projects that do not connect to primarily health outcomes. Projects primarily focused on documenting health disparities for PWD without reference to effects of ableism. Projects with interventions targeting the person experiencing the ableism and not systems level interventions.

Program will consider portfolio balance and the mission of the National Center for Medical Rehabilitation Research in funding decisions. Priority may be given to applications that propose to study ableism directed toward a diverse range of functional abilities or disabilities, or that focus on ableism impacting populations with physical disability.

NICHD Data Sharing Expectations and Requirements The NIH Policy for Data Management and Sharing (Policy) expects researchers maximize the sharing of scientific data and data be accessible as soon as possible and no later than the time of an associated publication or the end of the award period, whichever comes first.

NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (DMS Plan). The DMS Plan is expected to address the Elements as described in Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan ( NOT-OD-21-014 ). The Plan will be reviewed and approved by NIH Program Staff prior to award.

Awardees will be required to comply with their approved Plan and any approved updates. For human data, NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Information about DASH may be obtained at https://dash.

nichd. nih. gov/ .

For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP and the Sequence Read Archive, in line with the NIH Genomic Data Sharing Policy.

If use of DASH is not feasible, NICHD expects awardees to share data through other equivalent broad-sharing data repositories. For applications that aim to co-analyze already shared data with data that have not yet been shared with the broader research community, applicants should be aware that such primary data will be shared with the broad research community.

Additional information on the Data Management and Sharing Policy is available on the NICHD Office of Data Science and Sharing website. National Eye Institute (NEI) NEI invites applications addressing research gaps and opportunities to understand and/or mitigate the health impacts of ableism on people who are blind or have low vision. NEI will not support clinical trials that are greater than minimal risk on this funding opportunity.

For additional information on minimal risk definition and NEI Clinical Trial policies, see NOT-EY-23-001 . Applicants are strongly encouraged to contact the NEI Scientific Contact listed below to discuss the relevance of their proposed topic(s) to the research mission of NEI.

NIBIB Statement of Interest This mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. Under this NOFO, NIBIB will support applications that propose to develop or redesign medical technologies aimed at mitigating the health impacts of ableism.

To specifically meet the needs of populations with disabilities, applications developing novel technologies should incorporate a universal design approach and those building on existing technologies should provide significantly improved accessibility and ease-of-use for all.

Projects may span the development in research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed below to discuss the relevance of their proposed topic(s) to the research mission of NIBIB.

For applications proposing clinical trials, NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development.

NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

NCI Statement of Interest The National Cancer Institute (NCI) is interested in supporting research that addresses how ableism presents barriers to timely cancer preventive care, screening, diagnosis, treatment, and follow-up, and impedes access to and delivery of cancer care that contributes to health disparities for persons with physical/mobility and/or sensory (e.g., vision loss, hearing loss) disabilities.

NCI seeks to generate new knowledge that will help mitigate ableist attitudes and the stigma of disability so that persons with disabilities (PWD) can receive guideline-concordant cancer care.

In addition, NCI is interested in understanding the effects of structural ableism, which includes the physical barriers, policies, laws, and practices that exclude PWD from equal opportunity, and how these affect the quality of cancer care and contribute to health disparities, especially for PWD who are members of medically underserved minority or marginalized groups.

Research areas of interest include, but are not limited to: Understanding how the intersection of ableism with other forms of oppression (e.g., racism, homophobia, sexism, income inequality) affects the quality of cancer preventive care, diagnosis, treatment, and follow-up care, and contributes to cancer health disparities for PWD Developing strategies to improve participation of PWD in medical research and clinical trials Developing models of healthcare delivery that support PWD receiving guideline-concordant cancer care Applicants are encouraged to contact the NCI Scientific Contact to discuss the relevance of their proposed project to the research mission of NCI.

Applications must include a Plan to Include Lived Experience submitted as Other Project Information as an attachment (see Section IV; further below). The Plan will be assessed as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions.

Investigators are encouraqed to engage the consumers and/or users in a way that informs the scientific aims of the application and increases or validates the potential impact of the application (e.g., include people with disabilities and their lived experiences and /or care partners; disseminate the results to the community (including secondary use of data) as a way of engagement; and/or involve community in the planning stages thus increasing community participation).

See section IV Other Attachments for more details. To help accomplish the goal of increasing the diversity of the NICHD-supported research community, NICHD encourages applications from diverse investigators, including those that are underrepresented in the biomedical, behavioral or clinical research workforce (see data at http://www. nsf.

gov/statistics/showpub. cfm? TopID=2&SubID=27 and the most recent report on Women, Minorities, and Persons with Disabilities in Science and Engineering ).

Such individuals include women, those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds. See, Notice of NIH's Interest in Diversity, NOT-OD-22-031 . See, Notice of NIH’s Interest in Diversity, NOT-OD-22-031 .

See Section VIII. Other Information for award authorities and regulations. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards NICHD intends to commit $1,600,000 total costs in FY 2024 to fund 2-3 awards. NEI intends to commit $1,500,000 total costs in FY2024 to fund 2-3 awards. NIBIB intends to commit $800,000 total costs in FY2024 to fund 1 award.

NCI proposes to commit $650,000 total costs in FY2024 Budgets with direct costs of up to $499,999 per year may be requested. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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 Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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.

NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an 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 registrations; 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.

Eligible Individuals (Program Director/Principal Investigator) 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 their organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities , NOT-OD-22-019 .

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 SF424 (R&R) Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement. 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. 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, Grants. gov Workspace or an institutional system-to-system solution.

Links to apply using ASSIST or Grants. gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO. All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply: In an "Other Attachment" entitled "Plan to Include Lived Experience" all applicants must include a 1-page summary of strategies to advance the scientific and technical merit of the proposed project through expanded consideration of lived experience with disabilities.

The Plan will be considered as part of the scientific and technical peer review evaluation, as well as at the programmatic level with respect to funding decisions. Investigators are encouraged to engage with people with disabilities in a way that informs the scientific aims of the application and increases or validates the potential impact of the application.

The Plan will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.

Examples of items that advance the inclusion of people with lived experience in research and may be part of the plan can include, but are not limited to: Discussion of engagement with users and/or caregivers/partners such as focus groups that enable incorporation of lived experience from multiple individuals with disabilities.

Description of the plan to incorporate People with Lived Experience (PWLE) in a way that informs the scientific aims of the application and increases or validates the potential impact of the application. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan.

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 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.

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 SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. 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.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have