The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)

The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional) is sponsored by National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health, U.S. Department of Health and Human Services. This grant supports innovative population-based research on how work or occupation influences health outcomes and health status among health disparity populations and how work functions as a social determinant of health.

PAR-25-292: The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Minority Health and Health Disparities ( NIMHD ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Cancer Institute ( NCI ) National Institute on Aging ( NIA ) December 06, 2024 - Participation added ( NOT-AG-24-088 ) National Institute of Nursing Research ( NINR ) January 07, 2024 - Participation added ( NOT-NR-25-010 ) Funding Opportunity Title The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional) R01 Research Project Grant Notices of Special Interest associated with this funding opportunity January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs.

See Notice NOT-OD-26-029 . March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

January 7, 2025 - Notice of Participation of the National Institute of Nursing Research (NINR) in PAR-25-292, "The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)". See Notice NOT-NR-25-010 . December 6, 2024 - Notice of Participation of the National Institute on Aging in PAR-25-292, "The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)".

See Notice NOT-AG-24-088 . April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

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 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 307, 93.

242, 93. 279, 93. 393, 93.

396, 93. 399, 93. 866, 93.

361 Funding Opportunity Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities.

Funding Opportunity Goal(s) The National Institute on Minority Health and Health Disparities (NIMHD) mission is to lead scientific research to improve minority health and reduce health disparities.

To accomplish this, NIMHD plans, coordinates, reviews, and evaluates NIH minority health and health disparities research and activities, conducts and supports research in minority health and health disparities, promotes and supports the training of a strong research workforce, translates and disseminates research information and fosters innovative collaborations and partnerships.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. 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.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. 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 Although scientific and technological discoveries have improved the health of the U.S. population overall, some populations continue to experience a disproportionate burden of disease and risk factors, unmet health care needs and other adverse health conditions.

Work activity is known to be important to health as a source of “exposures and risk factors,” a source of beneficial social and economic resources, and attainment of social position and status. In addition to formal work, under-employment and unpaid and informal work arrangements are also important work activities to understand.

While the contribution of work to health outcomes and substantial occupational segregation for populations that experience health disparities are known, few studies have explored to what extent and by what mechanisms work explains health disparities.

Because work can be modified and is amenable to intervention, the examination of the role of work as a social determinant of health (SDOH) presents an opportunity for research that may illuminate causal pathways and potential solutions for health disparities.

Research demonstrates the importance of work for health outcomes, mostly through direct effects due to exposures and risk factors arising from someone’s occupation or workplace experiences. For example, 8. 4% of all cancer deaths are attributable to workplace exposures including secondhand smoke.

Workplace physical conditions such as excessive heat or cold, noise, physical exertion, and chemical hazards have been linked to multiple diseases. Workplace psychosocial hazards such as job strain (low control, high psychological demands) are consistently associated with cardiovascular disease. Job strain is also associated with depression, postpartum depression, and obesity.

Precarious employment is linked to poor mental health. Underemployment is linked to lower levels of health and wellbeing than adequate employment. Workplace discrimination is linked to poor mental health and substance use.

Work, as a source of beneficial social and economic resources, is also linked to better quality health care and improved health outcomes. In the U.S., employment linked benefits constitute the primary source of health insurance coverage for about half of the population, which influences access to and use of care, and the type of insurance contributes to quality of care.

Work policies, such as paid sick leave, are linked to use of preventive health services, such as cancer screenings and immunizations. Also, increases in paid parental leave are linked with decreases in perinatal, neonatal, post-neonatal, infant, and child mortality. Profound occupational demographic differences in the U.S. labor force has been documented.

For example, African American/Black and Latino/Hispanic persons are the least likely to be in managerial and professional jobs and the most likely to be in service and blue-collar jobs. A national study found consistent associations between working in demographically segregated occupations and poor worker health.

However, the degree to which occupational segregation can be explained by education versus other factors needs to be evaluated. Another study found that occupational segregation accounted for disproportionate mortality rates for Latino/Hispanic and African American/Black workers.

There is also segregation within a workplace by social identities (e.g., sex, age, social class, disability status, marital status, head of household) that can result in large differences in exposure to workplace hazards and receipt of benefits from workplace policies, but the extent to which this explains disparities in health and health care outcomes is unknown.

Macro-level conditions that limit opportunities, resources, and power, shown by census tract areas with high social vulnerability, are linked to substantial health disparities. However, what is not known is the extent that these place-based health disparities are due to regional or location specific income disparities, unfavorable labor market conditions, uneven occupational opportunities, and/or high unemployment rates.

Moreover, there are large differences in life trajectories based on someone’s work, including differences in achieving social status and position, and in access to work-related resources and social networks, but how these influence health and health care disparities is yet to be examined.

Given the uneven distribution of “work” among populations affected by health disparities, work is implicated in both health and health care disparities and research is needed to examine the mechanisms and pathways through which this uneven distribution influences health and health care disparities.

Occupational health disparities research has mainly focused on work as a source of hazardous exposures linked with a specific health outcome. This initiative is a call for research to examine work beyond only being a source of “exposures and risk factors,” examining it also as a source of beneficial social and economic resources and attainment of social position and status.

The main objective of this initiative is to determine the extent and mechanisms by which work as a SDOH both contributes to, and helps ameliorate, health and health care disparities. A workshop on September 28-29, 2020 that was organized by NIMHD ( https://www. nimhd.

nih. gov/news-events/conferences-events/hd-workshop. html ) highlighted key ideas for furthering research on work as a SDOH that include conceptualizing work as a social class marker, as a source of “exposures and risk factors,” and as a source of beneficial social and economic resources such as income and wealth, neighborhood conditions, health care access, education, and social networks.

Some key questions include: What are the specific and modifiable mechanisms by which work explains health disparities? To what extent does work as a social class marker, source of “exposures and risk factors” and/or source of beneficial social and economic resources explain health disparities? Which health disparities does work as a SDOH explain?

Of particular interest are projects designed to examine pathways and mechanisms using conceptual model(s) grounded in minority health and health disparities theories that recognize that health disparities arise by multiple and overlapping contributing factors acting at multiple levels of influence (See the NIMHD Research Framework, https://www. nimhd. nih.

gov/about/overview/research-framework. html). Projects must include a focus on one or more of the NIH-designated populations that experience health disparities in the United States.

Studies involving primary data collection with human participants are strongly encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit ( www. phenxtoolkit. org ).

For conceptualization of SDOH, see the description provided by the NIH-wide Social Determinants of Health Research Coordinating Committee . Of interest are intersectional approaches that consider different social identities and the embeddedness of individuals within families, households, and communities.

Life course approaches that consider the role of work in shaping cumulative processes and critical transitions including periods of unemployment, under-employment, and unpaid and informal work arrangements, are also encouraged. Also, of interest is considering the role of work at the household level with influences on the health of partners and extended families, and the intergenerational transmission to children and their health.

In addition, exploring the role of mechanisms that constrain choices around work and health is also encouraged.

Additionally, of interest are projects that explore whether work can explain the health or health care disparities seen within diseases or conditions (e.g., opioid use disorder, mental/behavioral health, diabetes, cancer, heart disease, asthma, and maternal and infant health) as well as disparities in co-morbidities and general indicators of health such as greater global burden of disease, quality of life, and daily functioning.

Projects that utilize a syndemics lens (i.e., multiple disease states that are interlinked because of social, environmental, and structural conditions), to examine the role of work in disparities in co-occurring health conditions, are encouraged.

Also, of interest are projects that explore how work contributes to health care disparities including but not limited to disparities in access to preventive, specialty, and emergency care, in health insurance coverage, and in quality of health care.

Moreover, given the reciprocal relationship between work and health, of interest are projects that examine how health impacts access to different work opportunities, working conditions, and work benefits, and how that varies by different social identities. Projects may involve primary data collection and/or secondary analysis of existing datasets.

Projects may utilize observational studies, natural experiments, quasi-experiments, simulation modeling, as well as use of large-scale longitudinal data sets, data mining techniques, registries, surveillance data, and linking to administrative data sets such as the Occupational Information Network (O*NET). Quantitative and mixed methods approaches are encouraged.

Investigators are encouraged as appropriate for the research questions posed, to forge research collaborations with community partners and stakeholders in the conceptualization, planning and implementation of the research to generate better-informed hypotheses and enhance the translation of the research results into practice.

Applications Not Responsive to the FOA Projects that only explore pathways and mechanisms for how hazardous exposures are linked to a specific health outcome, without exploring how they contribute to population-level minority health, health disparities or health care disparities. Projects that do not include a focus on one or more NIH-designated populations that experience health disparities in the United States.

Projects conducting research outside the U.S. or its territories and possessions, the Commonwealth of Puerto Rico, or the Trust Territory of the Pacific Islands, or requesting foreign components. Projects that do not utilize a clear conceptual framework and theoretical model to guide the analyses.

Projects that only describe the existence of health disparities related to work without examining the mechanisms through which work contributes to these disparities.

Areas of Research Interest National Institute on Minority Health and Health Disparities (NIMHD): NIMHD is interested in studies that evaluate: The role of work as a SDOH, teasing apart work as a social class marker, as a source of “exposures and risk factors”, and/or source of beneficial social and economic resources.

The extent to which work as a SDOH further explains health and health care disparities, in the context of and after accounting for socioeconomic status (years of education and/or household income) among racial or ethnic minority populations. The mechanisms and causal pathways by which work contributes to health and health care disparities.

This includes mechanisms influenced by factors such as occupational segregation and workplace segregation as well as other i mechanisms such as perceived societal discrimination based on sex, age, marital status, social class, disability status, and other factors that constrain choices around work and health.

The mechanisms and causal pathways by which work as a SDOH contributes to health disparities for specific diseases or clusters of diseases (e.g., syndemics), health conditions, and general indicators of health such as greater global burden of disease, quality of life, and daily functioning.

The mechanisms and causal pathways by which work as a SDOH contributes to health care disparities in access to and quality of primary care, preventive services, and specialty consultations, after accounting for type of health insurance coverage.

The role of work as a SDOH for household units of the primary employee, and the mechanisms and pathways by which work influences health disparities for household members, such as partners, children, grandparents, dependents, and extended families.

The extent to which work as a SDOH influenced by macro-level conditions (e.g., workplace restructuring, entrepreneurism, rise of self-employment occupations, rise of the gig economy, increases in precarious jobs, natural disasters, recessions) can explain, exacerbate, or mitigate national, regional or location specific health disparities.

The extent to which work as a SDOH is influenced by system-level trends, shifts in labor, and sector disruptions and their role in exacerbating or mitigating the contribution of work to health and health care disparities.

The implementation of employee benefits (e.g., paid family and medical leave, paid sick leave, workers compensation, medical benefits, and wage level policies) and their differential effects for populations with health disparities.

The reciprocal relationship between work and health, and how health for populations, such as increased prevelance of disease and co-morbidities impacts work as a SDOH, including access to different work opportunities, working conditions, and work benefits, and how that varies by different social identities.

National Institute on Drug Abuse (NIDA): NIDA is interested in research that explicates the mechanisms by which employment and drug use are related, in order to inform the future development and testing of interventions to directly address those mechanisms. NIDA encourages stakeholders and end users to be active partners in all stages of research so that findings have greater potential to directly influence practice.

Examples of NIDA interest areas include, but are not limited to: Studies to understand the structural (e.g., loss of venues or sectors) and individual level (e.g., occupational injuries) aspects of employment and their influence on drug use (including opioids and stimulants) and related health problems including infectious disease (e.g., HIV, HCV) and mental illness.

Studies of the effects of drug involvement on employment opportunities, job seeking behaviors, job training/job readiness, and job retention to identify the mechanisms by which use impacts employment and vice versa. Studies that examine structural or social aspects work environments that might facilitate or hinder recovery, e.g., peer recovery groups in restaurant or entertainment industry.

Studies that examine how structural aspects of engaging in treatment (e.g., residential treatment, daily visits to an Opioid Treatment Program, timing of appointments, transportation) influence occupational opportunities and outcomes.

Studies that examine the influence of structural aspects of work environments and/or employment outcomes for family members or supportive others (e.g., parents, spouses) and how those factors influence substance use, treatment and recovery outcomes for individuals who have a substance use disorder. Studies that examine how working in a peer recovery support role influences the worker’s own substance use, mental health, and recovery.

National Institute on Mental Health (NIMH): NIMH is interested in studies that examine: The mechanisms and potential causal pathways by which work as a SDOH affects mental health symptoms/disorders, either by contributing to, or ameliorating mental health care disparities in individuals and among household members.

Establishing causal pathways could be examined through randomized controlled trials where appropriate, or through analytic methods such as instrumental variables, propensity score matching, or other appropriate analytic methods.

The extent to which work as a SDOH differentially impacts the presence and severity of mental health symptoms in individuals who have histories of job loss and/or periods of underemployment, and/or the mechanisms and potential causal pathways that contribute to the impact of such job loss/underemployment on the mental health symptoms among members of their family, neighborhood, and community.

The extent to which work as a SDOH impacts interpersonal relationships that may affect mental health status, for example, by creating differences in quality of interpersonal relationships within the work environment (e.g., perceptions of interpersonal disconnectedness, bullying, verbal abuse) that contribute to worsening mental health status, including feelings of hopelessness, isolation, burdensomeness, emotion dysregulation, and presence of suicide ideation and behaviors.

The extent to which work as a SDOH promotes positive experiences at the individual (e.g., improved self-efficacy, improved belongingness), familial (e.g., positive familial relationship, reduced family conflict, improved family functioning), neighborhood (e.g., neighborhood cohesion, support), and community-level (e.g., improved community investment, reduced community violence) to reduce presence and severity of mental health symptoms.

For research on the effectiveness of interventions or services, NIMH requires a study design using an experimental therapeutics approach, in which clinical trials test intervention effects on mental health outcomes as well as elucidate the intervention’s mechanism(s) of action. Clinical trials applications that do not adhere to the experimental therapeutics framework will be considered non-responsive to this FOA.

Therefore, applications must specify intervention target/mechanism and assess whether intervention-induced changes in the target account for the hypothesized outcome. In the case of services interventions, targets/mechanisms might involve change in service-user, family and/or provider behavior, or in organizational/system-level factors to improve access, engagement, continuity, quality, equity, and/or value of services.

Studies adapting interventions for racial and ethnic minority populations (e.g., American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and other Pacific Islanders), socioeconomically disadvantaged populations, and underserved rural populations should provide an empirical rationale for the adaptation/augmentation target and a clear hypothesis and plan to address the target mechanism by which the adapted intervention will enhance outcomes.

See the Support for Clinical Trials at NIMH web page for additional information. NIMH also encourages researchers to provide a data analytic plan that specifies how multi-level factors, effects and interactions, or outcomes will be conducted. 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 Grant: A financial assistance 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 How to Apply 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 The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. 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 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 Organizations) 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 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 the 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.

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.

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. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

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. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- 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 How to Apply- Application Guide.

All instructions in the How to Apply-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 How to Apply- 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 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 Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply- 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 How to Apply- Application Guide must be followed. PHS Assignment Request Form 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