Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose:

This funding opportunity announcement (FOA) seeks to support research that examines the impact of leveraging health information technology (health IT) to reduce disparities by increasing access to care, delivery of higher quality of care, improving patient-clinician communication, and health outcomes for minority health and health disparity populations in the U.S.

Background:

Health information technology (health IT) has tremendous potential for increasing health equity for racial and ethnic populations. Health IT tools such as electronic health records (EHRs), patient portals/patient health records (PHRs), and clinical decision support (CDS) may yield population health benefits for underserved populations by enhancing patient engagement, improving implementation of clinical guidelines, patient safety, and reducing adverse outcomes. EHRs and CDS may help improve documentation of social determinants of health (SDoH) & inform patient care for those most vulnerable who have multiple chronic diseases and higher health risks. Availability of real time actionable patient data , clinical care coordination, and decision support enabled by health IT tools may also reduce disparities in quality of care for underserved populations who often experience a greater burden of chronic diseases and are more likely to demonstrate signs of poor management of chronic disease. Better clinical care coordination via health IT could improve clinician performance and adherence to clinical guidelines, reduce redundant testing due to clinician biases, detect treatment risks, and thus consequently facilitate equitable treatment for underserved populations.

Although health IT holds much promise for reducing disparities in underserved populations by facilitating behavior change and improving quality of health care services and health outcomes, few studies have examined the impact of health IT adoption on racial/ethnic disparities in outcomes. In fact, the federal health IT strategic plan 2015-2020 ( https://www.healthit.gov/sites/default/files/9-5-federalhealthitstratplanfinal_0.pdf ) calls for research evidence on how health IT can reduce disparities in the quality, accessibility, and safety of health care and long-term support services.

Of the limited studies, the findings, for example, indicate that health IT investment can reduce disparities in process of care and care standardization. Additionally, attention to unintended consequences associated with the use of health IT needs to be monitored to ensure health disparities are not inadvertently exacerbated. Research is needed to investigate the potential unintended consequences of health technologies such as, impact on clinician-patient communication in general and with vulnerable patients in particular, barriers that prevent the uptake and engagement with EHRs and PHRs by medically underserved patients, effective approaches and models to deliver CDS in safety net clinical settings, and the best models for the inclusion and utility of SDoH in EHR systems/CDS tools that will have the most effect of improving health equity for racial and ethnic populations.

Health IT and Primary Care Transformation :

Research is also needed to explore the contributions of health IT on new models of primary care delivery such as advanced primary care and the patient-centered medical home (PCMH), in a variety of settings- particularly in safety net clinics . Health IT tools are vital to the success of the PCMH innovation effort which holds promise for achieving the triple aim of improved population health, lower co sts, and better patient experiences in health care. For example, clinical data from patient registries can help clinicians identify gaps in care and opportunities for outreach. EHRs can facilitate teamwork to ensure follow up of key test results are completed and care gaps of patients are addressed. E vidence-based solutions are also called for in low resource primary practice settings where the potential benefits of health IT are greater g iven challenges to utilize EHR systems for quality improvement of care processes.

Health IT tools can also have potential for great utility in the care of complex chronic diseases (e.g., CKD/ Chronic Kidney Disease, RA/ R heumatoid Arthrit is, COPD/Chronic Obstructive Pulmonary Disease , post-solid organ transplants ) in primary care settings that serve health disparity populations who often experience a disproportionate burden of chronic diseases and require more complex care because of co-morbidit ies. For example, CKD is often poorly detected in primary care and treatment is suboptimal. Emerging evidence indicates support for the use of electronic CKD registries to enable guideline-concordant care of CKD in primary care settings.

Research is needed to explore the potential of decision support tools, and new technologies such as artificial intelligence and natural language processing on EHR platforms , to improve health outcomes for complex chronic diseases . Limited studies exist that investigate RA outcome improvements via EHR interventions in clinical care in diverse settings. Primary care EHR data and CDS tools to improve the uptake of COPD guidelines also warrants further investigation to determine the practice patterns most effective for disease management in diverse primary care settings . I mple mentation models that leverage health IT to manage the health outcomes of vulnerable patients who have received solid organ transplants in partnership with transplant specialists are also needed.

Health IT and Patient-Clinician Communication:

The complexities of patient-clinician communication in the era of EHRs will also need to be evaluated with ethnically diverse vulnerable populations with chronic disease since communication barriers during medical encounters may further augment health disparities via decreased patient participation in shared decision making. Additionally, changes such as information overload, documentation burden, and stress that EHRs bring to relationships between patients and clinicians or between clinicians warrant further investigation in the context of minority health and health disparity populations . Patients of safety net clinics often face challenges of limited digital and health literacy, and/or English proficiency, that impede their usability of patient portals. This disparity in usability of patient health portals raises the concern that a digital divide may exclude the most vulnerable patients from the benefits of portal use. The issue of a digital divide will also need to be investigated in other specialty settings such as oncology to determine how patients from vulnerable populations access incoming portal data.

Health IT and Social Determinants of Health (SDoH) :

Finally, the inclusion of SDoH in EHR/CDs is critical for advancing population health equity. R esearch is needed to explore the optimal approaches of collecting and integrating SDoH into EHRs /CDs to effectively guide clinical care and increase shared decision making between physicians and patients . The American College of Physicians published a position statement on SDoH (https://www.acponline.org/acp_policy/policies/addressing_social_determinants_to_improve_patient_care_2018.pdf ) recommending the development of best practices of utilizing EHRs to screen and collect SDoH data to assist in health impact assessment and inform evidence driven decisions. Documentation of SDoH into EHRs is also supported by the National Academy of Medicine (2014). SDoH, as defined by healthyPeople.gov ( https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-of-health ) are conditions in the environment in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. Examples of SDoH factors of interest include finance (e.g., employment, income, debt, food security) , neighborhood/built environment (e.g., housing, transportation, public safety, walkability, parks, social capital, access to local food markets, residential segregation) , education (e.g, literacy, access to job training) , and a ccess to health care services .

Advances in big data, geospatial technology, and public access to large data sets that provide contextual information also make it feasible to embed community level geocoded data into EHRs. Having this geocoded data readily available would allow healthcare teams to see for example, if patients live in a high poverty area, have access to healthy food sources, walkable streets, social capital, and how these resources (or lack of) predict increase risks for adverse health outcomes and impact treatment adherence. CDS tools could provide alerts to healthcare teams of patients who, for example, may need to be screen or monitored for depression based on a community level predictor (e.g. high unemployment) or public health concern. Research is needed to examine when and how in the clinical workflow geocoded community level data can be utilized with CDS tools to have the most impact on health outcomes of vulnerable patients. In addition, individual perception of community level metrics such as perceived safety, access to healthy food and community cohesion, may be utilized in a similar manner.

Research Objectives

This funding opportunity announcement (FOA) seeks to support the use of clinical trials, comparative effectiveness research, observational studies, and implementation science to investigate how to leverage health information technology (health IT) to improve minority health care and reduce health disparities by increasing access to care, delivery of higher quality care, improving patient-clinician communication and health outcomes for minority health and health disparity populations in the U.S.

Research Methodology

Projects should include a focus on one or more NIH-designated health disparity populations in the United States, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations of any race, underserved rural populations, and sexual and gender minorities. Projects should involve collaborations from relevant stakeholders in U.S. health disparity population groups, such as researchers, community organizations, healthcare systems or clinics, clinicians, public health organizations, consumer advocacy groups, and faith-based organizations.

Projects that focus exclusively on mHealth interventions at the patient level (e.g., the use of fitness related mobile applications), in the absence of incorporation of health IT elements within a healthcare system, are not targeted for support in this FOA.

Projects that examine the financing of health care or the cost and efficiency of health care service delivery, without linking such economic analysis to measurable health outcomes, are considered outside of NIH's mission and will not be supported. See NOT-OD-16-025 for more information.

Specific Areas of Research Interest

Areas of research interest include but are not limited to the following:

• Implementation models of delivering CDS in diverse settings (e.g. small, rural, safety net clinics) and the usability of these tools to determine what is working & what is missing in reducing disparities in quality of care and outcomes;
• Multi-level (system, clinician , patient) i nterventions that leverage health IT to improve the care of complex chronic diseases in diverse primary care settings including PCMH- that serve health disparity populations ;
• Implementation models of leveraging health IT for quality improvement in less resourced primary care practices that serve health disparity populations;
• Enable interoperability of health IT tools (e.g., mobile apps, wearables, and other devices) with EHR systems to support the integration across high and low-resource clinical settings, health systems, to screen, communicate, share data, and enhance decision support for patients and providers.
• Advance human-centered design methodologies to develop multilevel communication tools to translate, transcribe and analyze patient information into digital platforms. Studies may include examination of implementation and systems integration of digital health technologies within existing health care workflows and home/community settings and organizational and policy impact.
• The unintended negative effects of EHR use on patient clinician & clinician-clinician communication , relationships, and health outcomes and the impact on underserved health disparity populations;
• The impact of using automated algorithms to inform disease risk assessment, detection, diagnoses, and treatment decision-making on disparities in healthcare quality or outcomes;
• Interventions that address the health literacy demands of EHR driven conversations on shared decision making and the health outcomes of patients in safety net clinics ;
• Disparities in adoption rates of patient portals/PHRs especially among older minority users, rural residents, low-income patients, persons with LEP and/or limited health literacy, and racial/ethnic minority patients;
• The types of interventions/personalization needed to foster patient engagement of patient portals/PHRs in a sustained and relevant way for underserved populations;
• The utility and effectiveness of the inclusion of SDoH & community level geocoded data and/or perceived community level measures in EHRs/CDS on health outcomes;
• Evaluation of when in the clinical workflow can SDoH & community level geocoded data in EHRs/CDS have the most beneficial impact on health outcomes;

National Cancer Institute (NCI)

The National Cancer Institute encourages submission of applications designed to study development, testing and implementation of multi-level digital health technology interventions aimed at improving cancer prevention and control along any aspect of the cancer control continuum to reduce cancer health disparities and promote health equity. These digital health technologies should enable identification or monitoring of health disparities, integration of social determinants of health in patient care and public health (without exacerbating existing disparities), or enable the delivery of interventions to reduce health disparities. Importantly, NCI defines multi-level broadly, to include studies that incorporate interventions addressing two or more of the following levels: individual (patient, caregiver, clinical provider), clinical team (two or more providers including primary and specialty care and support staff), Health care institution ( Collection of primary and specialty care providers, and support staff, health care administrators, medical facilities, and organizational structures. Together these people, institutions and resources provide the environment for the comprehensive delivery of healthcare services) , home, workplace, social network, community setting, , public health, social service, and policy environments. NCI encourages intervention components to be clearly specified and explicitly linked to new, refined, or existing multi-level theories and the digital health technology should be used to connect data, information, communication, interventions across levels. The use of novel and alternative research and intervention designs (e.g., sequential multiple assignment randomized trial (SMART), multiphase optimization strategy (MOST), hybrid effectiveness and implementation designs and factorial experimental designs, human centered design approaches are highly encouraged. Note, NCI’s definition for health disparities and health equity: https://cancercontrol.cancer.gov/research-emphasis/health-disparities.html

NCI is interested in diverse submissions - including but not limited to those that:

• • Develop and test effectiveness, acceptability, and adoption of health communication platforms tailored to different environments among racial/ethnic populations and underserved low resource communities for cancer prevention and control.
  • Develop and test digital health tools that enable integration of geospatial information and technology designed to facilitate health-related uses of social and environmental data that are spatially linked, including integration that allows for studies examining barriers to accessing health care services and/or cancer care and prevention.
  • Development of data visualization, NLP, AI and other products that facilitate communication of electronic health information for prevention or control of cancer or cancer co-morbidities to patients, caregivers and providers in clinical settings. These may include integration of innovative combinations of data (e.g., genetic information, environmental exposures, contextual factors) to inform the design of multi-level interventions aimed at cancer prevention and control.
  • Develop and test digital health tools for monitoring and surveillance of health care treatment disparities and racial/ethnic, socioeconomic, gender, and sexual orientation/identity bias, to enhance quality of care for cancer patients and survivors.
  • Develop and test IT-based interventions that improve information sharing and care coordination across time and space among clinicians delivering care to cancer patients, especially in rural and other under-served areas.
  • Examination of implementation outcomes (e.g., adaptation, acceptability) in developing tools for implementation of decision support tools, mobile health behavioral monitoring protocols, and cancer symptom management platforms.
  • Integrate novel patient-generated data capture tools (i.e., wearable technology) to identify clinically-relevant, actionable information to improve patient care and outcomes for cancer health disparities related outcomes.
  • Develop, test and or implement tools that enable and enhance patient engagement in chronic disease management and prevention among cancer survivors across age, sociodemographic, health and digital literacy and linguistic barriers.
  • Develop and test the efficacy of digital health tools (mobile, EHR) that can be used collectively to promote recruitment, enrollment and data collection for clinical trials, particularly for groups underrepresented in clinical trials.

Office of Behavioral and Social Sciences Research (OBSSR)

The research priorities described in this funding opportunity announcement align well with the OBSSR Strategic Plan (https://obssr.od.nih.gov/about/strategic-plan/ - Priority Two: Enhance and promote the research infrastructure, methods, and measures needed to support a more cumulative and integrated approach to behavioral and social sciences research). OBSSR will not be assigned any applications from this funding opportunity announcement. Instead, OBSSR supports the stated research priorities of the participating Institutes/Centers, and the office may co-fund applications assigned to those Institutes/Centers.

Section II. Award Information

Section III. Eligibility Information

1. Eligible Applicants

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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• 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
• Regional Organizations

Applicant organizations

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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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.

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 NOT-OD-11-101)

Section IV. Application and Submission Information

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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

Beda Jean-Francois, Ph.D.

National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9764
Email: beda.jean-francois@nih.gov

R&R or Modular Budget

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

Research Strategy. Describe how the project will contribute to understanding the impact of leveraging health technology (health IT) to reduce health disparities among health disparity populations. Identify the health disparity populations included in the study and provide a rationale for this population focus. Describe how the project uses a multidisciplinary approach, including integration of the disciplines and expertise of the research team, to understand the challenges of leveraging health IT to reduce disparities in access to care, delivery of higher quality of care, improving patient clinician communication, and health outcomes for minority health and health disparity populations in the U.S. If there are foreign component(s), describe how the proposed activities at foreign sites will improve minority health and/or help reduce health disparities in the United States.

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Generally, Resource Sharing Plans are expected and are applicable for this FOA

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.

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 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). 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 Policy on Late Application Submission.

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 the SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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.

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

For all CT FOAs, add the following questions, after the standard questions for the Significance criterion.

For all CT FOAs, add the following questions, after the standard questions for the Significance criterio

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

For all CT FOAs, add the following questions, after the standard questions for the Investigator(s) review criterion.

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

For all CT FOAs, add the following questions, after the standard questions for the Innovation review criterion

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?

In addition, for applications involving clinical trials

For all CT FOAs, add the following questions, after the standard questions for the Approach review criterion.

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, gender, 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/gender 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?

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/gender, 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?

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

For all CT FOAs, add the following questions, after the standard questions for the Environment review criterion.

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?

Study Timeline

Specific to applications involving clinical trials

For all CT FOAs, add the following questions, before the Human Subjects Protections criterion.

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 Women, Minorities, and
Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. 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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Resubmissions, 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

Revisions

For Revisions, 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.

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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

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.

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 policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

• 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.
• Will receive a written critique.

• 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.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

3. Reporting

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application processes and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

I-Jen Castle, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-827-4406
Email: I-Jen.Castle@nih.gov

Laura E. Kwako, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov

Tiffani Bailey Lash, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: baileylasht@mail.nih.gov

Beda Jean-Francois, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9764
Email: beda.jean-francois@nih.gov

April Oh, Ph.D., MPH
National Cancer Institute (NCI)
Telephone: 240-276-6709
Email: April.oh@mail.nih.gov

Elizabeth Ginexi, Ph.D.
NIH Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 240-594-4574
Email: LGinexi@mail.nih.gov

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

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Angela Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: aeldridge@mail.nih.gov

Priscilla Grant, J.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Section VIII. Other Information