Firearm Injury and Mortality Prevention Research (NIH-wide research funding opportunity PAR-20-143, PAR-21-191, PAR-21-192) is sponsored by National Institutes of Health (NIH). NIH supports scientific research to develop, evaluate, and implement effective public health interventions to understand and prevent violence, including firearm violence, and the resulting trauma, injuries, and mortality.

Expired PAR-21-192: Firearm Injury and Mortality Prevention Research (R01Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations Office of Behavioral and Social Sciences Research ( OBSSR ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute on Minority Health and Health Disparities ( NIMHD ) Sexual and Gender Minority Research Office ( SGMRO ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

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

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention ( ODP ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Firearm Injury and Mortality Prevention Research (R01Clinical Trial Optional) R01 Research Project Grant Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) 93. 242, 93. 279, 93.

307, 93. 865, 93. 273, 93.

866, 93. 313 Funding Opportunity Purpose Nearly 40,000 people in the U.S. die from firearm-related deaths each year, primarily from suicide (60%) or homicide (37%), and many more have experienced non-fatal firearm injuries, both intentional and nonintentional.

The Joint Explanatory Statement accompanying the Consolidated Appropriations Act, 2021 ( Public Law 116-260 ) included funding for the NIH to conduct research on firearm injury and mortality prevention and recommended that NIH take a comprehensive approach to studying the underlying causes and evidence-based methods of prevention of firearm injury, including crime prevention.

Within the legislative mandates and limitations of NIH funding ( NOT-OD-21-058 , NOT-OD-21-056 ), the NIH encourages research to improve understanding of the determinants of firearm injury, the identification of those at risk of firearm injury (including both victims and perpetrators), the development and evaluation of innovative interventions to prevent firearm injury and mortality, and the examination of approaches to improve the implementation of existing, evidence-based interventions to prevent firearm injury and mortality.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to application due date Renewal / Resubmission / Revision (as allowed) All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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 SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. 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. Funding Opportunity Description The National Institutes of Health (NIH) is committed to understanding effective public health interventions to prevent violence, including firearm violence, and the trauma, injuries, and mortality resulting from violence.

The Department of Health and Human Services (HHS) is committed to improving the health and well-being of the nation through Healthy People 2030 (HP2030). HP2030 establishes targets for national health objectives and monitors and catalyzes progress over time to measure the impact of research and prevention efforts. Both injury prevention and violence prevention are identified as priority areas in HP2030.

Scientific research is critical to understanding and preventing firearm violence. NIH has supported research on the causes and prevention of firearm violence for many years and this funding announcement is intended to build upon the existing NIH research portfolio and address gaps and emerging opportunities to understand and prevent firearm violence injury and mortality.

The lives lost from firearm injury each year in the U.S. are comparable to the lives lost to motor vehicle accidents. When firearms are involved with violent events (including suicide, intimate partner violence, child or elder maltreatment, youth and gang related violence, sexual assault, and hate crimes), the risk for injury and mortality increases.

Firearm violence is responsible for three quarters of homicide deaths and is the most common and lethal means of suicide. In addition to physical injury, chronic health impacts, and potential mortality, witnessing or experiencing violent victimization increases the risk of acute and chronic mental and behavioral health conditions.

Firearm injury and mortality also contribute to health disparities - among males aged 20-24, the firearm homicide rate is more than 10 times higher for black men than for white men. Modifiable risk factors associated with firearm violence include a number of personal (e.g., alcohol abuse), interpersonal (e.g., social network), and community (e.g., high unemployment) factors.

Research encouraged by this FOA is consistent with a broad public health approach to firearm injury and mortality prevention including: 1) identifying those at risk for firearm injury and mortality (both victims and perpetrators); 2) development and evaluation of theoretically-grounded programs to prevent firearm injury and mortality; and 3) implementation research to explore the barriers and facilitators to support broader adoption of effective programs.

In addition to interventions delivered by healthcare providers and systems, this initiative encourages research delivered in community settings, and that integrates individual, family, interpersonal, community, and structural or system (e.g., criminal or juvenile justice, child welfare, drug courts) approaches to firearm injury and mortality prevention.

Thus, development of cross-sector partnerships and/or integration across disparate databases may be necessary. As a trans-NIH initiative, research on identification and screening for those at risk of firearm injury and mortality as well as prevention efforts should consider a comprehensive range of risk factors that transcend specific populations of interest to individual NIH institutes and centers.

As such, this FOA is comprehensive in its consideration of risk for victimization and/or perpetration across the lifespan and across sexual and gender identities , people with developmental disabilities or cognitive impairments (i.e., Alzheimer’s disease and its related dementias), comorbid conditions (e.g., psychiatric or substance use disorders), or other at-risk populations such as pregnant and post-partum women, justice system involved individuals, veterans, and members of the military.

In addition, consideration of NIH health disparity populations (who are often disproportionately impacted by firearm injury and mortality) is encouraged: specifically, Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

Priority research topics within the scope of this FOA may include but are not limited to: Understanding underlying causes and risk for firearm injury and mortality: Improve the ability to identify individuals at risk for firearm injury and mortality (victims and perpetrators), including suicide, homicide, and accidental injury and mortality.

This may include but is not limited to: a) developing, testing, or validating innovative tools and technologies to screen and/or monitor firearm violence risk and mechanisms; b) applying advanced predictive analytic approaches (e.g., artificial intelligence, computational modeling) in situations for which these approaches can best inform risk identification, and informed by an understanding of the limits of these approaches (e.g., less precision for under-represented groups; data that reflect biases already in systems), and c) developing and testing models addressing the spread of firearm violence (e.g., social contagion).

Develop, validate, and study implementation procedures, particularly for healthcare systems (including emergency departments and primary care) to determine who should be screened and how to screen accurately and efficiently for risk of firearm injury and mortality.

Improve understanding of developmental, situational, structural and contextual factors associated with firearm injury and mortality that extends individual risk assessment to include factors related to the specific incident (e.g. concurrent use of alcohol or substances) as well as other potential contextual influences (e.g., current social and public health crises).

In addition, consideration of multiple levels of influence (e.g., peers, family, community, and structural determinants), and interactions across these levels is encouraged.

Developing, evaluating and implementing interventions to prevent or mitigate the impact of firearm injury and mortality: Develop and/or evaluate innovative and culturally competent interventions delivered online, in healthcare, and/or community settings (e.g., schools/childcare, workplaces, justice settings, social service or public health agencies, assisted living facilities) to prevent injury and mortality and revictimization/repeat injury or retaliatory firearm violence among those at risk.

Interventions that involve multiple levels and sectors are encouraged and rigorous evaluations of natural experiments (e.g., firearm injury or mortality prevention programs that are already being implemented) will be considered.

Improve understanding and promotion of potential protective factors at the individual, family, community and structural levels (and their interactions) that could be enhanced to reduce the negative effects of risk exposure (e.g., resilience).

Conduct implementation research with existing evidence-based interventions (e.g., safe storage counseling, lethal means counseling, motivational interviewing (e.g., safERteens), community-based violence interrupter programs) to assess barriers at multiple levels (e.g., provider, social, environmental, system, structural or policy); improve fidelity, adherence, adoption and scale-up of these programs; and rigorously test strategies for implementing evidence-based interventions with fidelity and potential for sustainability.

Apply precision health and personalized medicine strategies to public health questions that determine for whom various firearm injury and mortality prevention programs are likely to be most effective. Assess the impact of combining public health and criminal justice (crime prevention) approaches to reduce firearm injury and mortality.

This includes the evaluation of natural experiments involving changes in or natural variation of various firearm laws and policies as well as laws and policies that may influence the impact of firearm injury and mortality prevention efforts (e.g., changes in alcohol or marijuana access and distribution, community policing programs, child welfare policies, clinician-reporting policies).

Research proposed in applications must be ideologically and politically unbiased. NIH funds may not be used, in whole or in part, to advocate or promote gun control or to support lobbying activities, as outlined in Section 4 of the NIH Grants Policy Statement (GPS).

Prior to submission, investigators are strongly encouraged to contact the IC scientific contacts listed in this FOA for advice on alignment with program priorities and polices.

NIMH support for clinical trials research follows an experimental therapeutics approach, whereby clinical trials are designed, not only to test the intervention effects on outcomes of interest, but also to inform understanding of the intervention’s mechanisms of action.

As such, applications that propose to develop and/or test the efficacy/effectiveness of preventive, therapeutic or services interventions must include specification of the intervention target(s)/mechanism(s) and assessment of intervention-induced changes in the presumed target mechanism(s) that are hypothesized to account for the intervention outcome.

See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated FOAs for NIMH clinical trials. See Section VIII. Other Information for award authorities and regulations.

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

Only those application types listed here are allowed for this FOA. 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 NIH intends to commit up to $12. 5M in FY 2021 on this topic, pending available funds. Application budgets are limited to $500,000 Direct costs per year.

Awards are multi-year funded with all funds awarded in the first year. The scope of the proposed project should determine the project period. The maximum project period is 3 years.

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration, but 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 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.

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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. 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 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 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 It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

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

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

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

SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

The following modifications also apply: Applicants to this funding opportunity must submit a data sharing plan that describes their proposed process for making resulting publications, code, and to the extent possible, the underlying primary data immediately and broadly available to the public. See Section 8. 2.

3. 1 of the NIH GPS. Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered “Yes” to the question “Are Human Subjects Involved?

” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

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

1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4. Submission Dates and Times Part I.

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

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 . Awards issued under this FOA will be multi-year funded with all funds awarded in the first year of the award.

Therefore, NIH will not issue awards, under this announcement, that allow future year funding. Recipients may request a one-year no-cost extension. Due to multi-year funding reporting requirements, additional extensions will not be allowed.

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

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

Any instructions provided here are in addition to the instructions in the policy. Section V. Application Review Information Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission 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.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?

How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

In addition, for applications involving clinical trials Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics?

For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented?

If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/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?

Data sharing plans: Are plans for data sharing adequately described? In addition, for applications involving clinical trials Does the application adequately address the following, if applicable Is