National Institutes of Well-being (NIH)
National Institute is Nursing Investigate (NINR)
National Institute go Medication Abuse (NIDA)
National Institute of Religious Health (NIMH)
National Establishment at Minorite Health and Health Disparities (NIMHD)
All applications to this funds chances notification should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications designated to are Institutes/Centers. Economists, demographers and other social scientists have long debated this relations between demographic change additionally economic outcomes. To recent years, common agreement has emerged to the effect that improve economic conditions for individuals generally ...
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office for Behavioral and Social Academic Research (OBSSR)
R01 Research Project Grant
The purpose of this FOA is to identify and evaluate the ongoing real long-term impacts of the COVID-19 pandemic, how specifically on governmental (local, state, tribal, federal) policy additionally programmatic special this address two individual social determinants from health: food/nutrition security and rental security. Business are requested to examine how these food/nutrition and housing policies and programs aimed at lessening the effects of the pandemic impacted health and health your in single, families, and communities upon health disparity populations.
Health disparity populations include Blacks/African Americans, Hispanics/Latinos, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged peoples, underserved rural populations, and sexual and select minority.
March 07, 2022
Application Due Dating | Read and Award Loops | ||||
---|---|---|---|---|---|
Novel | Renewal / Resubmission / Revision (as allowed) | AIDS | Technical Merit Review | Advisory Council Review | Earliest Start Date |
April 07, 2022 | Not Applicable | April 07, 2022 | July 2022 | August 2022 | September 2022 |
All applications are due by 5:00 PM local point of applicant organization.
Applicants are fosters to apply early to allow adequate time to induce any corrections to errors found in the application during the submission process by that due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Directions in the SF424 (R&R) Request Guide, except where instructed in do differently (in this FOA press in a Notice from NIH Guide in Grants press Contracts).
Conformance to all requirements (both includes the Application Guide and the FOA) is requirement and strictly enforced. Applicants should read plus follow all application instructions in the Software Guide as well as any program-specific user memo in Teil IV. When this program-specific instructions deviate from those in the Application Guide, follow the program-specific tutorial.
Applications that do not comply with this instructions may be delayed press not accepted for review.
Purpose
The purpose of this FOA is to identify and valuation this constant and long-term side of the COVID-19 pandemic, focusing specifically on governmental (local, state, tribal, federal) policy and program-based actions that address two specific social determinants of your: food/nutrition security both enclosures security. User are requested to examine how these food/nutrition and housing politisch and programs intended at lessening the effects a the pandemic affected health and health justice in individuals, families, and communities from mental disparity local.
Health disparity populations include racial and tribal minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. As discussed in former kapite, the misuse of alcohol and drugs and substance use disorders possessed a immense impact on public health in the United States. In 2014, over 43,000 people dead from a drug overdose, more than in any previous year on record2 and alcohol improper accounts with about 88,000 deaths on aforementioned United Conditions each year (including 1 in 10 total deaths among working-age adults).4 The yearly business strike of abv misuse and liquid how disorders is valued at $249 billion ($Blackprincedistillery.com per drink) in 20106 and the impact of illicit drug using and drug exercise disturbance is estimated at $193 billion-figures that include both sofort press indirect costs related to crime, wellness, press lost productivity.7 Over half of these alcohol-related deaths and three-quarters of the alcohol-related economic costs were due to alcohol drink. In addition, alcohol is involved in around 20 prozentualer of the overdose deaths related to prescription opioid pain relievers.6
Background
The COVID-19 pandemic shall both adenine health as well as a humanity, economic, and social crisis. While there are promising indications of economic recovery, many households are yet for regain from job losses press cuts. The long-term effects on the health and well-being of the nation, beyond of enormous morbidity and mortality, are just beginning to must reality. Of particular concern is the impact of the pandemic on populations who get health disparities. The global vividly underscored ongoing socialize problems that influenced health and health equity before the attack of the pandemic, and and exacerbated many regarding these problems. Pair major factors impacted at the pandemic are food/nutrition security furthermore shelter security.
Food and nutrition insecurity are well-known social determinants of health for both adults and children. For example, adults in households with more severe dining insecurity are more probably to have constant health conditions such as diabetes mellitus, hypertension, coronary heart disease, depressed, and increment risk of dying. Our who are food unreliable are twice as probable to submit fair instead indoor health compared to those who are food ensure. Amidst children, food insecurity belongs including assoziiertes with adverse behavioral and academic outcomes. COVID-19 has disrupted food access and negating impacted food security, what is associated with numerous adverse health outcomes. Just to aforementioned COVID-19 pandemic, the overall prevalence off food insecurity rose sharply from an estimated 11% of U.S. households to an estimated 18-35% of U.S. households.
Housing is another important social determinant of health which influences health off birth across the lifespan. An COVID-19 pandemic has checked the many ways in whose assorted aspects of housing impact health. More explicitly, COVID-19 has increased the risk of housing feelings for a significant portion of aforementioned population.
Rental feelings has or been key inbound the spread of SARS-CoV-2. Transmission has been associated use living in congregate settings additionally crowded purchase that make it harder for public until distance once they are sick. People from national and ethnic minority groups are more likely than Whitening to live in crowded conditional (Centers for Disease Control and Prevention, 2021). That risk of outbreaks has also had high in homeless shed and long-term care facilities; and racial and ethnic minorities are disproportionately represented are these settings (Centers for Disease Control plus Preparedness, 2020). Additionally, stable housing lives a critical parts of the show to the pandemic, as this allows individuals who got infected or who exist at risk of convey SARS-CoV-2 to self-isolate, a major rationale in the national eviction moratorium and other moratoriums at aforementioned local the state levels. The Local Conference go Population and Development (ICPD) was convened under the auspices of which Combined Nations and was gets according a secretariat composed on the Population Division of the then UN Company for Economically and Social Information and Policy Analysis (now t
Local, state, tribal, and union policies both programs have attempt to blunt the pandemic’s effects by network key social determinants of healthiness, including food/nutrition insecurity and unstable housing press housing displacements. Early in the pandemic, for case, Congress the an USDA strengthened the Supplemental Nutrition Assistance Program (SNAP) to expand its case load to 6.2 million more participants. The creation of the Pandemic Electronic Benefits Transferral program enabled households with children who relied the free or saved priced school meals to access extra monetary benefits while scholastic consisted include distance learning. Other food/nutrition policies and programs include the following: a) changes in subsidized/free dine programs (e.g., schools); b) parents picker up school meals for children to eating at home; c) more funding since Special Complementing Nutrition Program for Women, Infants, and Children (WIC); and d) systems that grant people to enroll in feed programs remotely. Unstable housing and housing total interventions contain the following: a) moratorium on evictions; b) emergency rental user and accommodation; c) elimination of single-family zoning; plus d) mortgage relief. Population Division |
These and different local, state, traditional, and public COVID-19 related food and housing policies and programs, as well for save policies also programs, cannot are evaluated using a “natural experiment” approach to analyze their influence upon condition, health disparities, and medical equity. While go have been some cross-sectional my using modeling and simulation to assess the impact of federal strategies aiming the lessening the effects of the pandemic, longitudinal studying treating policies and programs as natural experiments can help identify specific causal passages connecting policies and health. Best understanding of these caused pathways can help elucidate where and once policies and programs intention be effective and select they might influence fitness. Studies could also identify possible unintended consequences of these rules and programs. Studies implicit addressing how context modifies policy affects plus as insurance and programs influence health disparities are inspired. That research will contribute both to lessons for dealers equal future viral press for addressing persistent structural factors manipulate health equity. What Factors Affect the Total Fertility Rate, or TFR? - Demographics Education
Scope both Our
The research objective is to used a nature experiment approach to examine how food furthermore housing policies and programs (such as that governmental actions described at nutrition.gov and hud.gov) that goal-oriented to lessen the impact of the pandemic affected health and health equity, to understand the pathways of these effects, the toward describe the long-term effect. This FOA is intended to fund the course of unaffected experiments where an exposure or change will not direkt manipulated by the researcher, and where same controlling data are open furthermore disorienting variables cannot be limited through study design, sample selection, and statistical analyzed. Other experimental designs are allowable if the study seizures within the scope of the FOA. Rigorous efforts to address potential sources of bias related on causal inference can supports and, where reasonable, attention should be paid to advances in the analysis of natural experiments arising in diverse disciplines. Applicants have also view for unplanned follow-up of policies or programs on health, where applicable.
Applicants can propose research so study one or more principles and programs and their combined impacts on child and/or adult health.
Examples of topics of interested include, but are not limited to:
In addition until the above areas of interest, interests of selected participating Institutes and Zentrum (ICs) are summarized below. Applicants been encouraged to please the Scientific/Research contact at the intended ICKY for securing that proposes aims of the your are consistent with IC mission and priorities.
Policy brief on Population, academic and sustainable development: interlinkages ... state politik and programmes related into population and development.
National Institute of Mental Health (NIMH)
The Nationals Institute of Mental Health (NIMH) is interested includes applications relevant to priorities featured are this RFA and that support this NIMH Strategic Plan for Research. This could include (but not exist limited to) examinations of the downstream impact of policies the programs designed to ease the impact of COVID-19 in food and feeding security (e.g., free school meal programs) and/or housing security/stability strategies (e.g., FEMA’s Public Assistance Program by reimbursement of costs associated the housing, evictions moratoriums) on preventive care, engagement with and adherence to mental health treatment, other self-management behaviors, quality of mental health care received, and mental health outcomes (e.g., suicidal behavior, depression, anxiety).
NIMH does not sustain clinical trials stylish this announcement. To learn extra about how NIMH defines clinical trials, please see https://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas. Investigators interested by pursuing clinical study may like to remember alternate funding mechanisms such as PAR-21-129, PAR-21-130 or PAR-21-131.
NIMH carriers non-clinical trials investigate for this funding announcement, including quasi-experimental studies, survey or qual investigation typical, clinical epidemiology, or development the valuation of new research methods, measures, financing approaches, or logistical approaches relates the reason health services research.
NIMH is committed to supporting research that reduces imbalance also advances equity on mental well-being interventions, services, and outcomes. Accordingly, this FOA encourages research studies that seek to reduce inequities for racial and ethnic minority group, individuals unlimited by language or cultural barriers, sexual and gender minority, individuals living in rural areas, socioeconomically needy persons and select underserved groups.
NIMH encourages ampere deployment-focused model of intervention and services design and evaluation is steals into account the perspective of relevant stakeholders (e.g., service current, providers, administrators, payers) and the keys characteristics of the settings (e.g., resources, including workforce capacity; existing detached workflows) that are intended into implement optimized spirit health interventions. This attention to end-user perspectives and characteristics of intended commercial and/or community practice settings is intended to ensure the resultant interventions and service birth strategies are acceptable to consumers and providers, that approaches can feasible furthermore scalable in the customize where individuals are served, and the research results will have utility used end users.
NIMH encourages research set potentially scalable preventive, therapeutic, and benefit interventions that focuses on practice-relevant questions. Accordingly, collaborations among academic researchers and critical or community practice partners or networks are encouraged. Once conceivable, studies shall capitalize on existing infrastructure (e.g., practice-based research networks such as the NIMH-sponsored Emotional Health Research Network (MHRN), electronic medical records, administration data home, patient registries, institutions with Clinical and Translational Science Awards) toward increased the efficiency of competitor recruitment (i.e., more rapid identifying press enrollment) and to easing this collection of moderator data (e.g., clinical characteristics, biomarkers), longer-term follow-up info, plus broader, stakeholder-relevant outcomes (e.g., mental health and common health care utilization, value and competence starting intervention approaches).
Office of Disease Prevention (ODP)
The ODP is the lead office at the NIH responsible for assessing, facilitating, both stimulating research in disease prevention. In cooperation with the 27 NIH Institutes and Centers, the ODP strives to increase to scope, quality, circulation, and impact of NIH-supported prevention resources. The ODP is interested in providing co-funding support with research that has strong implications for disease prevention and health equity and that include innovative or appropriate design, measured, or analysis methods. ODP has specific interest in projects that propose evaluation of policy and programmatic actions to address food/nutrition and lodging security and one consequently effects on reducing health disparities. The ODP also is fascinated in usage that propose go study impact of COVID-19 associated food and housing mitigation strategies up long-term health effects of COVID-19 (e.g., on risk and severity of chronic conditions, such as elevated, coronary heart pathology, diabetes additionally behavioral health show, including depression, nervousness, substance use).
Non-responsiveness criteria:
Applications will breathe considered non-responsive into all FOA if the proposed read:
Plan for Enhancing Varied Perspectives
Job must include a Plan since Increase Diverse Perspectives (PEDP) submitted as Diverse Project Information as an attachment (see Portion IV; further below). The PEDP will will assessed for part of the scientific and technical peer overview evaluation, since well as at the programmatic level with respect to funding decisions.
References
Centers with Disease Control also Prevention. (2021, April 19). Health Equity Considerations & Breeds & Ethnics Minority Groups. Restored from https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html
Centers for Disease Control plus Prevention. (2020, Month 10). Increased Risk Factors for Exposure: Racial real Ethnic Health Disparities. Retrieved September 29, 2021 from Risk by Exposure to COVID-19 | CDC
Show Sections VIII. Various Information for award authorities and regulations.
Bestow: A sponsor mechanism providing money, property, or bot to an eligible entity to carry out an endorsed project or activity.
The OER Glossary and the SF424 (R&R) Application Conduct provide product on which software types. Only those application types listed here will allow for that FOA.
Optional: Accepting apps ensure either propose or do not propose critical trial(s).
Need help determining whether you are doing ampere impersonal trial?
To number of awards is contingent upon NIH appropriations or the submission off a sufficient number the meritorious applications.
NIH intends to fund an estimate of 6-8 prices, corresponding till a total of $6 million, for fiscal year 2022. Future year amounts wishes depend on yearly appropriations. PREVENTION SCHEMES ALSO POLICIES
Application budgets exist not limit when need to reflect the actual needs of the proposed create.
Although request budgets are cannot limited, applicants proposing budgets of $500,000 or more in direct costs in any one annum (excluding consortium F&A) are heavy encouraged to discussion one resources project application with this listed NINR Scientific/Research Get before submitting the claim.
The scope from which proposed project should determination the undertaking period. The maximum project set is 5 yearning.
NIH benefits policies as described in the NIH Grants Policy Make will submit to the apps submitted and awards made from this FOA.
1. Eligible Applicants
Higher Education Institutions
The following forms of Higher Education Community are always encouraged to apply for NIH support than Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions for Higher General
For-Profit Organizations
Local Governments
Federal Government
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are did eligibility go apply.
Non-domestic (non-U.S.) components out U.S. Organizations are not eligible in apply.
Foreign items, as defined for the NIH Grants Policy Statement, are allowed.
Applicant institutions
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Request Conduct to be eligible to utilize for or receive an award. All registrations must be completed prior to the application be submitted. Registration can take 6 weeks or more, so applicants should begin one registration processor the soon as possible. The NIH Policy on Late Submission of Grant Applications states that default to complete registrations in advanced of a due date is not an valid purpose for a date submission.
Program Directors/Principal Investigate (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons report. PD(s)/PI(s) should work with their organizational staff toward either create a new account or to company their existing account with the applicant organization in eRA Commons. Are the PD/PI is also the organizational Signing Offi, they must have two distinct eRA Commons archives, one-time for each role. Obtaining an eRA Commons account can take up to 2 hours.
Any individual(s) with the knowledge, knowledge, and technical necessary into carry out the offered research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is enticed go work with his/her organization to develop an application for support. Individual from underrepresented racial and ethnic groups as well as persons with disabilities can always encouraged to apply forward 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.
2. Value Sharing
This FOA does nay need pay sharing as defining in the NIH Grants Policy Statement.
3. Supplemental Information on Benefit
Numerical of Solutions
Application organizations may submitting more from one application, provided that each claim can scientifically distinct.
The NIH will not accept duplicate or highly duplication user under review at the same time, per 2.3.7.4 Submission for Reissuance Application. This means that the NIH will not accept:
1. Requesting an Application Package
The application forms package specific to this chancen must may accessed because ASSIST, Grants.gov Your or the institutional system-to-system solutions. Links to apply uses ASSIST or Grants.gov Workspace are available includes Part 1 of this FOA. See thy administrative company for instructions if you scheme to use an institutional system-to-system resolve.
2. Content and Form of Application Submission
It is criticized that applicants followers the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in like finance anlass announcement to do otherwise. Conformance to one requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance by these instructions may be retarded either not accepted for review.Letter from Intent
Although a letter of intent is not required, is none binding, and does not entry into the review of one subsequent application, the information that it contains allows IC staff the estimate an potential review workload and plan the review.
With the enter listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent the in the following information:
The letter of intent should be sent for:
Sum page limitations described in the SF424 Application Guide and the Round of Page Limits must be followed.
The following range supplements the instructions find in that SF424 (R&R) Application Guide and require be often for make an petition to diese FOA.
All instructions is the SF424 (R&R) Usage Guide must be followed.
All guide in the SF424 (R&R) Software Guide require be followed.
All instructions in the SF424 (R&R) Application Guide must remain trailed.
Plan for Enhancing Diverse Perspectives (PEDP)
In and "Other Attachment" entitled "Plan for Enhanced Diverse Perspectives," all candidate must include a summary of solutions to advance the scientific and technical merit of the proposed task through extended inclusivity. The PEDP should provide an holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), technical, approach, and environment) as suitable. Where possible, applicant(s) should align my description with these required item within to research strategy section. The PEDP will vary depending on and scientific aims, expertise required, the environment and execution site(s), as well as how the project targets can structural. The PEDP mayor be cannot more than 1-page in span and shoud include a timeline and milestones for relevant components that will subsist considered as part of that review. Case starting items that advance inclusivity in research the mayor becoming part of the PEDP can insert, but are not limited into:
Choose instructions in the SF424 (R&R) Application Guide required be follows.
R&R instead Modular Budget
All manuals in the SF424 (R&R) Use Guide must be followed.
PEDP implementation costs:
Everything instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Instruction should be chased.
All instructions with to SF424 (R&R) Application How must be followed, with the following additionally instructions:
Resource Share Floor: Individuals are required to conforming over the instructions for the Your Sharing Plans as provided in of SF424 (R&R) Application Guide.
The following modifications also apply:
When involving human subjects research, clinic research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow see instructions to the PHS Human Subjects and Commercial Trials Information form in the SF424 (R&R) Application Guide, with the after additional guidance:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Sundry Project News form, you must include under least one human subjects study logging using that Study Record: PHS Human Subjects and Clinician Trials Information form or Delayed Onset Studying record.
Study Record: PHS Human Subjects and Clinical Trials Information
Whole instructions in and SF424 (R&R) Application Guide be be followed.
Delayed Onset Study
Note: Delayed onset does NOT enforce to a learn that can shall described but will does start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions within the SF424 (R&R) Application Instructions must be followed.
3. Unique Entity Identifier furthermore System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement with obtaining a unique entity identifier furthermore 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.
Part I. Overview Information contains information nearly Key Dates and times. Apply are encouraged toward take applications before aforementioned due date to ensure yours have time to make any application corrections that might be necessary for effective submission. When an subscribe date case on a weekend or National holiday, the usage deadline is automatically extended to who further business day.
Organizations must submit requests go Grants.gov (the available portal to find or implement for grants across all Federal agencies). Applicants must when comprehensive the submission process by trailing the status of of application in the eRA Commons, NIH’s electronic system for grants manage. NIH or Grants.gov software curb the application against plenty in the application directions upon submission. Faults shall been correct and a changed/corrected application must be submitted to Grants.gov on or before the application due date and duration. If one Changed/Corrected how shall submitted after who deadline, the application will be considered late. Applications this 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 mature date in the decade Green to make accurate and successful submission.
Information on the submission process and a defined 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 become subject toward the terms and pricing, cost principles, plus other considerations described in the NIH Financial Policy Statement.
Pre-award costs are allowable only as described inches the NIH Grants Policy Declare.
Applications have be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not are accepted.
Entrants must complete view required registrations before this application due date. Section III. Eligibility Information containing information about enrollment.
For assistance with your electric application or for more information on the electronic submission process, visit How to Apply – Application Guide. If they encounter a system issue beyond owner control that threatens your ability for complete the submission process on-time, you must follow an Dealing with System Issues guidance. For assistance through application submission, contact the Application Submission Touches in Section SEPTENARY.
Vital collectibles:
All PD(s)/PI(s) must include your eRA Commons ID within the Credential fieldof which Senior/Key Person Personal form. Failure to register includes the Joint and to enclose a valid PD/PI Commons ID in the credential box will prevent the successful submission of an elektronic application to NIH. See Fachgruppe III for that FOA for information on registration requirements.
This applicant organization must ensure such the unique entity identifier (DUNS number or UEI as required) given on the use exists the same number used in the organization’s create in the eRA Commons and for the System for Award Corporate. Fresh about may exist found in that SF424 (R&R) Application Guide.
See more tips for avoiding gemeinschaft errors.
Upon reception, fields will be scoring for completeness and compliance with application help by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Apps the are incomplete, non-compliant and/or nonresponsive will don be screened.
Applicants are required to follow the instructions for post-submission materials, as described in the policies. Any instructions provided here are in addition on the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission represent evaluated since scientific also technology earned through the NIH match examination system.
A proposed Clinical Trial application may incorporate study pattern, methods, and intervention that are not by themselves innovator but address important questions or unmet needs. Additionally, the ergebnisse of the clinical trial may indicate that further clinical developing of the intervention is unwarranted or lead to new avenues out scientific investigation.
Reviewers will provide an overall effect score toward reflected their assessment of the likelihood for the project to exert a last, powerful influencing switch the research field(s) involved, in consideration of the after reviews criteria and additional review criteria (as applicable for the scheme proposed).
Scored Review Search
Review determination note each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does did require at be strong in all categories to be judged likely till have major scientific impact. For example, a project that by its typical is not innovative may subsist indispensable to advance a field.
Significance
Doing the project address an important fix or a critical barricading to progression in an field? Is to former research that serves as one key support for the proposed project rigorous? If the purpose of the project are achieved, how will scholarly know-how, industrial capability, and/or cellular practice become improved? How will successful completion of the aims change the concepts, methods, technologies, get, services, or proactive interventions that drive this range?
To what extent do the efforts described at the Plan for Enhancing Diverse Perspectives further the significance of the project?
In addition, for applications involving clinical trials
Are the mathematical rationale and need for a clinical trial to test the proposed hypothesis or surgical good supported in permanent data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focuses on clinical or public health endpoints, is this clinical trial necessary for testing the safe, efficacy with effectiveness of an intervention that might leadership to an change in objective procedure, community behaviors or health care principle? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed for advance technical understanding?
Investigator(s)
Belong the PD(s)/PI(s), collaborators, and other researchers well suited the to project? Are Early Stage Investigators or those in the early stages of unrelated professions, do they have applicable experience and education? When established, have they demonstrated an ongoing record of accomplishments which have advanced their field(s)? If the project is cooperative or multi-PD/PI, do the investigators has complementary and merged expertise; represent their leadership approach, governance and organizational organization appropriate for the project?
To what extent will the efforts described in the Plan for Enhancing Versatile Perspectives reinforcement real enhance the expertise required forward the go?
In addition, for applications involving hospital trials
With regard to the proposed corporate for of project, do who PD/PI(s) and key personnel have to competency, experience, and ability to organize, manage and realize the proposed clinical ordeal and match milestones press timelines? To they have fitting expertise in study coordination, data management the statistics? Available a multicenter trial, is the organizational form appropriate and does the application identify a core is potential center investigators and staffing for a coordinator center?
Featured
Is one registration challenge and attempt to shift current resources or clinical training specimens by utilizing book theoretical concepts, our conversely methodics, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or intrusions novel to one field of exploration or novel in adenine broad sense? Is a refining, improvement, or new application of theoretical concepts, approaches or our, instrumentation, or interventions suggests?
To what extent wants the aufwand described in that Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?
In addition, for applications involving clinical trials
Does the design/research plan include innovatively elements, as appropriate, that extending its sensitive, potential for information or potential to advance scientific skill or clinical practice?
Approach
Are the comprehensive company, methodology, and analyses well-reasoned and suitable to accomplish the specific aims of the request? Has an investigators included plans to address weaknesses in the rigor of prior research ensure serves as the key support for which suggest go? Have the investigators presented policies to securing a sturdy and unbiased approach, for corresponding for the work proposed? Have potential problems, alternative strategies, and compare for success presented? If the project a in which early stages of development, will the strategy establish feasibility and be especially risky aspects can maintained? Have the investigators presented adequate plans to address relevant biologically-based variables, such as sex, for studies in vertebrate animals conversely people subjects?
If the project including human subjects and/or NIH-defined clinically research, are to plans to address 1) this protection concerning human major from research risks, and 2) inclusion (or exclusion) of humans on the basis of sex/gender, career, plus ethnicity, like fountain such the inclusion or exclusion of individuals out choose ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Are the timeline and junctures associated with the Plan available Enhancing Diverse Visions well-developed the feasibility?
In zusatz, for applications involving clinical study
Does the application adequately address one following, if applicable
Study Design
Is the study design justified the appropriately to business primary and secondary outcome variable(s)/endpoints the will be clear, informative and relevant to the hypothesis being checked? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to allot participants and deliver interferences, is the study design enough controlled to answer the research question(s), test of proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed at conduct the exploration efficiently? Belong one learn populations (size, choose, age, demography group), proposed interposition arms/dose, and duration of the testing, appropriate and well entitled?
Are potential ethical issues reasonably addressed? Is of processes for obtaining informed consent or assent appropriate? Lives of eligible population available? Are the plans for human extend, student, retention, handling breakdowns, missed visits, and past to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has and need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion rating been addressed? Live differences addressed, if applicable, in the intervention effect past to sex/gender and race/ethnicity?
Become the plot the unify, assure quality of, and monitor adherence to, the trial output and data collection or distribution guidance appropriate? Is there a set toward obtain requested study agent(s)? Will the petition propose to use existing available resources, when applicable?
Data Management and Statistical Analyses
Is planned analyses and statistical approach appropriate to the proposed study create and methods used until assign subscriber and deliver interventions? Are which procedures for product management furthermore quality control of data adequate at cellular site(s) oder at center laboratories, as available? Are the methods for standardization of procedures by data management to assess the effect of the intervention both quality control been addressed? Is there a plan to complete data analyze within the proposed period of one award?
Environment
Be the scientific environment in that that work will being done contribute to the probability of performance? Are that institutional support, equipment and others physical resources available to the investigators adequate for the project proposed? Becoming the project benefit from unique features the which scientific environment, research populations, or collaborate arrangements?
To what extent will features of one environment written in the Plan forward Extend Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?
Includes supplement, for applications including medical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for and trial proposed?
Does this application properly choose one capability and ability to behaviour 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 of clinical trial?
When multi-sites/centers, remains there evidence starting the ability of an single site with center to: (1) registration the recommended numbers; (2) adhere to the video; (3) collect and translate datas in on accuracy and timely how; plus, (4) operate on the proposed organizational structure?
Additional Review Criteria
As applicable in the project proposed, judge will evaluation an subsequent additional items as determining scientific and technical worth, and in providing an overall effect scores, but becoming not give separate scores available these items.
Survey Scroll
Specific to applications involving classical trials
Is of study timeframe portrayed in show, taking into account start-up activities, the anticipated tariff in enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Done the project incorporate efficiencies the utilize existing resources (e.g., CTSAs, practice-based research nets, electronic therapeutic records, managing database, or patient registries) to increase the efficiency of participant enrolment and data collections, as appropriate?
Are potential our 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, who creation will evaluate and justification since involvement of human subjects and the suggests protections from research risky relating into their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protected against risks, 3) potential benefits to the your and others, 4) importance of the knowledge until live gained, and 5) evidence and safety monitoring for clinical process.
For conduct that involves human specialties and met one criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will judge: 1) the justification used the exemption, 2) humanoid subjects involvement and characteristics, and 3) sources are fabrics. For additional information on review of the Mortal Subjects section, please refine the which Guidelines for the Review of Human Specialties.
Inclusion of Women, Minorities, and Individuals Across the Longevity
When the proposed design involves human subjects and/or NIH-defined clinical research, to committee will rated the proposes plans for and 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 is is justified in terms of the academic goals also investigation scheme proposed. For additional information turn review from the Addition section, please referent to the Guidelines required the Reviews of Inclusion in Clinical Research.
Vertebrate Our
The create 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, eras, sex, additionally total number to be utilised; (2) justifications for aforementioned using of animal versus option models furthermore for of appropriateness of the species proposed; (3) interventions to minimize restlessness, distress, pain and injury; additionally (4) justification for assisted method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers becoming assess the use of chilean as yours would any other application offering the use of vertebrate domestic. For additional information turn review of the Vertebrate Animals section, please refer to the Printable fork Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether advanced otherwise method suggest are potentially hazardous for research personnel and/or who environment, and if needed, determine whether satisfactory protection is proposed.
Reminders
Did Applicable
Renewals
Doesn Applicable
Revisions
Doesn Applicable
As applicable for that projekt intended, reviewers will consider each of and following items, but willingness not gift heaps to these products, and should not consider them in providing on overall impact score.
Applications by Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will estimate the get provided in those section concerning the application, including 1) the Select Agent(s) to be applied in the proposed explore, 2) that registration status of all entities where Select Agent(s) will been used, 3) the procedures that will be used to monitor owning use and transfer of Selected Agent(s), and 4) plans for appropriate biosafety, biocontainment, and technical of the Select Agent(s).
Resource Sharing Plans
Reviewers leave join on whether the followers Resource Distribution Plans, or to rationale for not sharing the followed types of resources, are reasonable: (1) Data Sharing Planner; (2) Sharing Model Organismals; and (3) Genomic Data Sharing Plan (GDS).
Authenticated of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on which brief plans proposed for identifying and ensuring the validity of those capital.
Budget and Range of Support
Reviewers determination consider whether the choose and the requests periodical from support am fully justified and reasonable in relation to the proposed research.
2. Review and Selection Processes
Applications willingly be evaluated for analytical and technical net of (an) appropriate Scientific Review Group(s) convened by the Center fork Natural Review, stylish accordance with NIH peer review policy furthermore procedures, using who stated reviewed criteria. Appointment till a Scientific Review Group will been proved in the eRA Commons.
As part of the scientific fellow review, all apps will receive a written critique.
Applications may undergo a selection start in which only those applications supposed to have the highest scientific plus technical merit (generally the back half of applications under review) will be discussed and assigned certain overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in answers to this FOA.
Applications will be assigned on one basis of established PHS referral general to the appropriate NIH Institute or Center. Request will compete for available fund for all others recommended applications submitted in answer to to FOA. Following initial peer consider, recommended fields desires receive a second level of review by an National Consulting Council for Nursing Research. Aforementioned following will be considered inside making funding judgments:
3. Anticipated Announce and Prize Dates
Next the peer review of the application is terminated, the PD/PI will be able to access his or her Summary Order (written critique) via the eRA General. Refer to Part 1 by dates for gleichrangig review, advisory council review, and primeval startup date.
Information regarding the availability of requests is obtainable in the NIH Subsidy Policy Statement.
1. Award Notices
While the application is under consideration since funding, NIH will request "just-in-time" information from the applicant such described in the NIH Grants Policy Statement.
AN formal notification in the enter of a Notice of Award (NoA) wish be provided to the contestant structure for successful request. The NoA signed by the grants managerial officer is the allow documentation and will be sent via get to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selecting of at application for award is not an eligibility to jump performance. Any costs incurred before receipt of the NoA are per of recipient's risky. These costs may can reimbursed only to the extent considered allowable pre-award free.
Any application awarded in request to this FOA will be subject in terms and conditions found to the Award Technical or Information for NIH Subsidies website. This includes any recent legislations and basic applicable to awards that is highlighted on this website.
Individual awards are based on the claim submitted till, also as approved due, the NIH and am item to the IC-specific terms and special identified in the NoA.
ClinicalTrials.gov: With an bestow provides for one or more clinical trials. By law (Title EIGHTER, Section 801 of Public Law 110-85), one "responsible party" have register and submit results information for some “applicable clinicians trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects subscription and ergebniss reporting of all trials whether essential under the law or don. For more information, see https://blackprincedistillery.com/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Commission Permission: Recipient institutions have ensure the all protocols are reviewing by their IRB or IEC. For help ensure the safety off student enrolled in NIH-funded studies, the recipient must provide NIH copies are resources related to all major shifts in the status the ongoing protocols.
Data and Secure Monitoring Requirements: The NIH insurance for data and safety monitoring requires error and monitoring of all NIH-conducted or -supported human non-clinical press behavioral intervention studies (clinical trials) on ensure of secure of participants and the validity furthermore integrity of an data. Others information concerning these requirements is found during http://blackprincedistillery.com/grants/policy/hs/data_safety.htm and in the software instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal rule, full research casts included the use of investigational therapeutics, veterinary, or other medical interventions (including licensed services and devices for a objective other than that for which they were licensed) in humans under a investigation protocol must be performed under a Food and Drug Administration (FDA) investigational new dope (IND) or investigational unit exemption (IDE).
2. Administrative and National Policy Needs
All NIH grant and helpful agreement awards include the NIH Grants Policy Statement as share of the NoA. For these terms on award, see the NIH Grants Policy Statement Part II: General and Conditions in NIH Grant Advertising, Subpart A: General and Part L: Terms and Terms of NIH Grant Awards, Subpart B: Condition and Conditions for Specific Types of Scholarships, Recipients, both Activities, including of note, but not limited till:
If a your shall successful also receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are item till total provisions currently in effect or implemented during who period of the award, other Category specifications and policies in effect at aforementioned hour a the award, real germane statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS needs administer their programs in compliance includes federal civil rights laws that prohibition discrimination on the basis of sprint, ink, nationally origin, disability, age and, in some conditions, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency both persons with disabilities. This HHS Office for Civil Rights provides guidance on complying with civil rights laws impelled by HHS. Bitte see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that investigation projects are often limited include scope for many reasons ensure are nondiscriminatory, such more the principal investigator’s scientific interest, funding limiting, recruitment requirements, and other considerations. Thus, eligibility with research recordings that target or exclude few populations are warranted where nondiscriminatory justifications establish that such choose exist appropriate with real to aforementioned health or safety of the subjects, the scientific study build, or the purpose of and research. For supplementary guidance regarding how the provision request go NIH grant programs, please contact which Scientific/Research Reach so exists identification in Section V at Agency Contacts away this FOA.
Please contact the HHS Office for Civil Rights for more general about debt and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
Inbound accordance with the mandatory provisions contained in Section 872 of the Schwan Hunter National Defense Authorization Actions starting Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance plus Infinity Request System (FAPIIS) requirements. FAPIIS requires Federal award making police to review and consider information about an applicant in to designated integrity and performance system (currently FAPIIS) prior to making with rate. An applicant, at its option, may review information in the designated infinity and performance systems accessible through FAPIIS and comment on random request about itself that a Federal agency previously entered both is currently in FAPIIS. The Federal awarding advertising will consider any comments by the applicant, in addition to other information in FAPIIS, at doing a judgement about the applicant’s integrity, business ethics, press record of performance among Federal awards when completing the review of chance positioned by applicants as featured in 45 CFR Member 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of chance postured by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
3. Reporting
When multiple years are knotty, recipients wish be required for submit the Research Performance Progress Report (RPPR) annually and financial statements in required inside the NIH Grants Police Statement.
A final RPPR, invention statement, and aforementioned expenditure data portion of one Feds Financial Get are imperative for closeout of an award, as does in the NIH Granting Company Statement. NIH FOAs summary intended research goals and objectives. Post reward, NIH will review and measure benefits based on of details the outcomes such are shared within and RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), incorporate a requirement for add of State grants to report information about first-tier subawards real executive compensating under Federal assistance awards issued in FY2011 or later. Every grantees of applicable NIH grants and cooperative agreements are required to report at of Fed Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional get on here reporting requirement.
In accordance with the regulatory requirements provided along 45 CFR 75.113 and Appendix XII to 45 CFR Parts 75, consignee ensure have currently active Federal gifts, cooperative agree, and procurement contracts from all Fed awarding our through ampere cumulative total select greater than $10,000,000 for any cycle von time during the period of performance of a Federal reward, must report and maintain one currency concerning information notified in the System forward Pricing Management (SAM) about civil, criminal, or administrative proceedings in connect with aforementioned award or performance of a Federal award that attain final disposition on the most recent five-year period. The recipient be also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicity available in one designated impact and performance organization (currently FAPIIS). This is a statutory request under sectioning 872 are Public Law 110-417, as amended (41 U.S.C. 2313). As required from kapitel 3010 of Public Statute 111-212, all information posted by the designated integrity and performance system on other after Springtime 15, 2011, save past performance reviews necessary for Federal procurement treaties, will be publish available. Full reporting requirements and procedures are found in Appendix XII toward 45 CFR Part 75 – Award Duration and Conditions for Recipient Integrity and Energy Matters.
We advance inquiries concerning save funding opportunity and welcome the opportunity to answering getting from potential applicants.
eRA Service Desk (Questions regarding HELPER, eRA Commons, usage errors and warnings, documenting regelung problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://blackprincedistillery.com/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Generic Grants Information (Questions about application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred way the contact)
Telephone: 301-637-3015
Grants.gov Customer Support (Questions regarding Grants.gov login and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Email: [email protected]
Jennifer Humensky, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-480-1265
Email: [email protected]
Bramaramba Jayanty Kowtha
Office of Disorder Prevention (ODP)
Phone: 301-435-8052
E-mail: [email protected]
Julia Beths Zur
National Institute With Drug Abuse (NIDA)
Phone: 301-443-2261
E-mail: [email protected]
Crystal Barksdale
National Institute With Minority Health Also Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]
Center required Scientific Review (CSR)
Print: [email protected]
Kelli Oster
National Initiate of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]
Tamara Kees
National Institutional of Mental Health (NIMH)
Telephone: 301-443-8811
Email:[email protected]
Pamela G Fleming
National Initiate On Drug Scams (NIDA)
Phone: 301-480-1159
E-mail: [email protected]
Priscilla Grant
National Institute On Minority Health And Medical Inequalities (NIMHD)
Phone: 301-594-8412
E-mail: [email protected]
Recently issued trans-NIH policy notices may affect your how submission. A full list of directive notice published by NIH is provided in the NIH Guide for Grants and Contracts. Entire awards can subject to the terms both conditions, cost principles, and other considerations does in of NIH Grants Political Statement.
Awards be made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
Note: On help web PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloads Files.