- October 6, 2021 - This RFA has been reissued as RFA-ES-21-007
- June 8, 2021 - Notice of Intent to Publish a Funding Opportunity Announcement for Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER) (R01 Clinical Trial Optional). See Notice NOT-ES-21-008.
- March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077.
- August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
- July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
- November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
Key Dates
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.
August 1, 2019, August 1, 2020, August 1, 2021
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
- Use the NIH ASSIST system to prepare, submit and track your application online.
- Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
- Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Part 1. Overview Information
Part 2. Full Text of the 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
Purpose
The National Institute of Environmental Health Sciences (NIEHS) seeks to advance understanding of how environmental agents impact human health by supporting a rich collection of research activities. This is reflected in the broad scope of the NIEHS grants portfolio (http://tools.niehs.nih.gov/portfolio/), which spans molecular, cellular and whole animal laboratory-based studies to population-based research. The integration of knowledge arising from these disparate approaches and disciplines can be achieved most effectively in transdisciplinary/translational research environments. NIEHS has a special interest in promoting such integrative research efforts, which hold promise for accelerating progress toward achieving improvements in public health. For the purpose of this FOA, translational research is defined as research that involves the bidirectional flow of information across the spectrum of in vitro, model organisms, animal models, human population or clinically-based research to provide data useful for the prevention of, or the intervention in, human disease. Transdisciplinary research is defined as research that involves scientists from multiple disciplines working interactively on a common problem to develop novel cross-disciplinary methods, insights and research approaches that would not have occurred with a traditional uni-disciplinary investigation.
Many of the large NIEHS-supported programs such as the Centers for Children’s Environmental Health and Disease Prevention Research and the Breast Cancer and the Environment Research Program support translational and/or transdisciplinary research by encompassing both fundamental and human-based translational research and in many cases community engagement activities. The greater part of the NIEHS grants portfolio comprises individual research projects, however, and few of these fully incorporate integrative research aims. This reflects, in part, difficulties that investigators face in pursuing interdisciplinary and collaborative research in the context of a single research project. These include a lack of resources to form and nurture early-stage collaborations and enable production of preliminary data to establish the feasibility and value of bringing together multiple disciplines and approaches. Long distance collaborations, where investigators with complementary expertise are located at different institutions, create additional challenges for sustained engagement of interdisciplinary teams.
In 2010, NIEHS developed the Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER) program. This program addressed key obstacles in conducting integrative research in the context of a single research project. However, since this original version of ViCTER existed as a supplement program for currently supported NIEHS R01 awardees, it restricted the number of potential applicants and provided limited time for the newly formed teams to collaborate and establish a record of productivity.
This new funding opportunity announcement represents an update to the ViCTER program and includes a set-aside of funds and a special review. ViCTER is intended to encourage investigators with interest and expertise in areas relevant to the field of environmental health sciences to develop and implement a translational and/or transdisciplinary research project. ViCTER projects are expected to foster a better understanding of the mechanism of disease/dysfunction in those areas where environmental factors are known or are suspected to influence the development or progression of disease. Eligibility for this updated ViCTER program does not depend on whether an applicant has existing or prior NIEHS funding. The initiative will allow investigators to extend existing areas of research in new directions and/or develop novel lines of inquiry through the creation of a virtual consortium that includes new perspectives, such as basic mechanistic, clinical, epidemiological, computational, engineering and/or health risk communication approaches. By implementing translational and/or transdisciplinary approaches, investigators will be able to improve the potential impact of their work on public health.
The NIEHS Division of Extramural Research and Training (DERT) recently generated a Translational Research Framework to capture the full spectrum of translational and interdisciplinary research related to environmentally relevant exposures and diseases. Applicants are encouraged to refer to the following publication for more information: https://ehp.niehs.nih.gov/ehp3657
Research Objectives
The primary goal for creating this ViCTER program is to support the exchange of knowledge among individuals from a diverse set of disciplines and accelerate the translation of scientific research into meaningful improvements in human health in those areas where environmental factors are known or suspected to influence the development or progression of disease. To accomplish this goal, each newly established collaborative team is expected to initiate research in the development and application of novel approaches for understanding the etiology of environmentally-related disease and, where appropriate, explore clinical and public health implications for diagnosis, treatment and/or prevention.
Each ViCTER consortium must consist of at least three key participants (the PD/PI plus two scientists designated by the PD/PI as "co-investigators") that together represent a newly collaborative team. For the purposes of this FOA, a team is considered newly collaborative if there are no co-authored original research publications among the PD/PI and co-investigators within the last 5 years (excluding reviews, white papers, commentaries etc.). NIEHS strongly recommends but does not require that at least one co-investigator be at a different institution from the PD/PI.
A critical component of the ViCTER program, particularly in cases where team members are located at different institutions, is their virtual aspect. This allows researchers at remote locations to form a consortium to integrate their research through the development of a virtual center that houses the overall ViCTER project. The PD/PI serves as the Director of the consortium and is responsible for scheduling regular conference calls (at least monthly) and in-person (at least yearly) meetings.
The PD/PI must propose a series of aims that are thematically related, foster collaboration among team members and reflect transdisciplinary/translational approaches to environmental health. The PD/PI and co-investigators should each have a substantial and meaningful role in developing and conducting the overall ViCTER project, demonstrated by each assuming primary responsibility for leading one or more of the proposed Specific Aims.
NIEHS particularly encourages applicants to propose research aims that are high risk/high reward which, if successful, are likely to contribute significantly to one or more areas of environmental science and be the motivator of future collaborative research.
The proposed ViCTER project must fall within the NIEHS mission. Environmental agents which are considered of primary interest for NIEHS include: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Investigators who propose studies with a primary focus on NIEHS mission relevant exposures are encouraged to consider inclusion of other relevant environmental exposures (e.g., nutrition) in order to assess their role(s) as cofactors/modifiers of the risk or protection associated with the primary exposure(s). Applications that propose laboratory-based studies using only model compounds (i.e., those without potential for human exposure) must provide a clear, reasonable and specific description as to how research on the model compound will lead to a better understanding of the mechanisms involved in responses to specific environmental agents which are included in the mission responsibility of the NIEHS.
Examples of collaborative research projects responsiveto this ViCTER FOA include, but are not limited to, projects that seek to:
- Establish causal links between a toxicant and altered reproductive function in humans through studies in different experimental systems and levels of analysis (whole animal models, cell culture, in silico modeling) to compare site of action; dissect cellular mechanism(s); and identify response biomarkers that may be appropriate for use in clinical settings
- Evaluate the role of environmental agents in risk for psychiatric disorders through parallel learning and memory studies conducted in rodents and human adolescents, together with preliminary studies to assess the feasibility of using brain imaging methods to probe relevant functional networks in one or both species.
- Assess the impact of multiple endocrine disrupting-chemicals (EDC) on child development through collaborative studies to determine the association of EDC exposure and growth trajectory in a childhood cohort; develop laboratory assays to evaluate estrogenic effects of real world complex mixtures; and apply innovative methods to engage with community partners to disseminate information about potential health hazards of EDC.
- Determine mechanisms of cardiovascular disease risk from ambient air pollution through complementary studies to detect epigenomic and transcriptional signatures of exposure and disease susceptibility in human populations; develop improved statistical models for dissecting contributions of individual chemicals in complex air pollutant mixtures to disease risk; and conduct controlled exposure studies in animals to pursue the biology underlying associations observed associations.
- Identify effects of environmental chemicals on critical pathways in development of obesity and diabetes through the collective efforts of neuroscientists, endocrinologists, immunologists and toxicologists using rodent models to demonstrate chemical exposure-induced obesity phenotypes; assess potential immune alterations; explore the role of structural and functional changes in regulation of energy balance by the central nervous system; and assess feasibility of detecting obesity-related immune signatures in human biosamples.
- Explore the role of the exposure-induced alterations in the gut microbiome in the development and progression of human disease through complementary studies that characterize the gut microbiome in human populations with known exposure and clinical histories; identify causal relationships among exposures, alterations in the gut microbiome and health outcomes in animal models; and explore feasibility of possible interventions to prevent or reverse harmful exposure-induced changes in gut microbial populations.
- Investigate genetic susceptibility and resilience to environmental exposures through data harmonization and coordinated analyses of available GWAS studies; develop and validate improved statistical methods to identify GXE; and conduct functional genomic studies in cell culture and whole animal experimental systems to understand underlying biologic mechanisms.
The preceding examples are provided only to illustrate collaborative projects in keeping with the spirit of the ViCTER FOA. These examples fall within the broad mission areas of the NIEHS, but do not necessarily designate areas of highest priority. It is expected that applicants will develop collaborative translational/transdisciplinary approaches that blend the unique skills of specific members of the team to address a significant question in environmental health sciences.
Applicants are strongly encouraged to contact NIEHS Scientific/Research staff prior to submission to determine if their project meets the interests of the NIEHS, have questions about the eligibility of their co-investigators or any other issue relevant to the ViCTER application.Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Need help determining whether you are doing a clinical trial?
NIEHS intends to fund an estimate of 3-4 awards, corresponding to a total of $2,500,000 for each fiscal year, FY2019, FY2020 and FY2021.
1. Eligible Applicants
- Public/State Controlled Institutions of Higher Education
- 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 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)
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- 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
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.3. Additional Information on Eligibility
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)
1. Requesting an Application Package
Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.2. Content and Form of Application Submission
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.For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
Janice B. Allen, Ph.D.
Telephone: 984-287-3232
Fax: 301-480-3705
Email: [email protected]
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants can request support for a variety of activities, including but not limited to, the sharing of tissues, assays, animals, and biosamples; coordination of bioinformatics for sample analysis; coordination of analyses; cross training of students, postdoctoral fellows and technicians among labs; research dissemination and community outreach activities; and regular in-person meetings.
Allocation of Funds among Collaborative team: While the budget allocations may be predicated by need, a minimum of $75,000 direct costs should be requested to support the activities proposed under each aim. The activities of the PD/PI and the co-investigators and related costs must be separately identified and justified in the budget justification, consistent with the requirement that each member of the collaborative team lead one or more of the specific aims.Specific Aims:
- State the overall transdisciplinary/translational objective of the ViCTER project and the proposed aims that will be used to meet the overall objective.
- Identify which member of the collaborative team will have primary responsibility for each aim and how each of the aims draws on unique expertise and skills of the PD/PI or co-investigator(s).
- Identify any research aim(s) that are considered exploratory high risk/high reward.
- For each aim, summarize the methods to be used, the specific hypotheses to be pursued, expected outcomes and relation to the overall theme of the project.
- Describe the interdependence of the proposed collaborative aims and how each is needed to address the central problem and the potential scientific synergy to be achieved.
Research Strategy: The Research Strategy should include the following elements:
Organizational and Administrative Structure of the ViCTER consortium:
- Provide a succinct description and accompanying diagram of the organizational structure of the consortium including an administrative and management plan that will achieve an integrated, coordinated and interdisciplinary research consortium.
- In broad terms describe how the proposed administrative structure supports the goals and organization of the consortium.
- Describe the roles and responsibilities of the PD/PI and designatedmembers of the ViCTER collaborative team in the areas of leadership and oversight of the overall research efforts.
- Indicate how the consortium’s progress towards the expected scientific outcomes will be monitored and adjusted as needed.
- Describe the relationships between the proposed ViCTER consortium and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.
- Describe the frequency and type (e.g., face-to-face, virtual, teleconference, etc.) of meetings for all ViCTER consortium participants.
Significance:
- State and justify the complex biological problem to be solved and its relevance to environmental health sciences.
- Describe the transdisciplinary and/or translational nature of the ViCTER project and the range of scientific expertise to be brought to bear on the problem.
- Identify potential outcomes of the proposed project and how the research will advance the field of environmental health science and impact human health.
Innovation:
- Describe the innovation associated with the collaborative approaches, specific methods, concepts or instrumentation proposed for the ViCTER project
- Describe advantages of the proposed approaches over existing methods.
- Describe any potential changes in clinical or public health practice that may be spurred by the outcomes of the ViCTER project.
Approach:
- For each specific aim, describe the overall strategy, methodology, and analyses to be used.
- For any aims designated as exploratory, note the high risk/high reward nature and provide preliminary data to demonstrate the feasibility of the approaches (methodology, tools, techniques, etc.).
- For well-developed (non-exploratory) aims, provide preliminary data to support the specific hypotheses to be pursued.
- Describe the relationships and co-dependencies among the aims (e.g., sharing of data, samples).
- Discuss potential problems and alternative strategies (e.g, adjustments that will be made if one of the interdependent aims is not successful).
- Describe a timeline for proposed activities.
The following modifications also apply:
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
If you answered "Yes" to the question ?Are Human Subjects Involved?? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed,
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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.
Section V. Application Review Information
Important Update: See NOT-OD-18-228 for updated review language
for due dates on or after January 25, 2019.
1. Criteria
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
The ViCTER will be reviewed as a whole with emphasis onits translational and/or transdisciplinary nature as well as the degree of synergy (interaction and collaborative research opportunities) that will be stimulated by the consortium.
Is the environmental health focus of the proposed virtual consortium an area where environmental factors are known or expected to influence the development or progression of disease?
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?
Does each key participant of theproposed ViCTER team contribute unique expertise, resources, methods and/or technologies to the virtual consortium? Does the PD/PI have a track record of embracing the ideas of rigor and reproducibility and of transparency in science including data sharing and collaboration?
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 proposed virtual consortium represent a new, unique opportunity to foster translational and/or transdisciplinary research that has not been possible previously?
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?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Are plans in place to support the regular interactions among collaborative team members, including those that may be remote?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Translational and/or Transdisciplinary Nature
Do the aims cross multiple disciplines or stimulate the bidirectional flow of information across the spectrum of in vitro, model organisms and animal models, human populations or clinically-based research to provide data useful for the prevention of, or the intervention in, human disease?
Synergy
Are there strong synergy and integration among the combined efforts of the various investigators within the overall project? Will the creation of the virtual consortium make a greater contribution to the central environmental health problem of focus than if each of the investigators conducted their projects alone? Will the outcome move the field in a new direction or stimulate new collaborations? How will data from one aim feed into the other aims?
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIEHS,in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.- May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
3. Reporting
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267
Heather F. Henry, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3268
Email: [email protected]
Janice B. Allen, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3232
Email: [email protected]
Jenny Greer, M.A.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3332
Email: [email protected]
