National Institute of Environmental Health Sciences (NIEHS)
Reissue of PA-18-260
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
This Funding Opportunity Announcement (FOA) encourages multidisciplinary projects to investigate the potential health risks of environmental exposures of concern to a community and to implement an environmental public health action plan based on research findings. Projects supported under this program are expected to employ community-engaged research methods to not only conduct research but also to seamlessly translate research findings into public health action. This announcement reflects NIEHS goals in bi-directional communications and in supporting research to address environmental health disparities and environmental justice concerns.The Research to Action program is part of the National Institute of Environmental Health Sciences (NIEHS) “Partnerships for Environmental Public Health” (PEPH) network (https://www.niehs.nih.gov/research/supported/translational/peph/index.cfm).
November 7, 2019
December 21, 2019
January 21, 2020; December 4, 2020
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
May 2020; March/April 2021
October 2020; October 2021
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
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.
Protecting the public from environmental health risks requires both the generation of science-based information about exposure occurrences and exposure-health relationships, as well as the translation of such information into actions to reduce or eliminate exposure, prevent disease, and promote health. The distinctive needs of individual communities are key for identifying environmental health problems and devising appropriate disease and exposure prevention or remediation tactics. Furthermore, by fostering community-researcher partnerships, vital information that has been identified by the community about exposures and disease prevalence can be used by the researchers to identify the linkages between such exposures and disease and to develop preventive strategies to promote health and reduce risk of disease across the populations at highest risk. Placing an emphasis on equitable partnerships between community and researcher in environmental public health research also ensures that:
Community engagement (CE) lies on a continuum that reflects the level of involvement of community members, or representatives of specific subpopulations, in the research. The continuum of involvement ranges from community consent to research to full participation and shared leadership of community members in the research design and implementation. Community based participatory research (CBPR) is a recognized approach of Community Engaged Research (CEnR).
For the purpose of this FOA, CEnR is defined as the full participation of community members in the identification of exposures of concern to that community, suitable cohorts and the specific needs of subpopulations; the development of the research questions and research design; the translation and dissemination of study results; the development and implementation of an environmental action plan; and the development of methods for evaluating the success of the project. In addition, for the purpose of this FOA, CEnR should entail the involvement of sufficient numbers of individuals and community-based organizations to adequately represent all segments of their community. By the involvement of larger numbers of community members, CEnR can more effectively reflect the diversity of community values, create an inclusive environment for all affected stakeholders, nurture collaboration, build community capacity to sustain interventions and implementation plans, and increase health and environmental literacy among those involved.
CEnR is particularly vital in addressing environmental justice issues. Environmental justice refers to the need to remedy the unequal burden of exposure and disease borne by socioeconomically disadvantaged persons (e.g. populations defined as minority, low income, or American Indian/Alaska Native tribes). Geographic location and socioeconomic status play important roles in environmental exposure of these sub-populations as does multigenerational exposures. In addition, the lack of resources for early identification of the effects of toxic agents, or the means to address known exposures, may lead to an increased disease burden among people who are economically least able to cope with it. Research to identify and characterize environmental exposures that disproportionately burden these sub-populations can lead to public health action that will reduce the associated health disparities. Furthermore, active participation of community members in the formulation of environmental health research questions and in the conduct and translation of research findings can help community members better understand the associated health risks and empower them to make informed decisions or to initiate local activities to prevent ongoing chronic and/or cumulative exposures that disproportionately affect them.
Objectives and Scope
Since 2009, the NIEHS has invited applications for the Research to Action program to bring together environmental health researchers and community members to assess and address environmental public health issues of greatest concern to their communities. This program is a key component of the PEPH network, that encompasses a variety of research, communication, and training/educational activities to identify, prevent, reduce, or eliminate environmental exposures that lead to adverse health outcomes in communities. PEPH meetings involve grantees from many NIEHS programs, including Research to Action, and allow opportunities for networking, interaction and collaboration across programs.Currently funded projects are addressing a variety of environmental health issues and include a diverse set of communities. A description of currently funded grants under the Research to Action program can be found at: https://www.niehs.nih.gov/research/supported/translational/peph/prog/rta/index.cfm.
This FOA intends to expand the number and scope of projects supported through the NIEHS Research to Action program. The two main objectives of this initiative, however, remain the same: 1) to conduct multi-disciplinary research to collect and characterize information about environmental health concerns of significance to a community and 2) to develop and implement a strategy to translate and disseminate research findings to community members, public health professionals and/or policymakers to support an action that will ultimately promote the reduction of exposure(s) and reduce the health impact from environmental stressors.
To meet these stated objectives, applicants should propose CEnR projects that incorporate three elements - research, community engagement and public health action. A third, optional element is evaluation. These three elements are discussed further below.
All projects should include, at a minimum, one health researcher with a background in environmental health research and community partners (such as member(s) of affected communities and/or representatives of community-based organization(s) (CBOs). CBOs relevant to this announcement include community and neighborhood organizations; youth, elder or faith-based organizations; disease advocacy organizations; Citizen Science groups; and/or educators. Additional organizations who would be relevant research partners in addition to the community partner include local or state public health departments and laboratories, and regional or national organizations whose mission is to address environmental risks to health.
Project teams are also encouraged that incorporate expertise in social science, evaluative methods, and communications and be comprised of, and co-developed by, researchers and community members. The projects developed by these partners should be focused on environmental agents or diseases that have been identified by the community as potential or existing public health issues.
Because participation of the affected community is essential for both the identification of environmental health risks to be studied and formulation of research and translation plans, it is expected that fully incorporating equitable input from both researchers and community members is a priority throughout the entire research process. Furthermore, the partnership between the researcher and community partners should appropriately draw upon the unique strengths that each brings to the partnership.
For purposes of this FOA, “community” refers to populations and groups affected by, or with a shared interest in, environmental exposures and related health outcomes. Populations may be defined by socioeconomic status, geography, exposure(s), race, ethnicity, gender, age, occupation, religion, sexual orientation, disability, illness, or other health condition. The term “community-based organization” (CBO) is broadly defined. The CBO does not need to be a formally recognized organization, such as a non-profit organization, but should be an established community group(s) or network(s) with a common interest in a particular environmental health concern and that includes representatives of the community . Of note, the involvement of more than one CBO may be necessary to represent the interests and concerns of all members of the community (for example, the distinct needs of different age groups or diseases, the cultural constraints related to a particular ethnic or religious sub-population.)
Responsibilities of the research partner and community partner include, but are not limited to, collaborating on (a) determining what information and research questions the proposed study can and cannot provide and address, (b) identifying the most appropriate research design and methodology, (c) ensuring research findings are translated effectively into public health action, and (d) helping translate and communicate study findings to community members in appropriate and accessible formats.
Given the advanced scope of the NIH R01 mechanism used for this FOA, it is anticipated the community-research partnerships will already be established and that applicants will be able to demonstrate evidence of successful past collaboration such as preliminary data from previous research in the community. Capacity building activities to develop training and educational programs, or to establish a new community-researcher partnership, would not be considered appropriate for this FOA.
The objective of this element is to support research that will increase knowledge of how environmental exposures impact health and disease in communities. This can include descriptive studies intended to increase understanding of exposure levels, sources or prevalence of exposure-related health conditions among the community, or hypothesis-driven studies designed to improve understanding of the exposure-health outcome relationship. All studies must be motivated by the expressed concerns of a community and the need for scientifically-based information to develop or test the environmental public health action element of the project. The research element of projects may include descriptive research to fill research gaps by characterizing sources of exposures, measure exposure levels, or the prevalence of exposure-related health conditions among members of the community and the community itself, as well as hypothesis-driven studies designed to improve understanding of the exposure-health outcome relationship. A key requirement is that research findings should be used to directly inform a public health implementation action plan. Furthermore, while it is anticipated that research will entail primary data collection, projects should build upon previous research conducted with the community and existing findings, and may also take advantage of existing data sources if such resources can adequately address the research question(s) co-developed by the researcher-community partnership team and produce the new information needed for a public health action plan. Projects are encouraged that include methodologies for integrating local knowledge about the environment or locally gathered data, such as Tribal Ecological Knowledge approaches and/or citizen science efforts, along with traditional research approaches.
For purposes of this FOA, “environmental exposure” is broadly defined and can include a variety of environmental contaminants. This does not include exposures to infectious diseases, poorly built or maintained housing, or other aspects of the built environment related solely to social conditions (e.g, poverty, food deserts, density, noise and/or violence). Instead, projects should focus on environmental exposures that meet all the following criteria:
The type of research study proposed should be motivated by existing needs identified by the community and lead to an environmental public health implementation action plan. Specific examples of research topics that are of interest for this FOA include, but are not limited to:
Applications that consider interactions between environmental contaminant exposures and the social or physical environment or infectious diseases (as a potential modifier of the health risk associated with exposure to an environmental chemical) are encouraged. However, applications that focus on the social/physical environment or infectious disease alone will not be considered responsive to this initiative.
Public Health Action Element
For the purposes of this FOA, public health action includes campaigns, programs, interventions, and policies intended to elicit a change in behavior or practice that will lead to the reduction or elimination of exposures, the prevention of disease and disability and to promote the health of a population. Public health action may be targeted at the individual, neighborhood, or community level, or developed as models that have national public health practice application. Participation of the affected community in identifying the most effective public health action plan is essential.
The environmental public health action element may include a variety of educational, communication, prevention, or behavioral change activities. This element should be evidence-based, incorporating knowledge gained through the research element of the project, and targeted towards supporting change that will improve the health of a community, reduce or eliminate the exposure, or decrease the prevalence of local exposure-related health conditions. Additionally, each project team is encouraged to implement an evaluation of project processes and, when possible, outcomes. The evaluation element could provide systematic information that can be used to strengthen the project over its life cycle and to assess the effectiveness and impact of the project.
Examples of environmental public health action include, but are not limited to:
Applicants should develop strategies that translate the findings from the research element of the study to action. The strategy should be designed to help support or promote action that will result in the prevention or reduction of exposure among community members at the local, regional or national level, ultimately leading to improved health outcomes and quality of life. Examples of possible public health action strategies include, but are not limited to:
Evaluations help community-research partners assess the effectiveness and impact of their projects as well as the factors that led to program success (or failure). In addition, evaluations can supply ongoing, systematic information that strengthens projects during their life cycle. Evaluations should be designed to reflect program goals and objectives.
The NIEHS PEPH program has developed an Evaluation Metrics Manual to serve as a resource for applicants in developing and implementing an evaluation plan for environmental public health research projects. The complete Evaluation Metrics Manual can be accessed electronically at: http://www.niehs.nih.gov/pephmetrics. Key areas addressed in the Manual include community-research partnerships, the translation and dissemination of messages based on research findings, education and training, and capacity building. Applicants are encouraged to review the Evaluation Metrics Manual for guidance on development of an evaluation plan or to include evaluation scientific expertise on the study team.
Examples of potential measures for evaluating the project's processes (activities and outputs) may include:
Applicants are encouraged to involve social scientists in the development of these quantitative and qualitative tools to assess progress and programmatic achievements. Applicants are encouraged to implement evaluation during any and all phases of the study. The development and use of a project logic model(s) are also encouraged for evaluation planning (see the Evaluation Metrics Manual, Chapter 7 at http://www.niehs.nih.gov/research/supported/assets/docs/a_c/peph_evaluation_metrics_manual_11513_508.pdf for more information on logic models). In addition to the PEPH Evaluation Metrics Manual, applicants may wish to use the Environmental Health Translational Research Framework to describe how their research will address research gaps and inform practice. The Translational Research Framework and supporting resources can be found online. (https://www.niehs.nih.gov/research/programs/translational/framework-details/index.cfm)See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
NIEHS intends to commit $2M in FY 2021 to fund 4-5 awards.
The maximum project period is 5 years.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
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:
The letter of intent should be sent to:
Alfonso R. Latoni, PhD
All instructions in the SF424 (R&R) Application Guide must be followed.
Applications are expected to
Additionally, applicants are encouraged to
Letters of Support:
The following modifications also apply:
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.Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
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.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Is there evidence of the investigators prior experience working with the specific subpopulations named in the application ?
Do the investigators speak the language(s) spoken in the affected communities or involved individuals to serve as translators for the project?
Do the investigators demonstrate awareness of specific cultural activities or beliefs that would affect or constrain the conduct of the project?
Do the investigators demonstrate the needed expertise for developing appropriate translation of findings back to the community or have they involved the appropriate disciplines to ensure culturally sensitive approaches?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?In addition, for applications involving clinical trials
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 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?
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)?
Does the project proposed include a balance between appropriate community engagement and demonstration that the scientific activities conducted will add to the knowledge base and not duplicate activities or approaches that simply confirm existing knowledge?
If applicable, is there evidence of the appropriate range of expertise for conducting a multidisciplinary study e.g., does the study include those with expertise in community-engagement, environmental health science and social science, at a minimum?
Will the project lead to new methodologies or approaches, or increase trust in research processes that will improve community-based research efforts?
Evidence of an established community-academic partnership ( at least one of the following criteria are required ):
Is there evidence that the partnership has existed for at least a year?
Have these partners conducted research together and/or published together? If this is a new partnership, does the community or professional/governmental organization have previous experience in research and have the infrastructure to handle federal funding?
Does the application include letters of support that specifically notes the proposed project?
Community partner roles and responsibilities
Does the application name community partners or organizations as Key Personnel?
Does the application include the CVs of community partners?
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
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.As part of the scientific peer review, all applications:
Information regarding the disposition of applications is available 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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that 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).
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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations 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. 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.
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.
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Contact Center Telephone: 800-518-4726
National Institute of Environmental Health Sciences (NIEHS)
Alfonso R. Latoni, Ph.D.
National Institute of Environmental Health Sciences
Jenny L. Greer
National Institute of Environmental Health Sciences (NIEHS)
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