National Institute on Deafness and Other Communication Disorders (NIDCD)
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.
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.
This FOA requests research to increase accessible and affordable hearing health care (HHC). In this context, HHC refers broadly not only to hearing technology but also to the systematic and comprehnsive hearing-related services involved in diagnosis, treatment, auditory rehabilitation, and counseling of individulas with hearing loss, as well as other services that collectively allow the individual to maximize his or her communication outcomes. The overarching emphasis is on the acquisition of knowledge that can be translated into new or enhanced approaches for HHC. Applications should focus on delivering better healthcare access and outcomes and should seek solutions that are effective, affordable, and deliverable to those in need. Research is needed to develop or test new and innovative adaptations of current approaches and practices. These adaptations should be implementable and sustainable in clinical and community practice settings beyond the research environment and may have the potential to address disparities in health care. Research applications may span HHC in the context of a medical model to a psychosocial model of hearing loss. Outcomes research and health services research related to accessible and affordable HHC are also responsive to this FOA. Because some aspects of this research area are new for the NIDCD scientific community, there will likely be a need to obtain preliminary data or conduct early-stage developmental activities before moving to a full-scale project. The Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism is appropriate for this purpose. It provides opportunity for creating, developing, and strengthening new and necessary collaborations, provides opportunity for acquisition of preliminary data, and allows for milestone-driven research, supporting a phased research project with a stepped approach for implementation. Applications not requiring a phased research approach are encouraged to apply under a different funding mechanism (e.g., investigator initiated R21 or R01).
Hearing loss is a major public health issue, and yet it remains a neglected part of most mainstream models of healthcare. In 2015, nearly 7% of the world’s population had disabling hearing loss, a stark uptick from estimates just two years prior. In the United States (U.S.) alone, some 30 million people (13%) have measurable hearing loss, which includes nearly two thirds of individuals aged 70 and older. Recent estimates place the US economic burden of adult hearing loss from lost productivity and excess medical costs in the billions of dollars. Hearing loss has been associated with loneliness, depression, and declining physical function, and there is a growing association linking sensory decline with cognitive faculty and, possibly, dementia. Despite this, most people with hearing loss do not seek or do not receive hearing health care. Since its inception, the National Institute on Deafness and Other Communication Disorders (NIDCD) has prioritized supporting basic and translational research into the normal and disordered mechanisms of hearing and hearing loss, as well as science focused on the care and re/habilitation of persons of all ages with hearing loss. Despite these efforts, little attention was given to systematically exploring hearing health care access, delivery, and affordability. In August 2009, NIDCD convened a working group charged with developing a research agenda to increase accessibility and affordability of hearing health care for adults with mild to moderate hearing loss. The group generated a comprehensive list of research recommendations that identified gaps in evidence-based practice at all levels of the HHC pipeline, for both the consumer and the clinician. This launched a focused and formalized effort from NIDCD to develop a research agenda and portfolio around improving accessible and affordable hearing health care. Following the NIDCD working group, a National Academies of Sciences Engineering and Medicine (NASEM; previously Institute of Medicine IOM) consensus study titled "Hearing Health Care for Adults: Priorities for Improving Access and Affordability", was published in 2016. At nearly the same time, the President’s Council of Advisors on Science and Technology (PCAST) developed an independent report, "Aging America & Hearing Loss: Imperative of Improved Hearing Technologies". The overlapping and consistent initiatives and recommendations related to improving hearing healthcare from both non-government and government agencies represented a unique and compelling opportunity for the field. Following these reports, in August 2017, H.R. 2430 was signed into law, which directs the U.S. Food and Drug Administration (FDA) to create a first-of-its-kind category of over-the-counter hearing aids for adults with perceived mild to moderate hearing loss. The field of clinical audiology and auditory rehabilitative science is changing quickly and dramatically, and rigorous scientific research is needed to address the many lingering and new questions surrounding this public health issue. Many of the articulated research needs identified by NASEM and PCAST, in addition to the NIDCD working group, may be appropriate for an Exploratory/Developmental Phased Innovation (R21/R33) grant mechanism to support research and/or infrastructure needs. Addressing the research needs will require increased collaboration among various relevant parties (e.g., researchers, audiologists, hearing aid dispensers, otolaryngologists, primary care physicians, public health researchers, health services researchers, industry, professional and patient-advocacy organizations) as well as infrastructure support and expertise. This FOA is one of several NIDCD research initiatives created in response to the NIDCD working group and NASEM recommendations.
The purpose of this FOA is to encourage research and increase infrastructure support leading to accessible and affordable hearing health care and improved outcomes. This includes research on the development of technologies (e.g., low-cost hearing aids, NIDCD open speech signal processing tools), screening (e.g., effectiveness in typical primary care settings), access and management through new delivery systems (e.g., telehealth, internet, kiosk, convenient care clinics), system barriers (e.g., availability of services, cost, location, insurance coverage, referral network) as well as behavioral research at the individual patient level (e.g., variables influencing one’s perceived need for HHC, patient outcomes). Solutions should be implementable and sustainable in settings beyond the research environment and should have the potential to address disparities in health care. Generally, health disparities populations include racial and ethnic minorities, low socioeconomic populations, conditions with comorbid conditions in addition to hearing loss, and rural populations.
Infrastructure support may include the creation of research partnerships among interested organizations (e.g., academia, practice-based research networks, community-based health care organizations, industry, and professional and patient organizations). It may also include support for creating pooled clinical data sets across institutions, agencies, or health care systems to analyze characteristics of patient populations, provider or health care settings and patient outcomes.
Responsive R21/R33 applications must be milestone-driven and may include, but are not limited to, the following questions and research needs:
The developmental and/or piloting portion of the research occurs during the R21 phase of the research plan and implementation and/or further research/development occurs within the R33 phase. Transition from the R21 phase to the R33 phase is contingent on successful completion of milestones delineated in the application and is subsequently approved by NIDCD staff (see Section IV.6). At the end of a successful R21/R33, it is expected that there will be measurable and documented advances leading to accessible and affordable HHC. If the application proposes infrastructure development, the organizational structure and information on how investigators will access the support activities must be delineated. Patient access, recruitment services and data collection issues may be included as part of the R21/R33 application.
As an example, in the R21 portion of the application the PD/PI may propose pilot work in which investigators pilot hearing aid fitting using a new delivery system. Upon proof of the feasibility, the R33 phase would provide funds to assist in a research paradigm on a larger population. A second example might be one in which a new technology is developed/or refined. Upon completion of the technology development and readiness (R21 phase), the R33 phase would evaluate the utilization of this tool in a larger clinical population. A third example may be one in which in the R21 phase, questionnaires are developed and piloted addressing barriers to access and utilization of HHC services. Upon completion, the R33 phase would utilize the questionnaire in a research paradigm.
This announcement seeks to encourage outcomes research (also defined as effectiveness research) and/or health services research. Outcomes research seeks to determine to what degree an intervention works in general, real-world settings, such as in diverse populations among varying provider and clinical practice settings. It may also include evaluation of economic impacts linked to health outcomes. This research typically employs broader inclusion criteria, has fewer restrictions for participation and research outcomes, and often includes variables such as functional status, well-being, quality of life, cost, health care resource use, etc. Health services research seeks to examine the impact of organization, financing and management of health care services on the delivery, quality, cost, access to and outcomes of such services. Studies may include research focused on the varying factors that impact access, utilization, quality, and outcomes of HHC.
This FOA also encourages Community-Based Research practices and encourages inclusion and attention to the needs of special populations (e.g., elderly, low socioeconomic status, disparities, rural, second language populations, conditions with comorbid conditions in addition to hearing loss).
This announcement applies only to research applications addressing issues in support of HHC for adults with mild to moderate hearing loss. Studies including individuals with hearing loss greater than mild or moderate (e.g., severe hearing loss) are allowed under this FOA if the project results or outcomes will also have an impact on adults with mild to moderate hearing loss.
Questions about the suitability of applications should be addressed to the research/scientific (program) contact listed in the "Agency Contacts" section. Investigators are strongly encouraged to contact NIDCD program staff to ensure that their applications are responsive.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The R33 phase may not exceed four years and direct costs are limited to $1.4 M with no more than $400,000 in direct costs in any single year of the R33 phase.
The total duration of the award (R21 and R33 phases) may not exceed five 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.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
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.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
The letter of intent should be sent to:
Kelly King, Au.D., Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
All instructions in the SF424 (R&R) Application Guide must be followed.
Specific aims for both the R21 Phase and the R33 Phase should be contained in the Specific Aims section and must be clearly demarcated.
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
with the following additional instructions:
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.
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 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.
General Information about a Combined R21/R33 Phased Innovation Award Application
The R21/R33 Phased Innovation Award application must be submitted as a single application with one PHS398 Cover Page Supplement component and one Research & Related Budget component.
The Specific Aims page should list the aims of both R21 and R33 Phases.
For the R21/R33 Phased Innovation Award application, the initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase. Thus, clarity and completeness of the application with regard to specific goals and the feasibility of each phase and the Milestones are critical. A single overall impact/priority score will be assigned to each discussed application. Milestones that are not sufficiently rigorous scientifically to be valid for assessing progress in the R21 phase will reflect poorly on the scientific merit of the application as a whole. The initial review group may recommend that only the R21 phase be supported, based on concerns related to the application’s specific goals and the feasibility milestones justifying the expansion to the R33 phase. Deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may affect the merit rating of the application.
The R21 component of an R21/R33 application will be considered exploratory, so that extensive preliminary data from the applicant’s own laboratory are not required. However, the project must be based on a strong rationale, and the applicant should provide evidence that the proposed approach and methods are feasible. The R21 Phase provides time for necessary preliminary work, for example, the substantial modification of approaches, methods, or technology, and subsequent pilot testing. Although preliminary data are not required for an R21/R33 application, any preliminary data that will support or justify the proposed hypothesis, rationale or development plan may be included. Applicants are encouraged to include all information required for adequate evaluation by reviewers. However, in the event that a technology is not yet patent protected and the applicant does not wish to include complete details, the application should at a minimum provide a demonstration of the capabilities of the proposed approach.
The milestone section must include specific estimates of expected progress during the R21 phase that includes a timeline, a description of the milestones and discussion of their suitability for assessing success in the R21 Phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 Phase. Stating well-defined, measurable milestones is critical to the application. Milestones should be specific, quantifiable, and scientifically justified; they should not be simply a restatement of the R21 specific aims. The milestones will be considered in evaluating the approach proposed by the investigator. Applications that lack Milestones will not be reviewed. Milestones will vary depending on the nature of the proposed research, and should be tailored to the specific research goals. The clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones are critical. These milestones will be evaluated in the peer review process. Prior to award, the Program Officer will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Officer and the applicant will discuss the final set of R21 milestones, which must ultimately be approved by NIDCD staff. Any negotiated actions must be mutually agreed upon by the applicant (Authorized Organizational Representative (AOR)), the PD/PI, and the NIDCD program and grants officers prior to the award of the R21 phase. These will be incorporated into the terms and conditions of the award and will be the primary basis for judging the success of the R21 work. Funded applicants are solely responsible for planning, directing, and executing the proposed project.
Transition to the R33 Phase of the Award
For funded applications, the PD(s)/PI(s) will submit an AOR-approved R33 transition package to the NIDCD Grants and Program Officers. The R33 transition package should describe progress and completion of the initial R21 milestones and a clear description of how those goals were met. This report should clearly indicate which milestones were or were not completed successfully. In the latter case, an explanation should be provided as to why the milestone(s) was not met and discuss the impact upon the R33 research goals. Receipt of this transition package will trigger an NIDCD administrative program review that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on original R21/R33 peer review recommendations, successful completion of mutually agreed upon negotiated scientific milestones, program priorities, and the availability of funds. For funded applications, peer review is not anticipated between the two phases of the project, but NIDCD reserves the right to conduct a program review with outside opinions.
Both conventional development applications and high-risk, high-reward applications are encouraged. Dependent upon the nature of the risk in the application, success rates in moving to the R33 stage are expected to vary. The R21 and R33 cannot be funded in the same fiscal year.
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.
The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.
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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
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?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
For all CT FOAs, add the following questions, after the standard questions for the Environment review criterion. If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Are the steps and milestones clearly defined? Are the milestones feasible, well developed and quantifiable with regard to specific goals and accomplishments? Are criteria provided that will be utilized in determining milestone completion before proceeding to the next phase of the project? Are contingency plans provided for each work stage?
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)?
For research that involves human subjects but does not involve one of the six 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 six 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 children 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).
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.
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.
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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://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 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 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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