apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
New Date March 12, 2021 per issuance of PAR-21-123. (Original Expiration Date: May 08, 2021 )
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
Optimization of novel therapeutics is usually dependent upon preclinical evaluation in animal models or ex vivo model systems. In addition, it is widely recognized that the ability to monitor the direct effects of potential therapeutic agents on the intended biological target using pharmacodynamic (PD) markers is essential for accurate interpretation of clinical data. Unfortunately, many drug discovery programs focused on neurological disease lack both PD markers and validated models of disease and are therefore unable to adequately inform or predict translational outcomes. This FOA is intended to support the development of validated and clinically relevant animal models, model systems, and/or PD markers focused on neurological disorders. These model systems and PD markers should translate to the clinical setting to the degree that they can inform the decision to advance a therapeutic candidate to clinical testing and can inform clinical study design.
Animal Models and Model Systems
Animal models and model systems should represent a significant advance over those that currently exist for a defined neurological disease. They can include genetic, chemical, and/or physiological manipulations in animals or ex vivo systems that recapitulate a significant component (clinical manifestations and underlying physiology) of the disease condition in humans. Animal models should be compatible with endpoints that are measurable and relevant to the disease process in both preclinical and clinical settings.
Development of animal models or model systems that translate to a human disorder or disease requires rigorous internal and external validation. In order to demonstrate internal validation, it is important to evaluate and understand the precision, reliability, sensitivity, accuracy, and dynamic range characteristics of the endpoints used to assess the effect of therapeutic or physiological intervention in the animal model or model system. In addition, it is essential that the general experimental design procedures utilized in characterizing the model are conducted in a rigorous manner, utilizing randomization, blinding and the appropriate power analysis.
It is also important to address external validation, showing that the animal model or model system can recapitulate aspects of the disease phenotype and etiology, where endpoints or biomarkers of disease are similar and measurable in both the model system and in human disease. One component of external validity is face validity-the similarity between the model and the clinical manifestation of the disease (as measured by overt clinical symptoms, patterns of activation using fMRI or EEG, functional or behavioral read-outs, disease progression, etc). Another component of external validity is construct validity--the similarity between the physiological or biological basis of the model and the actual human disorder (i.e., genetic, proteomic, metabolomic markers). Although components of both face and construct external validity are certainly desirable in an animal model or model system, predictive validity provides the most confidence in the ability of the animal model or model system to translate to human disease. Predictive validity refers to the probability that a clinically validated therapeutic agent (biologic or small molecule) will have the same effects in the animal model or model system as it will in the intended clinical population. By definition, the evaluation of predictive validity requires a validated molecular tool that has been shown to alter disease progression in humans. Since these tools do not necessarily exist for many neurological diseases, it is not always possible to obtain true evidence of predictive validity until the candidate therapeutic is actually tested in humans. Therefore, it may not always be possible to evaluate the predictive validity of a new animal model or model system. However, it is important to include evaluations of internal validity, and face, construct, and predictive validity (to the extent possible), to provide evidence that the proposed animal model or model system represents a significant advance over existing animal models or model systems.
Pharmcodynamic (PD) Markers
This FOA will also support the development of PD markers that indicate the biologic effect of therapeutics administered to treat neurological disease. PD markers typically represent a component of the molecular pathway mediating the biological effects of therapeutic target modulation. Some examples of PD markers include receptor occupancy, phosphorylation of proteins in the target signaling pathway, changes in substrate or product levels as a result of target enzyme modulation, gene transcription, physiological changes, etc. These PD markers are intended to: 1) represent endpoints that can be measured in both preclinical and clinical settings, and 2) represent a significant advance over PD measurements that may already exist for the therapeutic agent and targeted neurological disorder.
Since PD markers should represent meaningful and quantitative indices of a therapeutic agent's effects in humans, evidence of robust internal and external validation must be demonstrated. Internal validation includes evaluation of the precision, reliability, sensitivity, accuracy and dynamic range characteristics of the PD measurement. External validation typically verifies that the PD marker represents a component of disease etiology and/or therapeutic target mechanism of action that can be demonstrated in both preclinical and clinical settings. For example, manipulation of the therapeutic target (i.e., knockdown, silencing, activation) should result in a quantitative change in the PD marker that is consistent with knowledge of the target pathway. In addition, manipulation of the target with a therapeutic agent that has been in clinical testing (if any are available) should have the same effects on the PD marker in preclinical and clinical settings.
The FOA will support applications to develop animal models of neurological disease that recapitulate aspects of the disease pathophysiology as well as its etiology, where endpoints or markers of disease are similar and measurable in the animal model and human disease (i.e., neurological deficits, patterns of activation using functional Magnetic Resonance Imaging (fMRI) or electroencephalography (EEG), measurable genetic markers, functional or behavioral read-out, disease progression, etc). The FOA will also support the development of non-genetic models (i.e., motor function, physiological manipulations such as artificial vessel obstruction or diet) that expose disease symptoms in animals and humans. In addition, it will support the development and validation of ex vivo testing systems that utilize existing human cell systems (i.e., induced Pluripotent Stem Cells (IPSC). Finally, the FOA supports the development and validation of PD markers (receptor occupancy, gene transcription, protein synthesis/secretion, etc.) that can be used to follow the biological effects of the therapeutic test agent in the context of a defined neurological disease. Since this FOA does not support the development of animal models or model systems for the purpose of testing hypotheses about disease etiology, it is assumed that model development will be based upon widely accepted hypotheses or knowledge regarding disease etiology.
The knowledge gained from these studies should lead to the development of "next generation" translational models of neurological disease and/or PD markers of target engagement for therapeutics designed to treat a defined neurological disease. Taken together, the new translational model systems and PD markers developed as a result of applications to this FOA should provide an improved “translational toolkit” that will better predict the efficacy and safety of new therapeutic entities, thereby facilitating future drug discovery and development in the field of neurological disorders and stroke.
Out-of-scope activities include :
Applications focused on any of the above will be deemed inappropriate .
Phased Award Activities
The identification and characterization of clinically relevant preclinical models typically require a multi-step process that includes initial feasibility testing of the model system followed by internal and external validation. Therefore, this funding opportunity will use a phased R61/R33 mechanism. The R61 phase will support initial development, internal validation and optimization of the animal model, model system, or PD marker.
The R33 phase will support any required scaling along with external validation studies. The final outcome should be a fully validated model system, or PD marker that can be utilized in both preclinical and clinical settings to test the biological effects of candidate therapeutics designed to treat neurological disease. Transition from the R61 to the R33 phase is contingent upon the successful completion of proposed milestones. Milestones are goals that are quantifiable for measuring success that can be used for go/no-go decision making at the R61/R33 transition point, and should have timelines and quantitative criteria associated with them. All milestones should be useful as a measure of progress toward the overall goal of the project. Specific Aims or a list of activities planned for each year are not considered milestones because they do not provide decision-making goals. NINDS emphasizes the importance of the robustness and reproducibility of experimental results in evaluating progress.
Examples of activities in the R61 Phase include, but are not limited to:
Demonstration of collaborative relationships between applicants with preclinical and clinical drug development expertise (such as biostatisticians and clinicians) is highly encouraged. It is preferred that the collaborating clinician is listed as a co-investigator or a formal member of the investigative team. Alternatively, a letter of support from the collaborating clinician can be used to demonstrate involvement in the project, but should include a plan for collaboration with the principal investigator. The clinician should have demonstrated experience in the development of therapeutic entities to treat neurological disease.
Applicants are strongly encouraged to contact Scientific/Research staff to discuss potential research projects prior to submitting an application.
Small Business applicants who are eligible for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are strongly encouraged to submit through either the SBIR or STTR Omnibus Solicitations (https://sbir.nih.gov/funding#omni-sbir) to take advantage of the congressionally mandated set-aside specifically for small businesses. Please see https://www.ninds.nih.gov/Funding/Small-Business-Grants for more information about the programs.
Prior to funding an application, NINDS Program staff may contact the applicant to discuss the proposed milestones and any changes suggested by the NINDS review panel or Program staff. A final set of approved milestones will be specified in the Notice of Award.
For more information about other NINDS Translational Programs visit the website
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
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.
Intellectual Property (IP): Applications should include an Intellectual property (IP) strategy, if appropriate. Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials.
Applicants should describe the IP landscape surrounding their model system or PD marker. Applicants should describe any known constraints that could impede their model system/PD marker discovery and development (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar model systems/PD markers that are under patent protection and/or on the market, etc.) and how these issues could be addressed with achieving the goals of this program. If the applicant proposes using a technology or agent(s) for validation purposes whose IP is not owned by the applicant's institution, either an investigational therapeutic, FDA-approved therapeutic, or other licensed product, the applicant should include a letter (see letter of support) from any entities owning the IP indicating there will not be any limitations imposed on the studies or the product which would impede achieving the goals of the funding program.
If patents pertinent to the model system/PD marker technology or validating agent(s) being developed under this application have been filed, the applicant should indicate the details of filing dates, what type of patents are filed, and application status, and associated USPTO links, if applicable.
Applicants should discuss future IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the technologies to practical application and for coordinating these efforts (e.g., licensing, managing IP) among the institutions. Applicants should clarify how IP will be shared or otherwise managed if multiple PD/PIs and institutions are involved, consistent with achieving the goals of the program.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Milestones Transition from the R61 to the R33 phase is contingent upon the successful completion of one set of proposed milestones. The specific milestone(s) proposed in the application will depend on the goals of the application and the accomplishments necessary in the R61 phase for advancement into the scaling and validation studies proposed for the R33 phase. These milestones are to be included as the last element of the Research Strategy section of the application and will be evaluated as part of the scientific and technical merit of the R61/R33 application. The milestones proposed in the application should be well-described, quantifiable, and scientifically justified to allow program staff to assess progress in the R61 phase. Specific aims or a list of activities are not considered milestones because they would not provide decision-making goals. A discussion of the milestones relative to the progress of the R61 phase and the implications of successful completion of the milestones for the R33 phase should be included. The clarity and completeness of the R61/R33 application with regard to specific goals and feasibility milestones are critical. Milestones should provide clear indicators of a project's continued success or emergent difficulties and will be used to evaluate the application as part of the consideration of the awarded project for further funding of non-competing award years by the Program Director(s)/Principal Investigator(s), and Program Official For frequently asked questions and milestone examples, please see https://www.ninds.nih.gov/Current-Research/Research-Funded-NINDS/Translational-Research/Funding-Programs-Researchers/IGNITE.
Timeline Provide a timeline with specific milestones for progression from the R61 phase to the R33 phase. The timeline, specific goals and feasibility milestones should be clear and complete. Indicate when it is anticipated that essential components of the project will be completed. The proposed timeline with specific milestones should be clearly delineated and should appear as the last element of the Research Strategy section.
Rigorous Study Design and Supporting Data
An R61/R33 Phased Innovation Award application in translational research should have a strong biological rationale for the intended approach, supporting data from rigorously designed experiments, and proposed studies that exhibit methodological rigor. NINDS urges applicants to the program to consider the rationale for the chosen animal model(s) and endpoints, adequacy of controls, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results. (See https://grants.nih.gov/reproducibility/index.htm and NOT-NS-11-023: Improving the Quality of NINDS-Supported Preclinical and Clinical Research through Rigorous Study Design and Transparent Reporting.)
Collaboration NINDS strongly encourages applicants to form multidisciplinary teams that consist of academic/industry experts relevant to the research plan (i.e., biostatisticians, clinicians, technical experts). This multidisciplinary team should be able to define the goals of the research, outline specific gaps that need to be addressed during this funding period, outline detailed plans and experiments, and execute the research strategy.
Letters of Support: Applicants should include a letter of support from a clinical collaborator, as described in Part 2, Section I. The letter of support should outline a collaboration plan between the preclinical and clinical applicants. The collaboration plan should include the roles and responsibilities of the preclinical and clinical scientists in developing the model system or PD marker as it relates to the pathophysiology and/or disease etiology of clinical populations typically recruited in drug development programs focused on a specific neurological disease. The plan should also address the feasibility of endpoint measures in preclinical and clinical settings, along with the strategy for external validation.
Applicants should include letters of support from consultants, contractors, and collaborators.
If applying from an academic institution, include a letter of support from the technology transfer official who will be managing intellectual property associated with this project.
If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions.
If collaborating with a private entity, include a letter of support that addresses any agreement to provide agent(s), any limits on the studies that can be performed with said agent(s), any limitations on sharing of data (including negative results), and whether a licensing agreement(s) is in place. This letter should come from a high official within the private entity who has authority to speak on these issues.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.
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.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is 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?
Further criteria specific to this opportunity: 1) What is the potential of the animal model system, model system, or PD marker to translate to human disease? 2) How carefully have the investigators considered the phenotype, physiology, and feasibility of measurement of the targeted clinical population in the design and validation of their preclinical model system? 3) What are the feasibility and utility of the model system or PD marker from both preclinical and clinical perspectives? 4) How strong is the rationale of unmet need for the model system or PD marker in the defined neurological disease area? 5) Has the investigator carefully considered the role of the model system or PD marker in the drug discovery and development process? 6) What is the overall potential for the proposed studies to significantly advance translational medicine and drug development in the disease area described?
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?
Further criteria specific to this opportunity: Are the investigators knowledgeable and experienced about the biological target and/or disease biology? Do the investigators have sufficient expertise in the areas of in vivo or ex vivo pharmacology, experimental design, statistical analysis, systems analysis, etc (as appropriate) for the project? Have they formed collaborations with clinicians who have drug development experience? Is there evidence that the clinical collaborator will play an active role in the design and validation plans of the animal models, model systems or pharmacodynamic markers? Are the roles of all collaborators carefully defined in the research plan?
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?
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?
Further criteria specific to this opportunity: Has the application included plans to optimize the animal model, model system, or PD marker (if necessary)? Are there plans to estimate the feasibility of the animal model, model system, or PD marker for validity testing? Does the application include a carefully detailed plan for animal model, model system or PD marker validation (both internal and external validation)? In the case of endpoint measures (PD markers, animal models, or model systems), have methods for addressing internal validity characteristics such as dynamic range, precision, accuracy, etc., been addressed? Is the proposed statistical analysis appropriate for the experimental design and the quantitative characteristics of the endpoints? Have methods for evaluating external validity characteristics (how well the model system recapitulates human clinical symptoms, pathology, physiology and genetic basis for disease) been systematically outlined in the application for animal model, model systems and PD marker characterization? Has the applicant thoughtfully considered the potential to produce an animal model, model system or PD marker that will be feasible to implement and will meaningfully translate to human biology?
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?
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?
Milestones and Timelines
Are milestones robust and associated with clear, quantitative criteria for success that allow go/no-go decisions at the R61/R33 transition point? If criterion is not to be used for go/no-go decisions is it justifiable?
Does the set of milestones allow the evaluation of progress in the R61 phase and will successful completion of these milestones provide confidence that the investigator will be able to successfully implement the R33 phase?
Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without unnecessary steps? Are there additional key experiments that need to have milestones designated?
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.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
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
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see 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.
Rebecca Roof, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
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