Reissue of PAR-18-734.
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
93.865, 93.273, 93.121, 93.113
The purpose of this funding opportunity announcement (FOA) is to promote initial establishment of basic science-clinical collaborations by providing small grants to teams of basic scientists, physician scientists, and/or clinicians. These interdisciplinary teams may include but are not limited to the following: developmental biologists, cell biologists, geneticists, genomicists, physician-scientists including individuals with DVM/VMD degrees, clinicians, epidemiologists, biostatisticians, and/or bioinformaticists.
Applications must include at least one scientist with expertise from the basic science side of the spectrum as well as one from the clinical side. The multiple PD/PI model is strongly encouraged but not required. The goal is to facilitate the gathering of preliminary data to support future, larger research grant applications that will combine expertise and integrate basic, translational, and/or clinical approaches to understanding the developmental biology, genetics, and/or environmental basis of structural birth defects.
November 25, 2019
Standard dates apply.
The first standard due date for this FOA is February 16, 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.
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.
According to the Centers for Disease Control (CDC), in 2013 there were 3.93 million births in the United States. Of these, approximately 1 in 33, almost 120,000 infants, was born with a structural birth defect. Often overlooked are the untold number of miscarriages and fetal deaths potentially attributable to birth defects. Most states only report fetal deaths at 20 weeks gestation or more, and in 2013 a total of 23,595 fetal deaths were reported in the United States. While surgical interventions have improved the survival rate of children born with birth defects, during the first year of life birth defects are the leading cause of pediatric hospitalizations, medical expenses, and death. Despite the devastating impact of birth defects on the affected children and/or families, we still understand little of their etiology. Throughout childhood, they continue to rank among the top 10 causes of death and hospitalization among children of all ages. Thus, structural birth defects have a great impact on family life, the affected individual over the lifespan, public health, and socioeconomics.
From the perspective of developmental biology, over the past decade or so, the ability to detect spatial and temporal patterns of gene expression and to test gene function by targeted disruption or misexpression of specific genes has enhanced our understanding of the roles of genes during the development of organs and organ systems in animal models. Events like specification of organ primordia, inductive signaling, outgrowth, and patterning are routinely investigated at the level of molecular genetic mechanisms. An emergent theme from these studies is the conserved role of growth factors, signaling molecules, and signaling pathways across vastly different animal species in all organ systems. An outstanding question being addressed more recently relates to how these genetic processes are linked to tissue level organization and key cellular processes in order to modulate morphogenesis. This work is truly expanding our conceptual framework for understanding morphogenesis in animals and has implications for the translation of basic developmental biology research findings to the clinical setting, potentially improving diagnosis and clinical management of and therapeutics for human structural birth defects.
From the clinical perspective, the identification of specific patient populations, careful phenotyping of affected individuals, and sequencing of patient cohorts place the field of structural birth defects research on the verge of major advances. Currently, most birth defects are lumped into categories despite the fact that many phenotypically similar patients can have dramatically different outcomes. The role of genetic variation and the ability to improve our functional understanding of sequence variation may allow stratification of diagnoses and better predictions of outcomes. Identification of birth defect-specific genetic variations feeds back to the development biology arena and the ability to perform functional analyses in animal models. Challenges persist in efforts to bridge clinical and research arenas and in fostering true collaborative endeavors.
Addressing the problem of structural birth defects has been a high priority goal of NICHD's since the Institute was established in 1962. In 2000, this priority was emphasized by the establishment of the NICHD Structural Birth Defects Initiative. Recognizing the wide range of organ systems that can be affected by structural birth defects, the NIH established, in 2014, the Trans-NIH Structural Birth Defects Working Group, bringing together Extramural staff from ten Institutes under the leadership of NICHD. This working group leverages existing resources and fosters collaborations with the ultimate goal of accelerating the translation of basic research findings in developmental biology into better diagnoses, prevention, treatment and cures for structural birth defects. It is clear that this goal will only be reached when more basic scientists are working alongside clinical scientists in synergistic collaborations tackling problems related to structural birth defects.
The intent of this FOA is to support basic scientists, physician scientists (including individuals with DVM/VMD degrees), and/or clinicians in a collaborative effort to develop a multi-pronged research program focused on the etiology of a structural birth defect. The R03 funding will specifically support formulation of the overall collaborative experimental approaches as well as the collection of preliminary data to support a future, larger grant application such as an R01.
The first aspect of developing an interdisciplinary collaboration is often time spent breaking down barriers between differing disciplines and establishing effective lines of communication. For example, it is anticipated that pediatricians might need to learn more about developmental biology and genomics while developmental biologists might need to learn more about human genetics or epidemiology. Therefore, part of the R03 should be devoted to the cross-disciplinary discussions necessary to build the foundation for the experimental approaches to tackle the problem at hand.
Depending on the combination of experimental approaches to be undertaken, the areas of expertise required are expected to vary. For birth defects research to succeed in the long run, it is clear that interdisciplinary teams including but not limited to the following are necessary: developmental biologists, cell biologists, geneticists, genomicists, clinicians, veterinarians with animal modeling and comparative medicine expertise, epidemiologists, biostatisticians, and/or bioinformaticists. Therefore, the collaborative R03 should minimally include at least two PD/PIs with differing expertise. Expertise from both the basic science side of the spectrum as well as the clinical side should be engaged in the R03 research. The multiple PD/PI model is strongly encouraged but not required. The scope of the research proposed is expected to vary as well. The proposed studies should develop, adapt, and use approaches to identify genetic contributions as well as environmental interactions and other non-genetic determinants that contribute to various structural birth defects. It is clear that genetic factors can be the primary cause of structural birth defects and/or may act in concert with environmental exposures. Genetic and epigenetic factors provide a basis for functional studies in animal models or cell culture systems such as patient-derived induced pluripotent stem cells. Introducing genetic variants into animal model systems can bolster the causative role of the variant as well as provide insight into the embryological mechanisms underlying structural birth defects. Depending on the birth defect in question, the most appropriate model(s) will vary. Examples of research areas that are appropriate for this FOA are described below. This is not intended to be all-inclusive but is designed merely to provide guidance and direction for applicants.
Research Interests of Participating Institutes
Of particular interest to the NICHD are applications to study developmental defects of generalized body patterning and localized dysmorphic anomalies of various systems, such as the skeletal, nervous (e.g., neural tube defects), and visceral systems, that lead to clinically significant and major congenital structural malformations. In particular, studies that focus on the role of quantitative aspects of development, such as gene dosage or copy number variation and the role of modifier genes as well as environmental factors that cause teratogenesis are of interest.
While applications focusing on developmental disorders that result in intellectual disabilities and related neurobehavioral disabilities are of interest to the NICHD, they are outside the scope of this FOA. However, syndromic conditions, which exhibit intellectual disability as part of the phenotype, are acceptable as long as the focus of the project is on associated structural anomalies (e.g. Cornelia de Lange syndrome).
Alcohol is a known teratogen capable of causing fetal alcohol spectrum disorders (FASD), a collection of birth defects and developmental disabilities that occur in individuals whose mothers drank alcohol during pregnancy. Of particular interest to the NIAAA are multidisciplinary research applications into the etiology of brain and craniofacial abnormalities associated with prenatal alcohol exposure as well as structural birth defects not considered necessary for the diagnosis of fetal alcohol syndrome (FAS). Examples include, but are not limited to, congenital abnormalities of the heart, kidney, bone, eye and ear. Studies in which genetic susceptibility to alcohol related birth defects is examined in both animal models and in humans with FAS/FASD are encouraged.
The NIDCR will support applications proposing studies of developmental defects of craniofacial structures, particularly those developing new animal models of human gene-environment interactions; novel, clinically relevant animal models of human craniofacial dysmorphologies; and investigations of understudied craniofacial developmental disorders. Priority will be given to applications from teams effectively combining clinical and bench science expertise.
NIEHS will consider applications related to gene-environment interactions of developmental defects. Differential response for susceptibility to particular toxicants and exploration of gene variants that influence sensitivity to toxicity, and ultimately birth defect risks, are of particular interest. Hypothesis-driven research of specific gene-environment interactions and structural birth defects including novel or improved assessment of environmental exposures, use of biomarkers of exposure, effect, and susceptibility, and unique animal models of human gene-environment interactions are especially encouraged.
Environmental agents which are considered of primary interest for NIEHS generally include: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants and particulates, as well as biologically derived toxins.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.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The maximum project period is two 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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
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.
Since the intent of this FOA is to foster collaborative efforts between basic and clinical scientists, the multiple PD/PI format is strongly encouraged but not required as a means to clearly demonstrate the intent to establish a successful collaboration that will carry over into the development of further grant applications. Applications must include at least one scientist with expertise from the basic science side of the spectrum as well as one from the clinical side. These two individuals must serve as Multiple PD(s)/PI(s) or one must serve as PD/PI with the other serving as Senior/Key Personnel.
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.
The following attachment must be included and must be no more than 2 pages maximum.
Applications must include a proposed Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award. The following areas should be addressed: Organizational structure; Management plan detailing how existing resources will be utilized; Planned interaction and responsibilities of key personnel other than PD(s)/PI(s); Description of how the research team will communicate (e.g., in person, videocast, web meeting, etc.).
The filename "Collaboration Plan-PI-NAME.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers.
Since the intent of this FOA is to foster collaborative efforts across the spectrum of basic to clinical science, at least one scientist with expertise from the basic science side of the spectrum as well as one from the clinical side must participate as Senior/Key Personnel or PDs/PIs.
All instructions in the SF424 (R&R) Application Guide must be followed.
The following modifications also apply:
NICHD Plans for Sharing Human and Non-Human Data and/or Biospecimens
NICHD expects that data, biospecimens, and results of NICHD-funded research will be shared with the wider scientific community to the extent feasible and in a timely manner. NIH Data Sharing Policy expects the timely release and sharing of data to be no later than the acceptance for publication of the main findings from the final dataset. All NICHD applications, regardless of the amount of direct costs requested for any one year, are expected to include a Sharing Plan that addresses sharing of data as well as biospecimens, if applicable. Ideally, this plan would include submitting data or biospecimens to an appropriate repository. These plans will also be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program.
Specifically, for human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. They can also submit information about the location and availability of biospecimens to DASH, if applicable. Submission of data to the NICHD DASH is one way that grantees may meet the requirements of the NIH Data Sharing Policy and make study data available for secondary analyses. Information about DASH may be obtained at https://dash.nichd.nih.gov/
If use of DASH is not feasible, NICHD expects awardees to share data and/or biospecimens through other equivalent broad-sharing data and/or biospecimen repositories. For projects generating large-scale human genetic data, applicants should provide a Provisional or Institutional Certification specifying whether the individual-level data can be shared through an NIH approved repository, such as dbGaP, in line with the NIH Genomic Data Sharing Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html).
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.
Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
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, NIH. Applications that are incomplete or non-compliant 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.For this particular announcement, note the following:
The R03 small grant supports discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research project usually is limited, an R03 grant application may not contain extensive detail or discussion. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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?
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?
Does the investigative team possess sufficient expertise in basic and clinical areas that will foster a synergistic, collaborative approach to the investigation of the structural birth defect of interest?
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 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?
Is the Collaboration Plan well defined with identifiable responsibilities for the PD/PIs? Is a plan for management of the collaboration clearly presented, with well-defined descriptions of what each participant proposes to provide to the collaborative partnership?
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?
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.
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.
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.
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 the Center for Scientific Review (CSR), 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.
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.
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.
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Reiko Toyama, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
William Dunty, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Kathryn Stein, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
James R. Williams
National Institute of Environmental Health Sciences (NIEHS)
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