Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by National Institute on Aging (NIA) (http://www.nia.nih.gov) on behalf of the NIH.
The purpose of this FOA is to invite applications for additional Preclinical Animal Study Sites (PASS) to join the Molecular Transducers of Physical Activity Consortium (MoTrPAC; http://commonfund.nih.gov/MolecularTransducers). Awards made through this FOA will support investigations into the molecular mechanisms of molecules mobilized in response to exercise identified by the existing MoTrPAC PASS and Chemical Analysis Sites (http://MoTrPAC-data.org). The new PASS members will use MoTrPAC data to conduct detailed mechanistic studies to explore the functions, sources, and target tissues of molecules that transduce the beneficial effects of physical activity that have been identified in MoTrPAC. Additional exercise studies and tissue collection from Fisher 344 rats for analysis by the MoTrPAC Chemical Analysis Sites are not the focus of this FOA.
Six companion FOAs established the original elements of the MoTrPAC in December, 2016. Clinical Centers are collecting blood, muscle, and fat from well-characterized trained and healthy sedentary people engaging in physical activity. Biospecimens will be analyzed by Genomics, Epigenomics, and Transcriptomics Chemical Analysis Sites (RFA-RM-15-010) and Metabolomics and Proteomics Chemical Analysis Sites (RFA-RM-15-011). The original Preclinical Animal Study Sites have provided 16 additional tissues from Fisher 344 rats (19 tissues total) that cannot be obtained from human subjects and will greatly expand the scientific impact of MoTrPAC and allow for further characterization and validation of molecular transducers identified from the chemical analysis of human samples (RFA-RM-15-013). Analysis of additional tissues/organs from animals will substantially broaden the impact of MoTrPAC since it will demonstrate how many tissues in the body are responding and adapting to exercise. These analyses are underway. A Bioinformatics Center is overseeing data standardization, integration, and storage and will implement data sharing and computational tools for the integrated analysis of clinical and molecular data (RFA-RM-15-012). Overall coordination is being provided by a Consortium Coordination Center (CCC) (RFA-RM-15-014).
Awardees from this FOA will represent an integral component of the MoTrPAC and must work collaboratively within the consortium to plan and execute this study to begin characterizing the molecular mechanisms of molecules identified in the 'molecular map' that underlie the beneficial effects of physical activity. The product will be a publicly available data resource that will enhance and accelerate subsequent mechanistic research on overall physiology and diseases and/or conditions affected by physical activity.
January 10, 2020
February 20, 2020
March 20, 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.
This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact in science. All Common Fund initiatives invite investigators to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
The purpose of this FOA is to invite applications for Preclinical Animal Study Sites (PASS) as part of the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) (http://commonfund.nih.gov/MolecularTransducers). Awards made through this FOA will support preclinical mechanistic studies on a range of molecular compounds identified in the initial PASS exercise protocol which was designed to complement and substantially expand the data from the human clinical study in MoTrPAC. This FOA is expected to support up to 4-6 additional Preclinical Animal Study Sites (PASS) as part of the MoTrPAC.
The work of the three existing PASS is divided into two phases. In Phase 1, the investigators developed and utilized treadmill running and tissue sampling protocols for Fisher 344 rats that parallel and greatly expand the potential impact of the MoTrPAC clinical protocols for active and sedentary volunteers. The PASS Phase 1 included two separate arms to examine the response of two age groups (6 and 18 months) of male and female animals to either an acute bout of exercise or to an intensive and progressive aerobic (70% VO2max) training protocol ranging from one to eight weeks in length. Harvesting tissues from both acutely- and training-exercised Fisher 344 rats along with appropriate sedentary controls has been completed, and the tissues have been distributed to the Chemical Analysis Sites for analysis according to MoTrPAC guidelines
In Phase 2 the three original PASS study sites are designing and conducting detailed mechanistic studies to identify the sources, signaling pathways, physiological targets, and functions of mobilized and identified molecular transducers of physical activity; recognize feedback and interaction effects among different pathways and tissues; and discover specific roles of the molecules associated with specific health benefits. The original three PASS sites have begun analyses of mechanisms involved in transducing the effects of exercise. Preliminary data from five abundant PASS tissues indicate that molecular signals produced by physical activity are abundant and diverse (MoTrPAC-data.org)
In view of the enormous number of molecules mobilized in the two treadmill exercise arms of the study, this new RFA calls for additional applications to join the consortium for the remainder of the MoTrPAC funding period to explore the mechanistic links between the candidate molecular transducers of physical activity and functional effects of exercise in tissues. Building on existing and future animal and human data, such preclinical studies will extend knowledge of the benefits of molecular transducers of exercise. Overall, data from existing and newly funded PASS studies are anticipated to substantially increase our understanding of how tissues and organs other than muscle, fat and blood adapt to the exercise induced changes. Data from the 19 PASS tissues will extend the analyses of candidate transducers of physical activity from the clinical study (muscle, adipose tissue and plasma) across multiple organs and tissues that are not accessible from human participants. Applicants should propose what they think is the best strategy and approach for investigating how these mobilized compounds synergize to coordinate the overall homeostatic response to exercise in a variety of tissues. Grantees from this RFA will work in conjunction with the MoTrPAC Steering Committee (of which they will be members) to finalize the molecules that will be investigated
The MoTrPAC Bioinformatics Center (BIC) will conduct a data Webinar for interested applicants at a date to be announced on the MoTrPAC Data Hub Website, the MoTrPAC site, and the Common Fund site soon after publication of this FOA.
The goal of the Molecular Transducers of Physical Activity in Humans Consortium (MoTrPAC) is to assemble a comprehensive map of the molecular changes that occur in response to physical activity and, when possible, relate these changes to the benefits of physical activity. This map will contain the many molecular signals that transmit the health effects of physical activity and indicate how these molecules are altered by variables such as age, sex, body composition, fitness level, and chronic exposure to exercise. Information will be housed in a user-friendly public data resource that any researcher can access to develop hypotheses regarding the molecular mechanisms through which physical activity can improve or preserve health
Lack of physical activity is at the root of numerous common chronic health problems. Despite this, we still have a poor understanding of the actual molecular mechanisms by which the benefits of physical activity are realized. The development of a ‘molecular map’ of circulating and/or tissue specific signals produced in response to physical activity and the molecular changes produced in target tissues is a daunting task. Yet, it is now possible because of recent advances in several powerful high-throughput discovery approaches, including metabolomics, genomics, transcriptomics, and epigenomics
Applicants are expected to take full advantage whenever possible of resources such as databases, catalogues, technologies, protocols, and data standards developed through other national and international efforts, particularly NIH Common Fund programs which are described at http://commonfund.nih.gov/. Examples include Libraries of Integrated Networks of Cellular Signatures (LINCS) (http://commonfund.nih.gov/LINCS/index); Epigenomics (https://commonfund.nih.gov/epigenomics/index); Extracellular RNA Communication (https://commonfund.nih.gov/Exrna/index); Human Microbiome Project (https://commonfund.nih.gov/hmp/index); Genotype-Tissue Expression (GTEx) (https://commonfund.nih.gov/GTEx/index); and Metabolomics (https://commonfund.nih.gov/metabolomics/index).
Preclinical Animal Studies Sites (PASS)
The purpose of this FOA is to provide support for four to six additional Preclinical Animal Study Sites (PASS) as part of the MoTrPAC. The PASS will extend the analyses of candidate transducers of physical activity from the PASS tissue collection across multiple organs and tissues that are not accessible from human participants, as well as to provide comparisons to human data (using muscle, adipose tissue and plasma). As noted in the Chemical Analysis Sites FOAs (RFA-RM-15-010 and RFA-RM-15-011), the PASS element of the MoTrPAC has produced approximately 8,000 samples of various tissues (e.g. blood, muscle, adipose tissue, brain, liver, kidney etc.). Harvested tissues have either been distributed to the Chemical Analysis sites for analyses or are stored at the MoTrPAC Biorepository according to MoTrPAC protocols.?
As part of this FOA and for the remainder of the study, all of the PASS sites will investigate the source and signaling mechanisms responsible for effects of candidate molecules and classes of molecules mobilized in response to acute or chronic physical activity from animal or human (once available) studies on target tissues; decisions regarding which molecules to pursue will be made in consultation with the Steering Committee. Participants are being recruited to the Clinal study, but at this writing human biopsy derived data is not yet available. The goal is that the initial mechanistic studies based on PASS data will begin to elucidate molecular cascades likely contributing to findings in the human studies. In addition, PASS studies are likely to substantially expand the findings in the human studies by identifying previously unexplored tissue interactions not possible in human studies. Data from MoTrPAC is expected to serve as a catalyst for future investigator-initiated studies examining the molecular mechanisms of the benefits of exercise and to facilitate a greater understanding of human physiology
Applicants can propose studies that include but are not limited to assays:
1. designed to identify target tissues of candidate molecular transducers, or classes of transducers, using high throughput screening methods or cell and animal models;
2. focused on the functional or molecular changes and targets associated with the effects of physical activity on specific pathways, systems or tissues;
3. focused on finding the function of specific families of molecules altered by physical activity, such as miRNAs, altered gene expression, modified lipids or amino acids, or a variety of post-translational modifications.
4. focused on elucidating the systems biological relationships whereby exercise molecular transducers might produce broad effects across multiple target tissues to connect with existing mechanistic literature. For example, studies might examine the impact of myokines on innate and adaptive immune signaling
The MoTrPAC Bioinformatics Center (BIC) will conduct a data Webinar for interested applicants at a date to be announced on the MoTrPAC Data Hub Website, the MoTrPAC site, and the Common Fund site
Additional exercise studies and tissue collection for analysis by the MoTrPAC Chemical Analysis Sites are not the focus of this FOA
The entire cadre of MoTrPAC PASS investigators (6-9 teams) will collaborate to design and conduct detailed mechanistic studies to identify the sources, signaling pathways, physiological targets and functions of the molecular transducers of physical activity found in blood and tissues, recognize feedback and interaction effects among different pathways, and discover the specific roles of the molecules associated with specific health benefits. Awards under the second preclinical FOA are expected to begin by the end of FY 2020.
PASS PD/PIs will be expected to:
Program Formation and Governance
The award funded under this FOA will be a cooperative agreement (see Section VI.2.A. Cooperative Agreement Terms and Conditions of Award). Close interactions amongst the awardee, awardees from the companion FOAs, and NIH is required. The PDs/PIs of these awards will join MoTrPAC and will meet and participate on the MoTrPAC Steering Committee. Each funded element of the consortium has one vote. Consortium governance rests with the Steering Committee and is subject to oversight by an NIH MoTrPAC Program Management Team and the NIH Common Fund.
The NIH appointed a chair of the Steering Committee from among the initial MoTrPAC PDs/PIs. The Steering Committee Chair presides at all Steering Committee meetings and serves on an Executive Committee. Subcommittees facilitate development, implementation, and monitoring of specific MoTrPAC functions as needed, such as participant phenotyping, study monitoring (protocol adherence, participant safety, etc.), disbursement of tissues among the Chemical Analysis Sites, tissue analysis, data handling, and quality control. Key personnel will be expected to serve on subcommittees as appropriate according to their expertise.
The Steering Committee meets in person at least annually. Monthly teleconferences are held for the Steering Committee and its subcommittees meet as needed. The CCC is responsible for arranging and facilitating the meetings and teleconferences.
External Study Monitoring
Five to seven External Scientific Advisors provide input based on their individual areas of expertise as needed over the course of the program. They advise the NIH on issues that arise during the project and will help ensure that the resources to be delivered by the program are as useful as possible for the end users
An independent DSMB has been established to monitor and provide recommendations to the NIH regarding participant recruitment/enrollment, safety, data quality, and other issues, as appropriate. The DSMB reviews the Steering Committee-approved common protocol, informed consent templates, milestones, and monitoring plans prior to the start of recruitment. A single central Institutional Review Board (IRB) has streamlined the protocol approval process and to standardize the monitoring of human subjects’ protection in the MoTrPAC.See Section VIII. Other Information for award authorities and regulations.
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.
NIH intends to fund an estimate of 4-6 awards, corresponding to a total of $6,000,000 for fiscal year 2020. Future year amounts will depend on annual appropriations.
The maximum project period is 3 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 not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
John P Williams
National Institute on Aging
All instructions in the SF424 (R&R) Application Guide must be followed.
The following modifications also apply:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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 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?
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 thecategories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Awardees of this initiative will be full members of the MoTrPAC consortium, and will agree to abide by the data sharing policies of the consortium. Thus, separate resource sharing plans are not applicable for this FOA.
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 Center for Scientific Review, 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 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.htmlor 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 following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities will be reached by consensus and that NIH staff will be given the opportunity to offer input to this process.
The Project Scientist(s):
Areas of Joint Responsibility include:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
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 agreementsare 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
John P Williams, Ph.D.
National Institute on Aging (NIA)
Richard Ingraham, Ph.D.
Center for Scientific Review (CSR)
Grant Management Specialist
National Institute on Aging (NIA)
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