National Institutes of Health (NIH)
Funding Opportunity Title
Intestinal Stem Cell Consortium Research Projects (U01)
U01 Research Project – Cooperative Agreements
Reissue of RFA-DK-08-010
Funding Opportunity Announcement (FOA) Number
Companion Funding Opportunity
Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.847, 93.855, 93.856
Funding Opportunity Purpose
This Funding Opportunity Announcement (FOA) invites research project applications to participate in the Intestinal Stem Cell Consortium (ISCC) to support research projects on stem cell biology of the small intestine epithelium.
August 5, 2013
Open Date (Earliest Submission Date)
October 21, 2013
Letter of Intent Due Date(s)
October 21, 2013
Application Due Date(s)
November 21, 2013, by 5:00 PM local time of applicant organization.
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.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date
November 22, 2013
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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 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.
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
This Funding Opportunity Announcement (FOA) will continue a research consortium, the Intestinal Stem Cell Consortium (ISCC), by supporting research projects on stem cell biology of the small intestine epithelium. In order to maximize scientific exchange and accelerate this area of research, information, data, biomaterials, models, reagents, resources and methods will be shared within the ISCC and with the research community. The consortium will include a Coordinating Center that will facilitate activities of the consortium and facilitate communication of research results, data and methods within the consortium and to the community. The Coordinating Center is being considered under FOA RFA-DK-13-505 "Limited Competition for the Intestinal Stem Cell Consortium Coordinating Center (U01)."
The absorptive and protective functions of the intestine depend in part on the intestinal epithelium. This epithelium is characterized by continual turnover, with cells lost at the surface (large intestine) or villi (small intestine) and replaced from stem and progenitor cells in the crypts. These stem cells, influenced by other cells, extracellular factors and factors in the lumen, produce the multiple cell types necessary for healthy epithelial function and self-renew to continue to replenish the epithelium. However, in diseased or inflamed conditions, the epithelium may not be renewed at the pace needed to maintain a barrier against the potentially harmful contents of the digestive tract. The resulting exacerbation of inflammation is thought to contribute to the development and/or maintenance of inflammation-related conditions and diseases of the intestine. Thus, the ability of resident stem cells to heal and maintain the epithelial barrier, commensurate with the need resulting from epithelial cell loss, is essential to normal function of the intestine.
While the existence of stem cells in the intestinal epithelium has been known for decades, these cells have only been isolated more recently. The ability to isolate and characterize stem cells is key to enabling research to understand their roles in biology and disease of the intestine, determining the influence of environmental (niche) factors, and developing therapies influencing or using stem cells to modulate healing or inflammation in the intestine.
In the mouse, several different molecular markers of putative intestinal stem cells have been described. The different markers and methods label cells in sometimes different and sometimes overlapping locations in the epithelium in vivo. The functional significance of the differences and overlaps in labeling of cells at these locations is an active area of study, and some labeled populations have been demonstrated to generate the full complement of intestinal epithelial cell types. Evidence points to the existence of more than one population of stem cells and in some cases, either inter-conversion between populations, or derivation of other populations from upstream populations, under conditions that require healing from injury. As yet, it is unclear how stem cell populations identified with different markers in the mouse relate to each other in normal or disease and healing conditions. It is unclear how the populations found in mouse relate to those that may exist in the human, and how human populations may interact as a system to renew and heal epithelium. Considerable work needs to be done to more fully understand which populations act as stem cells to maintain or heal the epithelium, the regulation of stem cells and what cells and factors in the environment control activity of the stem cells. Further work is needed on how this knowledge can best be used to develop therapies that will enhance epithelial repair, and allow for replacement or regeneration of intestinal segments.
Studies in these areas have been aided by a coordinated, collaborative effort established with the first project period of the Intestinal Stem Cell Consortium (ISCC). The ISCC web site can be found at http://iscc.coh.org and describes ongoing studies to isolate and characterize intestinal stem cells, compare populations, and determine how their activity is controlled. This initiative began as a result of the NIDDK workshop on Local Influences on Health and Repair of Intestinal Epithelium held March 25-26, 2008. In addition, this research underpins multiple goals in the Research Plan of the National Commission on Digestive Diseases (http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/NCDD/FinalResearchPlanPosting.htm). While this announcement emphasizes stem cells of the small intestine, it is anticipated that the methods and research results from the supported ISCC projects will aid similar studies in other areas of the gastrointestinal tract and other organs.
Applications are invited to participate in a coordinated research effort to define roles and controls on activity of critical populations of stem cells in the small intestine. Work will continue a major focus on the basic biology of stem cells but also pursue the newly developed ability recently reported by the ISCC to isolate and culture human crypts and isolated human stem cells. Thus, basic biology of the human system is to be elucidated through use of animal models and human cells, as a first step toward being able to translate principles to eventually be able to treat disease and enhance healing of the gut. It is anticipated that use of damage models, particularly radiation injury, will be an important part of studies. Research is encouraged that will develop an in situ, graft-based small intestinal assay for stem cell function in the intestine. Because the ISCC will meld the work of multiple laboratories and approaches, it is expected that the group will continue systematic integration and testing of protocols and resources for release to the community. Projects are not, however, to focus on methods or tool development, but are expected to focus on significant gains in understanding of the biology of the stem cell system that maintains the intestinal epithelium. While projects will be proposed as individual research efforts and collaborations, the funded projects will be fully discussed by the entire Consortium and extensive modifications are likely in order to determine where common interests and aims exist, and common approaches should be taken to maximize the outcomes of the research. Thus, research is encouraged that could be expanded to take advantage of broad expertise and opportunities in a consortium, for example to investigate and compare multiple populations of cells, or to broaden approaches to understand control and manipulation of several populations in order to provide a fuller picture of the system of epithelial maintenance and healing.
Methods, reagents, resources, biomaterials (including cells or cell lines), data and models are expected to be made available to the research community. Because the individual projects will be coordinated through this consortium and are intended to generate methods, information and materials that are to be made available to the research community, policies for operation of the consortium; final composition and design of coordinated research projects; validation of models, reagents and data; data standards; and the timeline and processes for sharing within the consortium and with the research community will be established by the ISCC Steering Committee (see below). All participants will be expected to adhere to these policies as a term of the award. Policy documents for the ISCC, as currently established, can be accessed on the web site.
Projects may include study of animal models, particularly mouse models, and/or human cells and tissues of the small intestine. However, clinical studies in humans, beyond collection of tissues or cells for in vitro use or engraftment into animal models, are beyond the scope of this FOA. Further, use of primary human tissues and cells is likely to lead to derivatives that may be of broad research use for the scientific community. Suggested consents and Material Transfer Agreements for development and sharing of Induced Pluripotent Stem Cell lines have been developed by the NIH Center for Regenerative Medicine (CRM), along with information on use of human samples for shared cell lines. This information is posted on the NIH CRM web site at www.crm.nih.gov/researchtools and may provide helpful models for projects that propose use of human tissues and sharing of derivatives inside and outside of the Consortium. All research using human subjects, tissues, and cells is subject to Institutional Research Board and NIH and Office for Human Research Protections (OHRP) policies and approvals.
Research of interest includes the areas described above and the examples listed below. These are examples only, and are not intended to be limiting.
Characterization of stem cells in vivo and in vitro with respect to gene expression, location, differentiation potential, self-renewal, and clonogenicity.
Comparison of characterized populations of intestinal stem cells from mouse and human tissues.
Characterization of interrelationships (if any) between putative stem cell populations expressing different markers, in different locations, or with differences in other properties, and studies to determine the hierarchy of cells in the system of stem cell maintenance and healing activities.
Development of methods for expanding and grafting stem cells back into the intestine.
Studies that incorporate IPS cell differentiation into small intestinal epithelium and how stem cell lineages that may exist in that epithelium are derived from IPS cells.
Studies on the influence of the local microbiome on activity of stem cell populations.
Studies to determine the developmental lineage of characterized populations of stem cells in the small intestine.
Studies to identify key niche factors influencing maintenance, replenishment, or roles of stem cells.
Studies to define conditions controlling proliferation and differentiation of intestinal stem cells and their progeny.
Studies to determine how inflamed, damaged (e.g. by radiation), or diseased environments alter the activity or function of intestinal stem cells.
Studies to aid healing of inflamed, damaged (e.g. by radiation), or diseased epithelium through control of stem cell activity.
Studies to understand conditions that regulate quiescence and the emergence of stem cells from a quiescent state.
Studies to compare stem cells of the small intestine with stem cells from other regions of the gastrointestinal tract.
Studies to determine the possible role of intestinal stem cells in development of tumors and why some parts of the intestine are less prone to development of tumors.
The ISCC will consist of the following components: the NIH, research projects, a Coordinating Center (CC), a Steering Committee and its Subcommittees, External Consultants, Working Groups and other committees as needed.
The NIDDK and NIAID will be responsible for organizing and providing support for the ISCC and will be involved substantially with the awardees as a “partner” consistent with the Cooperative Agreement mechanism. Designated NIDDK and NIAID Program Officers will provide programmatic oversight, and will monitor progress and adherence to NIH policies. An NIDDK Project Scientist will also be designated and will have one vote on the Steering Committee. The NIAID Program Officer will be an ex officio member of the Steering Committee. The NIDDK and NIAID will jointly appoint the Chairperson of the Steering Committee, and the External Consultants.
A network of synergistic projects will be established through this program to enable multiple, but coordinated, approaches to advance this area of research. The Consortium will be governed by a Steering Committee to coordinate and facilitate research activities for the overall program and to ensure synergy and efficiency. In addition, the Steering Committee will determine policies and implement processes for quality assurance of any data and information disseminated through public resources or activities of the CC. The Steering Committee will also be responsible for establishing and implementing a process for recommendation of pilot projects for consideration for funding consistent with expectations set forth in this announcement. The Program Directors/Principal Investigators (PDs/PIs) (or only the Contact PD/PI, in the case of Multiple PDs/PIs grants) from all awarded U01 cooperative agreements (research projects and CC) will be members of the Steering Committee. In the case of projects with multiple PDs/PIs, the designation of the member, Contact PD/PI must be a part of the Multiple PDs/PIs Leadership Plan.
ISCC members will cooperate within the Consortium to share resources, materials, models, methods, information and data to facilitate progress. All research groups will share responsibility for program development and resource coordination through the ISCC Steering Committee that will be established upon award of the grants. When appropriate, and in accordance with NIH policies (http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/intell-property_64FR72090.pdf), U01 awardees will be expected to collaborate; share novel reagents, biomaterials, methods, models and resources; and share both positive and negative results that would help guide the research activities of other ISCC members. The NIDDK and NIAID, in concert with the ISCC Steering Committee, will have the option to redirect research activities within the ISCC grants if it is considered beneficial to the overall program.
During the course of the funding period, knowledge and technologies will likely improve, and the rate of progress and focus of work supported by the cooperative agreement may change. It is expected that the PDs/PIs, in consultation with NIH Program staff and the Steering Committee, will make necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects to avoid overlaps and competition within the Consortium, and to incorporate new research advances.
Bi-annual Meetings of the ISCC Steering Committee
Members of the Steering Committee must participate in person in an initial meeting soon after award, as well as meetings to be held at least bi-annually thereafter. Meetings are expected to be 1-2 days long. In addition, Subcommittees of the Steering Committee, and Working Groups for scientific planning may be established and require participation by the members through in-person, electronic, or teleconference meetings as appropriate. Steering Committee meetings will be organized and administered by the CC in order to determine the final coordinated research projects to be conducted by the research grantees; determine the administrative and scientific needs to be fulfilled by the CC in coordination with the final research projects; share both positive and negative results; share materials including reagents and techniques; evaluate progress; and identify new research opportunities. At the initial meeting, and thereafter as needed, the Steering Committee members will develop policies for confidentiality, what information and materials will be shared, when they will be shared, and how they will be shared within the ISCC and with the research community. All participants will be obligated to abide by the policies adopted by majority vote of the Steering Committee. In the application, research project budget requests must include costs for the PD/PI and up to one other member of the individual project to attend the initial meeting and the bi-annual meetings. Note that the CC will support costs of the Steering Committee meetings except for costs for research project investigators to travel and attend the meetings. The CC is also responsible for providing and maintaining a record of minutes of the meetings, which will be approved by the Steering Committee Chair and membership. Any Subcommittee, Working Group and conference call meetings will be similarly documented. The External Consultants will meet approximately yearly with the Steering Committee.
The NIDDK and NIAID will appoint 3-5 External Consultants to meet with the Steering Committee. This group will be updated on progress and give feedback to the Steering Committee and NIH on adjustments and future directions for the ISCC research projects and CC. The CC will support costs for consultants to meet once yearly with the Steering Committee.
Pilot and Feasibility Studies
Depending on availability of funds, and as unexpected research opportunities arise, the NIH plans to use administrative supplements to support small exploratory pilot and feasibility research projects recommended by the Steering Committee and approved by the NIH, including external review as appropriate, in order to capitalize on emerging opportunities. The Steering Committee will establish goals, priorities, and evaluation criteria for their recommendations of projects to the NIH. PDs/PIs awarded under this FOA will have an opportunity to request funds, but, optimally, projects proposed for these funds will include outside collaboration and clearly have the potential to lead to ancillary studies (see PAR-13-066). Expenditure of funds will be restricted until a process for the prioritization, solicitation and evaluation of applications is established and agreed upon in writing by the Steering Committee.
Annual continuation of funds for each research project is dependent on demonstrated progress from the previous year’s funding.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
NIDDK and NIAID intend to commit an estimated total of $3M to fund 6-9 awards in FY 2014.
Application budgets are limited to $225,000 direct costs per year.
Award Project Period
The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.
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.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
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, preferably electronically, should be sent to:
Francisco Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Room 752, MSC 5452
Bethesda, MD 20892-5452
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
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, with the following additional instructions:
The Biographical Sketch must include a Personal Statement that addresses experiences that make the investigator particularly well suited for their role. For this FOA, this statement must address past collaborative interactions leading to research progress as evidence of ability to participate in a consortium with shared and collaborative research projects and objectives.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research project budget requests must include costs for the PD/PI and up to one other member of the individual project to attend the initial meeting and the bi-annual meetings.
All instructions in the SF424 (R&R) Application Guide must be followed.
Research Strategy: Applications should describe outstanding research and suggest ways the consortium will increase opportunities for the proposed research and maximize its benefits. Projects to be conducted by the consortium will be shaped by the Steering Committee and may incorporate or alter the proposed research to maximize coordination and efficiency of the consortium.
Letters of Support: Letters of support from collaborators may include information on past collaborative experience.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. 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.
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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
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 Applying Electronically.
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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at firstname.lastname@example.org when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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? 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 New Investigators, or 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? Do the investigators have experience in productive collaborations or consortium interactions?
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?
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
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion 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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Collaborative Research Opportunities
Does the research project present an opportunity for research that would be enhanced by consortium interaction, collaboration and expertise?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. 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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 Renewals, the committee will consider the progress made in the last funding period.
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.
Applications from Foreign Organizations
Select Agent Research
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).
Resource Sharing Plans
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) Genome Wide Association Studies (GWAS).
Budget and Period of Support
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 NIDDK, 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:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate National Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and
not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable
when State and local Governments are eligible to apply), 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 ISCC consists of Research Project sites and a Coordinating Center, cooperating through a Steering Committee as described above.
The PD(s)/PI(s) will have the primary responsibility for:
NIH Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
Areas of Joint Responsibility include:
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 arbitration after first attempting to resolve the issue through the Steering Committee or its subcommittees, as appropriate. An Arbitration 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 in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
Contact Center Telephone: 800-518-4726
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Jill Carrington, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Andrea DiCarlo-Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Francisco Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Donna R. Sullivan
National Institute of Allergy and Infectious Disease (NIAID)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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