Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov)

Title: Intestinal Stem Cell Consortium (U01)

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Request For Applications (RFA) Number: RFA-DK-08-010

Catalog of Federal Domestic Assistance Number(s)
93.848, 93.855

Key Dates
Release Date: October 29, 2008
Letters of Intent Receipt Date: February 18, 2009
Application Receipt Date: March 18, 2009
Peer Review Date(s): May/June 2009
Council Review Date: October 2009
Earliest Anticipated Start Date:
September, 2009
Expiration Date: March 19, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

PURPOSE

This Funding Opportunity Announcement (FOA) will establish a research consortium, the ISCC, by supporting individual research projects to isolate, culture, characterize, functionally validate, and compare stem cell populations from the small intestine epithelium in vivo and in vitro.  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; facilitate communication of research results, data and methods within the consortium and to the community; and facilitate the availability of biomaterials, models, reagents and resources to the community.  Therefore, this FOA is soliciting two types of applications:  research project applications to accomplish the research objectives, and applications to establish a single Coordinating Center.

BACKGROUND INFORMATION

The absorptive and protective functions of the intestine depend 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 matrix 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 be a part of 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 not been isolated for characterization and experimentation.  This isolation and characterization of the stem cells are key to understanding their role in biology and disease of the intestine and to development of therapies influencing or using the stem cells to contribute to healing or modulation of inflammation.  A necessary part of characterization of intestinal stem cells is the development of a clonal, in vivo assay to demonstrate both self renewal and appropriate differentiation of progeny.

To date, 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 unknown, although some labeled populations have been demonstrated to generate the full complement of intestinal epithelial cell types.  At least some of the markers in use also label cells in human tissue and in tumors.  However, how the different labeled populations of putative stem cells in the intestine are related to each other, how stem cell self-renewal and differentiation of progeny are controlled, when and how stem cells are generated in development, and how they are related to tumor cells are unclear.  Studies in these areas would be greatly aided by isolation and characterization of the cells, comparisons between cell populations labeled by different means, and the ability to study their differentiation and proliferation in vivo and in vitro.  The value of a coordinated, collaborative effort to isolate and characterize intestinal stem cells was emphasized in discussions at 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 Draft Research Plan of the National Commission on Digestive Diseases (http://www2.niddk.nih.gov/AboutNIDDK/CommitteesAndWorkingGroups/NCDD/NCDDPublicComments022008.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.

RESEARCH OBJECTIVES AND SCOPE

Applications are invited to participate in a coordinated research effort to isolate and characterize small intestinal epithelial stem cells, and make methods, reagents, resources, biomaterials (including cells or cell lines), data and models available to the research community.  The specifics of each project in this consortium will vary, however all projects must include studies to isolate and characterize small intestine stem cell populations.  Characterization must include development of clonal in vivo assays to demonstrate self renewal and multi-lineage differentiation.  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 at the first meeting of the ISCC Steering Committee (see below).  All participants will be expected to adhere to these policies as a term of the award. 

Projects may include study of mouse 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.  In addition, studies that focus on isolation and characterization of stem cells in other animal models, without primary focus on mouse and/or human cells, are beyond the scope of this FOA.

Research of interest beyond isolation and characterization of the stem cells includes, but is not limited to the examples listed below: 

It is expected that new methods will be generated to allow these studies to be conducted and any new methods that are generated and validated will be shared within the ISCC and with the public per the timelines and processes established by the Steering Committee (see below).  The funding from this FOA will support the development of these methods as an integral part of a larger project.  However, applications that are solely for development of tools or methods are not appropriate for this FOA.

It is also expected that these studies will generate additional hypotheses regarding disease mechanisms, healing of epithelium, and other areas.  These projects may be suitable for independent R01 applications.  In addition, the ISCC Coordinating Center will include potential funding for pilot projects in years 2-5 that may be used to explore hypotheses directly related to the research under this FOA as preliminary to an R01 application.  Because these pilot projects will be through subcontracts administered through the Coordinating Center, they will be integrated into the ISCC and the data, methods, materials, models and resources they generate will be shared according to policies established by the Steering Committee.

COORDINATING CENTER (CC) OBJECTIVES AND SCOPE

The CC will be responsible for facilitating administration, and data and information sharing within the ISCC, as well as data and information sharing with the research community.  The formation of this consortium will likely provide new opportunities for investigators to collaborate on research and for the CC to develop new data analysis and interface functions.  Thus, the CC must include scientific expertise appropriate to the research area of this FOA.

The CC project must include but is not limited to:

ORGANIZATION OF THE ISCC

The ISCC will consist of the following components:  the NIH, 5-7 research projects, a CC, a Steering Committee and its subcommittees, an External Advisory Committee, 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 Project Scientists, will provide programmatic oversight and will monitor progress and adherence to NIH policies. Together, the NIH will have one vote on the Steering Committee.  The NIDDK Project Scientist will be a voting member:  the NIAID Project Scientist will be an ex officio member.  The NIDDK and NIAID will jointly appoint the Chairperson of the Steering Committee, the members of the External Advisory Committee, and the External Advisory Committee Chair.  Additional NIDDK and NIAID Program Officials will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Steering Committee

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 activities of the CC.  The Steering Committee will also be responsible for establishing and implementing a process for selection of pilot projects for funding with discretionary funds through the CC.  The Steering Committee will include the Principal Investigators (PIs) from all awarded U01 cooperative agreements (research projects and CC) as well as the NIH Project Scientists.  In the case of projects with multiple PIs, only one PI will be a member of the Steering Committee.  The designation of the member PI must be a part of the Multiple PD/PI 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.

Bi-annual Meetings of the ISCC Steering Committee

PIs must participate 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 may be established and require participation by the members.  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, the Steering Committee members will develop policies for information and materials to 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 PI and up to one other member of the individual project to attend the initial meeting and the bi-annual meetings.  The CC application should request a budget for costs of the Steering Committee meetings except for costs for research project PIs to travel and attend the meetings.  The CC is responsible for providing and maintaining a record of minutes of the meetings, which will be approved by the Steering Committee Chair and Committee membership.  The CC budget should include costs to arrange the Steering Committee meetings and to generate minutes.  Any subcommittee and conference call meetings will be similarly documented.  The External Advisory Committee will meet yearly, coordinately with the Steering Committee.

External Advisory Committee (EAC)

The NIDDK and NIAID will appoint an EAC of 3-5 members to meet initially and then at least yearly with the Steering Committee.  This group will be updated on progress and advise the Steering Committee and NIH on adjustments and future directions for the ISCC research projects and CC.  The CC application should include a request for full costs for EAC members to meet once yearly with the Steering Committee.

Discretionary Funds

Depending on availability of funds, the NIH plans to set aside up to $500,000 total costs per year, beginning in year two, in discretionary funds to support small one-to-two-year exploratory pilot research projects to capitalize on emerging opportunities.  Starting in the second year after award, the CC will be responsible for disbursement, management, and reporting on discretionary funds and projects approved by the Steering Committee.  The Steering Committee will establish goals, priorities, and evaluation criteria for the use of the discretionary funds to support pilot projects.  PIs awarded under this FOA will have an opportunity to compete for the discretionary funds, or they may be awarded to investigators outside of the initially established ISCC for projects that directly relate to and interact with Consortium projects.  Expenditure of discretionary funds will be restricted until a process for the prioritization, solicitation, and evaluation of proposals and the disbursement of funds is established and agreed upon in writing by the Steering Committee. 

Annual continuation of funds for each project is dependent on demonstrated progress from the previous year’s funding. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U01 Cooperative Agreement award mechanism.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  If progress and institutional priorities make it appropriate, a funding opportunity announcement may be reissued to support stem cell projects beyond the initial period of award.

2. Funds Available

The estimated amount of funds available for support of 5-7 research projects and one CC awarded as a result of this announcement is $3.0 Million total costs for fiscal year 2009.  The NIH plans to make an additional estimated $500,000 per year available through the CC for total costs of pilot projects in years 2-5, dependent on availability of funds. Direct costs are limited to $250,000 per year for a maximum five-year period for research projects and $350,000 per year for a maximum five-year period for the Coordinating Center. Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit applications for the CC and for research projects.  However, an applicant may not have the same Principal Investigator on both a CC and research project application.

Because of the interactive nature of this consortium, foreign applicants are not allowed.  However, domestic projects with foreign subcontracts are allowable as long as the domestic Principal Investigator commits to full participation in the ISCC and the foreign component agrees to the sharing terms and policies of the ISCC.

Applicants may submit more than one application, provided each application is scientifically distinct.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: February 18, 2009
Application Receipt Date: March 18, 2009
Peer Review Date(s): May/June 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: September, 2009

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent 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 20892-5450
Telephone: (301) 594-8897
Fax:  (301) 480-3505
Email:  fc15y@nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Francisco Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard
Room 752
Bethesda, MD 20892-5450
Telephone: (301) 594-8897
Fax:  (301) 480-3505
Email:  fc15y@nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date) described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Two types of applications are being sought through this FOA:  Research project applications and applications to establish a CC.  The applicant should state which type of support is being sought in the Title, Project Description and Specific Aims sections of the application.  Applications for the CC must demonstrate within the research plan the ability to interface with the scientific areas of investigation that are included within this consortium.  Because of the central role of the CC to interact with the other principal investigators and the scientific community in order to synthesize and usefully present research results and information, purely administrative responses, without this demonstrated scientific interface, are not appropriate in response to this FOA. 

Applicants for research projects should submit their applications describing outstanding research suitable for the consortium, and suggest ways the consortium will increase opportunities for the proposed research and maximize its benefits.  The final 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.

Applicants for the CC should submit plans and evidence of the capacity for meeting the needs of the consortium and the research community, and for integration of information from the projects.  The final plans of the CC will similarly be adjusted to accommodate the final defined projects undertaken by the consortium.

Steering Committee:  Applicants must indicate their willingness to be part of a Steering Committee consisting of PIs from projects funded through this FOA and both NIDDK and NIAID Project Scientists.  The Steering Committee will meet soon after grants are awarded and at least bi-annually thereafter, and may meet additionally in subcommittees or through telephone conference calls.  A major goal of these meetings will be to facilitate progress by establishing communication between the participating projects so that skills, ideas, technology, data, methods, biomaterials such as cells, and reagents are exchanged.  The participants at the meeting will discuss progress of each project, coordination of projects, sharing, collaboration and means of informing the research community of progress.  This consortium is expected to conduct research that will enhance the overall research effort of the related scientific community and investigators will share the data, biomaterials, models, reagents, resources and methods from their projects per policies established by majority vote of the Steering Committee, and as a term of the award.  Accordingly, the application must include a statement agreeing to this sharing requirement and a statement agreeing to the coordination and integration of research plans by the ISCC Steering Committee, including changes to the originally proposed projects.  Costs for PI attendance at the Steering Committee meetings should be included in the application budget.

External Advisory Committee:  In addition to the Steering Committee, the consortium will receive input from an EAC of 3-5 experts in stem cells, intestinal biology, and related fields.  This committee will be appointed by the NIDDK and NIAID with meetings to be coordinated with the Steering Committee.  Meetings will be organized by the CC and the CC budget should include costs for travel and attendance of the EAC members at the initial Steering Committee meeting and one Steering Committee meeting per year thereafter.

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 PIs, in consultation with NIH Program staff and the Steering Committee and EAC, will make any necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects, and to incorporate new research advances.

ISCC Coordination:  Research Project applications are expected to provide plans that address sharing and demonstrate commitment to make data, biomaterials, models, reagents, resources and methods available to the ISCC and the research community through the CC.  The terms and timelines for sharing within the ISCC; adjustments for coordination of research plans; validation of models, materials, methods and data; and sharing with the research community will be established by the Steering Committee consistent with achieving the goals of the program and NIH policies and all participants are expected to adhere to these terms as a condition of award.  Applicants should agree in the application that they will work collaboratively with the CC to maximize research accomplished by the Consortium, and to implement procedures to submit quality controlled (per Steering Committee-approved procedures) data and information to the CC.  In addition, applications are expected to include plans for the form and method to make resources, materials and models available to other investigators (for example, cell lines that are developed may be deposited in resource centers), consistent with achieving the goals of the program.  These plans should address releasing data and information to the CC as soon as they are validated per Steering Committee policies, and make materials and resources available to the research community in accordance with Steering Committee policies and at least upon acceptance of the research results for publication. 

The CC application should provide detailed plans for facilitating 1) ongoing exchange of information between members of the ISCC 2) meetings of the Steering Committee and External Advisory Committee 3) receipt of data and information from research projects and 4) development of electronic exchange of quality-controlled data and information with the ISCC and the research community.  The application should demonstrate that the CC has the capability to build and synthesize a variety of data forms into a usable quality-controlled and actively maintained interface that is scientifically suitable for the user research community. The CC is responsible for distribution of information on research progress, methods and data.  Each research project is responsible for plans to provide research materials, models and resources to investigators as outlined in the application.

Other Special Performance Requirements

Applicants must explicitly state their commitment to:

1.    Participate in Steering Committee meetings and teleconferences as needed, site visits by the NIDDK and/or NIAID, and regular telephone conference calls

2.    Cooperate with other awardees in the development and design or modification of research protocols and cooperate with other awardees in carrying out collaborative protocols

3.    Abide by common definitions and common protocols, procedures, tests, and reporting forms as chosen by majority vote of the Steering Committee and implemented by the CC

4.    Comply with all study policies and quality assurance measures approved by the Steering Committee

5.    Transmit study data and information to the CC in a timely and accurate manner consistent with NIH policies and achieving the goals of the program

6.    Cooperate with other awardees in the publication of study results and release to the scientific community of methods, materials, information and resources as described above

7.    Serve on and chair subcommittees as assigned by the Steering Committee or the NIDDK/NIAID

8.    Accept the “Cooperative Agreement Terms and Conditions of Award in Section VI.2.A “Award Administration Information.”

A statement addressing these commitments should be included as a part of the sharing plans for each application (see below).  In addition, the proposed form and method for sharing of models, resources and materials should be included in sharing plans that are submitted.

Research Plan Page Limitations

Page limitations as specified in the PHS 398 instructions apply.

Appendix Materials

All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Plans for sharing should incorporate principles of the operation of the ISCC as outlined above.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Diabetes and Digestive and Kidney Diseases and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the applicant propose to develop an in vivo clonal assay which, if it succeeded, would be useful to the broader scientific community?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation:  Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?  

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?  

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

Interactions:  Are there adequate plans for effective interaction and coordination with other Consortium components and the NIH?  Do the applicants state their commitment to collaborate extensively and share information, methods and materials fully, consistent with achieving the goals of the program?  Are the form and method for sharing models, resources and materials stated and reasonable?  Do applicants state their willingness to abide by the priorities and policies agreed upon by majority vote of the Steering Committee?  Have the applicants proposed sound strategies for communication with the CC and other ISCC projects?

Review of the CC application will also be based on the following specific criterion:

Communication:  Are the proposed plans for acquisition, transfer, management and accessibility of information and data from the research projects adequate to maximize the potential of the ISCC research results to be of benefit to the Consortium members and the scientific community?  Does the application demonstrate that the proposed CC has the scientific expertise to communicate with the research projects, and to synthesize a variety of data and build them into a usable quality-controlled and actively maintained interface for the user research community?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:  

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIDDK and NIAID will designate program staff and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement.

The NIDDK and NIAID will form an EAC with relevant scientific expertise.  The External Advisory Committee will meet regularly to review the progress of the ISCC projects and to advise NIH Project Staff of scientific developments and opportunities that may enhance the achievement of the ISCC goals.

The NIDDK and NIAID Project Scientists will be members of the Steering Committee and, as determined by that committee, its subcommittees as needed.  The NIDDK Project Scientist will have one vote on the Steering Committee.  The NIAID Project Scientist will be an ex officio (non-voting) member.

The NIDDK and NIAID Project Scientists will coordinate and facilitate the ISCC projects, attend and participate as voting members in all meetings of the Steering Committee, and act as liaisons between the Steering Committee and the EAC.

The NIDDK and NIAID Project Scientists will help the Steering Committee develop and draft operating policies

The NIDDK and NIAID Project Scientists will review the scientific progress of the individual ISCC projects, review projects for compliance with operating policies developed by the Steering Committee, and may recommend to the NIDDK or NIAID to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.  Review of progress may include regular communications with the Principal Investigator and staff, periodic site visits for discussions with awardee research teams, fiscal review, and other relevant matters.  The NIH retains the option of periodic external review of progress.

The NIDDK and NIAID Project Scientists will make recommendations for continued funding based on overall progress, cooperation in carrying out the research, and maintenance of high quality research.

The NIDDK and/or NIAID will name additional scientific advisors as necessary from within the NIH whose function will be to assist the  Project Scientists and the Steering Committee in carrying out the goals and aims of the approved studies.  The NIDDK will have one vote for all key committees, regardless of the number of NIH personnel involved.

The NIDDK and NIAID Project Scientists will have substantial scientific programmatic involvement in quality control, preparation of publications, and coordination and performance monitoring.  The dominant role and primary responsibility for these activities resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDDK and NIAID Project Scientists.

The NIDDK and NIAID Project Scientists serve as a resource with respect to other ongoing NIH activities that may be relevant to the ISCC studies to facilitate compatibility and avoid unnecessary duplication of effort.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

The Steering Committee composed of each of the Principal Investigators of the ISCC (including research projects and CC) and the NIDDK/NIAID Project Scientists will be the main governing board of the Consortium. Only the Principal Investigators and the NIDDK Project Scientist or designee will be voting members of the Steering Committee and all major scientific decisions will be determined by a majority vote.  This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project.  Steering Committee activities and decisions will factor in the advice of the External Advisory Committee.

The Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed.  The NIDDK/NIAID reserve the right to augment the expertise of the Steering Committee when necessary.

There will be an initial meeting and two Steering Committee meetings annually.  Once yearly, these meetings will incorporate participation and recommendations of the External Advisory Committee

A Chairperson will be chosen from among the Steering Committee members by the NIDDK and/or NIAID or, alternatively, from among experts in an appropriate scientific field who are not participating directly in the study.  In collaboration with the CC and the NIDDK and NIAID Project Scientists, the Chairperson is responsible for coordinating the Committee activities, for preparing meeting agendas and for chairing meetings.

The Steering Committee, including the Project Scientists, is responsible for establishing and implementing processes and criteria for award of discretionary funds for Pilot Projects in years 2-5.

Each research project awardee and the CC awardee agree to the governance of the ISCC through the Steering Committee. 

The NIDDK and NIAID Project Scientists may work with awardees on issues coming before the Steering Committee and, as appropriate, other committees.

Through the Steering Committee, the ISCC will cooperatively develop and implement processes to submit information and data to the CC, determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the ISCC, consistent with NIH policies and achieving the goals of the program.  

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4. Arbitration Process

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 arbitration. 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 arbitration 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.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jill Carrington, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy 2, Room 661
6707 Democracy Boulevard,  MSC 5450
Bethesda, MD 20892
Telephone: (301) 402-0671
FAX:  (301) 480-8300
Email:  jc189n@nih.gov

Andrea DiCarlo-Cohen, Ph.D.
Radiation/Nuclear Countermeasures Program
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
6610 Rockledge Drive, Room 1111, MSC 6601
Bethesda, MD  20892
Telephone: (301) 451-9199
FAX: (301) 480-6597
Email: cohena@niaid.nih.gov

2. Peer Review Contacts:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy 2, Room 719
6707 Democracy Boulevard,  MSC 5450

Bethesda, MD 20892
Telephone: (301) 594-8846
FAX:  (301) 594-9523
Email:  fc15y@nih.gov

3. Financial or Grants Management Contacts:

Ms. Diana Ly
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Democracy II, Room 723
6707 Democracy Boulevard, MSC 5450
Bethesda, MD 20892
Telephone: (301) 594-3197
Fax: (301) 594-9523
Email: dl244e@nih.gov  

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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