Expired PAR-07-412: Large-Scale Collaborative Project Awards (R24/U54)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)

Title: Large-Scale Collaborative Project Awards (R24/U54)

Announcement Type
This is a reissue of PAR-04-128, which was released July 20, 2004, and will expire June 18, 2010, unless it is reissued.

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

December 1, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond. If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the 06/2009 version of the PHS 398 application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the 11/2007 version of the PHS 398 application forms and instructions.
March 13, 2009 - See Notice NOT-GM-09-017 Notice of Change in the June 2009 Receipt Date.

Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For general information on this transition, please see the electronic submission website at http://era.nih.gov/ElectronicReceipt/ and the transition timeline at http://era.nih.gov/ElectronicReceipt/files/Electronic_Receipt_Timeline_Ext.pdf. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

Program Announcement (PA) Number: PAR-07-412

Catalog of Federal Domestic Assistance Number(s)
93.859

Key Dates
Release Date: July 23, 2007
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Date (s): Phase I September 17, 2007-2009; Phase II June 17, 2008-2010
AIDS Application Receipt Date (s): Not Applicable
Peer Review Date(s): Phase I November/December 2007-2009; Phase II October/November 2008-2010
Council Review Date(s): Phase I January 2008-2010; Phase II January 2009-2011
Earliest Anticipated Start Date(s): Phase I February 2008-2010; Phase II - April 2009-2011
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date:June 18, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The National Institute of General Medical Sciences (NIGMS) re-announces the program of large-scale collaborative project awards (glue grants), last issued as PAR-04-128 in July, 2004. These awards are intended to solve critical, complex biological problems within the mission of NIGMS by supporting a team of independently funded investigators to synergize and integrate their research efforts.
A phase I award consists of $50,000 in direct costs for up to one year, for project planning.
Because the nature and scope of the proposed research will vary from phase II application to application, it is anticipated that the size and duration of each award will also vary. The maximum phase II award is $25 million in direct costs over a five-year period; applications for fewer years may not exceed an average annual direct cost of $5 million. Direct costs for one year may not exceed $7 million. This high level of resources is intended to allow investigators to form a consortium to solve a research problem by using a comprehensive and highly integrated approach. Indirect costs for consortium arrangements are not counted toward the maximum amounts.
Investigators are encouraged to limit budget requests to reflect the scope of the biomedical problem being addressed. The total amount awarded and the number of awards will depend upon the numbers, quality, duration, and costs of the applications received, though typically no more than one maximum-cost phase II award per year is anticipated.
Application mechanisms are the NIH R24 grant for phase I awards and U54 Cooperative Agreements for phase II awards.
Eligible organizations include: State Government; U.S. Territory or Possession; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); Indian/Native American Tribally Designated Organization; Hispanic-serving Institution; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); Alaska Native and Native Hawaiian Serving Institutions; Regional Organization; Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations. However, a collaborative project may include participating investigators from for-profit and foreign organizations. Multi-institutional applications are encouraged.
Eligible principal investigators (PIs) include persons with the skills, knowledge, and resources necessary to carry out the proposed research. It is expected that the principal investigator will devote a substantial effort to the phase II project. Persons from underrepresented racial and ethnic groups and those with disabilities are encouraged to apply.
Applicants may submit more than one application, provided the applications are scientifically distinct.
Applications must fall directly into the areas of research supported by NIGMS. Applicants may visit the Institute web site (http://www.nigms.nih.gov) for information on NIGMS areas of interest and the NIGMS web site created for information on this initiative (http://www.nigms.nih.gov/funding/gluegrants.html).
See Section IV.1 for application materials.
All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.
Telecommunications for the hearing impaired is available at TTY 301-451-5936.

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
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
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

The goal of this research opportunity is to enable the solution of complex biological problems critical to advancing biomedical science within the NIGMS mission (see http://www.nigms.nih.gov/about/overview.html). The program is designed to facilitate funding of scientific research beyond the means of a single research group. Although the research will likely involve technology development, the primary focus must be solution of a biological question. Large-scale collaborative project awards offer a unique mechanism to support interdisciplinary teamwork. They allow independently funded investigators to form teams to coordinate and integrate their research; to develop state-of-the-art, large-scale technologies; and to create the infrastructure for high-volume data collection, management, and analysis. Application of this mechanism is reserved for study of the most pressing scientific problems that have reached a stage requiring this type of approach for advancement. The paramount considerations for large-scale collaborative project awards are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame. For examples of successful applications and results of previous competitions, visit the web site for the NIGMS glue grant (see http://www.nigms.nih.gov/Initiatives/Collaborative/GlueGrants/).

See Section VIII, Other InformationRequired Federal Citations for policies related to this announcement.

The proposed consortium must identify a critical problem in biomedical science that requires a large-scale collaborative approach. Strong justification must be provided for the importance and scope of the problem and possible approaches to its solution. The proposal should focus on intense and meaningful interaction among the participating scientists to address the central problem so that the progress expected is substantially greater than the sum of individual achievements. Each large-scale collaborative project will likely require considerable new resources (e.g., a centralized facility), but must entail a synthesis of information from participating laboratories in various scientific areas to solve the problem under study.

Phase I applicants will submit an overview of the proposed large-scale project for peer review. Applicants must demonstrate selection of an appropriate complex biological problem, an innovative approach to its solution, and appropriate commitments from participating investigators and institutions. The purpose of the phase I award is to provide the resources for assembling a more fully developed proposal. Only applicants who receive a phase I (planning grant) award are eligible to submit an application for a phase II award to support the large-scale project. The phase II application should provide significantly more information on the proposed project, including specific intermediate goals (milestones) and a timeline for their accomplishment.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH R24 grant award mechanism for phase I applications. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

The NIH Specialized Centers U54 mechanism will be used for phase II applications. The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and NIH staff is substantially involved as a partner with the PI, as described under Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award.

This funding opportunity for both phase I and phase II awards uses just-in-time concepts. For phase I and phase II applications, use the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

Only applicants who receive a phase I award are eligible to submit a phase II application, which will be a new (type 1) award. Large-scale collaborative project awards are intended to be ten-year efforts to solve a major biomedical problem. The U54 awards will run for a maximum initial five years of support and will be eligible to compete for only one five-year renewal period.

2. Funds Available

A phase I award consists of $50,000 in direct costs for up to one year, for project planning.
Because the nature and scope of the proposed research will vary from phase II application to application, it is anticipated that the size and duration of each phase II award may vary. The maximum phase II award is $25 million in direct costs including all equipment over a five-year period; awards for fewer years may not exceed an average of $5 million in direct costs per year. Direct costs for any one year may not exceed $7 million. This level of resources is intended to allow investigators to form a consortium to address a research problem by using a comprehensive and highly integrated approach. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation (see NOT-OD-05-004).
The total amount awarded and the number of phase II awards will depend upon the numbers, quality, duration, and costs of the applications received, though typically no more than one maximum-cost phase II award per year is anticipated.
Although the financial plans of NIGMS include 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
State Government
U.S. Territory or Possession
Indian/Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organization
Hispanic-serving Institution
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Regional Organization
Other(s): Eligible agencies of the Federal government; Faith-based or community based organizations

For-profit and foreign institutions are not eligible to submit an application as a lead institution. However, a collaborative project may include participating investigators from foreign and/or for-profit organizations. Multi-institutional applications are encouraged.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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.

The major research activity of the PI must be in the research area of the large-scale collaborative project application, and the PI is expected to make an appropriate level of commitment of effort to directing and managing operation of the project. A substantial level of effort will be necessary to manage projects of the largest magnitude.

NIGMS expects that the applications will be multi-institutional with more than one participating investigator, but minimum and maximum numbers of participating investigators or institutions have not been set.

2. Cost Sharing or Matching

This program does not require cost sharing. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Large-scale collaborative project awards must include a PI, participating investigators, a steering committee, and an advisory committee. See Section VI.2.A.1VI.2.A.3. (Award Administration Information) for the roles and requirements for these elements. The proposed members of the advisory committee should not be contacted or selected until an award has been made, and the names of prospective members should not be included in the application.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available in an interactive format (see http://grants.nih.gov/grants/funding/phs398/phs398.html). Applicants must use the currently approved version of the PHS 398. For further assistance, contact GrantsInfo: telephone, 301-710-0267; e-mail, [email protected].

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

2. Content and Form of Application Submission

Applications (Phase I and Phase II) must be prepared by using the most current PHS 398 research grant application instructions and forms. Applicants must have a Dun and Bradstreet (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 on line 2 of the face page of the application form, and the YES box must be checked.

Applicants should also refer to IV.6, Other Submission Requirements, which provides additional information on organization of a large-scale project award and its elements.

Phase I Application

The parts of a phase I response to this program announcement (PAR) should be assembled in the order prescribed by the PHS 398, and the response should follow the PHS 398 instructions with the following modifications:

List of personnel on page 2, including 1) all participants, including consultants and private sector alliances; 2) all institutional and industrial affiliations for each participant; and 3) each participants role in the project.
Description of the proposed budget allocation; all phase I awards will fund up to $50,000 direct costs for up to one year.
Biographical sketch and one-page letter of commitment from each participating investigator who has indicated interest in joining the collaborative project. Biographical sketches should list research support including only the grants of each participating investigator that are in the area of the large-scale collaborative project.
Statement (three-page limit) of institutional and other resources available to the consortium.
Replacement of research plan with the following:

1) Statement (two-page limit) by the PI describing his or her commitment to the large-scale collaborative project, identifying the members, and describing the commitment of the steering committee. This statement should also describe the commitment to developing plans 1) for handling intellectual property and sharing research data and resources and 2) for increasing diversity of investigators working on the biomedical problem.

2) Research Strategy project summary (12-page limit) describing the scientific goals and operation of the large-scale collaborative project. State and justify the complex biological problem to be solved. Describe in adequate detail and explain the scientific approach to this problem. Explain why a large-scale collaborative project is critical to its solution. Describe the range of scientific expertise to be brought to bear on the problem. Make clear the significance of the biological problem chosen, and explain the value-added benefit of pursuing the problem with a collaborative project rather than individual grants. Describe possible approaches to the key elements of a large-scale collaborative project, and explain the roles of bridging projects, pilot projects, and/or core resources in the collaborative project. The project summary will serve as the research plan for the phase I application.

3) Letter of commitment to support the collaborative project, signed by the authorized business official of each participating investigators institution(s). Arrangements for participation of investigators from industry and foreign sites and for the resources they may bring to the collaborative project should be documented.

An appendix is not allowed because a detailed plan is not required at this stage. A section listing cited literature is permissible.

Phase II Application

Phase I awardees may submit a phase II application for peer review for the receipt date immediately after award of the phase I application or for the subsequent receipt date. The phase II application should include detailed plans for the large-scale collaborative project.

In addition to items requested in the PHS 398, applications should include:

An abstract of the research plan: a brief description of the proposed large-scale collaborative research project (on page 2), and a list of all key personnel.
A detailed table of contents that includes all elements of the application. Use numeric pagination only. Units should be presented in the order in which they appear in the application. Under the research plan, identify each component core with a capital letter (e.g., A, B, C) and a title, and provide the name of the core director. Major areas to be listed are budget estimates, biographical sketches and letters of commitment, research environment, participant affiliations, research plan, institutional commitments, and appendices.
Budget Estimates. Specific examples of allowable costs that may be requested include:
Salaries for the PI, members of the steering committee, participating investigators, and technical and support personnel commensurate with their level of effort in the large-scale collaborative project. Although a substantial level of effort is expected for the PI, NIGMS has not set minimum levels of effort; however, the appropriateness of the level of effort of the PI will be a factor in the assessment of scientific merit and in the Institute's funding selections. The level of effort and commitment to the collaborative project of the members of the steering committee will also factor into the assessment of scientific merit as well as the Institute's funding decision.
Bridging projects to the laboratories of participating investigators.
Pilot projects to investigators without current independent research support in the area. These subprojects must not exceed $100,000 in annual direct costs and must be limited to no more than three such projects per application.
Travel of personnel, which may include technicians, predoctoral students, postdoctoral fellows, and investigators, to different laboratories to gain specialized expertise.
Travel to and conduct of regular meetings of the steering committee and regular meetings of the participating investigators.
Core facilities (examples: instrumentation, genomics, proteomics, model organism, or high-throughput assay cores).
Travel to and conduct of regular meetings of an advisory committee.

In addition to the overall budget, include a separate budget for each bridging project and pilot project and each core resource. Salaries for support personnel required for coordination and maintenance of the project, such as secretaries, may also be included as necessary in an administrative core.

Applications for large-scale collaborative project awards may not request more than $25 million in direct costs (exclusive of subcontract indirect costs requested as a direct cost by the applicant organization, but including all equipment) for a five-year award and no more than $7 million in direct costs for any one year. Applications must include a rationale for why the requested level of resources is critical to success of the project. Also, experience has shown that large-scale collaborative project awards require considerable time to come up to full speed (including hiring of personnel and purchase and installation of equipment). First year budgets should take that into consideration and will most likely require a lower level of resources than succeeding years. Experience has also shown that bioinformatics needs are frequently underestimated and these should be planned for appropriately.

Composite budget: Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of Form PHS 398 to present the total budget for all requested support for the first year. For each category such as "Personnel, "Equipment," etc., give the amount requested for each core unit and each component project, with subtotals. For consortium arrangements involving other institutions or organizations, include total (direct and facilities and administration) costs associated with such third-party participation in the "Consortium/Contractual Costs" category. Note: each participating consortium/contractual organization must submit a separate composite budget for both the initial budget period (using Form Page 4) and the entire proposed project period (using Form page 5). Costs for purchased services should be itemized under "Other Expenses."

Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS 398 to prepare a budget, by category, which provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual component subprojects (bridging projects and pilot projects) and core unit budgets.

Individual component core and research budgets: Place the budgets for consortium components, cores, bridging projects, and pilot projects immediately prior to the description of the relevant individual component. For the -01 year budgets of each of the cores and projects, use Form Page 4 of the PHS 398. Use Form Page 5 of the PHS 398 to report the budgets of each of the projects and cores for entire project period (years 01-05).

Budget justifications and explanations: Describe the specific functions, including the level of effort, of all key personnel, including consultants, collaborators, and technical staff. Provide detailed justifications for requested equipment.

Biographical Sketches. Requirements for biographical sketches are as follows:

Biographical sketches for all participating investigators and one-page letters of commitment indicating their role in the consortium and willingness to follow guidelines and procedures established for the large-scale collaborative project.
List of all research support for all participating investigators, including the PI, heads of core resources, and PIs of bridging and pilot projects. Support for other investigators such as postdoctoral students should not be listed.
Highlights of relevant grant support that allows participating investigators to be part of the large-scale collaborative project.
List of specific aims of the project and description of the relationship of the funded grant to the goals of the proposed large-scale project, in sufficient detail for evaluation.
Research Environment. Complete the "Resources" page of PHS 398 for the overall large-scale collaborative project, including the following:
List of resources available from the host institution and any participating institutions.
Brief description of the features of the institutional environment(s) relevant to effective implementation of the proposed program.
Description of available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources.

Participant Affiliations. To facilitate review, applications should include a separate cover sheet that lists 1) all participants, including consultants and private sector alliances, 2) all institutional and industrial affiliations for each participant, 3) their roles in the project, and 4) the percentage of the total effort for each role.

Research Plan. Required components of all applications are PHS 398 Research Plan Components, with a Research Strategy for the overall application, and for each project and core. Also required are cores A (administrative) and B (information dissemination and data coordinating); and responses to the bioinformatics questions listed (see Section IV.2. Core Resource C Bioinformatics Core) if the optional bioinformatics core is used. The optional bioinformatics core may be combined with core B.

To provide applicants with flexibility to organize a large-scale collaborative project in a manner that best facilitates progress on the project, applicants may combine cores or bridging projects in a way that best facilitates achieving the research objectives. The remainder of the research plan may be organized as appropriate, keeping in mind that the major purpose of a large-scale collaborative project award is to provide resources to enable collaboration rather than primary research support. For example, scientific cores and bridging projects may be presented in a combined or more integrated fashion. If this or an alternate structure is used, applicants should explain in the Overall Research Strategy the reason a different organizational structure is proposed. The number of pages in any combined unit may not exceed the sum of the page limits allowed for the individual pieces of the unit. For example, if two bridging projects were submitted as a combined unit, the page limit for the combined unit would be twice that for one bridging project. The research plan, including the required components, may not exceed 160 pages. Investigators should endeavor to be clear and concise.

Overall Research Strategy (includes Program Summary, Administrative Management Plan, and Project Management Plan)

Program Summary (Required). Describe the goals and operation of the large-scale project as follows:

Explain the complex biomedical problem to be solved, why it is critical to advancing biomedical science, the necessity of using a large-scale collaborative project, and why the time is right for solution of this problem within a ten-year period.
Provide the background that has dictated your choices of approaches for the project.
Discuss the range of scientific expertise to be used to address the research problem.
Explain the interactions that will occur between investigators at the host site and participating sites.
Outline how each element of the large-scale collaborative project will contribute to a cohesive overall program.
Explain the programmatic value of the core resources, bridging projects, and pilot projects.
Describe how the information coming from the collaborative project and the laboratories of the participating investigators will be integrated into a comprehensive whole.
Discuss how and when information and other research resources generated by the collaborative projects will be disseminated to the participants and to the scientific public.

Administrative Management Plan (Required). Required elements of the administrative management plan are as follows:

Describe the structure, organization, and operation of the project, and give the reasons this plan has been selected to solve the chosen biomedical problem.
Explain the organizational framework, and provide an organizational chart.
Describe how information will flow within the large-scale collaborative project.
Explain the role of the steering committee.
Discuss arrangements among the collaborating institutions that are important to effective operation of the project.
Detail use of core resources by participating investigators and outreach to provide access by outside investigators.
Explain how decisions will be made to add or delete participating investigators and to respond to changes in short-term goals necessitated by research findings.
Discuss how the views of the scientific communities impacted by the collaborative project will be considered.

Project Management Plan (Required). A project management plan to keep the collaborative project moving forward is required and its elements include:

Define yearly milestones for the first five-year period of support.
Describe the planned role of the steering committee in project management.
Explain how progress in the bridging projects and pilot projects and efficiency of the core resources will be tracked.
Present an evaluation plan to determine progress of the collaborative project.
Discuss the plan for evolving milestones.
Explain how the advisory committee will be used in updating the project management plan.

The program summary, administrative management plan, and project management plan have an aggregate page limit of 30 pages. Investigators should endeavor to be clear and concise.

Plan for Handling Intellectual Property and Sharing of Data and Research Resources (Required 3 page limit)

The nature of large-scale collaborative projects is to move entire fields forward. NIGMS intends that, to the extent possible, all investigators in a field have equal access to data and research resources generated by these collaborative projects. To address this interest in ensuring that data and research resources are accessible, the NIH requires applicants who respond to this PA 1) to submit a plan for sharing the research resources generated through the award and 2) to address how they will exercise intellectual property rights, should any be generated through this award, while making such research resources available to the broader scientific community. Computational tools developed for analysis, visualization, or modeling the data and the annotated source code must be freely shared with the scientific community.

List and comment on methods for handling issues of sharing of data and research resources and intellectual property in the first five-year period of support. The list should include data and information, materials such as cell lines and mutant animals, and novel reagents and techniques. The PI and steering committee should 1) present the plan for providing access to the research resources generated by the large-scale collaborative project to the members of the project and the scientific public; 2) address whether or how intellectual property rights will be exercised; 3) discuss guidelines for licensing of joint inventions; 4) discuss procedures for settling of disputes about intellectual property; 5) discuss any pre-existing intellectual property rights, including options to for-profit research sponsors; and 6) propose a plan for disseminating the research resources developed in this large-scale collaborative project.

See also Section IV.6, Plan for Sharing Data and Plan for Sharing Research Resources.

Plan for Diversity Development (included in Research Strategy)

An essential element of the plan for diversity development is a description of the approach to increasing and retaining the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences. The adequacy of this plan will serve as an award criterion.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/). Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands. In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program. Applicants must describe their specific plans for and recent experience with the recruitment and selection process. Development of partnerships with minority and minority-serving institutions and organizations is also encouraged. Information on relevant minority-serving institutions may be obtained by consultation with staff of the NIGMS Division of Minority Opportunities in Research (http://www.nigms.nih.gov/Minority/).

Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

Individuals from disadvantaged backgrounds who are defined as:

Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/indix.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.
Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career. Recruitment and retention plans related to a disadvantaged background are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement.

Core Resource A - Administrative Core Research Strategy (Required - 6 page limit)

Core Resource A must be directed by the PI. The plan for this administrative core should include 1) the objectives of the core, 2) a description of staffing, and 3) a listing of services to be provided to other core resources and to the participating investigators. Communicating the objectives of the collaborative project and fostering opportunities for collaboration are encouraged. Expenses associated with the operation of the steering committee, meetings of all or subgroups of the participating investigators, and meetings and operation of the advisory committee fall under the administrative core.

Core Resource B - Information Dissemination and Data-Coordinating Core Research Strategy (Required - 6 page limit)

Dissemination of information on techniques, scientific findings, and methods is a vital component of each large-scale collaborative project. Computer technology, print media, and telecommunications are relevant.

Required elements of the plan for Core Resource B are as follows:

Describe staffing (e.g., core director and professional or technical personnel) and staff duties, facilities, and resources for this project.
Indicate plans to make research results or other unique features of the collaborative project available to the widest audience.
Describe integration of data generated by core resources and participating investigators into the information to be disseminated.
Discuss plans and timing for dissemination of published and unpublished data.

Core Resource C - Bioinformatics Core Research Strategy (optional; may be combined with core B) (12-page limit)

A bioinformatics core including data assembly and organization for querying and developing tools for querying, computation, and modeling may be requested as a separate core or combined with information dissemination (maximum for combination, 18 pages).

Policies on future dissemination of data and computational tools should be explained. Computational tools developed to analyze, visualize, or model data must be freely shared with the scientific community as well as the annotated source code. Others should be free to modify the source code and share the modifications, and the code should be made available for incorporation into commercial products.

For Core Resource C or for a combination of Core Resources B and C Research Strategy, the description must include answers to the following questions:

What are the plans for sharing research data and the timing for release policies, and what are the associated intellectual property issues?
How will data be made available to the scientific community? Are there formats for browser access to download complete data sets, online computational aids, or other relevant resources to accomplish this goal?
What are the nature and structure of the data? Describe the projected plans for ontologies, schema, or other data models.
What is the underlying structure of the database (e.g., relational or object oriented)?
What is the projected mechanism for communication (both computational and human) between the distributed sites and the database managers? Are there data liaisons?
What are the key interacting databases? How are the data to be linked? What are the plans for modifying or enhancing those linkages?
How is progress made available to the public? Are lists of the systems being analyzed made available?
What experience in bioinformatics is available in the group, and on what resources can the consortium draw? Discuss the qualifications and experience of the bioinformatics team.
How will the bioinformatics plan evolve over the initial period of support?

Core Resource D - Scientific Resource Core(s) Research Strategy (Optional 12-page limit per core). Required elements of the plan for Core Resource D are as follows:

Provide specific titles for proposed scientific resource cores (e.g., instrumentation, genomics, proteomics, model organism, or high-throughput assay) and designate a core director with expertise in the area of core.
Describe the planned direction, management, and use of the core(s) and the professional and technical staff for the core(s) and their duties.
Provide plans for use of the core(s), including services to be provided, to whom, and their bearing on productivity and quality of the collaborative research effort.

Bridging Projects Research Strategy (Optional six-page limit for each). Bridging projects will support work in the laboratories of the participating investigators. Required elements of the plan for bridging projects are as follows:

Describe the research proposed in the bridging project, and explain how it more fully integrates the participating investigator's independently supported work into the large-scale collaborative project or provides a necessary service or technology to the project.
Address the underlying rationale and potential impact of the studies.
Describe bridging projects in sufficient detail to permit evaluation through the competitive peer-review process.
Provide a combined summary addressing the specific aims, significance, preliminary studies, and Approach for each bridging project.
For each bridging project, include, as applicable, an abstract (one paragraph) and sections on Human Subjects Research and Use of Animals in Research (see Section VIII. Other Information Required Federal Citations) and Literature Cited. (The abstract and these sections do not count against the page limitations for the section or the overall page limit.)

Pilot Projects Research Strategy (Optional 12-page limit for each). Pilot projects will support the work of investigators not already supported in the area of the collaborative project who have unique skills or expertise to add to the project effort. Required elements of the plan for pilot projects are as follows:

Address the underlying rationale and potential impact of the studies.
Describe how the pilot project will add new elements essential to achieving the goals of the collaborative project.
Describe projects in sufficient detail to permit evaluation through the peer-review process.
For each pilot project, include an abstract (one paragraph) and sections on Specific Aims, Background, and Significance, Preliminary Studies, and Approach. As applicable, also include sections on Human Subjects Research and Use of Animals in Research (see Section VIII. Other Information Required Federal Citations) and Literature Cited. (The abstract and these sections do not count against the page limitations for the section or the overall page limit.)
A maximum of three pilot projects are allowed for a large-scale collaborative project at any given time.

Summary of Page Limits

Combined length of Overall Research Strategy, including the project summary, administrative management plan, and project management plan - 30 pages
Plan for handling intellectual property and sharing research resources - 3 pages
Plan for increasing diversity - included in Research Strategy
Administrative core Research Strategy - 6 pages
Information dissemination and data-coordinating core Research Strategy - 6 pages
Bioinformatics core (optional) Research Strategy - 12 pages
Scientific cores (optional) Research Strategy - 12 pages each
Bridging projects (optional) Research Strategy - 6 pages each
Pilot projects (optional) Research Strategy - 12 pages each
Combined units (optional) - combined total of pages for individual units
Overall limit for research plan - 160 pages

Institutional Commitments: Letters signed by authorized business officials of each of the participating investigators' institutions committing support to the large-scale collaborative project must be included. Applicants that include consortium arrangements should refer to the appendix on consortium arrangements in the NIH Grants Policy Statement (see http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium).

Appendices: Appendices are allowed for phase II applications as a whole, but they should follow rules for appendices in the PHS 398 instructions (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html).

Foreign Organization: A collaborative project may include participating investigators from foreign organizations.
Several special provisions apply to applications submitted by participating investigators from foreign organizations:

Request budgets in U.S. dollars.
Prepare detailed budgets for all applications (that is, complete the Research & Related Budget component of the SF424 (R&R) application forms not the PHS398 Modular Budget component). See NOT-OD-06-096.
Charge back of customs and import fees is not allowed.
Format: Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
Funds for up to 8% administrative costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.
Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements.

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Receipt, Review, and Anticipated Start
Letters of Intent Receipt Date(s): Not Applicable
Application Receipt Date(s): Phase I September 17, 2007-2009; Phase II June 17, 2008-2010
Peer Review Date(s): Phase I Novermber/December 2007-2009; Phase II October/November 2008-2010
Council Review Date(s): Phase I January 2008-2010; Phase II January 2009-2011
Earliest Anticipated Start Date(s): Phase I February 2008-2010; Phase II - April 2009-2011

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

Applications must be prepared by using the research grant application 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)

At the time of submission, two additional copies of the Phase I or Phase II application and all five sets of any appendix material (applies to Phase II only) must be sent to:

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, Rm 3An.12F, MSC 6200
Bethesda, MD 20892-6200

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

3.C. Application Processing

Applications must be received on or before the application receipt/submission date(s) given here (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review. Incomplete 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 merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique.

Information on the status of an application should be checked by the PI in the eRA Commons (see 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(see http://grants.nih.gov/grants/policy/policy.htm).

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 or competing continuation award if such costs are necessary to conduct the project and 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 or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or noncompeting award imposes no obligation on the 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. The 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

Annual Meetings: All PIs will be expected to budget for and attend and send staff, as appropriate, to scheduled annual meetings about the NIGMS large-scale collaborative project awards.

Resubmissions: NIGMS will accept only one resubmission for a phase I application. Phase II applications that are not funded must submit the phase I application again before submitting a revised phase II application except under extraordinary circumstances and with the concurrence of the National Advisory General Medical Sciences Council. Twice-resubmitted applications will not be accepted for either phase I or phase II applications.

Collaborative Project Organization and Resources: The organizational structure of the large-scale collaborative project may vary depending on the approach needed to address the research problem. The project might require only an administrative structure consisting of a data-coordinating core and information dissemination. If the project requires additional components, the applicant may request the types of resources discussed here, either as distinct entities or in integrated combinations.

Support to Individual Laboratories: Participating investigators are expected to have support for their individual laboratories that they can contribute to the collaborative project. The award mechanism for large-scale collaborative projects is not meant to support R01-type projects. However, laboratories of participating investigators may need to enhance their efforts, to support the needs of the consortium or to integrate the work of a participating investigator with the consortium. To meet this need, bridging projects and pilot projects may be integrated separately or in combination into the collaborative project.

Bridging projects may be used to support work in the laboratories of participating investigators when that work is intended to provide either a bridging function to more fully integrate the individual work with the collaborative project or a service function to develop data, resources, or technology to benefit the overall project. Examples include support to allow 1) use of a standardized model system to improve comparability among the results of project members, 2) development of an assay for use by consortium members, or 3) exchange of personnel among laboratories of participating investigators to transfer technology or to help in coordinating and integrating programmatic goals of the large-scale collaborative project. Bridging projects should add to or bridge the intellectual and technological approaches of the collaborative project and add to the overall cohesiveness of the large-scale effort. They are not meant to be stand-alone research efforts but are to be subprojects that tie together or enhance the contribution of the independent work and expertise of the participating investigator to the large-scale collaborative project and extend the independent work in new directions. A bridging project to do more of what the investigator is already doing should be considered only if there are extraordinary circumstances that make it essential for the effective functioning of the large-scale project. If the participating investigator's work is already closely tied to the large-scale project, a bridging project should not be needed. Stand-alone new research projects should not be submitted for bridging projects. If a bridging project could be submitted as a regular R01 application, it should not be requested as a bridging project, even if it adds value to the large-scale project. Judgment is required on the part of applicants and reviewers to distinguish between projects that are appropriate for support by consortium resources and those that should be submitted and reviewed as regular research grants (R01s).

Pilot projects may be requested for investigators with no current independent support in the area of the large-scale project, to add elements where gaps exist or to add investigators who have critical knowledge or expertise but do not have a research background in the area of the collaborative project. The pilot project should be of sufficient scope to qualify as a stand-alone research effort. It is primarily intended to allow the collaborative project to add investigators outside the scientific mainstream of the collaborative project area in a mode that will allow them to develop independent research in the area of the project. Applicants must explain why the PI's expertise is needed for the large-scale project and how the pilot project will contribute directly to accomplishing the aims of the large-scale project. Although funding for a pilot project may run for five years at the discretion of the steering committee, it is expected that the PI of a pilot project will seek R01 funding during the period of the collaborative project, on the basis of results from the pilot project.

Core resources may be requested to speed progress on the scientific goals of the project or to enhance the collaborative project by developing new or improved technology or standardizing data among the research teams. Examples include chip microarray technology for genetic studies and establishment of a core resource for model organisms. Each large-scale collaborative project must request core resources for information collection, coordination, and dissemination. A bioinformatics core, including assembly and organization of data for querying and development of tools for querying, computation, and modeling, may be requested as a separate core or in combination with the information dissemination core. Other types of resources might be for instrumentation, genomics, proteomics, or high-throughput assay cores. Requests for core resources must be strongly justified in terms of value to achieve the goals of the project, value to increase the synergy of the collaborative project, and cost-effectiveness.

Administrative Management Plan: Each large-scale collaborative project award must include an administrative management plan that describes the goals and delineates the organization of the project to achieve the goals. It also must outline the policies and procedures whereby participating and non-participating investigators can have access to the collaborative project resources. The application should address the flow of information within the project and plans as to how the information will be integrated into the solution of the biological problem being addressed. The application should address the mechanism that will be followed to add new participating investigators and delete members whose association with the project has not been productive. The plan should also include proposed methods for information dissemination both within the collaborative project and to the scientific community. Furthermore, each large-scale collaborative project should discuss the mechanism whereby concerns of the scientific community directly affected by the project will be considered and responded to. A discussion of scientific community views will be part of the agenda for annual meetings of the steering committee with the advisory committee.

Project Management Plan: Each application for funding of a large-scale collaborative project must include a project management plan, including an ongoing evaluation plan, to ensure consistent progress. Each project management plan should define, at a minimum, yearly milestones, which can be modified at the time of the award, with concurrence of NIGMS. It is expected that the milestones will be adjusted annually at the award anniversary dates, both to incorporate a team's scientific accomplishments and progress in the field in general and to reflect the recommendations of the advisory committee. Timelines for ramping up to a fully operational level should be included. The NIGMS program director responsible for the large-scale collaborative project may include outside consultants in the annual progress review and may recommend reducing or withholding funds or terminating the award for failure to meet milestones. The NIGMS program director will report annually to the National Advisory General Medical Sciences Council on progress of the collaborative project and on recommendations for any modification(s) in funding.

Disclosures: To aid the project in avoiding conflict-of-interest situations, it is suggested that the members of the large-scale collaborative project disclose to the steering committee any ties to profit-making organizations. The grantee institution is required to disclose each subject invention to the Federal agency providing research funds within two months after the inventor discloses it in writing to personnel of the grantee institution responsible for patent matters.

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data-sharing plan will be assessed by the reviewers and the proposed data-sharing plan will factor into the determination of scientific merit or the impact/priority score. The nature of large-scale collaborative project awards is to serve a larger community than the just the participants themselves. Therefore, data sharing plan and the record of the investigators in sharing research data will be considered by the review group in assigning an impact/priority score and by the Institute in making award decisions.

Also see Section IV.2. Content and Form of Application Submission, Plan for Handling Intellectual Property and Sharing of Research Resources.

Sharing Research Resources

NIH policy expects that phase II grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. (For NIH Grants Policy Statement, see http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131.) Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The nature of large-scale collaborative project awards is to serve a larger community than the just the participants themselves. Therefore, the research resources sharing plan and the record of the investigators in sharing research resources will be considered by the review group in assigning an impact/priority score and by the Institute in making award decisions. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each noncompeting Grant Progress Report (PHS 2590). (See http://grants.nih.gov/grants/funding/2590/2590.htm and Section VI.3. Reporting.)

Also see Section IV.2. Content and Form of Application Submission, Plan for Handling Intellectual Property and Sharing of Research Resources.

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.

In general, the phase I application will be used to gauge the merit of the basic idea and the conceptual framework for the phase II large-scale collaborative project. Only phase I awardees may submit phase II applications for scientific merit review. Phase I and phase II applications will be evaluated by appropriately constituted peer review groups.

2. Review and Selection Process

Applications will be reviewed by staff in the Center for Scientific Review for completeness and if found to be incomplete will be returned to the applicant without further consideration. Applications for Phase I support will be reviewed for responsiveness to this program announcement by staff in NIGMS and applications judged to be non-responsive will be returned without further review.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate review group convened by NIGMS in accordance with the review criteria stated below.

As part of the initial merit review, all applications will

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.
Receive a written critique.
Receive a second level of review by the National Advisory General Medical Sciences Council.

The following will be considered in making funding decisions for phase I and phase II awards:

Scientific merit of the proposed project as determined by peer review.
Availability of funds.
Relevance to program priorities.
Program balance.
Plans for sharing research resources.
Plans for handling intellectual property.
Uniqueness as a large-scale effort.

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 will be 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 high impact/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.

The paramount considerations for large-scale collaborative project awards are the potential impact on biomedical science, the value added over individual grant approaches, and the likelihood of success in a ten-year time frame.

REVIEW CRITERIA FOR PHASE I APPLICATIONS

Overall Impact. Reviewers will provide an overall impact/priority 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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.

Significance: 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? How significant is this research problem to the advancement of biomedical science? Given the present knowledge base and state of technology, is this group well poised to solve this research problem within the next decade? Have the investigators presented a compelling case for pursuing it at this time? Is use of a large-scale collaborative team the best way to approach this problem? Is the potential outcome clear and exciting?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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? Principal Investigator and Steering Committee. Is there evidence that the PI and the central governing body have the vision, scientific expertise, administrative capacity and leadership skills to successfully lead the large-scale project?Is the level of commitment for the PI and consortium leaders adequate?

Participating Investigators. Are the participating investigators already committed to the project among the best in their respective fields? Is the skill set for the participating investigators sufficient? Are there plans to apply expertise from diverse disciplines and fields to the scientific question, and if not, what specific expertise is lacking? Is the level of commitment for each investigator adequate?

Innovation: 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?

Approach: 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 managed? 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?

Environment: 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? Are the scientific environments where the work will be performed optimally selected to enhance the probability of success? Does necessary institutional support appear likely? Will open and free exchange of information be supported by this environment? Are the bioinformatics facilities well-positioned and supported in their planned locations?

REVIEW CRITERIA FOR THE OVERALL PHASE II PROJECT

Significance: 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? How significant is this research problem to the advancement of biomedical science? Given the present knowledge base and state of technology is this group well poised to solve this research problem within the next decade? Have the investigators presented a compelling case for pursuing it at this time? Is use of a large scale collaborative team the best way to approach this problem?Is the potential impact clear and exciting?

Principal Investigator and Steering Committee. Is there evidence that the PI and the central governing body have the vision, scientific expertise, administrative capacity and leadership skills to successfully lead the large-scale project? Is the level of commitment for the PI and consortium leaders adequate?

Participating Investigators. Are the participating investigators among the best in their respective fields? Is the skill set for the participating investigators sufficient? Does the project apply expertise from diverse disciplines and fields to the scientific question, and if not, what specific expertise is lacking? Is the level of commitment for each investigator adequate?

Other staff. Do the professional staff without independent research funding used in critical positions have the necessary expertise and experience to successfully meet the consortium requirements?

Innovation: 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 proposed aims original and innovative? Will the collaborative project challenge existing paradigms and/or develop new methodologies or technologies? Does the selection of participating investigators bring new approaches to the problem?

Approach: For the project as a whole, are the conceptual framework, design, methods, and analyses reasonably and adequately developed, well integrated, and appropriate to achieving the scientific aims? Is there a good balance between the application of current ideas and approaches, and the development of required new state-of-the-art ideas and tools? Are potential problems acknowledged and are alternative models and approaches considered? Are the individual parts well-conceived and necessary for the accomplishment of the project as a whole? What will be the value added over individual grants?

Environment: 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? Are the scientific environments where the work will be performed optimally selected to enhance the probability of success? Is a high level of institutional support evident? Will open and free exchange of information be supported by this environment? Are the bioinformatics facilities well-positioned and supported in their planned locations?

REVIEW CRITERIA FOR THE CORE RESOURCES

Consideration of the technical merit of the core units will include the following:

Comparison of core facilities with state-of-the-art facilities in terms of potential contributions of the cores to fulfilling the goals of the collaborative project.
The extent to which core units promote greater collaboration and cohesiveness among the participating investigators.
Qualifications, experience, and commitment of the investigators responsible for the core resources to the mission of the large-scale collaborative project and their availability to devote the required time and effort to the program.

REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS

Significance: 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? Does this study address an important problem? Will the bridging project tie or enhance the independent work of the participating investigator to the collaborative project, or will the pilot project add an essential missing aspect to the collaborative project? Will this bridging or pilot project serve to increase the cohesiveness of the large-scale project?

Approach: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 managed?
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?

Environment: 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?

Phase I and Phase II Applications

In addition to the criteria already presented (Section V.2.,Review and Selection Process), Phase I and Phase II applications will be reviewed with respect to adequacy in the following areas:

Commitment and record of the leadership to the sharing of research resources (including data and information, materials such as cell lines, model organisms, and mutant animals, and novel reagents and techniques) generated by the large-scale project with the broader scientific community;
Commitment to developing in Phase I and implementing in Phase II a diversity development plan (see section IV.2) to increase the number of participating investigators who are currently underrepresented in the biomedical, clinical, behavioral, and social sciences;
Commitment of the host institution to supporting the consortium, which is reflected, for example, in willingness to work out potential issues of intellectual property before submission of the phase II application and to remove any institutional barriers to establishment and healthy maintenance of the large-scale collaborative project; and,
Commitment in Phase I and adequacy of the plans in Phase II to effectively and realistically manage intellectual property issues for the collaborative project.

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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.

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.

Vertebrate Animals. 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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Biohazards. 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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Select Agents 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).

Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

2.C. Sharing Research Data

Data-Sharing Plan: The reasonableness of the data-sharing plan will be assessed by the reviewers and reviewers will factor the proposed data-sharing plan into the determination of scientific merit or the impact/priority score. The presence of a data-sharing plan will be part of the terms and conditions of the award. Data sharing is required, and dissemination is a critical aspect and fundamental purpose of this funding opportunity. Thus, there should be evidence of a genuine commitment of the large-scale project leadership to the sharing of data. The funding organization will be responsible for monitoring the data-sharing policy. Evaluation of annual progress reports and of subsequent renewal applications will include assessment of the effectiveness of the sharing of research data.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. (See the NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://ott.od.nih.gov/policy/rt_guide_final.html). The reasonableness of the research resources-sharing plan will be assessed by the reviewers and reviewers will factor the proposed research resources-sharing plan into the determination of scientific merit or the impact/priority score. The presence of a research resources-sharing plan will be part of the terms and conditions of the award. Research resources sharing is required, and dissemination is a critical aspect and fundamental purpose of this funding opportunity. Thus, there should be evidence of a genuine commitment of the large-scale project leadership to the sharing of research resources. The funding organization will be responsible for monitoring the data-sharing policy. Evaluation of annual progress reports and of subsequent renewal applications will include assessment of the effectiveness of the sharing of research data.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

The scientific review group will also comment on the adequacy and feasibility of the intellectual property plan. In a phase I application, the intent is to judge the adequacy of the applicant institution's commitment to develop a workable intellectual property plan. In a phase II application, effectiveness of the management of intellectual property issues will be considered as part of the scientific merit review. Accordingly, reviewers will factor the plan into the determination of the scientific merit and impact/priority score. This consideration will also be an important factor in the decision of NIGMS to make an award and will become a term and condition of award.

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, the NIH will request just-in-time information from the applicant. (For details, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a notice ofaward (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 e-mail notification from the awarding component to the grantee business official (designated in item 12 on the face page of the application). If a grantee does not have access to e-mail, 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 they are considered allowable pre-award costs. (See 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 at 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 at 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 PI, 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 administrative guidelines of the Office of Management and Budget (OMB), grant administration regulations of the Department of Health and Human Services (DHHS) at 45 CFR Parts 74 and 92. Part 92 is applicable when State and local governments are eligible to apply. Guidelines of other DHHS, Public Health Service (PHS), and NIH grant administration policies also apply.

The administrative and funding instrument used for the phase II portion of this program will be the cooperative agreement U54 mechanism, is an "assistance" mechanism rather than an "acquisition" mechanism. 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 here.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Exercising prime responsibility and authority for scientific and technical direction, administration, and overall operation of the large-scale collaborative project.
Selecting and chairing the steering committee.
Abiding by the operating rules and guidelines developed by the Steering Committee.
Accepting participation of the NIGMS project scientist in the aspects of project management (see Section 2.A.2. NIH Responsibilities).
Ensuring timely dissemination of information generated by the large-scale collaborative project to both the project members and the scientific public.
Coordinating project activities scientifically and administratively.

Awardees will retain custody of and have primary rights to the data and research resources, including software, developed under these awards, subject to government rights of access consistent with current DHHS, 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 here.

The NIGMS project scientist will have the following responsibilities:

Duties and responsibilities of a Steering Committee member, attendance at all meetings, and service as a voting member.
Substantial programmatic involvement.
Facilitation of interactions among the steering committee, advisory committee, and NIGMS.
Provision of advice and guidance to ensure adherence of the large-scale-collaborative project to the NIH and NIGMS rules and regulations.
Facilitation of communication with the scientific community directly affected by the collaborative project.
Actions to ensure that the steering committee and the advisory committee address issues and concerns raised by the community.
Additional responsibilities as negotiated at the award, depending on characteristics of the award.
Additionally, an NIGMS program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. At the Institutes discretion, the assigned program director may also serve as the NIH Project Scientist, depending on the nature of the large-scale collaborative project award.

2.A.3. Collaborative Responsibilities

Participating Investigators

Participating investigators are scientists who have externally peer-reviewed grant support in the area of the project and who are involved with and committed to the goals of the project. It is expected that the majority will be funded through research grants supported by NIGMS; other NIH institutes, centers, or both; and other governmental and private agencies. Exceptions may include participating investigators from industry, foreign institutions, or allied fields not traditionally supported by the NIH (e.g., physics and mathematics). PIs of pilot projects are also included as participating investigators.

Participating investigators will have the following responsibilities:

Work with the PI, the steering committee, and the other members of the large-scale collaborative project to set goals and develop working procedures.
Support the project goals and abide by operating guidelines and procedures established for the project.
Provide a list of organizational resources from their institution that will be committed to the project.
Be actively involved in the project and interactive with the other members of the project.

During the period of the award, a participating investigator whose independent research support terminates may continue as a participating investigator at the discretion of the steering committee and with the approval of the NIGMS program director. However, funds from this award are not to be used to support the independent research of such an investigator. It is expected that new participating investigators will be added to the collaborative project over the period of the award as deemed appropriate by the PI and the steering committee and with the approval of the NIGMS program director. These additions will be reported in the annual progress report.

Steering Committee

Steering committee members will be chosen from a select group of investigators actively involved in the consortium, including the PI, scientists and administrators from the staff, and participating investigators of the project. Membership of the steering committee must be sufficiently broad and balanced to be representative of the overall project. Members will be selected by the PI in consultation with the existing members of the steering committee and with the approval of the NIGMS project scientist. The steering committee will include the NIGMS project scientist as a voting member. The steering committee will meet annually with the advisory committee.

The steering committee will have the following responsibilities:

Give scientific and administrative advice to and assist the PI by providing oversight and strategic planning for the consortium as a whole and for the individual components.
Work with the PI to establish the scientific and technical direction of the project, develop common guidelines and procedures, establish rules for access to resources of the project, deal with intellectual property issues, and participate in the process of developing a cohesive group.
Develop a policy on disclosure of ties between scientists and for-profit organizations, to help avoid conflicts of interest.
Monitor bridging projects, core resources, and pilot projects for progress and efficiency and recommend modification of support and addition or deletion of these activities to facilitate progress toward the goals of the large-scale collaborative project.

Advisory Committee

The members of the advisory committee will be appointed by the PI after an award is made in consultation with the steering committee and with the approval of the NIGMS program director. At least three scientists not otherwise associated with the large-scale collaborative project will serve on the committee. The NIGMS project scientist will attend the meetings of the advisory committee as a member of the steering committee but will not be a member of the advisory committee.

The advisory committee will have the following responsibilities:

Provide scientific and administrative advice to the PI, the steering committee, and consortium members.
Meet at least once a year immediately before submission of the annual progress report, to advise the PI and steering committee about meeting the goals of the large-scale collaborative project and to comment on plans for future directions.
Raise issues for consideration by the PI and the steering committee.
Offer advice on the appropriateness of the level of NIGMS support to achieve the project goals.
Comment on the impact of the collaborative project on the relevant scientific communities.

2.A.4. Arbitration Process

Any disagreements between award recipients and the NIH that may arise in scientific or programmatic matters, within the scope of the award, may be brought to arbitration. An arbitration panel will be convened. The panel 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 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 DHHS regulations 45 CFR Part 16.

3. Reporting

The NIGMS program director will summarize and make progress reports annually to the National Advisory General Medical Sciences Council. At the end of third year of the five-year award period, the progress report to Council will be prepared and presented in person by the large-scale project principal investigator. The PI should plan for this in the requested budget.

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590, annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Dr. Michael E. Rogers
Division of Pharmacology, Physiology and Biological Chemistry
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
FAX: (301) 480-2802
Email: [email protected]

Dr. Catherine Lewis
Division of Cell Biology and Biophysics
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0828
FAX: (301) 480-2004
Email: [email protected]

Dr. Judith H. Greenberg
Division of Genetics and Developmental Biology
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-0943
FAX: (301) 480-2228
Email: [email protected]

2. Peer-Review Contacts:

Dr. Helen R. Sunshine
Office of Scientific Review
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2881
FAX: (301) 480-8506
Email: [email protected]

3. Financial or Grants Management Contacts:

Ms. Grace Olascoaga
Chief, Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5520
FAX: (301) 480-1969
Email: [email protected]

Section VIII. Other Information

Required Federal Citations

Vertebrate Animals:
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 U.S. Department of Agriculture Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. (Au: Include?)

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 (see 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); and 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. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, at 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. (See http://grants.nih.gov/grants/policy/data_sharing.)

Investigators should seek guidance from their institutions on issues related to institutional policies and local institutional review board 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 impact/priority score.

Access to Research Data Through the Freedom of Information Act:
The 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. (For NIH guidance, see 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:
The 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 at 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 plan for sharing model organisms is not subject to a cost threshold in any year and is expected to be included in all applications for funding of research in which the development of model organisms is anticipated.

Inclusion of Women, Minorities, and Children:
It is the policy of the NIH that women and members of minority groups and their subpopulations 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 (see 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). (For a complete copy of the updated guidelines, see 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 1) that all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by gender and/or racial/ethnic groups, including subgroups if applicable and 2) that investigators must report annual accrual and progress in conducting analyses, as appropriate, by gender and/or racial/ethnic group.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21 years) 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 Guidelineson the inclusion of children as participants in research involving human subjects (see 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. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.)

Human Embryonic Stem Cells:
Criteria for Federal funding of research on human embryonic stem cells (hESCs) can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission system (http://www.nihms.nih.gov/) at PubMed Central an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from the NIH. The author's final manuscript is defined as the final version accepted for journal publication and includes all modifications from the publishing peer-review process.

The NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from the NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from nonNIH-supported research projects should not be submitted.

For more information about the policy or the submission process, see the NIH Public Access Policy web site at http://publicaccess.nih.gov/and view the policy or other resources and tools, including the Authors' Manual, at http://publicaccess.nih.gov/publicaccess_Manual.htm.

Standards for Privacy of Individually Identifiable Health Information:
The 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 web site (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?" (For 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, see 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 online journal articles. Unless otherwise specified in this solicitation, 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 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 PA is related to one or more of the priority areas. (For a copy of Healthy People 2010, see 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 or Health Systems Agency review. 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 (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:
The NIH encourages applications for repayment of educational loans from qualified health professionals who have made a commitment to pursue a research career in clinical or pediatric areas or involving contraception, infertility, or health disparities. The Loan Repayment Program (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, see http://www.lrp.nih.gov/.)