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 22, 2010, unless it is reissued.
Update: The following update relating to this announcement has been issued:
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 (Changed to: July 28, 2009 per NOT-GM-09-017)
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
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 Information—Required 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.
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
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:
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.1–VI.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, 301-435-0714; e-mail, GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-0088.
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:
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) Project summary (10-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 investigator’s 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 or in lieu of items requested in the PHS 398, applications should include:
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:
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. To provide applicants with flexibility to organize a large-scale collaborative project in a manner that best facilitates progress on the project, applicants may organize and present the project by using the following format, or alternate combined formats may be used for some parts of the application as described here. Required components of all applications are the program summary; administrative and program management plans; a plan for data sharing and intellectual property; 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.
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 format or an alternate format is used, applicants should explain in the program summary 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. 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.
Program Summary (Required). Describe the goals and operation of the large-scale project as follows:
Administrative Management Plan (Required). Required elements of the administrative management plan are as follows:
Project Management Plan (Required). A project management plan to keep the collaborative project moving forward is required and its elements include:
The program summary, administrative management plan, and project management plan have an aggregate page limit of 30 pages. Page limits for other sections are given within each section and a summary follows at the end. Investigators should endeavor to be clear and concise.
Plan for Handling Intellectual Property and Sharing of Data and Research Resources (Required – three-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 (Required – two-page limit))
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:
Core Resource A – Administrative Core (Required - five-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 (Required - five-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:
Core Resource C – Bioinformatics Core (optional; may be combined with core B) (15-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, 20 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, the description must include answers to the following questions:
Core Resource D – Scientific Resource Core(s) (Optional – 10-page limit per core). Required elements of the plan for Core Resource D are as follows:
Bridging Projects (Optional – five-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:
Pilot Projects (Optional – 10-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:
Summary of Page Limits
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:
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 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 a 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 a 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
The following will be considered in making funding decisions for phase I and phase II awards:
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 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
Significance: 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?
Approach: For the project as a whole, are the conceptual framework, general approaches, and proposed analyses reasonable? Are all of the components necessary and sufficient to achieving the scientific aims? Is their planned integration appropriate? 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 do alternatives exist? Will there be value added over individual grants?
Innovation: 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?
Environment: 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?
Investigators: 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?
REVIEW CRITERIA FOR THE OVERALL PHASE II PROJECT
Significance: 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?
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?
Innovation: 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?
Environment: 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?
Investigators: 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?
REVIEW CRITERIA FOR THE CORE RESOURCES
Consideration of the technical merit of the core units will include the following:
REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS
Reviewers will be asked to discuss the following aspects of each bridging and pilot project.
Significance: 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 conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the proposed work appropriate for support by the large-scale collaborative project or would it be more appropriate for support by a regular research grant?
Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
Investigator(s): Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers (if any)?
Environment: Does the scientific environment in which the work will/has been done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?
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:
2.A.
Additional Review Criteria:
In addition to these criteria, the following items will
continue to be considered in the determination of scientific merit and the
priority score:
Resubmission
Applications (formerly “revised/amended” applications): Are the responses to
comments from the previous scientific review group adequate? Are the
improvements in the resubmission application appropriate?
Protection of Human Subjects from Research
Risk: The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan, Section E on Human Subjects in the PHS Form 398).
Inclusion
of Women, Minorities, and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups and subgroups,
and children, as appropriate for the scientific goals of the research, will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form
398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, the adequacy of proposed protection will be determined.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research will be considered, but the priority score should not be affected by
the evaluation of the budget.
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 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 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 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 of award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via 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:
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:
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:
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:
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:
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: rogersm@nigms.nih.gov
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: lewiscat@nigms.nih.gov
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: greenbej@nigms.nih.gov
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: sunshinh@nigms.nih.gov
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: olascoag@nigms.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the 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
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 and
Minorities in Clinical Research:
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-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (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. Applications that do not provide this
information will be returned without review.
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 non–NIH-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/.)
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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