Research Project Grant Guidelines

Application Receipt Dates: February 5, June 5, October 5

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) accepts unsolicited, investigator-initiated research project grant applications (R01). Research project grants are awarded to institutions on behalf of a principal investigator to facilitate pursuit of a scientific focus or objective in the area of the investigator's interest and competence. Institutional sponsorship assures the NIH that the institution will provide facilities necessary to accomplish the research and will be accountable for the grant funds. Applications are accepted for health-related research and development in all areas within the scope of NINDS' mission (see the planning document, "Neuroscience at the New Millennium"; http://www.ninds.nih.gov/about_ninds/strategic_plan.htm).

There is no specific program announcement for the R01 research project grants. Applications for R01 grants are either investigator-initiated or are solicited through specific program announcements or requests for applications (See: http://www.ninds.nih.gov/funding/neuroscience.htm).

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Mechanism of Support

The mechanism of support is the NIH research project grant (R01). Specific application instructions have been modified to reflect the purpose and nature of this mechanism, as well as to accommodate the "Modular Grant" and "Just-In-Time" streamlining efforts being implemented by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at the website http://grants.nih.gov/grants/funding/modular/modular.htm. There are no set limits for the requested budget of an R01 grant application. However, applications requesting $500,000 or more in direct costs for any year must contact NINDS staff before submitting the application. Complete information about consideration of unsolicited applications requesting more than $500,000 direct costs can be found at http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or an amended/revised version of the preceding grant application types for a clinical research project requesting $1,000,000 or more in direct costs for any year is advised that he or she must contact the NINDS a minimum of 3 months prior to the next submission deadline for new grant applications. Furthermore, the applicant must obtain agreement from the NINDS staff that the Institute will accept the application for consideration for award. Any application subject to this policy that does not receive permission to submit will be returned to the applicant without review. These guidelines apply to all unsolicited grant applications, including applications submitted in response to NINDS program announcements (see: http://grants.nih.gov/grants/guide/notice-files/NOT-NS-01-012.html).

NINDS research project (R01) grant support is renewable through the submission of competing continuation applications. The project period is for up to five years.

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Eligibility Requirements

In general, any organization is eligible to apply for regular NIH research grants, and unsolicited applications are welcome. The applicant is the research organization, although a principal investigator (PI) writes the research proposal; and if a grant is awarded, the grantee is the applicant organization. Applications may be submitted by domestic or foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. The NINDS encourages applications from new investigators.

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Application Procedures

Applicants are encouraged to contact program staff in their subject area with questions regarding proposed projects. A complete listing of contacts for both programmatic and fiscal/administrative inquiries may be found at: http://www.ninds.nih.gov/about_ninds/organization.htm#Extramural. NIH is in the process of converting to SF424 (Research and Related [R&R]) forms and electronic submission through Grants.gov. The transition timetable for specific grant mechanisms can be found at http://era.nih.gov/ElectronicReceipt/strategy_timeline.htm. General information on electronic submission of NIH grants can be found at http://era.nih.gov/ElectronicReceipt/. More information on NIH grants and other funding opportunities can be found at http://grants.nih.gov/grants/index.cfm. Application instructions can be obtained at http://grants.nih.gov/grants/guide/parent_announcements.htm .

Applications requesting $250,000 or less per year in direct costs must follow Modular Grant Application Procedures. A full description of the Modular Grant application may be found at: http://grants.nih.gov/grants/funding/modular/modular.htm.

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Review Considerations

Upon receipt, applications will be reviewed for completeness by the CSR and for adherence to the above guidelines and instructions by the NINDS staff. Incomplete and/or non-adherent applications will be returned to the applicant without review.

Applications that are complete and adherent will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NINDS Advisory Council.

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Review Criteria

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application 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, weighting them as appropriate for each application. Note that the 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 high risk/high impact research that by its nature is not innovative but is essential to move a field forward.

(1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

(2) 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

(3) 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?

(4) Investigator: 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)?

(5) Environment: Does the scientific environment in which the work will be performed 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?

In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following:

• The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated.
• The reasonableness of the proposed budget and duration in relation to the proposed research.
• The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application.

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Award Criteria

Applications will compete for available funds with all other recommended applications. Funding decisions will be made based on the quality of the proposed project as determined by peer review, program priorities, and availability of funds.

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Inclusion Of Women And Minorities In Research Involving Human Subjects

It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. An updated notice has been published and is available by accessing NOT-OD-02-001.

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Inclusion of Children as Participants in Research Involving Human Subjects

It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy.

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Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This program, "NINDS EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM" is related to the priority area of creative, novel, and/or high impact research. Potential applicants may obtain a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople.

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Authority And Regulations

This program is described in the Catalog of Federal Domestic Assistance No. 93.853. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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.

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