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Introduction |
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PAR
Number: PA 03-107
Release Date: 04-18-03
Expiration Date: 04-18-06, unless reissued |
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Scope and Priorities |
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Purpose
The National Library of Medicine (NLM) supports the use of the National Institutes of Health (NIH) Exploratory/Developmental Research Grant Award (R21) mechanism for exploratory/developmental research projects in biomedical informatics, biotechnology information, and health sciences library and information science. The R21 is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. The characteristics, requirements, preparation, and review criteria for the R21 application are described below.
Research Objectives
The evolution and vitality of the biomedical information sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, NLM seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance informatics research. For information on NLM's research priorities, consult the program announcement for research grants at http://www.nlm.nih.gov/ep/GrantResearch.html
The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on a field of biomedical, behavioral, or clinical research.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications. Projects of limited cost or scope that use widely accepted approaches and methods within well established fields are better suited for the R03 small grant mechanism. Information on NLM's Small Grant program can be found at http://www.nlm.nih.gov/ep/GrantSmallProjects.html . |
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Eligibility |
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Eligible Institutions
Applications may be submitted by institutions with any of the following characteristics:
- For-profit or non-profit organizations.
- Public or private institutions, such as universities, colleges, hospitals, and laboratories.
- Units of State and local governments.
- Eligible agencies of the Federal government.
- Domestic or foreign.
- Faith-based or community-based organizations
Individuals Eligible to Become Principal Investigators
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with an eligible 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 programs.
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Mechanism |
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Applicants responding to this PA must use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
The applicant may request a project period of up to two years with a combined budget for direct costs of up $275,000 for the two year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in any single year.
This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm ). This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm
Exploratory/developmental grant support is for new projects only; competing continuation applications will not be accepted. Two revisions of a previously reviewed exploratory/developmental grant application may be submitted as defined in NIH Policy at http://grants.nih.gov/grants/policy/amendedapps.htm. |
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Review Criteria |
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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, weighting
them 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.
1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
2. Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
3. Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
4. Investigators. Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score.
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.
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.
Award Criteria
Applications submitted in response to the Exploratory/Development Program will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review
- Availability of funds
- Relevance to program priorities
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Application Deadlines |
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Beginning with the June 1, 2003 receipt date, applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://www.nlm.nih.gov/ep/Deadlines.html . Application deadlines are also indicated in the PHS 398 application kit. |
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Application and Process |
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Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html For further assistance contact:
GrantsInfo@nih.gov
Telephone (301) 435-0714
Supplemental Instructions: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions:
Research Plan: Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted.
Appendix: Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included.
Specific Instructions for Modular Grant Applications: All investigator initiated R21 applications must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm
For the NLM Exploratory/Developmental Grant (R21), applicants may request direct costs in $25,000 modules, up to a total direct cost of $275,000 for the combined two year award period.
Sending an Application to the NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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
Bethesda, MD 20817 (for express/courier service)
Application Processing: Applications must be received by or mailed on or before the receipt dates described at http://www.nlm.nih.gov/ep/Deadlines.html The CSR will not accept any application in response to the Exploratory/Development Grant Program that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR 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 R21 application already reviewed, but such application must include an Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. |
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Review Considerations |
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Applications submitted for the Exploratory/Development Grant Program will be assigned for review to the National Library of Medicine, whose scientific review group (Biomedical Library and Informatics Review Committee), convened in accordance with the standard NIH peer review procedures ( http://www.csr.nih.gov/refrev.htm ), will evaluate applications for scientific and technical merit.
As part of the initial merit review, all applications will:
- Receive a written critique
- Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
- Receive a second level review by the National Library of Medicine's Board of Regents (current members)
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Contact Information |
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The NLM encourages inquiries concerning this PA and welcomes the opportunity answer questions from potential applicants. Before submitting an application, interested applicants should contact Dr. Valerie Florance to discuss their projects:
Valerie Florance, PhD
Extramural Programs
National Library of Medicine
Rockledge 1, Suite 301
6705 Rockledge Drive MSC 7968
Bethesda, MD 20892
Telephone: (301) 594-4882
FAX: (301) 402-2952
Email: floranv@mail.nih.gov |
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