Specific Guidance on Application
Application Research Plan
Additional Application Elements

Specific Guidance

Potential applicants are encouraged to use Form PHS 398, which may be downloaded from http://grants.nih.gov/grants/forms.htm. For ease of integrating the individual PHS 398 form pages into a single file, pilot project PIs are also encouraged to select the Microsoft® Word® version of the PHS 398.

Specific guidance for pilot projects is provided below:

• Make sure to capture the EARDA grant number and title of the pilot project in item 1 on the PHS 398 face page. Also capture information about the pilot project PI in items below.
• Animals/Human Subjects. If animals or human subjects will be used in the study, indicate the Institutional Review Board (IRB) or Internal Animal Care and Use Committee (IACUC) Assurance Number and the date reviewed on the Form PHS 398 face page, as appropriate. Also provide the IRB approval and sample consent form or IACUC approval (as appropriate) in the Appendix of your application. All non-exempt research that involves human subjects must include a Target/Planned Enrollment Table. Because pilot project support is a component in the EARDA grant award and not an independent NIH research award, pilot projects do not follow the just-in-time requirement for IRB approvals. Accordingly, PIs MUST provide IACUC and IRB approvals as appropriate when their projects are submitted for consideration for support.
• Complete PHS 398 pages 2, 3, 4, and 5 as appropriate. Be sure to provide a detailed budget and budget justification (PHS 398 pages 4 and 5).
• Biographical Sketch Format Page. Include a biographical sketch for the pilot project PI and any key participants. PIs are encouraged to work with mentors or consultants who can provide guidance in regard to the design of the pilot research project and with data analysis. A robust data analysis is highly desirable.

Research Plan

The pilot project application should include a four-part research plan. The research plan describes the proposed research, stating its significance and how it will be conducted. A full discussion on developing the research plan is available at http://grants.nih.gov/grants/writing_application.htm#developPlan. Highlights from this information are provided here for your convenience.

Specific Aims Section: What You Intend To Do
Specific aims are a formal statement of the objectives and milestones of the research project in regard to testing the hypothesis. List your aims and then list all the experiments you’ll do to support each aim. Keep in mind that your experiments support your aims, and your aims are the test of your hypothesis. A strong grant application is driven by a strong, solid hypothesis with clear research objectives. You may also want to make a brief statement concerning the innovation of your proposed research.

Background and Significance Section: Why the Work Is Important
This section should thoroughly describe the literature, particularly any scientific controversies in the field, to support your views and hypothesis. Make sure that you identify key references. Make sure the significance of the topic is explicitly stated—that is, state how scientific knowledge or clinical practice will be advanced, if the aims of the application are achieved. Be sure to critically evaluate existing knowledge that leads to your pilot project and specifically identify the gaps that the project is intended to fill. This should not be a thesis, but should provide information that directly pertains to the scientific need for your project. Two to three pages are recommended for the Background and Significance section.

Preliminary Studies Section: What You Have Already Done
Although the goal of a pilot project or feasibility study is to collect data to support a “full” research grant application, PIs on pilot project applications should not omit this section. Use this section to support your hypothesis and the future direction of your research, and to show your expertise and knowledge of the experimental approach, methods, data collection, and analyses to be employed in your project.

“Preliminary” data relevant to the pilot project may consist of your own publications in the field, publications of other researchers, unpublished data from your own laboratory or others, or a combination of these. This section of the application is intended to establish the PI’s experience and competence to pursue the study and the likelihood of success. Three to six pages are recommended for the Preliminary Studies section.

Research Design and Methods Section: How You Are Going To Do the Work
This section is critical for demonstrating that the applicant has developed a clear, organized and thoughtful study design that tests the central hypothesis. (It is not a list of recipes for methods, experiments, and data collection.) Describe any novel concepts, approaches, tools, or technologies for the proposed pilot project. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. Provide a tentative sequence or timetable for the project.

Additional Elements

In addition to the four sections mentioned above, there are additional sections of the application that may be required. These items may include (but are not limited to) Bibliography and References Cited, Appendices, Protections for Human Subjects from Research Risk, and Identification of Select Agents. For a complete discussion of these additional elements, please visit http://grants.nih.gov/grants/writing_application.htm#additional.

For ease of integrating the individual form pages into a single file, pilot project PIs are encouraged to select the Microsoft® Word® version of the PHS 398 form.

In addition, all PIs must submit their pilot research project applications to their respective program officers—Carl V. Hill, Ph.D., M.P.H., or Jean Flagg-Newton, Ph.D.—at nichddsp@mail.nih.gov.