Instructions for Pilot Project Applications to CAIRHE’s Request for Proposals (2018)
Deadline: Midnight on March 11, 2018
(IMPORTANT: See #6 below for time-sensitive IRB information.)
Read the complete Request for Proposals (RFP) here: www.montana.edu/cairhe/rfp/index.html.
Applications for both New and Continuation Pilot Project proposals should include the components below using PHS 398 forms (a federal forms package) and related instructions.
The instructions below for this RFP refer to relevant portions of the complete federal instructions for PHS 398, found online here: http://grants.nih.gov/grants/funding/phs398/phs398.pdf. (We do not require the entire PHS application forms package because NIH has reduced the paperwork burden for pilot projects to expedite review and approval.) Instructions for RFP requirement Nos. 1-4 and 7 refer in red to specific sections and page numbers in this online PDF document. Instructions for the Protocol Addressing Protection of Human Subjects (No. 5) are found in a separate supplemental instructions document, given as a link in No. 5 below.
All form templates, as Word files (or PDF in one case), are available for download through links in each section below.
Although not required and non-binding, an e-mail indicating an intent to apply will assist CAIRHE in its planning of the review process. Please e-mail Program Coordinator James Burroughs at firstname.lastname@example.org as early as possible before the application deadline.
Deadline and Submission Requirements
An electronic version of the complete proposal should be submitted no later than midnight on March 11, 2018, to James Burroughs (994-4407, email@example.com).
Submit all files in Microsoft Word format (not PDF, with the exception of the one PDF form and any IRB documents that are PDFs), with each section as a separate file and the PI's name in each file name. Use an 11-point font in Arial, Times New Roman, or Palatino Linotype throughout on the Word forms. These are NIH guidelines. (In most cases the forms default to 11-point Arial.) Please adhere to text limits given in red in the instructions below. Again, these are NIH guidelines.
Please contact James Burroughs or Dr. Alex Adams, CAIRHE director (994-6077, firstname.lastname@example.org), if you have questions about the proposal format or instructions, or if you would like to discuss potential project ideas.
1. FACE PAGE
See PHS 398 Instructions, Section 4.1, pages 25–30. Text limit: Do not exceed the single form page as provided.
Use the Word form “Face Page.” Many fields on the bottom half of this page are already filled in for you. In Box 6, enter the "Dates of Proposed Period of Support" as 09/01/18 through 08/31/19. Leave the vacant fields in Box 13 as is; the Office of Sponsored Programs will fill them in later. Note that your application is for one year only, so your budget numbers for 7 a/b and 8 a/b will be the same. (These figures will come from your budget page; see No. 7 below.) Calculate the total costs (direct costs + F&A costs) in box 7b/8b using MSU's F&A rate of 44%. For any subaward portion of your direct costs, apply the F&A rate to the first $25,000 only (for the life of the project).
Submit an optional second page, “Face Page-2-Optional,” only if your application has more than one principal investigator (PI).
2. PROJECT SUMMARY
See PHS 398 Instructions, Section 4.2, pages 31–32. Text limit: Do not exceed the spaces provided on the 2-page form.
Use the Word form “Project Summary.” Fill out both pages, as applicable. We do not require biographical sketches for senior/key personnel and other significant contributors.
3. SPECIFIC AIMS
See PHS 398 Instructions, Section 5.5.2, page 43. Text limit: 1 page (including any tables and figures).
Use the Word form “Continuation Format.”
4. RESEARCH STRATEGY AND BIBLIOGRAPHY
See PHS 398 Instructions, Sections 5.5.3 and 5.5.4, pages 44–46. Text limit: For Research Strategy, do not exceed 4 pages for the three main sections (Significance, Innovation, and Approach), including tables/figures, using the form provided. There is no page limit for the Protection of Human Subjects section (see No. 5 below) or the Bibliography/Works Cited (if applicable). Combine all parts into one Word file.
Use the Word form “Continuation Format.” Begin each of the three main sections of the Research Strategy with the appropriate section heading—Significance, Innovation, and Approach. Only these three sections count toward your 4-page limit. Continuation project applications should include information described under "Preliminary Studies for New Applications" (p. 45). New pilot project applications should include information on preliminary data if applicable, though preliminary data is not required. Continuation project applications should include the information described under "Progress Report for Renewal and Revision Applications" (p. 45), keeping this content within the three main sections.
If your project will involve human subjects, you must include a fourth section titled “Protection of Human Subjects” (see No. 5 below). Include a final section for Bibliography/References Cited (if applicable). This final section may include (a) references cited in the Research Strategy, and/or (b) for continuation projects, all publications and/or manuscripts accepted for publication that have resulted directly from prior CAIRHE support of your project. While the Protection of Human Subjects and Bibliography sections do not count toward your page limit, please be as succinct as possible.
5. PROTOCOL ADDRESSING PROTECTION OF HUMAN SUBJECTS
See the Supplemental Instructions Part II of the PHS 398: Supplemental Instructions for Preparing the Protection of Human Subjects Section of the Research Plan and Human Subjects Research Policy, pages II-1 through II-17.
If your project will involve human subjects, create a separate heading, “Protection of Human Subjects,” as part of your Research Strategy following the three main sections. Most of the information for this section will come from your IRB protocol that you submitted for IRB approval. In most cases, if your project is not exempt, this portion of your CAIRHE proposal should include the following sections and subsections (see p. II-8 through II-15):
A. Risks to Human Subjects
1. Human Subjects Involvement, Characteristics, and Design
2. Sources of Materials
3. Potential Risks
B. Adequacy of Protection Against Risks
1. Recruitment and Informed Consent
2. Protections Against Risk
C. Potential Benefits of the Proposed Research to Human Subjects and Others
D. Importance of the Knowledge to be Gained
E. Inclusion of Women and Minorities
F. Inclusion of Children
If your project is exempt, include the “Protection of Human Subjects” heading, then state the exemption and give a brief explanation for how the exemption applies. Include your exemption letter from IRB (see No. 6 below).
6. IRB AND HUMAN SUBJECTS DOCUMENTS (if applicable)
If your project will involve human subjects, you must also submit the following as part of your application:
- IRB approval letter or exemption letter with valid dates shown. NIH will accept tribal or MSU IRB approval, or both. See http://www.montana.edu/irb/index.html for MSU IRB application procedures and deadlines. If your IRB application has not been approved prior to the deadline for this RFP, submit an explanation with your RFP application and state when you expect approval. We cannot submit any application to NIH for approval without prior IRB approval. Start planning early!
- Human subjects education certification for PIs and key personnel. See http://www.montana.edu/irb/getting_started.html for information about, and access to, MSU’s CITI training module. CITI certification must be repeated every three years.
- PHS Inclusion Enrollment Report (not required for projects with a #4 Exemption). Use the PDF form “PHS-Inclusion-Enrollment-Report.” (If this form won't open in your browser, try copying the link and pasting it into the "Open" command, as the file name, in Acrobat Reader. Or James Burroughs can e-mail the file to you.) This form is the latest NIH version and may look different from what you have filled out in the past. Check the “Planned” box for Enrollment Type. Additional instructions for the form are online at http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.500-phs-inclusion-enrollment-report.htm.
7. ONE-YEAR BUDGET AND JUSTIFICATION
See PHS 398 Instructions, Section 4.4, pages 33–36. Text limit: Do not exceed the “Initial Budget” page for budget. There is no limit for the budget justification; use the appropriate level of detail.
Use the form “Initial Budget” (referred to as “Form Page 4” in the instructions). Note that Equipment includes only items that exceed $5,000 in unit cost. Itemize participant and community advisory board incentives under Supplies. (Call them “incentives.” Do NOT call them “stipends” or “honoraria,” which at NIH refer to different, prohibited costs.) If you budget for speaker fees, include those under Consultant Costs or Other Expenses and call them “speaker fees,” not “honoraria.” For help with benefit estimates, consult the OSP Information Sheet: http://www.montana.edu/research/osp/documents/InfoSht.pdf.
For your budget justification, use the form “Continuation Format” (referred to as “Form Page 5” in the instructions). Include headings to match the budget categories on the “Initial Budget” form.
If your project will involve one or more subawards, submit a separate budget page and justification page for each subaward recipient. You do not need to submit any other subaward paperwork at the time of your application.
For additional questions about forming your budget, consult with Maya Bronston, CAIRHE grants management specialist (994-2177, email@example.com).
8. OTHER SUPPORT
See the instructions link found on the form “Other Support” and the format example given on the form page itself. There is no text limit for this form.
Use the form “Other Support.” This will help CAIRHE and NIH (1) establish that the applicant is a junior investigator with available time and effort (see RFP under “Eligibility”), and (2) determine whether or not there is any funding overlap by other grants for the proposed research.
9. INSTITUTIONAL ANIMAL CARE DOCUMENTS (if applicable)
If your project will involve animals in research, contact James Burroughs at firstname.lastname@example.org for further instructions.