Instructions for Pilot Project Applications to CAIRHE’s Request for Proposals (2019)
Letter of Intent Deadline: February 1, 2019
Application Deadline: No later than 11:59 p.m. onApril 1, 2019
(IMPORTANT: See #6 below for time-sensitive IRB information, particularly for any
projects that will need tribal IRB approval.)
Read the complete Request for Proposals (RFP) here: www.montana.edu/cairhe/rfp/index.html.
Applications for 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: https://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 Human Subjects and Clinical Trials Information forms are found in a separate supplemental instructions document, given as a link in No. 5 below.
Although not required and non-binding, a Letter of Intent indicating plans to apply will assist CAIRHE in its planning of the review process. Please e-mail Program Coordinator James Burroughs at email@example.com by February 1, 2019. See more details about this letter in the RFP, found at the link at the top of this page.
Please e-mail James Burroughs at firstname.lastname@example.org for the complete forms package required for your application. By requesting the forms you are under no obligation to apply.
An electronic version of the complete proposal should be submitted no later than 11:59 p.m. on April 1, 2019, to James Burroughs (994-4407, email@example.com).
Submit all files in Microsoft Word format (with the exception of the PDF Human Subjects and Clinical Trials Information form, as well as any IRB documents and letters of support that are PDFs), with each section as a separate file and the PI's name in each file name. Use 11-point Arial as your font on the Word forms and adhere to text limits given in red in the instructions below. These are NIH guidelines. Please submit all of your files at one time.
Please contact James Burroughs if you have questions about the proposal format or instructions.
See PHS 398 Instructions, Section 4.1, pages 14-19. Text limit: Do not exceed the single form page as provided.
Use the Word form Face-Page-2019. Many fields on the bottom half of this page are already filled in for you. 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%.
Submit an optional second page, Face-Page-2-Optional-2019, only if your application has more than one principal investigator (PI).
See PHS 398 Instructions, Section 4.2, pages 20–21. Text limit: Do not exceed the spaces provided on the 2-page form.
Use the Word form Project-Summary-2019. Fill out both pages, as applicable. We do not require biographical sketches for PIs, senior/key personnel, and other significant contributors.
See PHS 398 Instructions, Section 5.5.2, page 33. Text limit: 1 page (including any tables and figures).
Use the Word form Continuation-Format-2019.
See PHS 398 Instructions, Sections 5.5.3 and 5.5.4, pages 33–35. Text limit: For Research Strategy, do not exceed 6 pages for the three main sections (Significance, Innovation, and Approach), including tables/figures. There is no page limit for the Bibliography and References Cited. Combine all parts into one Word file.
Use the Word form Continuation-Format-2019. 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 6-page limit. New pilot project applications should include information on preliminary data if applicable, though preliminary data is not required. You may use any citation style and format for the Bibliography and References Cited.
In 2018, the National Institutes of Health greatly increased the application requirements for projects involving human subjects and clinical trials, including an expanded definition of clinical trial that now encompasses certain behavioral interventions. Please follow these directions very carefully.
Full instructions for these forms are found here.
(a) Start with the PDF form Human-Subjects-Clinical-Trials-Information.Ignore the statements at the top of this form about the "Research & Related Other Project Information Form."
(b) Answer the first highlighted question, "Are Human Subjects Involved?"
(b1) If "No," move to the next section and follow the instructions. If you need to make an attachment, use the Word form Continuation-Format-2019 but save it as a PDF before attaching. You're now done with all human subject forms.
(b2) If "Yes," you will have to create a "Study Record." Ignore the "Other Requested Information" heading. Ignore the form box that says, "Click here to extract the Human Subject Study Record Attachment." This form is already in the forms package you received from CAIRHE by e-mail.
(c) Type the name of your study in Box #1 under the "Study Record(s)" heading. Now save this form, close it, and set it aside.
(d) Open the separate PDF form, Human-Subject-Study-Record. Fill out all fields in Sections 1 and 2 according to the instructions provided at the link above. When attachments are required, use the Word file Continuation-Format-2019 to create separate files but save them as PDFs before attaching. Just before Section 3, click "Add Inclusion Enrollment Report" to include data on your project participants. Please save often as you work.
(e) ALL human subjects studies must complete Sections 3.1 and 3.2.
(f) Whether or not you fill out the remainder of this form depends on how you answered the Clinical Trials Questionnaire in Section 1.4. If you answered "no" to ANY of the four questions, you should not fill out anything below Section 3.2. Save and close the form. However, if you answered "yes" to ALL FOUR questions, you must complete Sections 3.3, 3.4, 3.5, and all of Section 4. Ignore Section 5.
(g) Save and close the form Human-Subject-Study-Record. Reopen the form Human-Subjects-Clinical-Trials-Information, then add your PDF Study Record as an attachment next to your study title in #1. Save and close the form.
(h) As part of your application, submit only the Human-Subjects-Clinical-Trials-Information form. This contains all of the information required by NIH (captured inside three levels of PDF attachments!).
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. If your project will involve American Indian participants, NIH requires tribal IRB approval. This can be a time consuming process. Consult with CAIRHE for guidance. Once you have tribal IRB approval, you will also need to submit an application to MSU IRB, although the tribal IRB will be the IRB of record for NIH. 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.
See PHS 398 Instructions, Section 4.4, pages 22–25. 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-2019 (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-2019 (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, firstname.lastname@example.org).
See the instructions found on the form Other-Support-2019 and the format example given on the form page itself. There is no text limit for this form.
Using the format given on the form Other-Support-2019, describe any active and pending research support in a separate file using the Continuation-Format-2019 template. 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.
We encourage any letters necessary to demonstrate the support of consortium participants,
community partners, and collaborators such as Senior/Key Personnel and Other Significant
Contributors included in the grant proposal. Projects involving community-based participatory
research (CBPR) may include letters of support from a community advisory board or
letters indicating that a community partnership has been established prior to proposal
submission. In these cases, the required consultation with CAIRHE well before submission can assist with this process.
Signed PDF copies of letters should accompany your proposal email.