Instructions for Applications to CAIRHE’s Request for Proposals (2022)
Letter of Intent Deadline: February 1, 2022
Application Deadline: No later than 11:59 p.m. onApril 1, 2022
(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 provided to you by CAIRHE) and related instructions.
The instructions below for this RFP refer to relevant portions of the complete federal instructions for PHS 398, found online as a PDF here: https://grants.nih.gov/grants/funding/phs398/phs398.html. (We do not require the entire PHS application forms package because NIH has reduced the paperwork burden for projects to expedite review and approval.) Instructions for CAIRHE RFP requirement Nos. 1-4, 7, and 10 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.
A required 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 protected] by February 1, 2022. 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 [email protected] 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, 2022, to James Burroughs (994-4407, [email protected]).
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, with single line spacing, as your font on the Word forms, with 1/2-inch margins, and adhere to text limits given in red in the instructions below. These are NIH guidelines. Other important guidelines will be provided to you in a "Use of These Forms" document at the time you receive your forms. 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 or alter the single form page as provided.
Use the Word form Face-Page-2022. Many fields on the bottom half of this page are already filled in for you. Do not alter them. 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-2022, 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 or alter the spaces provided on the 2-page form.
Use the Word form Project-Summary-2022. Fill out both pages, as applicable. We do not require biographical sketches for 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-2022.
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-2022. 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.
See PHS 398 Instructions, Section 4.6, pages 25-29. Limit: Do not exceed 5 pages.
Use the form Biosketch-2022. Note that the format of the Biosketch has changed slightly since the instructions above were issued. As of 2022, Section B has been renamed "Positions, Scientific Appointments, and Honors." Section D, "Research Support," has been removed. You will instead report any current or past research support in the Other Support document (see #9 below).
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. Note that ALL attachments made to the Human Subjects forms must be PDF files. Compose them in a blank Microsoft Word file and use Arial 11-pt. font, single line spacing, and 1/2-inch margins.
(a) Start with the PDF form Human-Subjects-Clinical-Trials-Info.Ignore the statements in the box near the top of this form about the "Research & Related Other Project Information Form."
(b) Answer the two highlighted questions, "Does the research involve human specimens and/or data?" and "Are Human Subjects Involved?"
(b1) If you answered "No" to the second question, move to the next section and follow the instructions. If you need to make an attachment, save it as a PDF before attaching. You're now done with all human subjects forms.
(b2) If you answered "Yes" to the second question (which will be the case with most CAIRHE projects), 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-Subjects-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 a blank Word file (with Arial 11-pt. font, single line spacing, and 1/2-inch margins) 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 prospective participants. Fill out the "Planned" table only. 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. Contact James Burroughs at [email protected] if you have any questions about these sections.
(g) Save and close the form Human-Subjects-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 will need to provide IRB approval and human subjects education certification. These may be submitted at the time of your application, but we recommend waiting until CAIRHE has completed its internal review of all applications. If the internal review committee recommends your application for further review by CAIRHE's External Advisory Committee, you will receive notification around mid-April. At that time you can submit your protocol to IRB for review. Please note that a recommendation from the internal review committee does not guarantee that a project will be funded. It is only the first step in a three-step approval process.
IRB approval takes time, and CAIRHE cannot submit any application to NIH for final approval (the third and final step) without prior IRB approval, including tribal IRB approval where applicable. Start planning early so you will be ready to submit your protocol to IRB if and when you receive a favorable internal review. Contact James Burroughs with questions: 406-994-4407, [email protected].
Before NIH approval can be granted and project work can begin, you must supply the following:
- IRB approval letter or exemption letter with valid dates shown. It is imperative that the project title in your IRB protocol and the IRB approval letter match the project title given on your project application. 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/orc/irb/index.html for MSU IRB application procedures and deadlines.
- Human subjects education certification for PIs and key personnel. All personnel involved in human subjects research must have completed the base training "IRB Social and Behavioral Research." If the research also qualifies as a clinical trial, any personnel involved in the design and/or execution of the trial must ALSO complete the training "IRB Good Clinical Practice (GCP) for Social and Behavioral Research, Best Practices in Clinical Research." See http://www.montana.edu/orc/training/citi/index.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 or alter the “Initial Budget” page template for budget. There is no limit for the budget justification; use the appropriate level of detail.
Use the form Initial-Budget-2022 (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: https://www.montana.edu/research/osp/documents/infosheet.html.
For your budget justification, use the form Budget-Justification-Format-Template-2022 (referred to as “Form Page 5” in the instructions). This follows an easy-to-read format preferred by the NIH. Include headings/sections to match the budget categories you use on the “Initial Budget” form. Delete any content in the justification template that doesn't apply to your budget. Delete embedded document comments before submitting.
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.
IMPORTANT: Due to NIH rules, project leaders must spend funds completely during the project year, ending August 31. There can be no carryover of funding past this date.
For additional questions about forming your budget, consult with Maya Bronston, CAIRHE grants management specialist (994-2177, [email protected]).
See the instructions found on the form Other-Support-2022 and the format example given on the form page itself. There is no text limit for this form.
Using the format specified on the form Other-Support-2022, describe any active and pending research support you have. This will help CAIRHE (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 with other grants for the proposed research. Remember that you cannot hold simultaneous funding from CAIRHE and another program funded by an NIH Institutional Development Award, including Montana INBRE and the American Indian/Alaska Native Clinical and Translational Research Program. Please contact James Burroughs if you have questions about this rule.
We require 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. You
do not need a letter of support from your department head or dean.
Signed PDF copies of letters should accompany your proposal submission.