Instructions for Research Project (5-Year) 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 Research 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 COBRE projects to expedite review and approval.) Instructions for RFP requirement Nos. 1-4 and 8 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. Please note important evaluation criteria at the bottom of this page.
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 09/01/19 through 08/31/24. Leave the vacant fields in Box 13 as is; the Office of Sponsored Programs will fill them in later. Your budget numbers for 7 a/b and 8 a/b will come from your budget pages; see No. 8 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.
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 12 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 12-page limit. If applicable, include information described under "Preliminary Studies for New Applications" (p. 45). Omit the "Progress Report for Renewal and Revision Applications" (p. 45).
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). While the Protection of Human Subjects and Bibliography sections do not count toward your page limit, please be as succinct as possible.
Additional content to include in your Research Strategy section, according to NIH COBRE guidelines: "The application should describe the goals for the long term, and delineate the design principles supporting the research or the hypotheses to be tested. Preliminary studies are not required for COBRE applications, but they are encouraged. In the absence of preliminary results, applicants should describe the rationale and scientific basis for the proposed research. Each research project should describe its relationship to the area of multidisciplinary research that is the focus of the COBRE [i.e., CAIRHE and its mission]. It should also critically assess the existing knowledge and approaches that have been, or are being, directed in the area with a specific emphasis on how the multidisciplinary COBRE approach will advance the field. Moreover, the importance and health relevance of the proposed research should be concisely stated."
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. BIOGRAPHICAL SKETCH
See these online instructions (updated Sept. 2017) for formatting your Biosketch. Text limit: 5 pages. Please pay particular attention to the number of manuscripts you are allowed to cite.
Use the Word form “Biosketch.” Submit a biosketch for each PI if there are multiple PIs, and for each senior/key person affiliated with the proposed project.
8. FIVE-YEAR BUDGET AND JUSTIFICATION
See PHS 398 Instructions, Section 4.4, pages 33–36. Text limit: Do not exceed the “Initial Budget” and "Budget-Entire Project" pages for your 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.
Use the form "Budget-Entire Project" (referred to as "Form Page 5" in the instructions) for additional years of support (Years 2-5).
For your budget justification, begin on Form Page 5 and use the form “Continuation Format” for additional pages. Include headings to match the budget categories on the “Initial Budget” form. For subsequent years, include justification for any changes from Year 1 funding.
If your project will involve one or more subawards, submit separate budget pages and justification pages 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).
9. 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.
10. 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.
The NIH will evaluate CAIRHE's COBRE renewal application, in part, on the scientific and technical merit of its research projects. Below are the NIH review criteria for research projects in COBRE applications, which CAIRHE will use, in turn, to evaluate applicants to this RFP. Addressing these criteria will greatly enhance your application's chance of success.
Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the PD(s)/PIs, collaborators, and other researchers well-suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?
Are the strengths, academic qualifications, and biomedical expertise of the project investigator appropriate and sufficient for research productivity? Does the project investigator have the potential and ability to achieve independent status? Does the investigator demonstrate the ability to compete successfully for investigator-initiated support? Does the investigator publish his/her work in a timely manner? For project investigators new to the COBRE, do they show career development potential and/or an ability to achieve independent status?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? If this project involves community engagement and outreach research, are there clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond? Are there plans for developing a coalition of community and academic stakeholders and for implementing evaluation strategies for the proposed projects? Is the research characterized by substantial community input in the development of the proposed study? Are community members, persons affected by the health condition, disability, or issue under study, or other key stakeholders in the community’s health, full participants in each phase of the research, including conception, design, conduct, analysis, interpretation, drawing of conclusions, and communication of results?
Can this project stand alone?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?