Syracuse University Office of Sponsored Programs http://osp.syr.edu NIH 424 R&R Summary and Checklist http://grants.nih.gov/grants/funding/424/index.htm www.grants.gov Numbered Items (1., 2., 3., etc) represent individual files to be uploaded at PDF documents General Information & Guidance OSP, the authorized organizational representative for submitting applications to Grants.gov, is registered in all systems – ignore registration instructions. Read specific solicitation (FOA) for deviations on 424 (R&R) instructions and other specific guidance. This summary does not replace that review. Download fresh Grants.gov application file from FOA The NIH Grants.gov application is a combination of ‘generic’ and specific requirements. The 424 R&R and FOA instructions should be followed, even when something seems ‘optional’ (e.g., Commons User ID for PIs, etc) Annotated sample and example proposals from NIAID. http://www.niaid.nih.gov/researchfunding/grant/pages/samples.aspx NIH – Grants.gov Components Mandatory forms. Identified by orange boxes Optional forms: Budget forms - dashed orange boxes; one of the following must be included: PHS 398 Modular Budget or R&R budget . Other optional forms in blue boxes SF 424 (R&R) R01, R21, R03 Parent Applications on OSP website have Highlighted info pre-populated: http://osp.syr.edu/forms%20and%20pages/forms.html Sample SU NIH awarded proposals: https://sushare.syr.edu/display/vfc/Sample+Awarded+Proposals Create a shared site: Drop Box or Google Drive so you, OSP, dept support and others have access to files. Applications materials should be final three business days before application deadline. FORMATTING REQUIREMENTS Black Font: Arial, Helvetica, Palatino Linotype, Georgia 11 pt. or larger Figures and tables can have smaller black font. Legibility is guiding principle No more than 6 lines/vertical inch; no more than 15 characters/linear inch At least ½” margins – No headers or footers; no page numbers Name file PDFs using standard characters and underscore (_). PAGE LIMITS Introduction for Resubmission or Revision – 1 pg. Specific Aims – 1 pg. Research Strategy (or follow FOA instructions): o R03/R21 – 6 pg. o R01 – 12 pg. Biosketch – 4 pg. Other page limits: See table 2.6-1 in 424 guidelines Box 4.a Federal Identifier – for resubmission, renewal or revision applications. Enter C/I and 6 digit unique id: CA987654 for 1R01CA987654-01A1 Box 4.b Agency Routing Number – ordinarily n/a; use only if mandated by FOA Box 4.c Previous Grants.gov Tracking ID for change/corrected app Box 5. DUNS no.: 002257350 Legal Name: Syracuse University Dept/Address: Office of Sponsored Programs, 113 Bowne Hall, Syracuse, NY, 13244-1200 Contact Person: Your OSP Research Administrator Box 6. EIN: for NIH only this is 1150532081A1 Box 7. Applicant Type: O- Private Institution of Higher Education Box 8. Type of Application – select as appropriate: New, Resubmission, Renewal, Continuation (ordinarily not used) Revision (e.g., for Supplement) Box 9. NIH – pre-populated Box 10. CFDA - no action required Box 11. Descriptive Title. 81 characters & spaces. Ordinarily renewal app’s will have same title as previous award unless aims have significantly changed. Titles are important; they frame the readers thinking / mind-set about your project. Box 12. Project Start – end dates. Ordinarily per FOA or review cycle: http://grants.nih.gov/grants/funding/submissionschedule.htm#review Box 13. Congressional District: NY-024 Box 14. PI/PD name & Contact info Box 15. Estimated Project Funding. A. Enter Total Federal Funds requested. D. Program Income (if applicable) Box 16. Subject to EO 12372? Usually no. Check FOA Box 17. Certification. Completed by OSP, which relies on IRR Box 18. SFLLL – Ordinarily no Box 19. Authorized Representative: OSP Research Administrator Box 20. Pre-application – ordinarily n/a. Box 21. Cover letter. To Division of Receipt and Referral of Center for Scientific Review. Body should present (concise / single lines) - example: Please assign this application to the following: Institutes/Centers National Cancer Institute - NCI National Institute for Dental and Craniofacial Research – NIDCR Scientific Review Groups Molecular Oncogenesis Study Section – MONC Cancer Etiology Study Section – CE Please do not assign this application to the following: Scientific Review Groups Cancer Genetics Study Section – CG The reasons for this request are [provide a narrative explanation for the request(s)] PHS 398 RESEARCH PLAN – pdf files only 1. Introduction to Application Summarize changes from prior app and how changes are indicated (e.g. bracketing; indenting; change of typography) 2. Specific Aims Summarize goals; objectives; outcomes; impact 3. Research Strategy, present in separate sections: a. Significance b. Innovation c. Approach 4. Progress Report Publication List (renewal) (myBibliography may be helpful. http://www.ncbi.nlm.nih.gov/books/NBK53595/ Human Subjects Sections – Now in separate document: http://grants.nih.gov/grants/funding/424/SupplementalInstructions.pdf 5. Protection of Human Subjects 6. Inclusion of Women and Minorities o If included, “Planned Enrollment Report” is required (see Optional Forms) 7. Inclusion of Children Other Research Plan Sections 8. Vertebrate Animals 9. Selection Agent Research (contact EHO / OSP) 10. Multiple PD/PI Leadership Plan. For multiple PD/PIs applications only. Include a leadership plan. Described why the multiple PD/PI approach is appropriate, the governance and organizational structure of the leadership team and the research project. Include communication plans, and procedures for making decisions on scientific direction and for resolving conflicts. Define the roles and administrative, technical, and scientific responsibilities for the project or program for the PD/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific parts of the project or the individual PD/PIs should be delineated in the Leadership Plan. 11. Consortium/Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. 12. Letters of Support. Include letters demonstrating the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the application. Letters should stipulate expectations for coauthorship, and whether cell lines, samples or other resources promised in the letter are freely available to other investigators in the scientific community or will be provided to the particular investigators only. For consultants, letters should include rate/charge for consulting services and level of effort/number of hours per year anticipated. NOTE: Consultant biographical sketches should be included in senior/key personal form. Letters ensuring access to core facilities and resources should stipulate whether access will be provided as a fee-for-service. 13. Resource Sharing Plan – single document See Supplemental Instructions Part III, 1.5 Sharing Research Resources. Data Sharing Plan: Required for any requests of direct costs of $500k or more in any year or in Page 2 of 5 specific FOA. Provide a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/noticefiles/NOT-OD-03-032.html. Sharing Model Organisms: All applications that will develop model organisms must include a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042. Genome Wide Association Studies (GWAS): Provide a plan for submission of GWAS data to the NIHdesignated GWAS data repository, or an appropriate explanation why submission to the repository is not possible. See Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOTOD-07-088, and http://gwas.nih.gov/. 14. Appendix (if applicable): Do not use to circumvent research strategy page limits o Up to three publications only IF Accepted for publication/not yet published Published but free/online link not available Patents directly relevant to project o Surveys; questionnaires; data collection instruments as necessary o Up to 10 attachments total allowed; provide descriptive file names, as order in assembled application may change. A summary sheet listing all items is encouraged and should be at front of first appendix item. R&R SENIOR/KEY PERSON PROFILE (expanded) 1. Box 1.Project Director / Principal Investigator Box 2. Human Subjects o Clinical Trial o Agency-defined Phase III Clinical Trial Box 3. Disclosure Permission Statement – allows NIH to share contact info and title with other foundations etc for possible collaboration or investment Box 4. Program Income- Check yes if you will generate revenue directly from grant-activities (e.g., conference registration fees; fees from use of equipment, and the like) Box 5. Human Embryonic Stem Cells – Contact EHO and OSP if yes. Box 6. Inventions & Patents (for renewals only) PI(s) must have eRA Commons User Name o Postdocs and students should obtain eRA Commons user names for progress performance reporting Credential: eRA Commons User Name must be provided for anyone assigned PI/PD role Multi-PI application: All individuals have the PD/PI role, regardless of organizational affiliation. Co-PI is not recognized by NIH. Use Co-Investigator Postdocs should be included if they meet the definition of Senior/Key Personnel (individuals who contribute in a substantive, meaningful way to the scientific development or execution of project, whether or not salaries are requested) Project Role on budget = Role on senior/key person profile Include senior/key personnel from subcontracts Include senior / key personnel even if not receiving compensation (e.g., mentors, letter of support expected) Current/Pending Support: Not Applicable Biosketch: Use NIH format. Check out SciENcv: http://www.ncbi.nlm.nih.gov/books/NBK154494/ o o o o o PHS 398 Cover Page Supplement Box 7. Change of Investigator / Change of Institution. Ordinarily n/a for new applications Education: chronological order Personal Statement: briefly describe why your experience and qualifications make you well suited for your role in the project Positions/Honors: chronological order Publications: limit to no more than 15 Research Support: ongoing/completed in the past 3 years (no effort; no dollars). If none, state so R&R Other Project Information Box 1. Are Human Subjects Involved? o Exempt or non-exempt information o SU Human Subject Assurance No. 00007077 Box 2. Are Vertebrate Animals Used o SU Animal Welfare Assurance No. A3687-01 Box 3. Is proprietary / privileged information included? Box 4.Environmental impact? Box 5.Research performance site historical (ordinarily no) Page 3 of 5 Box 6.Project involve activities outside the US or partnerships with international collaborators? o Also note on IRR. (report also Performance site) 7. Project Summary / Abstract o No longer than 30 lines of text; succinct & accurate description of project 8. Project Narrative o 2-3 sentences in plain everyday language on the project’s relevance to public health 9. Bibliography & References Cited (in Research Plan) o References must include: all authors (as they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. o Limit to relevant and current literature. o For articles that PI / team authored subject to the Public Access Policy: include the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567). For those journals that submit articles directly to PMC on behalf of their authors, indicate “PMC Journal – In Process.” A list of these journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. o Citations not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference 10. Facilities and Other Resources – used to assess the capability of environment to support project success. Describe, institutional support, physical resources (e.g., (Laboratory, Animal, Computer, Office, Clinical and Other) in direct support of the project. Indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project and intellectual rapport). Describe ways in which the proposed studies will benefit from unique features of the scientific environment or subject populations or will employ useful collaborative arrangements. For Early Stage Investigators (ESIs), also describe institutional investment in your success, e.g., resources for classes, travel, training; collegial support such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI’s project, and availability of organized peer groups; logistical support such as administrative management and oversight and best practices training; and financial support such as protected time for research with salary support. See, http://grants.nih.gov/grants/new_investigators/. o If there are multiple performance sites, describe the resources available at each site. o Describe any special facilities used for working with biohazards or other potentially dangerous substances. Note: Information about select agents must be described in the Research Plan, Section 11 (Select Agent Research). 11. Equipment – list equipment already available for the project and, if appropriate identify location and pertinent capabilities 12. Other attachments - if required by FOA. PROJECT/PERFORMANCE SITE LOCATIONS Ordinarily, primary location is the applicant organization (SU) Any portion of the project performed at another site (e.g. subcontract) must be identified, need: o DUNS number and congressional district PHS 398 Modular Budget Used when annual direct costs are less than or equal to $250,000 per year or if required by FOA Cognizant Agency (Name, POC, and No.) Department of Health and Human Services Ryan McCarthy 212-264-2069 Indirect Cost Rate Agreement: 01/29/2014 Use OSP budget template and modular sheet NOTE: Budget Justification must be attached in order to navigate to next budget period BUDGET JUSTIFICATION For Modular Budget Personnel Justification: List all personnel who will be compensated on the project; include person months effort (cal or AY/Sumr); describe role, responsibilities and provide sufficient information justifying why effort committed is appropriate and necessary for work. Consortium Justification: provide estimate of total costs rounded to the nearest $1000; list org. (foreign/domestic); personnel; effort; role. Detailed subaward budgets not required for submission. Detailed Budget Component When Direct Costs exceed $250K per year or when required by FOA Page 4 of 5 Separate subcontract detailed budgets are required when submitting the Detailed Budget Component OSP budget template organized for easy comparison to NIH budget form Sr. Personnel role/committed effort all described Note 8.5 AY appt./3% salary escalation rate Justify all other personnel: post-doc; graduate students (AY 0.5 FTE; Sum. 0.5-1.0 FTE) Essential administrative/clerical support explicitly ordinarily justified to be allowable Equipment adequately justified (why essential (availability of other resources and why inadequate), impact of not acquiring Describe purpose of travel: where, who, how long and cost breakdown Consultant-describe work to be performed; daily rate of pay; number of days(must also provide a letter of collaboration with above described elements) Subcontracts Include Subaward R&R budget, budget narrative. NOTE: OSP will also require a scope of work, bios, letter of collaboration signed by authorized organizational representative (AOR) R&R Subaward Budget information developed (for the application) and gathered (during an award budget period) from other human subjects instruments. What is clinical research for NIH purposes? http://grants.nih.gov/grants/funding/women_min/women_min_qa.ht m#3877 See also: http://grants.nih.gov/grants/funding/women_min/women_min.htm http://grants.nih.gov/podcasts/All_About_Grants/episodes/race_vs_ethnicit y_July_2013.htm PHS 398 Cumulative Inclusion Enrollment Report Required for Renewal or Revision applications involving clinical research. For each protocol, present actual enrollment to date of research subjects and their distribution by ethnicity/race and sex/gender on the Cumulative Inclusion Enrollment Report. Feb 2014 Required when there is a subaward. To be completed by proposed subrecipient and provided to OSP. Subawardees service guidelines may differ from SU’s (e.g., all materials final 10 business days before deadline). These will trump SU’s. Planned Enrollment Report Required for new applications when women or minorities will be enrolled in human subjects clinical research. Provide one form for each human subjects protocol anticipated. Helps NIH and grantees adhere to and NIH monitor the Women and Minority enrollment policy. Targets for enrollment – consider 1) purpose of research project; demographics of population in accrual area; national demographics. These forms are *not* the instruments to be used with human subjects, but rather summarize Page 5 of 5