Nuts and Bolts of K Award Grant Submission Process Denise Wynn, MBA Training Coordinator Office of Research Administration January 9, 2014 Definitions • • • • • CDA – Career Development Award K – Career Development Award FOA – Funding Opportunity Announcement SF424 R&R – electronic application form packet name Adobe forms – current forms used by applicants that DO NOT have system-to-system capacity All Rights Reserved, Duke Medicine 2007 Multiple Systems Working Together • SPS: Sponsored Projects System • Grants.Duke: faculty interface with SPS • Grants.gov: single portal to apply for Federal grant funding – used by all 26 Federal grant-making agencies • eRA Commons: NIH electronic system – Retrieves applications from Grants.gov – Validates data submitted – Provides status/award information All Rights Reserved, Duke Medicine 2007 Registration Requirements eRA Commons registration • Principal investigators (including fellows) – must have a PI Commons account to submit electronically • Send Name, Preferred Login name, and email address to Department Business Office or [email protected] • Account will be established and affiliated with Duke University • Must validate account (confirm/complete Personal Profile information) UPDATE YOUR PROFILE May require up to 2 weeks to process. Must be able to log into Commons account before applications are submitted. All Rights Reserved, Duke Medicine 2007 K-Awards - Mentor & Ref Letters MENTOR REF LTRS Mentored Research Scientist Development Yes Yes K02 Independent Scientist Award No No K05 Senior Scientist Award No No K07 Academic Career Award * * K08 Mentored Clinical Scientist Development Yes Yes K18 Career Enhancement Award Yes Yes K22 Career Transition Award * Yes K23 K23 Mentored Patient-Oriented Research CDA Yes Yes K24 Mid-Career Investigator Award in Patient Oriented No No K25 Mentored Quantitative Research CDA Yes Yes K26 Midcareer Investigator Award in Mouse Pathobiology Research No No K99/R00 NIH Pathways to Independence (PI) Award) Yes Yes PROGRAM DESCRIPTION K01 *Varies with career status and source of award. Check the FOA All Rights Reserved, Duke Medicine 2007 K-Awards - Reference Letters • Electronic submission of reference letters is a separate/independent process from submitting an application. • Reference letters are submitted by the Referee directly via eRA Commons (referee does not need to log on to Commons) • Letters may be submitted prior to application receipt at Commons but must be submitted no later than the application deadline. (NOT-OD-11-079) All Rights Reserved, Duke Medicine 2007 Reference Letters Most Mentored CDAs require at least three but no more than five reference letters. • • • • Applicant's PI Commons User ID PI's last name as it appears on the Commons account Funding Opportunity Announcement (FOA) number FOA opening date and application submission deadline Letters are limited to 2 pages in PDF format All Rights Reserved, Duke Medicine 2007 What to include in the Reference Letter Describe the qualities and potential of the candidate for the career development award program for which support is being requested. This should include your evaluation with special reference to: • potential to become an independent research scientist; • evidence of originality; • adequacy of scientific background; • quality of research endeavors or publications to date, if any; • commitment to health-oriented research; and • need for further research experience and training • any additional related comments that the referee may wish to provide All Rights Reserved, Duke Medicine 2007 Submitting Reference Letters All Rights Reserved, Duke Medicine 2007 Reference Letters – cont. • Upon receipt of reference letter, both the Referee and the Candidate will receive a confirmation email • Candidates can check status on eRA Commons – Log in to your account – Check Status screen • Applications that are missing the required letters may be delayed in review or may not be accepted All Rights Reserved, Duke Medicine 2007 Grants.Duke.edu • • All Rights Reserved, Duke Medicine 2007 Use NetID and NetID Password Internet access Click Edit SPS Status: All Rights Reserved, Duke Medicine 2007 Init: Department entering data PNCA: Routing to departments for approval PCA: In ORA for review and approval Awaiting Submission: Ready for PI “release” Grants.Duke • Displays info from SPS • PI name links to Commons User Name and Degrees Menu includes • Opportunity • Attachments • Check • Release • Print Preview All Rights Reserved, Duke Medicine 2007 All Rights Reserved, Duke Medicine 2007 Grants.Duke • Validate Commons User Name • Confirm account is ACTIVE by logging into eRA Commons • Information in NIH Commons should match info in Grants.Duke • Enter degrees to appear in proposal All Rights Reserved, Duke Medicine 2007 Grants.Duke Delegates • Delegates may upload files • Delegates CANNOT submit proposals All Rights Reserved, Duke Medicine 2007 Adding Delegate to Grants.Duke All Rights Reserved, Duke Medicine 2007 K-Awards All Rights Reserved, Duke Medicine 2007 K-Awards All Rights Reserved, Duke Medicine 2007 K-Awards All Rights Reserved, Duke Medicine 2007 Grants.Duke • Opportunity • Check number against Grants.gov • Identifies available form packets • Checks title of opportunity All Rights Reserved, Duke Medicine 2007 PA-09040 K-Awards - Instructions • Applications are NEW unless resubmitting • Start date set by NIH – depends on submission cycle • Attach Introduction ONLY if you are resubmitting application - limited to 3 pages • Project Summary/Abstract – limited to 1 page • List of Referees – attach under Additional Attachments • Facilities – describe institutional facilities and resources available to candidate All Rights Reserved, Duke Medicine 2007 K-Awards - Biosketch Candidate’s Biographical Sketch • Biographical sketch limited to 4 pages • Position Title: “current” and “projected” position titles may be provided • Education – include month and year of degree conferred and professional certification within last 10 years • Personal Statement: Briefly describe why your experience and qualifications make you particularly well-suited to receive the K award for which you are applying. • Professional experience: begin with first position held and end with current position – Employment, Honors and professional societies/advisory committees • Publications – complete reference; if supported by NIH, provide the PMCID – visit the Medical Center Library http://www.mclibrary.duke.edu/ for guidance. • Research support – ongoing and complete, most relevant first, list title, dates, overall goals and responsibilities All Rights Reserved, Duke Medicine 2007 K-Awards - Mentors • Mentors are listed as Key – no effort required • Attached updated Biosketch for each mentor, co-mentor, or consultant (limited to 4 pages) • Attached Current and Pending Support for Mentors & Comentors – Modified version of Other Support; excludes overlap statement and level of effort, does not need to be comprehensive All Rights Reserved, Duke Medicine 2007 K-Awards - Budget Instructions • Only the candidate is listed in the budget • Identify effort committed to project – must be at least amount stated in FOA – Based on institutional effort • Only Current Institutional Base Salary is assigned – excludes VA and PDC salaries – If a change in salary is anticipated, Business Office must provide written authorization • Duke requires K Confirmation form (for competing submissions) and K TPE form (for competing or if changes since last non-competing) to be completed • http://research.som.duke.edu/research-administration/grantadministration/nih/k-award-resources All Rights Reserved, Duke Medicine 2007 K-Awards - Budget Instructions • Facilities & Administrative (indirect) costs are always 8% Modified Total Direct Cost (MTDC) • All other costs (Support personnel, Consultants, Equipment < $5000, Supplies, Travel, Other) grouped as Materials and Supplies. • Equipment =>$5,000, Pt. Care, tuition costs etc. will be entered into appropriate “Excluded Direct” category • Consortium costs will be entered into “Consortium/Subaward” category All Rights Reserved, Duke Medicine 2007 K-Awards - Budget justification Detailed description for specific items needed as part of the Research Development Support costs – Equipment – Supplies – Other personnel – Subcontracts – Tuition All Rights Reserved, Duke Medicine 2007 K-Awards - Special Instructions Project Summary/Abstract (Do not exceed 1 page): Include the candidate's immediate and long-term career goals, key elements of the research career development plan, and a description of the research project Facilities & Other Resources: Provide detailed description of the institutional facilities and resources available to the candidate. The information provided is of major importance in establishing the feasibility of the goals of the career development plan. Other Attachments: All mentored K applications must include a list of Referees. The list should include the name of the referee, departmental affiliation and institution. This same list is also provided in the Cover Letter. All Rights Reserved, Duke Medicine 2007 K-Awards - Cover Letter • Required for mentored K awards – must include the list of referees • Optional for independent K awards, however applicants are strongly encouraged to include this component • Cover letter is only for internal NIH use and will not be shared with peer reviewers. All Rights Reserved, Duke Medicine 2007 K-Awards - Proposal 12 page limitation (will allow up to 15 pages for white space) – – – – – Candidate’s background Career goals and objectives Career Development/Training activities during award period Training in the Responsible Conduct of Research Research Strategy Prepare as one document and split into separate PDFs to upload to Grants.Duke Caution: Exceeding Page limitation will prevent acceptance of application by NIH. All Rights Reserved, Duke Medicine 2007 For resubmissions only – 1 Page Limit Included in 12 PAGE LIMIT Background: additional information not described in Biosketch such as research or clinical training Career Goals: describe past scientific history, indicating how award fits into past and future research career development; justify award and how it will enable you to develop or expand your research career; include timeline Career Development: describe new enhanced research skills and knowledge you will acquire as a result of the proposed award; describe structured activities and course work; include percentage of time involved in each activity All Rights Reserved, Duke Medicine 2007 Training in the Responsible Conduct of Research – 1 Page Limit • Describe a plan to acquire training • No specific curriculum or formal requirements • Topics include – Conflict of interest – Responsible authorship – Research misconduct – Use of human and animal subjects – Data management and data-sharing Resources: Duke University Graduate School offers courses; Responsible Conduct of Research Course is offered by Trent Center for Bioethics; Duke University Clinical Research Training Program,… Plans and Statements of Mentor and Co-Mentor - required for specific FOAs - 6 Page Limit – Describe commitment to serve as mentor to other investigators – previous mentoring activities – Available pool of mentees All Rights Reserved, Duke Medicine 2007 6 Page Limit Statements of Support: to be completed by mentor, co-mentor, consultants, and contributors – all statements converted to ONE single pdf file. Plan for candidate’s training and research career development – Include developmental activities, such as seminars, scientific meetings, and presentations – Discuss expectations for publications over the entire project period – Define aspects of the research project the candidate will take with him/her to start their own program – Source of anticipated support for the candidate’s research project – Nature and extent of supervision and mentoring – Candidate’s anticipated teaching load, clinical responsibilities, committees and administrative assignments and the portion of time available for research for the period of the award – Plan for transitioning the candidate to independence – Mentor should describe previous experience as a mentor, number of mentees and career outcomes All Rights Reserved, Duke Medicine 2007 Description of Institutional Environment: 1 Page Limit – Document strong, well-established research program related to candidate’s area of interest – List key faculty members relevant to the candidate’s proposed developmental plan – Describe necessary facilities and other resources will be made available – Describe opportunities for intellectual interactions with other investigators – Describe courses offered, journal clubs, seminars, and presentations All Rights Reserved, Duke Medicine 2007 Institutional Commitment: 1 Page Limit Must be signed by Chair of sponsoring department – Use institutional letterhead – Describe commitment to candidate and candidate’s career development independent of the K award – State commitment to provide protected, adequate time to research and career development for the entire project period – Agree to release the candidate from other duties and activities to devote the required percentage of time for development of a research career and the continuation of salary should not be contingent upon the receipt of the award – State that equipment, facilities and resources necessary for the structured research career development experience, including appropriate office and laboratory space and access to clinical and research populations – State commitment for retention, development and advancement of the candidate during period award All Rights Reserved, Duke Medicine 2007 Excluded from page limit INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Excluded from page limit Abstract: limited to 1 page Project Narrative: Relevance statement – 2 to 3 sentences describing the relevance of the research to public health; use plain language that can be understood by lay audience Bibliography: any reference cited in proposal, included full reference and PMCID numbers -visit the Medical Center Library http://www.mclibrary.duke.edu/ for guidance. All Rights Reserved, Duke Medicine 2007 Excluded from page limit INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Excluded from page limit Specific Aims: broad, long-term objectives and the goal of the specific research proposed – recommended 1 page Background and Significance: Briefly sketch background leading to application, critically evaluate existing knowledge, and identify gaps project will fill… Preliminary Studies/Progress Report: Describe candidate’s studies pertinent to application… Research Design & Methods: Describe research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project... All Rights Reserved, Duke Medicine 2007 Excluded from page limit INCLUDED IN 12 PAGE LIMIT + 1 PAGE FOR SPECIFIC AIMS Excluded from page limit Inclusion Enrollment Report: renewal applications involving human subjects Progress Report Publication List: renewal application publications All Rights Reserved, Duke Medicine 2007 List Referees in cover letter List Referees here Attach files as need All Rights Reserved, Duke Medicine 2007 Attach files as needed All Rights Reserved, Duke Medicine 2007 Grants.Duke • Check • Limited validation • Errors must be corrected • Warnings should be evaluated carefully to determine if corrections are necessary All Rights Reserved, Duke Medicine 2007 Grants.Duke • Check continued • Quick review of sections (PDFs) that have been attached All Rights Reserved, Duke Medicine 2007 Grants.Duke • Print Preview • SF 424 R&R forms similar to NIH Commons • Save PDF copy on local drive • Count lines and pages for sections • Check formatting All Rights Reserved, Duke Medicine 2007 System-to-System via Grants.Duke • Complete SPS and route for approval – ORA will review and approve administrative sections – ORA will set status to Awaiting Submission • Complete Grants.Duke – – – – Upload all required files in PDF Check application for errors PI must Release application for submission Releasing on due date jeopardizes successful transmission to NIH • Grants.Duke will electronically submit proposal to Grants.gov – Track application status via Grants.Duke All Rights Reserved, Duke Medicine 2007 Grants.Duke • Release • Validation check • Combined with administrative and budget information in SPS • Streamed via xml to Grants.gov All Rights Reserved, Duke Medicine 2007 Grants.Duke • Assurances • PI must sign • NIH requires unique signature and date for each application • Generates a SnapShot of application All Rights Reserved, Duke Medicine 2007 Grants.Duke • Receipt from Grants.gov • Provides time and date of acceptance • Provides Grant Number assigned to application All Rights Reserved, Duke Medicine 2007 Submission Tracking Status All Rights Reserved, Duke Medicine 2007 Email Notifications • Grants.gov – sends emails to the Institution Signing Official – generate a Grants Tracking Number • eRA Commons – Sends emails to the Institution SO and the PI • Validations Complete/Check Assembled Application = application received • ACTION REQUIRED TO CONTINUE NIH GRANT APPLICATION SUBMISSION = application with errors All Rights Reserved, Duke Medicine 2007 Timeline • Complete SPS proposals must be routed to ORA seven (7) business days prior to deadline • Grants.gov may take up to 2 days to validate proposal If errors, application will be rejected. Make corrections and resubmit • eRA Commons may take up to 1 day to validate If errors, application will be rejected Make corrections and resubmit Reminder: Releasing on due date jeopardizes successful transmission to NIH. All Rights Reserved, Duke Medicine 2007 NIH Errors – NO application generated • Notify ORA to reset application • Correct errors • Notify ORA corrections are complete • Resubmit – release science in Grants.Duke • If after deadline, include cover letter explaining why application is late – will be considered under NIH’s late policy All Rights Reserved, Duke Medicine 2007 Validate Proposal on eRA Commons • Check submission status in eRA Commons • Check Assembled Application – If the application is acceptable, no further action is necessary. Will route to Center for Scientific Review within 2 days. – If the application does not correctly reflect the submitted application -- some part of the application was lost during the submission process or did not transfer correctly – application must be “rejected” by SO. PI will need to send an email to Grants Specialist or Director in ORA to “reject”. – PI will correct and resubmit All Rights Reserved, Duke Medicine 2007 Advice Read and follow all application instructions for the specific agency – Start early Reminder: Releasing on due date jeopardizes successful transmission to NIH. ALL files must be in PDF NO headers or footers: do not use the NIH PI name headers and page numbers MAINTAIN appropriate fonts, type size and line spacing MAINTAIN .5" margins on all sides: when converting from Word to PDF, make sure settings are NOT set to "fit to page"; this function reduces the text size below the acceptable NIH size NIH recommends completing all the science in one document then breaking it into the individual PDFs: follow page limits set by the mechanism. When separated, white space can add up to 3 pages: for example; the R21 limit is 15 pages, when separated, it should NOT be more than 18 pages All Rights Reserved, Duke Medicine 2007 Word and PDF help • • • • In Word, set Orphans and Widows = ON In Word, use tables to insert graphics and photos Make sure graphs and pictures do not extend into margin For changed text in resubmission, make sure line is within margin • To convert forms, open document, click Print, select Adobe PDF, and Print – this should flatten the file and remove form fields • Select page size as 8.5” x 11” • Size of pdf/application <40 mg All Rights Reserved, Duke Medicine 2007 Special Instructions for Individuals with Multiple Research Appointments • When an individual holds multiple appointments involving support for research activities, information from each appointment must be included. • List each appointment separately and include enough information on the type of appointment; (e.g., full time academic or 3/8 VA) so that an assessment of an individual’s commitment can be made. • Current (not older than one year), approved MOU (Memorandum of Understanding) must be on file with ORA Prior to submission. All Rights Reserved, Duke Medicine 2007 Help at Duke • Departmental Business Office • Office of Research Administration 684-5175 • DHTS Help Desk 684-2243 Request the RAD On Call person be paged • For NetID user names and NetID passwords contact DHTS Help Desk 684-2243 All Rights Reserved, Duke Medicine 2007 References • NIH Application Guide – Section 7 - Preparing an Individual Research Career Development Award (CDA) Application (“K” Series) – http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ad obe_VerC.pdf • ORA Website – K Award Resources – http://research.som.duke.edu/research-administration/grantadministration/nih/k-award-resources • NIH Page Limits – http://grants.nih.gov/grants/forms_page_limits.htm All Rights Reserved, Duke Medicine 2007 Questions?