1. Large and Complex Proposals: Making a Commitment to Achieve the Rewards Diane M. Meyer, Iowa State University Jerry Weinberg, Southern Illinois University - Edwardsville Nicole Nichols, Washington University – St. Louis

2. Intro Three Phases of Proposal Development Who are the Players in Proposal Development? Faculty Perspective Pre-Award Specialist (DRA) Role NIH-specific Topics

3. Three Phases of Proposal Development Phase 1: Framing Phase 2: Collaboration Phase 3: Refinement “Averting the Big Bang”, K. Dressler, L. Mulfinger, & N. Page; NCURA Magazine, March/April 2013

4. Who are the Players in Proposal Development? Principal Investigator (PI) needs to be supportive of the timeline. Ultimately controls the process, but relies on key players to complete tasks and stay on the timeline. Advocate (AV) needs to be identified by University and PI, perhaps an institutional administrator (i.e. Research Dean, Institute Director, Department Head) University “Averting the Big Bang”, K. Dressler, L. Mulfinger, & N. Page; NCURA Magazine, March/April 2013

5. Who are the Players in Proposal Development? Development Specialist (DV) is typically a Masters or PhD-level professional who serve as catalysts in the proposal process and participates in writing/editing Pre-Award Specialist (DRA) assists w/compliance, budget and administrative functions. May have university authority for proposal submission. “Averting the Big Bang”, K. Dressler, L. Mulfinger, & N. Page; NCURA Magazine, March/April 2013

6. Faculty Perspective: OMG! The hyper-complexity of large proposals is daunting, overwhelming, discouraging – Particularly for faculty have never been a part of a large grant – Where do I start? Particularly if the proposal is being “encouraged” by the Dean How do I find the right collaborators? Getting the right collaborators to “buy-in” just to the idea of submitting a proposal? – They will be daunted, overwhelmed, and discouraged too.

7. Faculty Perspective: OMG! – How to handle multiple units, multiple institutions Overcoming differing policies, needing myriad approvals, agreements to commitments of effort and resources – How can I figure out this incredibly complex budget? Sub-awards, salaries, participant costs, external evaluators – The proposal is asking for all sorts of institutional or regional data! where in the world does that come from?

8. Teamwork a.k.a. Compromise

9. Faculty Perspective: OMG! – How do I manage multiple authors? How do I get it to read like one proposal and not a patch work of thoughts and ideas – How does this all happen in the short time period between now and the submission deadline?

10. Helpful Tips – Identify potential collaborators Many ways to do this – I typically network through the Associate Deans – Have “kick-off” meeting – I, as the APR, typically contact the individuals first to lend to the importance of the meeting – I have my SPO staff handle the logistics of arranging the meeting Be sure there is a “can-do” person at the meeting – Preferably a faculty member who has been through a large grant before. » Typically it is me (APR), the Associate Dean for Research, or a research director Have a pre-award specialist who will be assigned to help and follow the progress.

11. Helpful Tips – The kick-off meeting Brainstorm initial ideas Re-assure faculty that there are solutions to hurdles even though they might not be readily apparent Emphasize the importance of the grant to the institution Re-assure faculty that your institution can put in a competitive grant – Identify potential multi-institutional partners if necessary Important things to conclude at the meeting – Identify the faculty member who is taking the lead – Offer help to answer difficult questions or make new contacts – Identify what information to gather or ideas to discuss with others by next meeting – Determine a high-level time-line

12. Helpful-tips – Have pre-award specialist follow-up Attend meetings when possible – Pre-award specialist provides project management principles Develop a detailed time line of proposal development Identify who is responsible for specific areas Set a schedule of meetings Support necessary document sharing

13. Take a deep breath and have some fun with it…

14. Pre-Award Specialist (DRA) Role – Phase 1 – Read the Guidelines Deadlines Budget – what’s allowable, cap, IDC limits, what’s required Type of award – Contract, Grant, Cooperative Agreement, other – Develop a Proposal Outline – Develop a Timeline Writing assignments Internal deadlines Meetings – this may include face-to-face as well as virtual meetings (conference calls, web conferencing)

15. Pre-Award Specialist (DRA) Role – Phase 1 – Identify resources for complex administrative issues Compliance Confidentiality/Non-Disclosure Agreements Intellectual Property Financial/Other Conflict of Interest Space Administrative support Broader Impacts Data management

16. Pre-Award Specialist (DRA) Role – Phase 1 – Download or Create Forms & Templates from sponsor or to meet institutional requirements – Develop the Draft Budget, Begin discussions with Advocate concerning Cost Share requirements Identify external partners (PI’s and DRA’s) – Notify Sponsored Research Office

17. Pre-Award Specialist (DRA) Role – Phase 2 – Review the Guidelines – Refine the Budget, including Cost Share if required – Request, Review, and Assemble Biosketches Current & Pending Support Conflict of Interest – Letters of Support, Commitment (internal and external)

18. Pre-Award Specialist (DRA) Role – Phase 2 – Assist with assembly of draft text – Editing – Attend meetings with the team – Stay in touch with the proposal leaders

19. Pre-Award Specialist (DRA) Role – Phase 3 – Review the Guidelines – Finalize the Budget, justification, cost share, and third party participation – Assure that the University approval process is completed prior to the deadline – Assist with assembly and submission of proposal, including uploading of files, email, or shipping – Requirements immediately after submission

20. “procrastination by team members early in the process leads to long work days in the last week and increases the likelihood of errors and missed opportunities in the application.” Dressler, Mulfinger, & Page

21. NIH Large Complex submissions Multi-project applications are the last remaining paper submissions. – They are often large projects or centers Contain an umbrella applications describing the overall effort Contain the equivalent of a full application for each subproject – They can vary in size (2-200+ components) – They an have a large number of key personnel

22. CURRENT SUBMISSION PROCESS 1 – Application is developed electronically 2 – Printed 3 – Mailed to NIH 4 – Data is manually inputted to set record in eRA Commons 5 – Paper application gets scanned and put in grant folder

23. NIH Several types of Large Complex Grants P01 – Research Program Project Grants P20 – Exploratory Grants P50 – Specialized Center Grants R24 – Resource-Related Research Projects U24 – Resource-Related Cooperative Agreements U19 – Research Program Cooperative Agreements

24. More Large Complex NIH grants G12 – Research Centers in Minority institutions Award P30 – Center Core Grants P40 – Animal Model, and Animal and Biological Material Resource Grants P41 – Biotechnology Resource Grants P42 – Hazardous Substances Basic Research Grants P51 – Primate Research Center Grants P60 – Comprehensive Center R28 – Resource Related Research Projects

25. And yet more NIH Large Complex Grants U10 – Cooperative Clinical Research U41 – Biotechnology Resource Cooperative Agreements U42 – Animal Model and Animal and Biological Materials Cooperative Agreements U45 – Hazardous Waste Worker Health and Safety Training Cooperative Agreements U56 – Exploratory Grants Cooperative Agreements UC7 – National Biocontainment Laboratory Operation Cooperative Agreement UM1 – Research Project with Complex Structure Cooperative Agreement U54 – Specialized Center Cooperative Agreements

26. List of all activity codes for NIH grants with descriptions: http://grants.nih.gov/grants/funding/ac_search_results.htm

27. A S S I S T Application Submission System & Interface for Submission Tracking

28. NIH ASSIST – new electronic submission program for Multi-project grant submissions – Application Submission System and Interface for Submission Tracking – The first FOA to use ASSIST has been announced (P42) – Some multi-projects will use ASSIST as of Sept 2013 (P01, P20, P50, R24, U24, U19) – Remaining multi-project submissions will have to use ASSIST as of Jan 2014 (except U54 & UM1 – May 2014)

29. Please note – the structure of NIH’s multi-project applications cannot be accommodated by the Grants.gov downloadable forms. The ASSIST system is a separate web-based submission system that works in conjunction with Grants.gov NIH Notice regarding ASSIST: http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 12-161.html

30. Once an activity code transitions to ASSIST, ALL applications (new, resubmission, renewal and revision) to an FOA for that code MUST be submitted electronically. – Reminder – September 25, 2013 is go date for P01, P20, P50, R24, U24, U19 – If you have one of these projects due on or after September 25 th, you should begin using ASSIST NOW

31. Electronic Submission of Project Applications Using ASSIST All ASSIST users must have eRA Commons credentials with one of the following roles: – Signing Official (SO) – Administrative Official (AO) – Principal Investigator (PI) – Assistant (ASST) – Account Administrator (AA)

32. Find Plan Initiate Build Team Enter Data Finalize Submit Track Find Opportunity Initiate application and create the application shell Enter application data for all components Submit your application through Grants.gov to NIH Get familiar with the process and create an application plan Define your team and provide application access Finalize components and prepare your application for submission Track status and view final application image

33. Find Multi-Project FOA’s in NIH Guide for Grants & Contracts Grants.gov Find

34. The FOA will link you to the ASSIST system NIH Guide for Grants & Contracts Grants.gov ‘Apply’

35. The SF424 (R&R) Application Guide provides general instructions for completing application forms. Section IV. Application and Submission Information of NIH FOAs includes important guidance for preparing your application in ASSIST.

36. Agency-specific instructions are marked with the HHS logo. When instructions in the Application Guide conflict with instructions in the FOA, the FOA wins. Just a reminder…

37. All electronic multi-project applications will include: A single Overall component – Provides overview of entire application A number of additional components – Component types allowed will vary by opportunity – Announcements will clearly indicate the types of components expected in a responsive application Automatically prepared data summaries – Compiled from information included in components – Helps reviewers and staff work with the applications

38. How will your application image will be assembled by NIH? – The Overall component is presented first Including system-generated data summaries – Additional component types are presented in alphabetical order (e.g., Cores before Projects) Components of the same type are grouped together and presented in the order created in ASSIST Components are identified by type and sequential number (e.g., Core-001, Core-002)

39. Sample excerpt from FOA (section IV)

40. Determine the order you want the components to appear in the final application image Create the application shell by initiating the application and adding the components in the appropriate order

41. ASSIST automatically provides application access to some individuals based on their Commons roles or role on the application –All SOs and AOs at the applicant institution have edit access for the entire application –All PD/PIs listed on the Overall application have edit access for the entire application –The Project Leads have edit access for their components –The person that initiates the application has edit access for the entire application

42. SOs at the applicant institution can – Manage application access for other users – Manage application status all the way to Ready for Submission status – Access the Submit action

43. Enter the data – ASSIST screen tips Found at the top of many data entry screens – Annotated form sets http://grants.nih.gov/grants/ElectronicReceipt/commu nication.htm#forms http://grants.nih.gov/grants/ElectronicReceipt/commu nication.htm#forms – Ten Checks to Help Avoid Common Errors http://grants.nih.gov/grants/ElectronicReceipt/avoiding _errors.htm#10checks http://grants.nih.gov/grants/ElectronicReceipt/avoiding _errors.htm#10checks

44. As component data is entered several actions are available: – Validate Component – Preview Current Component – Update Component Status Work In Progress – only status that allows editing Complete – component data entry is complete Final – component has been reviewed by applicant organization and incorporated into the application

45. Errors stop application processing and must be corrected before the deadline Warnings do not stop application submission and are corrected at the discretion of the applicant before the deadline Check out this resource: http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm http://grants.nih.gov/grants/ElectronicReceipt/avoiding_errors.htm

46. As components are marked ‘Complete’, the applicant organization can preview them and incorporate those that are ready into the final application by updating the component status to ‘Final’. All components must be marked ‘Final’ before an application can be prepared for submission.

47. Application Status Flow Work In Progress – Allows editing All Components Final – Can only be updated once each component status is Final; must Validate Application to move to next status All Components Validated – Automatically set once Application Validation is error-free Ready for Submission – Should be set after all internal reviews have taken place Submitted – Automatically set after submitting to Grants.gov

48. Error-free submission must be made by 5:00 p.m. local time (of submitting organization) on due date – It takes time to prepare your application for submission – Submit early (days, not minutes) to have time to address any unforeseen issues and to view your application image in Commons

49. Only a Signing Official (SO) for the Lead Organization who is an Authorized Organizational Representative (AOR) can submit an application. Applications are submitted from ASSIST to Grants.gov.

50. ASSIST sends out quite a few email notifications throughout the preparation and submission process to help you track your application –Application access changes –Component/application updates –Component/application status changes –Submission status updates Check out this resource: http://grants.nih.gov/grants/electronicreceipt/files/ASSIST_eNotifications.pdf http://grants.nih.gov/grants/electronicreceipt/files/ASSIST_eNotifications.pdf

51. Applicants have two (2) business days to view the assembled application image in Commons before it automatically moves forward to NIH staff for further processing SO can Reject application in Commons within viewing window and submit a Changed/Corrected application prior to the due date If you can’t VIEW it, NIH can’t REVIEW it!

52. If no action is taken to reject the application during the two business day viewing window, the application automatically moves forward to NIH for further processing.

53. ASSIST: public.era.nih.gov/assist public.era.nih.gov/assist Online help: era.nih.gov/erahelp/ASSIST/ era.nih.gov/erahelp/ASSIST/ Applying Electronically Website for Multi-project Applications: grants.nih.gov/grants/ElectronicReceipt/com_index.htm grants.nih.gov/grants/ElectronicReceipt/com_index.htm Webinar for Applicants: – grants.nih.gov/grants/webinar_docs/webinar_20121213.htm grants.nih.gov/grants/webinar_docs/webinar_20121213.htm Annotated form set: grants.nih.gov/grants/ElectronicReceipt/files/annotated_multi-project.pdf grants.nih.gov/grants/ElectronicReceipt/files/annotated_multi-project.pdf

54. Summary Large and Complex Proposals can be submitted smoothly if the team is assembled early, roles and responsibilities are clearly defined, and everyone works together with a Commitment to Achieve the Rewards!

55. Thank You! Diane Meyer, meyerd@iastate.edumeyerd@iastate.edu Jerry Weinberg, jweinbe@siue.edujweinbe@siue.edu Nicole Nichols, nnichols@dom.wustl.edunnichols@dom.wustl.edu