1. Sponsored Programs Administration Pre- Award Training October, 2005

2. Why are we here? Learn more about what goes on the grant admin world Get some tips and tools on how better to do our jobs Understand who I need to work with at SPA, when and how

3. Specific Tasks How do we manage the proposal process? How do I find a sponsor? How should we construct our budgets? What do I need to do once we receive an award?

4. The SPA Office Organizational chart Realignment of resources Director for Pre-Award Services – Carole Bach Director of Research Admin – Marlene Erno (Institutional Support) and Gail Ryan (Operations)

5. Other Presenters Vance Briceland, Information Officer Gail Ryan, Director of Post-Award Services and friends Post Award Presenters

8. What is SPA’s mission? Ensure consistency, reasonableness, allocability and compliance with institutional and agency policies Protect integrity of institution in its management of sponsored programs Provide the fiduciary review and management (Stewardship) of sponsor’s funds

9. Definitions Reasonableness Nature of goods or services acquired reflect the action that a prudent person would have taken under the same exact circumstances The expense is necessary for the grant’s performance, the recipient followed organizational policies Acted with due prudence in carrying out their responsibilities

10. Definitions Allocability Cost incurred solely for purposes of the grant Expense is clearly identified with the project Conformance Reasonable and Necessary In conformance with limitations/exclusions Consistency Treated in the same manner across all proposals and awards

11. What is College/Dept’s role? Proper Budgeting Development and Management Adhere and ensure compliance with unit’s policies Provide day-to-day management of sponsor funds Provide first line of support and communication to faculty and program staff

12. The Grant Life Cycle From when faculty has idea until the final report has been submitted … and, then some Extremely variable in timeframe, process, requirements Need to pay attention at all stages

13. Where do ideas come from? The “When I was a child …” model The “I had a family member …” model The “I had a college professor …” model Why is this important? – The passion of researcher

14. Find the money! There are many sources for money Identifying the right match(es) for their work Role of Vance Briceland – Information Officer

15. Sponsor Missions Governmental Sponsors exist to fulfill legislated or mandated goals Foundation fund projects which support initiative identified in their charters Not-for Profits support special purposes, e.g American Cancer Society, etc

16. When do we submit? RFP’s, RFA’s and Program announcements Regular scheduled cycles – NIH, foundations, organizations As part of larger proposal – “we, the subcontractor” Proposals with no deadlines Pre-Proposals

17. How long does it take to build a proposal? Should the question be “how long should it take?” Break proposal into manageable components Manage each piece individually Allow time for adequate reviews (internal and external) The answer - ????

18. Am I in the game? Acknowledgement from sponsor Assignment to study section (NIH) Peer review by sponsor 3  6  9 months Did I really get an answer? Positive feedback vs. award The tentative process

19. Receiving Award Needs to be handled by SPA Pre-Award SPA Starts wheels turning Need to begin communication with college/departments Need to make sure there is a proposal and it matches the award

20. Award activation The award has been accepted by the PI The award has been accepted by WSU SPA started the process: Do we have all the “right” pieces Does it need a new index? Established on BANNER SPA has executed a subcontract

21. Award Life Cycle for SPA Monitor the award from budgetary perspective Pay subcontractor, monitor invoices Manage revenue: Create invoices Make LOC draws Account receivable follow-up Track other award conditions – reporting, etc.

22. More Award Life Cycle for SPA Financial Close-out: Final invoice or FSR Indirect Cost reconciliation Other close out activities: Intellectual property Fixed Asset/Property

23. Award Life Cycle for Dept Complete the project Submit non-financial progress reports Monitor budget activities Timely Personnel charges Setting up blank orders or PO’s Appropriateness of charges

24. The Standard Proposal Components Agency Info Administrative Info Personnel and Subcontractors Facilities and Resources Budget Protocols (Human Subjects, Animals) The Science and Abstract

25. Agency Information Who is the sponsor of the work? Who is the prime sponsor of the work? Is this a subcontract? Is the proposal in response to an RFP or program announcement? Who is the Principal Investigator and what role do the play

26. Administrative Components What is title of program? And, in how many characters may I use to create the title? Where does it need to be sent? When is this proposal due? How many copies and in what format? How much $$ can we ask for? What is allowed what isn’t? What type of work is being proposed: Research Instruction Other Sponsored Activity Student Service Clinical Trials Fellowship

27. The Standard Proposal Components Agency Info Administrative Info Personnel and Subcontractors Facilities and Resources Budget Protocols (Human Subjects, Animals) The Science and Abstract

28. Personnel, Consultants & Subcontractors Need to identify all WSU employees that will be involved on project Can use named and unnamed individuals Identify role for each individual – PI, Research Asst. etc Identify level of effort for each individual Any intent to cost share any effort? Is there a requirement?

29. Am I a consultant or employee? No WSU employee should be noted as a consultant or subcontractor IRS has specific rules as to who is consultant and who is employee Do not confuse with the legal mechanism by which we pay to drive role definition If person controls work arrangement, they are a consultant

30. Are they a consultant or a subcontractor? Are they providing a service beyond expertise, creation of item to be analyzed? Are they supplying their own facilities and resources? Are they part of an organization that does task as part of their normal business? If these are true = subcontractor

31. What do we need from subcontractor? A proposal – nice but we won’t get one Statement of work to be included/merged into science Proposed budget for work they are proposing Statement of intent to subcontract

32. Effort Allocations for Personnel Identify each person’s expected level of effort for project Identify the time period for level of effort, be specific to their appointment type For academic appt, break into AY (9 months) and Summer (3 months) For fiscal year appointment, use 12 month period

33. Calculating Effort Effort the same over 12 months = % Effort Effort different for academic year & summer =(% Effort for academic year x 9 + % effort for summer month x # summer months)/12 Calculation 12 month = % Effort * 12 month salary or 9 month salary x 1.33 Two line entry for 9 month & Summer

34. The Standard Proposal Components Agency Info Administrative Info Personnel and Subcontractors Facilities and Resources Budget Protocols (Human Subjects, Animals) The Science and Abstract

35. Facilities and Resources Where will the majority of the work take place? Bldg and room Will there be any need to modify/renovate any of this space? Will there be any work completed at off- campus facilities? How much? Will there be any specialized WSU facilities or Service Center used to conduct of work? If so, to what extent would they be used?

36. Developing the Budget Step 1 – Review Sponsor/Program Guidelines What restrictions are invoked? Any cost sharing requirement? Ask SPA Step 2 – Finalize Personnel Component Is there a salary cap? Current salary cap for NIH is $180,100 Convert effort to dollars Apply applicable fringe benefit rates for staff Add amounts for any consultants

37. Developing the Budget Step 3 – Finalize Subcontract Component Identify direct vs. indirect portions of budget 8% F & A Costs allowed for International subcontractors on NIH Add total budget for subcontractors as direct costs in your proposal Step 4 – Finalize Travel Component Identify any planned trips Identify foreign vs. domestic Estimate cost of each trip, including actual travel, lodging, meals/per diem, registration Follow WSU Travel Policies

38. Developing the Budget Step 5 – Finalize Equipment What is equipment? $5,000 or more and a useful life of more than 2 years by WSU policy Does Sponsor have rules? Step 6 – Supplies Tangible Property Supplies for labs, equipment less than $5,000 Step 7 – Patient Care Costs Inpatient Costs Outpatient costs, some of which get billed to 3 rd party payers, must be Medicare rate for federal government Services able to be purchased with purchase requisition are not patient care costs

39. Developing the Budget Step 8 – Other Costs Other services Unique project needs Non-Tangible items needed for the project but you can’t see, touch or store it. Step 9 – Participant Costs For training programs outside of WSU courses Travel and subsistence Considered other costs

40. Developing the Budget Step 10 – Training Costs for Training Grants Only Tuition and Stipends for trainees Stipends set by grantor Institutional allowances – used for travel and other allowable costs, i.e. health insurance Not Employees

41. Cost Sharing on Grants Whenever we have a legitimate cost for which the sponsor doesn’t pay, we have cost sharing Cost sharing is a real cost to the University Therefore, as good business people, we should minimize cost sharing

42. Cost Sharing on Grants Cost sharing may be mandated by sponsor/program guidelines When cost sharing is mandatory, we should be careful to meet, not exceed, the requirement Construct a full budget, then determine what should be cost shared

43. Cost Sharing Types Mandatory – When agency states in their guidelines that the University must contribute funds to the project Cash match – University Expenses 3 rd Party – Cost sharing commitment met by someone else outside the University Voluntary – When the PI includes items in the budget that are not reimbursed by the grant Salary cap is considered voluntary –These include NIH’s current salary cap as well as some private agencies that have there own salary caps

44. Budget Justifications Justifies WHY they need the funding requesting Should relate back to the work outlined in the technical proposal Make sure justification matches budget as related to % effort, itemization of costs At the proposal stage: WSU requires the justification required by the agency

45. Indirect Costs Really, they aren’t all that bad Reimbursement for costs unable to be allocated to individual project Utilities, building/equipment depreciation Administrative costs – central and department

46. Indirect Costs (Facilities and Administrative F & A) Rates are structured by activity and location Current rates: on-campus off-campus Research 50.5%* 26%* Instructional 50.5% * 26%* Other 40.0%* 26%* Clinical Trials 26%* * based on Modified Total Direct Costs

47. What is MTDC? There are certain items that are excluded from Facilities & Administrative charges They are Rent, equipment, tuition, patient care costs, stipends, scholarships and the amount of the subcontract over $25,000 By subtracting these items from the total direct costs you arrive at Modified Total Direct Costs which is used to calculate F&A amount

49. Indirect Costs Rate Application Indirect Cost Rates can be set by Program Activity Normally, Federal pays full load for Research Normally, State and local government pay reduced rates Normally, industry should pay full load Normally, foundations pay reduced rate

50. Indirect Costs Waivers vs. Reductions A sponsor may restrict the level of indirect cost we can recover When sponsor mandated, this is reduction Sometimes, we “offer/propose” a reduced rate This is a waiver

51. Indirect Costs The Good Part A portion of the indirect cost collected is directly returned to the PI, Dept, College Current rate of return: PI – 7% Dept – 11.5% College – 7.5% Enforcement of waiver penalty already in place

52. Indirect Reductions If Agency only allows a reduced indirect costs, you should increase direct costs by: Including items normally covered by indirect costs, i.e. secretarial support, office supplies and computer supplies Acceptable unless written otherwise in Agency Guidelines

53. INDIRECT WAIVERS In the waiver situation; We will follow Executive Order 86-2: The General fund piece (54%) and the Research Facilities Fund piece (7%) and OVPR Operations piece (3%) of the indirect cost will be paid from indirect cost of PI/Department or College Actually amount will be calculated on actual expenses on a yearly basis or the end of the grant which ever comes first This will be done by JV from the designated account

54. The Standard Proposal Components Agency Info Administrative Info Personnel and Subcontractors Facilities and Resources Budget Protocols (Human Subjects, Animals) The Science and Abstract

55. Compliance Issues Internal Review Board (IRB) For Human and Animal Research Protocols HIC (Human Investigation Committee) 4 IRBS, 2 – Medicine, 1- Pediatric, 1- Behavioral AIC (Animal Investigation Committee) 1 IRB Research Protocols – set of documents submitted to one of the IRBs for approval to use either humans or animals in a specific research project

56. PROTOCOLS IRB Approval must match the funding agency and the title of the related grant proposal or award 1 project – 1 protocol 1 project – Multiple protocols Multiple projects – 1 protocol

57. When to Submit HIC Protocol Agency Dependent Part of “Just in Time Processing” of NIH Grant Application process Can be submitted at any time after the grant application has been submitted Recommendation: At the time that the PI has received a favorable priority score

58. When to Submit AIC Protocol Agency Dependent Part of “Just in Time Processing” of NIH Grant Application process Can be submitted at any time after the grant application has been submitted Recommendation: At the time that the PI has received a favorable priority score

59. Human Research Participants On-Line Training Program Implemented October 1, 2000 Mandated for all Key Personnel on NIH Awards All people listed on page 2 of the application must complete Key Investigators who do not come in contract with human participants still must complete the training program HIC training is now mandated for all investigators and key personnel prior to IRB approval is granted

60. On-Line Training Program Mandatory Modules Basics of Research History & Ethical Foundation of Biomedical Research Compliance with WSU Continuum of Approval Obtaining Informed consent Roles and Responsibilities Web site: www.hic.wayne.edu

61. On-Line Training Program Each Module can be taken individually After Each person has completed the mandatory modules, they receive an email from the Office of the Vice President about completing the training program SPA can verify that the training is complete via the database

62. Certification of Training NIH requires a Certification of Training on all new awards for all key personnel If a key personnel is international or does not work for a University in the United States they must take the WSU training If a key personnel is at another University in the US; we must have documentation that the training was completed at the other institution (this is submitted to NIH)

63. Certification of Training Certification of Training only needs to be done on Non Competing Application if a key personnel changes or is added The documentation needs are the same Certification requires a Pre-Award Signature and must be submitted before NIH will make the award

64. AIC Training Effective January 1, 2003 all investigators and key personnel on AIC protocols must take the AIC on-line training course before protocol approval is given There is no sponsor mandate at this time to document the training

65. AIC Training Modules 1. History & Background of Ethics in Animal Subject Research 2. Maintaining Public Trust 3. Federal Regulations and Regulatory and Accreditation Agencies 4. Roles and Responsibilities of Players in the Research Process 5. The Process of Using Animals in Research 6. The Continuum of Approval

66. IRB and Account Numbers In order to get an account number established the following must be correct: If applicable, the HIC Training must been completed by all KEY personnel IRB approval must be approved and valid AIC approvals are good for 3 years HIC approvals are good for 1 year

67. Completing The FES Summarizes the data for ease in review Completes certifications by PI and other key personnel Make sure compliance issues have been addressed in the areas of: Conflict of interest Compliance training HIC/AIC Approval Identifies cost sharing commitments Provides for endorsement of department (s) / colleges (s) Form for External Support

68. Activity Types Research – Proposals/Awards associated with investigation, analysis and discover ; the nature of which is scientific mechanical or similar Student Services – Proposals/Awards associated with support of special student programs, i.e. Upward Bound Instruction – Proposals/Awards associated with instructional and degree activities of the institution; includes development as well as delivery of course information; includes training activities of health professionals

69. Activity Types Fellowship – Proposals/Awards associated with the awarding of funds to named individuals to further their professional education/training Clinical Trials – Proposals/Awards associated with investigational components of drug discovery utilizing human subjects; does not include activity prior to the introduction of humans subjects Other Sponsored Activity – Proposals/Awards associated with activities not falling under other categories; 1)conferences, symposia and workshops; 2)preservation/maintenance of collection or archives; 3) individual travel awards; and 4) general support to the university

70. Completing The FES What did I agree to? As chair: you support the PI in these efforts; you acknowledge the scientific merit of the proposal you agree to supply resources as noted As dean: you support the PI in these efforts; you agree to supply resources as noted

71. Completing The FES What resources did I agree to? As chair/dean: Any cost sharing (dollars) resources Space to complete tasks Any required renovation to space Any other “noted” commitment

72. Completing The FES Signatures of all parties Co-PI’s and associated chair and deans SPA  back to PI for submission

73. Copy and Submit Make appropriate copies Get package ready ….. Is it US Mail or shipper? Submit!!

74. The submission process What, Where, When and How What – are the requirements for Institutional Approval Where – mailing address vs. shipping (FedEx) address When – is there a deadline? 3:00 at sponsor’s office; postmark vs. receipt How – Electronic vs. hard copy, how many copies

75. Award Acceptance Always Handled by SPA Can be a bottleneck if the award is not sent to us directly Simple grant document – award from NIH Complex contract – work with industry Review of terms and conditions to ensure compliance with institutional policies Signatures – PI, institutional official

76. Negotiating Awards Handled by SPA Informal vs. formal Budget changes/modifications Date changes Work with PI to refine scope (if necessary) Do we ever reject?

77. Who Signs? Grants vs. contracts Institutional Official – SPA Pre-Award Director or AVP Financial Official – SPA Post Award Director or AVP Maybe PI

78. Award Acceptance Standard Terms and Conditions Publication Rights Title to Inventions Indemnification Insurance Is the agreement acceptable?

79. Award Acceptance When does Pre become Post? Somewhere in the acceptance process Do we have detail budget that matches? Do we have all the pieces we need? FES A copy of the proposal sent to the agency Detail budget justification IRB Approval Internal Tentative

80. The tentative process If award is pending, but no document received – FAR Form Required If award is pending, but we have received Award document – Internal Tentative What is the real potential of the award? What is the risk to WSU? To determine the proper tentative see attached documents