Preparing Industry Proposals and Budgets

1. Preparing Industry Proposals and Budgets Scott Davis, CRA Associate Director, Office of Research Administration University of Oklahoma Health Sciences Center Debbie Newton, CRA Director of Research and Sponsored Programs The University of Tulsa

2. Research Type • Industry funded research • Pfizer, GlaxoSmithKline, etc. • Private funded research • American Heart, Komen, etc. • No direct Federal Funding

3. Will not be discussing • Contract Language • Clinical Trials

5. Definitions • CDA /NDA = Confidentiality Disclosure Agreement • CRA = Clinical Research Agreement • IDC / F&A / Overhead = Indirect costs • IDC Waiver = Administrative approval to accept a reduced rate of IDC lower than Federal Rate • IP = Intellectual Property • ORA = Office of Research Administration/ Central Research Office • PI = Principal Investigator • SOW = Statement of Work

7. Know Your PI • Under Pressure • Funding • Publishing • Entrepreneurial • Do Policy, Regulations and Rules Apply? • Unless there is a problem • Refer to Case Study • Start-up company involved?

8. Know Your Sponsor • PI Expertise • University • Cost at Minimum • Own IP • Indirect Costs • Results Focused • Timely • Golden Rule

10. Workflow • PI identifies funding • PI prepares the proposal/SOW • Research Office Reviews Proposal • Award • Award reporting and close-out

11. Differences with Federal Grants • Approve terms in advance • Allowable Costs • Allowable IDC

12. Problematic Areas • Cost share • Reduced or no F&A • Non-negotiable terms • One application per Institution • CDA

13. Instructions • Guidelines • Budget • IDC • Same Information / Different Forms • Different from NIH • Read and Follow All Application Instructions!

14. Questions to ask your PI • SOW to Sponsor? • Budget to Sponsor? • Sponsor’s written guidelines • Intellectual Property • Sponsor contact information

15. Review Process • What’s Needed • Required Institutional Paperwork • Copy of Guidelines • Statement of Work (SOW) • Budget • Research Agreement • Review guidelines

16. Required Institutional Paperwork • Routing form • Cost Share Approval • COI forms • IDC Exceptions • IACUC/IRB

17. Guidelines • Review • Requirements to apply • Restrictions • 501 C(3) • No tobacco funding • IDC • IP

19. Statement of Work (SOW) • Formal document that defines: • Work Activities • Deliverables • Timeline must execute in performance of specified work for a client. • Includes: • Requirements • Pricing • Regulatory and governance terms and conditions http://en.wikipedia.org/wiki/Statement_of_work

20. SOW Components • Description of work being performed • Location • Period of performance • Publication • Scientific input • Invention • Budget

21. SOW Bad Example • I will be reviewing square pieces of glass containing some goo. I will report to the guy in charge of the results.

22. SOW Good Example • EGG NOG expert pathology reviewers are assigned to active EGG NOG study protocols for confirming institutional diagnoses, to assess relevant enrollment criteria, for assigning subtypes of tumors to the appropriate protocol arms, and for validating the suitability of tumor tissues for biology-based studies. Reviewers will assess materials provided to them and return their reviews in a timely fashion to the EGG NOG Biopathology Center.

23. Budget • Industry or Private Funding • Simple or Detailed • Fixed Price or Cost Reimbursable

24. Fixed Price vs. Cost Reimbursable • Fixed Price operate under an established price that cannot be revised. • Cost-Reimbursable sponsored projects allow costs to be expended up to a set amount.

25. Cost Reimbursable Advantages • No incentive to cut corners • Quality vs. time • Less risk • Cost Reimbursable Disadvantages • Sponsor requires more financial reporting • Refund unused funds • Less incentive to be efficient • http://govwin.com/knowledge/cost-reimbursement

26. Fixed Price Advantages • Know total price upfront • Best interest to Control Cost • Leftover money to PI/Department • Fixed Price Disadvantages • No Price Adjustments • Maximum risk

29. Receive Award without Prior Review • Game plan • Start process as if new

30. Reasons for No Prior Review • Small amount we don’t need a contract • No IDC/F&A lead to larger studies • Competing against other Universities

32. Do I need Contract/Budget? Why? • A contract is a legally enforceable agreement • Creates binding obligations, rights and duties for each party • Payment of money • Institution has a legal obligation to protect its personnel, assets and resources • Institution must ensure that it limits its liability • Comply with the terms in the contract

33. Comply with state and federal laws and regulations • Contracts submitted for Institutional Approval • Office of Research Administration • Legal Office • Office of Technology Development • IACUC • IRB • Department

34. Case Study ABC interested in Dr. Cooper’s XYZ ABC would like Dr. Cooper to perform research PI informs ORA of pending research ABC approved the research ABC approved the budget

35. Budget

36. Problem Areas • Budget does not include IDC • Research disclosed not subject to CDA • Dr. Cooper has already hired Research Tech to start in 2 months

37. 3 Months Later • No Contract • Revised budget to include IDC • Dr. Cooper’s Department Business Office had to submit paperwork for advance so they could pay Research Tech

38. 18 months later • ABC will not pay • Contract not signed • Any research performed was not authorized by ABC • PI thought had approval • NO written record of approval • PI’s Department had to cover $18k

39. What was the true cost of this research? • $18,000 • How much time was expended • PI 20% - 96 hours • Research Tech 100% - 480 hours • ORA - 8 hours • Legal - 2 hours • Department Business Office - 1 hour • Grants Accounting Office – 1 hour • Could this time have been better used?

40. If it is not written down, it never happened/it was never agreed upon. • Documentation, documentation • Document the documentation

41. Ink is better than the best memory   -- Chinese proverb

42. Questions?

43. Thank You for Your Participation Scott Davis, CRA Associate Director Office of Research Administration University of Oklahoma Health Sciences Center P 405-271-2090 scott-Davis@ouhsc.edu Debbie Newton, CRA Director of Research and Sponsored Programs The University of Tulsa P 918-631-2192 deborah-newton@utulsa.edu