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

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

Will not be discussing – Contract Language – Clinical Trials

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

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?

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

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

Differences with Federal Grants – Approve terms in advance – Allowable Costs – Allowable IDC

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

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

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

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

Required Institutional Paperwork – Routing form – Cost Share Approval – COI forms – IDC Exceptions – IACUC/IRB

Guidelines – Review Requirements to apply – Restrictions » 501 C(3) » No tobacco funding IDC IP

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

SOW Components – Description of work being performed – Location – Period of performance – Publication – Scientific input – Invention – Budget

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.

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.

Budget – Industry or Private Funding – Simple or Detailed – Fixed Price or Cost Reimbursable

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.

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

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

BABOON STUDY Unit costNumber Total Adult Baboons $ 7, baboons $ 14,000 Per Diem Charges $ 15/day2 baboons15 days/each $ 450 IACUC Preparation by Veterinarian $ 125/hr.2hrs $ 250 Surgical Room Use Fee $ 250/ dayday 1 & day 14 $ 500 Anesthetics, Drugs, Disposables $ 800/baboon2 baboons $ 1,600 Anesthesia Charges for Veterinarian (ACLAM) for Physical exam & Ophthalmology Exam -1or - 2 day$1251 hour/ baboon2 baboons $ 250 Test day Anesthesia procedure$1252 hrs /baboon2 baboons $ 500 Anesthesia on test day for Toxicokinetics serum collection$1259 hours $ 1,125 Anesthesia for Toxicokinetics serum collection day 4,7,& 14$1251 hr./collection2 collections2 baboons $ 1,500 Euthanasia by Veterinarian$1251/2 hr. / baboon2 baboons $ 125 Baboon Carcass Disposal$ 45/each2 baboons $ 90 Surgical & Anesthetic Tech Support Technician time days -1, day 1,days 2,day 3, 4, 7, 14, & necroposy$ 45 hr.16 hrs $ 720 Necroposy by Veterinary Pathologist(ACVP) $ 1,000 Histopathology/cut in slides and staining$4020 slides $ 800 Comparative Medicine administrative costs, shipping,contracts,etc. $ 3,253 Indirect Costs (30%) $ 7,849 Total Estimated Costs for University $ 34,012

Receive Award without Prior Review Game plan – Start process as if new

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

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

– 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

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

Budget

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

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

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

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

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

Ink is better than the best memory -- Chinese proverb

Questions?

Thank You for Your Participation Scott Davis, CRA Associate Director Office of Research Administration University of Oklahoma Health Sciences Center P Debbie Newton, CRA Director of Research and Sponsored Programs The University of Tulsa P