1. Economic Issues for Mentors: preparing for economic success at UCSF Mandana Khalili, MD Modified slides courtesy of James Kahn MD

2. 10,000 foot view  The University is not empowered to “look-out” for faculty.  Faculty must look out for themselves  Research administration could use help and some understanding

3. Goals  Why it is important to read fiscal balance sheets  How to identify who is responsible for your accounts  Creating good working relationships with persons who are responsible for your contracts, subcontracts, expenditures  How to save money for the future  What happens if you run out of money?  Effective and successful delegation  Establish grounds rules and culture for fiscal health  Understanding how to diversify your funding

4. “Financial Issues”  The “University” is Generous, but not the “Deep Pockets”  Industry (or other sources of extramural support) is a Partner and is Willing to Cover Its Share of Costs  Budgeting and Financial Management Responsibilities Belong to the PI Don’t Make Assumptions or Minimize Legitimate Costs

5. How to repay debt from training?  NIH Loan Repayment Program  Clinical Research  Pediatric Research  Health Disparities Research  Clinical Research: persons from disadvantaged backgrounds  Contraception and Infertility Research  Repay qualified educational debt up to $35,000 per year;  Reimburse Federal and state taxes  Repay qualified educational debt after completion of the two-year commitment through competitive renewals  Each year >1,600 researchers are funded.  http://www.lrp.nih.gov/pdf/NIH_flyer.pdf

6. A Gift can keep giving  Gift: a voluntary, irrevocable transfer of something of value without consideration at the time of transfer or any time in the future. Gifts are not subject to Regents of the University of California overhead charges.  Private grant: an award to UCSF in response to a proposal that specifies reports on expenditures, guidelines for audits, consideration for the grantor, testing or evaluating, and/or satisfying specific conditions or requirements for a specified period of performance. These are subject to overhead.  Currently, the "Gift Fee" is 4% upon receipt of cash and a "Spending Fee" of 1% upon expenditure for donor-intended purpose.  http://policies.ucsf.edu/250/25010.htm http://policies.ucsf.edu/250/25010.htm

7. Clinical Research Realities  Clinical Research has Become More Complex  As PI, You Must Know the “Rules”  Clinical Research is Costly and Complex Significant Implications of Clinical Trials on Patient Care Coordination and Integration with “Routine” Clinical Care Understanding of Protocol Requirements, Resources High “Costs” of Clinical Services  Identify UCSF and Other Resources and Take Advantage of Them

8. “Financial Issues”  Define Investigational Activities  Differentiate them from Routine Clinical Care  Identify Anticipated Costs of the Trial  Understand Who Will Pay for Each Component of the Trial (or Sequelae) Know the Payor Mix of the Study Population

9. “Budgeting”  Direct Costs Direct Investigational Costs Associated Supplies and Materials Personnel, including Investigators “Other” Anticipated and Unanticipated Costs  Follow-up Care  Management of Complications  Prolonged Hospitalization  Indirect Costs (Currently 26%)

10. Actions that Lead to False Claims  Charging for items provided for free by the sponsor  Billing for non-covered services  Attesting that the trial is in compliance with all regulations when it is not

11. Minimizing Your Risks Maximizing Your Opportunities  Address Critical Issues Clinical Trials Budgeting Coordination of Care Fee for Non-Study Resources Validation of All Trial-Related Services/Costs  Standards of Care  Trial Associated Costs  “Hidden” Costs  Understand Billing Expectations

12. Resources  RSA:http://medicine.ucsf.edu/research/r esources/rsa.htmlhttp://medicine.ucsf.edu/research/r esources/rsa.html Contracts and Grants Cost Transfers General Ledger and Fund Accounting Post-Award Management of Funds  http://cbe.ucsf.edu/cbe/Home.html (ideas to IPOs) http://cbe.ucsf.edu/cbe/Home.html  http://ctsi.ucsf.edu/consult and http://accelerate.ucsf.edu/research/mc- consult http://ctsi.ucsf.edu/consult