Economic Issues for Mentors: preparing for

economic success at UCSF

Mandana Khalili, MDModified slides courtesy of

James Kahn MD

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

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

“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 PIDon’t Make Assumptions or Minimize

Legitimate Costs

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

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

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

“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

“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%)

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

Minimizing Your RisksMaximizing Your Opportunities

Address Critical IssuesClinical Trials BudgetingCoordination of CareFee for Non-Study ResourcesValidation of All Trial-Related

Services/Costs Standards of Care Trial Associated Costs “Hidden” Costs Understand Billing Expectations

Resources

RSA:http://medicine.ucsf.edu/research/resources/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://ctsi.ucsf.edu/consult and

http://accelerate.ucsf.edu/research/mc-consult