400-14 Industry-Sponsored Agreements

Effective Date: 10/01/06
Office of Origin: Office of Sponsored Research

I. Purpose

This policy outlines the requirements governing industry-sponsored agreements (research, clinical trials, instruction, and other sponsored activities), and sets forth definitions, campus approval requirements for proposals, financial requirements, and roles and responsibilities.

II. Definitions

Clinical Trial: an award given specifically for 
  1. The controlled, clinical testing of Investigational New Drugs (INDs) or Investigational Devices (IDEs) using either a sponsor - or investigator - developed protocol under a Food and Drug Administration (FDA) Phase I, II, III, or IV drug study or a FDA-regulated medical device study; or the controlled, clinical testing of a protocol performed under the sponsorship of an approved national cooperative consortium for clinical trial services. 
  2. Ancillary clinical support services at UCSF that support an FDA-approved clinical trial being performed at an outside agency, or a clinical trial sponsored under the direction of an approved national cooperative consortium.

    Clinical trials exclude any projects involving animal subjects.

Contract: an exchange of promises that gives rise to legally enforceable rights and duties. A contract is usually a binding agreement under which the sponsor provides funding for a proposed program in return for a product (e.g., services, scientific report). Contracts are specific as to the nature of the work to be done, the manner in which it is to be carried out, and the conditions of termination.

Direct costs: those costs that can be identified specifically with a particular sponsored research or training project. These costs include, but are not limited to: salaries and wages, employee benefits, consultants, supplies, other expenses, travel, equipment, animal care and use, radioisotope use and disposal, publication costs, and off-campus rent.

Facilities and Administrative (F&A) costs: those costs that have been incurred for common or joint objectives and that cannot be identified specifically with a particular project. These include costs of supporting activities such as maintenance and operation of the physical plant, use allowance for buildings and equipment, general, departmental, and sponsored projects administration and expenses, and library and student services.

Sponsored Research: the separately budgeted and accounted for research under an externally funded contract made in support of investigation or experimentation aimed at the discovery and interpretation of facts, revision of accepted theories in the light of new facts, or the application of such new or revised theories. Sponsored research includes basic, applied, and developmental research.

III. Policy

A.       Industry-sponsored Agreements

All extramural industry-sponsored projects must have a fully executed agreement prior to commencement of work on the project.  The acceptance of support from private industry commits the University to specific terms and conditions.  Agreements must be endorsed on behalf of the University by an individual to whom authority has been delegated by the Chancellor to solicit contracts and grants.

B.      Approval Requirements for Industry Agreements

1.  Before an agreement can be accepted and a fund established by the University, the Office of Sponsored Research (OSR) must receive the following documents:

a. Office of Sponsored Research Approval (OSR) Form;

b. a budget with direct and F&A costs;

c. a protocol or scope of work; and

d. copies of applicable compliance material

i.   Committee on Human Research (CHR) Approval Letter or equivalent;

ii.   Institutional Animal Care and Use Committee (IACUC) Approval Letter or equivalent;

iii.  State Conflict of Interest Form (700U) and supplements (research projects only);

iv.  as needed for the project

2.  Cost Reimbursement

Regental policy requires that extramurally funded projects be conducted at no cost to the University. For cost reimbursement agreements all direct and F&A costs must be recovered from sponsors. Costs must be accurate, allowable, and supportable.  For fixed price contracts (including clinical trails) a budget must be developed for internal budgeting and expenditures purposes.

      In general, the following categories of budgetary costs are to be included in proposals:

a.   Salaries and Wages

All individuals to be directly supported on the proposed project should be listed in the proposed budget.  Salary payment to support the time of faculty investigators and staff should be included.  Salary information should reflect anticipated merit increases and/or range adjustments applicable during the total proposed performance period.  Individual salary support requested should be in proportion to the time expected to be devoted to the project. 

The time devoted to the project by the Principal Investigator (PI) on an industry agreement must be sufficient for the PI to assume oversight of financial, scientific and compliance aspects of the project, and must be in proportion to the size and scope of the project. As an example, if a PI spent an average of 6 hours/week out of a normal schedule of 60 hours/week on project activities and/or oversight, then 10% of the investigator’s full salary should have been charged to the fund during the period of the contract.

b.    Employee Benefits

A proportionate share of employee benefits must be charged to the source of salary support.

c.    Supplies and materials

d.    Consultant costs

e.    Subcontracts

f.     Equipment

g.   Patient Care Costs

 Costs of hospitalization and other routine and ancillary services provided by a hospital or clinic to patients participating as research subjects should be included. Routine and ancillary services provided by academic departments or units and which are covered by the Department of Health and Human Services (DHHS) negotiated Patient Care Rate Agreement (generally, those services that are billed through UCSF Medical Center) are considered patient care costs. For detailed guidance on treatment of services provided at the UCSF Medical Center or at San Francisco General Hospital (SFGH), please refer to http://www.research.ucsf.edu/cg/memo/cgPatRecharges.asp. Patient care costs do not include services provided by commercial laboratories  that must be budgeted in the "Other Expenses" category and assessed F&A costs.

h.    Travel

i.     Other Expenses

Costs such as publication costs or participant support costs should be included in the budget as other expenses.

j.     Facilities and Administrative Costs

All contracts must include the University's negotiated F&A rate for the type of project involved. Current F&A rates for industry research and clinical trial sponsored projects are published by the Office of Sponsored Research. 

     3.  Financial Requirements

a.   Each industry-sponsored award shall have a separate account established through Extramural Funds Accounting (EFM) with specified project begin and end dates.

b.   All costs including salary and benefits for faculty and staff who are working on the project should be charged to an industry agreement.  For fixed priced contracts that are based on patient enrollment, charges may be estimated and corrected retroactively.  

c.   Time and effort reporting are subject to the existing requirements for UCSF Personnel Activity Reports.

d.   Industry-sponsored agreements should be closed within six months after the project end date.

e.  For fixed price contracts, funds remaining at the close of the project after all costs, including F&A costs, have been recovered are to be transferred to a new or already existing fund under the discretion of the PI.  Working in conjunction with the department, the remaining funds can be used for PI’s purposes.

IV. Responsibility

A.     Principal Investigator

It is the responsibility of the Principal Investigator (PI) to ensure that all contract related documentation is complete, accurate, and current, and that the submitted cost estimates are reasonable and factually substantiated.  The PI is responsible for oversight of financial, scientific, and compliance aspects of the project.

B.     Department Chair or Organized Research Unit Director

It is the responsibility of the department chair or organized research unit director to ensure that adequate space and facilities are available for the PI to carry out the proposed research, to ensure that the project is in alignment with the goals of the submitting department or unit, and to provide written approval for the proposed project. 

C.     Departmental Administrator

Upon closure of a fixed price project fund it is the responsibility of department administrative staff to transfer the residual balance to an account that the PI, department, or unit has designated to record and receive residual funds.

D.     Office of Sponsored Research

It is the responsibility of the Office of Sponsored Research to advise departments initiating contracts of University or sponsor requirements as needed, including those related to the preparation of proposals, and to approve and formally submit the completed contract to the extramural sponsor.  

E.     Controller’s Office

It is the responsibility of the Controller’s Office, Extramural Funds Accounting (EMF) to close all industry contracts funds in a timely manner and to monitor industry contracts for appropriate expenditures, as needed.

V. Related Policies

VI. References