UCSF home page UCSF home page About UCSF Search UCSF UCSF Medical Center
UCSF navigation bar
1. Introduction  
2. Setting up Office and Research Space
2.1 What should I do before I get to UCSF?
2.2 What should I do once I arrive at UCSF?
2.3 What Research Support Services are available?
3. Obtaining Regulatory Committee Approvals
3.1 Making Sense of Regulations
3.2 What is Research Online
3.3 Working with Biologicals
3.4 Working with Chemicals
3.5 Working with Radioactive Materials
3.6 Working with Radioactive Materials in Humans
3.7 Working with Controlled Substances
3.8 Working with Animals
3.9 Involving Human Subjects in Research
3.10 Serving on Committees
3.11 Working with Affiliates
4. Finding, Obtaining, and Managing Money
4.1 Fiscal Responsibility
4.2 Pre-award: How do I find and ask for funds?
4.3 Post-award: How do I manage funding awards?
4.4 Working with Industry
4.5 Minimizing Financial Conflicts of Interest
4.6 Intellectual Property
5. Being Responsible
5.1 Ethical Conduct of Research
5.2 Authorship and Publication
5.3 Confidentiality and Privacy
5.4 Data Management: Research Records
5.5 Training in Responsible Conduct of Research
5.6 Guidelines for Lab Notebooks
6. Leaving or Transferring Funds/Specimens Out of UCSF
 
Appendices
I. UCSF Acronyms
II. UCSF Research Links
III. Whistleblower Policies & Procedures
 
School of Medicine Clinical and Translational Research

THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

4. FINDING, OBTAINING AND MANAGING MONEY

4.4 Working with Industry?

• How can I work with Industry?
• Who do I contact?
• How do I start the agreement process?
• What am I responsible for?
• Top Tips to Speed Up Approval and Prevent Problems
• Relevant policies and procedures


How can I work with Industry?

You can work with Industry in a variety of ways when it comes to your research:

•  Sponsored Research – You develop the scope of work and Industry funds the project.
•  Collaborative Agreement – You and the company will both contribute to the development and performance of the scope of work.
•  Subcontract – You are asked by a company to perform a portion of a larger scope of work and the company will provide you funding. This includes subcontracts under NIH SBIR/STTR grants.
•  UC Discovery Grant – You will develop a scope of work with a California company within the guidelines of the UC Discovery Grant whereby the company will pay for 50% of the direct costs and 100% of the indirect costs, and the Grant will match the Industry funding thus contributing 50% of the direct costs.
•  Clinical Trial – You conduct a clinical trial where the protocol is authored by Industry or you author the protocol, and Industry provides funding.
•  Clinical Services Agreement (aka Clinical Research Support Services Agreement) – A one-time sale of a pre-developed clinical test or clinical evaluation service (such as radiograph review, MRI screening) by you and/or associated staff in direct support of a Clinical Trial. If the test is modified, improved or developed in any manner in order to provide the service, then the agreement is classified as sponsored research.
•  Material Transfer Agreement (MTA) – You request material from an outside agency to be used in your research or you provide material to an outside agency.
•  Laboratory Testing Agreement – You provide testing or assays of a material provided by Industry and deliver the data to the Sponsor, or you analyze data provided by the Sponsor, in return for funding. This can only be done of if there is an educational component that benefits the University; otherwise it would be considered a fee for service, which is not allowed under University policy.

Other interactions with Industry:

•  Consulting Agreement – Industry approaches you and requests your expertise. Consulting services cannot use any UC resources.
•  Licensing Agreement – Industry approaches you and wants to license an invention that you developed.
•  Gifts – Industry provides a gift for your lab or a general area of research to be used any way you deem appropriate. Industry cannot impose a requirement for deliverables, reports, or data, and it cannot require rights to intellectual property.

Top of page

Who do I contact?

•  For Sponsored Research, Collaboration Agreements, Clinical Trials, MTAs, subcontracts, UC Discovery grants, or Laboratory Testing Agreement, you should contact the Industry Contracts Division of the Office of Sponsored Research (OSR).
•  For Consulting Agreements, you should contact Dr. Neal Cohen at the School of Medicine Academic Affairs Office at (415) 476-1977 for a review of all consulting agreements regardless of your school affiliation.
• 
For Licensing Agreements, you should contact the Office of Technology Management.
•  For Gifts, you should contact the Development Office.

Note: All government and non-profit contracts and grants are processed by the Contract and Grants Division (C&G) of the OSR.

Top of page

How do I start the agreement process?

•  Once a research project has been developed between yourself and a scientist at a private company, you should provide a contact name to your Department’s Industry Contracts Officer in the Industry Contracts Division.
•  Each department is assigned its own Industry Contracts Officer to handle all industry research agreements.
•  The Industry Contracts Officer will contact the company and begin the contract negotiation.
• 
The Industry Contracts Officer Department Assignment List is available at the Industry Contracts Division website or call (415) 353-4446.

Top of page

What am I responsible for?

•  Negotiation of the budget and/or payment schedule.
•  Preparation and timely submission of the internal paperwork.

Top of page

What resources are available?

•  For assistance with developing the budget or payment schedule, you should contact your research administrator or your department’s Contracts & Grants Representative. To find out who your department’s primary and secondary C&G Rep are, contact C&G at (415) 476-2977.
•  For assistance with the industry agreement review, negotiation or approval process, you may contact your department’s Industry Contracts Officer (a list is available at the Industry Contracts Division website or call (415) 353-4446.)
• 
For assistance with submitting committee approval requests to CHR, IACUC, or any of the Technical Committees, please contact the respective office or your department’s research administrator.

Top of page

Top tips to prevent problems and speed up the approval process

•  Contact the Industry Contracts Division of OSR as soon as you know you want to work with Industry. Your Industry Contracts Officer can assist you with developing the project and address all the important concerns at the beginning to avoid unnecessary delays.
•  Work with ICD by having information available as to whether there is a scope of work/protocol, who authored the scope of work/protocol, what prime source of funding is, and whether the sponsor is funding all the costs of the project.
•  Prepare and submit your paperwork promptly. Much of the paperwork requires review and approval by other committees or requires signatures from your department chair and school dean.

Top of page

Relevant policies and procedures

•  Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects (UC Office of the President, Research Administration Office, Memo 95-05).
•  Guidelines for University-Industry Relations (UC Office of the President, Research Administration Office, Memo 89-20).
•  Summary of Sponsor Patent Rights Applicable to Funding Agreements with Industrial (for profit) Sponsors of Research (UC Office of the President, Office of Technology Transfer)
•  Guidelines For Patent Clauses In Agreements With For-Profit Sponsors (Contracts and Grants Manual, Section 11-340).