Confidentiality
How is a sponsor's confidential information protected?
Most companies want to ensure that certain proprietary information about the company remains confidential. However, UCSF must balance the interest of the company with the need to maintain an open teaching and research environment.
Therefore, UCSF will accept research agreements from companies only where:
- the extent of the confidential information shared with UCSF by the company is limited;
- the information is clearly identified by the company as confidential;
- the company agrees that UCSF will not be financially liable for disclosure; and
- the period of time that information must be kept confidential is reasonable.
Furthermore, the University should have the right to use the information for non-commercial, internal purposes, such as education, research and patient care.
How do I know if I need a confidentiality agreement? How do I go about putting one in place?
A Confidentiality Agreement (also referred to as a "CDA", "NDA" or "Nondisclosure Agreement") protects a party's proprietary or non-public information, and is typically used when parties must disclose such non-public information in order to evaluate a possible relationship with the other party. Industry sponsors will often ask UCSF to sign a CDA as a precursor to a sponsor-initiated clinical trial or a sponsored research project. If the UCSF investigator expects to disclose any confidential information to the industry sponsor, then the Confidentiality Agreement should be set up to protect UCSF and the investigator as well.
Note: UCSF investigators are not authorized to sign any agreements, including CDAs, on behalf of UCSF. In order to initiate a CDA or get one signed, contact us. See our Confidentiality Agreement page for more information.
Industry Sponsored Agreements
What documents are required in order to begin negotiation and award of an industry-sponsored project (clinical or non-clinical)?
You can download the Guide to Internal Documents for a list of required documents.
All required documents should be sent to [email protected].
Who should I contact to begin contract negotiations with an industry sponsor?
Please email us at [email protected].
Who is responsible for negotiating the budget for an industry sponsored clinical trial agreement?
Refer to information on our Industry-Funded Clinical Trials page about budget and contract negotiations.
What are the Facilities & Administrative (F&A) Cost Rate for Industry-Sponsored Projects?
Please see our detailed page about Facilities & Administrative cost rates.
What is the F&A Policy for Fellowship Awards? What are the differences between a grant and a fellowship?
The Academic Personnel Manual (APM 390-8) defines a Postdoctoral Scholar – Fellow as one who “…has been awarded a fellowship or traineeship for postdoctoral study by an extramural agency and the fellowship or traineeship is paid through a University account.” Most Postdoctoral Scholars receiving a fellowship award will have the Postdoctoral Scholar – Fellow title, as the Postdoctoral Scholar – Employee title is only used “…when (1) the agency funding the salary requires or permits the appointee to be an employee of the University, or (2) whenever General Funds, Opportunity Funds, or other University discretionary funds are used to support the position.” A postdoctoral scholar is appointed through the Graduate Division, and expected to retain that appointment for the duration of the award.
Facilities and administrative (indirect) costs are not assessed on individual fellowship awards. This policy is consistent with the University's facilities and administrative (F&A) agreement with the federal government. The F&A rate agreement excludes stipends and fellowships from the modified total direct cost base upon which F&A costs are assessed.
Should a particular fellowship award include a sum or a percentage of the award for "indirect costs", "overhead", or "institutional allowance" those funds should be considered "institutional allowance" to be used by the department toward the fellow's training costs such as health insurance, travel, supplies, etc. Current policy for these fellowships requires that the OSR Approval Form be signed only by the fellow and the sponsor. All fellowships should also be coded as “instruction” for the purpose type on the OSR Approval Form.
Note that certain awards are always designated as grants rather than fellowships. These awards include "scholar awards", "investigator awards", and even awards designated by funding agencies as "fellowships" which are made to individuals with advanced faculty appointments, and awards made to individuals who will make a transition from postdoctoral scholar to faculty member during the award period. Because these awards are considered grants, signatures of the Chair (or Dean if applicable) will be required on the C&G Approval Form, the F&A costs, if any, allowed under the particular award will be assessed by the University, and a Waiver of PI Status must be obtained as described under PI Eligibility at UCSF.
MTA FAQs
What is an MTA?
A material transfer agreement is a legal agreement between an institution providing material or data and the institution receiving that material or data. It governs the rights and obligations of each party in relation to the material or data.
MTAs protect the provider of materials. In addition to protecting the University and provider from liability, MTAs help to maintain the UCSF's property rights associated with materials "outbound" to other researchers. MTAs also ensure that our researchers get properly acknowledged for providing the materials to the scientific community.
When do I need to use an MTA?
UCSF researchers must use an MTA each time they transfer a material to a recipient outside of UCSF.
MTAs for materials coming in to UCSF are recommended but not required.
Why are outgoing MTAs required?
MTAs help UCSF fulfill its obligations to third parties and they protect the university and its researchers from legal liability. They also protect UCSF’s intellectual property and the rights of UCSF’s researchers.
What is the UBMTA?
The UBMTA is the Uniform Biological Material Transfer Agreement, a master agreement that was developed by the NIH to simplify transfers of biological research materials.
Institutions that have signed the UBMTA Master Agreement can transfer biological materials under the terms of the UBMTA by executing an Implementing Letter for each transfer.
Which institutions are signatories to the UBMTA?
UCSF and most US (and some ex-US) non-profit institutions are signatories to the UBMTA.
For a list of all UBMTA signatory institutions see here.
Who can sign an “Incoming” MTA or Data Use Agreement?
Industry Contracts Officers at OSR are the only personnel authorized to sign MTAs and Data Use Agreements for materials to be transferred to UCSF from outside parties (“Incoming Agreements”).
Who can sign an “Outgoing” MTA or Data Use Agreement?
Transfers of materials or data from UCSF to an outside organization are known as Outgoing Transfers.
OTM Officers are the only officials authorized to sign:
- Outgoing MTAs to for-profit companies, and
- Non-human, non-profit outgoing MTAs that have negotiated language changes from the pre-approved UCSF or UBMTA templates.
Principal Investigators may sign Do-It-Yourself Non-Profit Outgoing MTAs for their own non-human material upon the following conditions:
- The recipient institution is a non-profit academic research institution.
- The material to be transferred does not include human specimens or data, and was developed in the PI’s lab at UCSF.
- There are no third party rights to the material, or the third party rights have previously been cleared by the OTM.
- The recipient institution has agreed to accept the MTA template language without any changes.
What are third party rights/obligations?
UCSF may have obligations to third parties whose material is contained or incorporated into UCSF material. Third party obligations may also exist when a material is made or collected (in the case of biospecimens) under sponsorship terms that restrict its ownership, distribution and use.
If you answer ‘Yes’ to any of the following questions, third parties may have rights to your material and you should contact OTM for further assistance with your transfer.
- Were the materials generated outside of UCSF?
- Were any components (such as a DNA construct, parental mouse strain, gene insert, etc.) obtained from outside of the providing PI’s lab and do they remain incorporated within the material?
- Were any funds (for salaries and materials) from for-profit companies used to support generation or collection of the material?
- Did any individual involved with the generation of the material have a consulting relationship with a company under which the generation of the material might fall?
- Were there any other agreements (such as incoming MTAs, sponsored research agreements, CDAs, etc) that may be relevant to the generation of this material?
What if I want to transfer material I obtained from another institution?
Contact the OTM or [email protected] for further assistance.
What is a Data Use Agreement?
A Data Use Agreement is required when transferring a “Limited Data Set” as defined under HIPAA. Occasionally, agreements for other types of human data may also be referred to as a Data Use Agreement or a “Data Transfer Agreement.”