Dealing with the corporate world is mystifying to academics whose main training has been oriented toward research, teaching, and clinical duties. Alliances between universities and industry are playing an increasing role in facilitating cutting-edge basic and clinical research. This knowledge base will help both new and established faculty understand how to engage in alliances with companies, protect their research/publication rights and intellectual property, and avoid conflicts of interest when consulting for companies.
1.1 Getting started
1.0. Collaboration (alliance) with a company
1.1. Getting started
Either the company or you can contact the other regarding a potential alliance. There are some differences in processes and considerations depending on who is initiating the contact.
- How do I initiate an industry alliance?
There are several possible approaches; all require involvement of the University. Learn more or contact the Office of Innovation, Technology & Alliances (ITA) to help you evaluate opportunities, make decisions, and structure collaborations.
- How do I respond to a company's request for alliance?
To help you understand what types of information you should share (confidential versus non-confidential), please confer with those individuals at UCSF whose responsibility it is to support academic/industry alliances to help you evaluate the opportunity, make decisions, and structure collaborations. Ultimately, you will want to assess the proposed science or technology opportunity, whether it aligns well with your own research efforts, and whether an alliance would be beneficial to you and to your potential industry partner. It is also worthwhile to consult your colleagues to determine if they have worked with this company or used similar technology, or have other advice.
- Is help available for managing a complex collaboration?
The Office of Innovation, Technology & Alliances (ITA) offers Alliance Management services that can help to maintain a collaborative environment and manage many of the important contractual and relationship aspects of the partnership, so the investigators can focus on the science.
- How do I protect confidential information when meeting with industry?
Contact the Office of Innovation, Technology & Alliances (ITA) for advice and assistance on matters such as:
- Discussing intellectual property
- Protecting a patent position
- Secrecy, non-disclosure, or confidentiality agreements (CDAs)
- 2-way or mutual confidentiality CDAs
- When a CDA is needed, for example, giving a seminar at a company
- Liability issues
1.2. Types of industry collaboration
Industry sources may sponsor UCSF research via a contract, gift, subcontract, grant, grant-in-kind, sponsored research agreement, collaboration agreement, clinical trial agreement, materials transfer agreement (MTA) or fellowship.
- What are the various types of agreements into which I might enter?
- A contract is an agreement between two or more parties in which an offer of something of value is made and that offer is accepted. A contract defines all of the terms, conditions, expectations, and deliverables that govern any contemplated relationship between the parties. By defining the terms, conditions, expectations, and deliverables a contract protects the interests of all of the parties to the contract. Examples of contracts commonly executed by the University include—but are not limited to—Clinical Trial Agreements, Sponsored Research Agreements, Collaboration Agreements, Material Transfer Agreements, and Clinical Service Agreements. To alter the terms, conditions, expectations, or deliverables of a contract, an Amendment to the contract is negotiated and executed by all of the parties to the contract. Any change made to a contract in the absence of an Amendment is null and void.
- A subcontract is an agreement used by a party to arrange for a third party to perform some or all of the first party's obligations under a primary contract. For example, a pharmaceutical company may contract with the University for the University to serve as the coordinating site for a multi-center clinical trial. The contract between the company and the University is called the Primary or Prime Contract. Contracts between the University and other entities recruited by the University to participate in the multi-center study are called sub-contracts.
- A grant is a giving of funds for a specific purpose. The grantor may be entitled to receive some deliverables such as a detailed technical report of research results or a report of expenditures, and may require that unexpended funds be returned at the end of the grant period. See UCOP policy entitled Review of Gifts/Grants for Research for more guidance on distinguishing "gifts" from "grants."
- A gift is an agreement through which a party gives unrestricted funds to the university without imposing any contractual requirements and the award is irrevocable. See UCOP policy entitled Review of Gifts/Grants for Research for more guidance on distinguishing "gifts" from "grants."
- A gift-in-kind is a contribution of equipment, supplies, or other property provided to one or more researchers in lieu of money by one or more companies generally for use in an industry sponsored research project.
- A sponsored research agreement (SRA) is a contract between a private industry organization and the Regents of the University of California on behalf of UCSF for a research project that is directed by one or more UCSF investigators. Sponsored research agreements specify the research to be completed, deliverables to be provided by industry organization and the University, and the rights that the parties have to intellectual property and data that are generated in the performance of the project. Sponsored research agreements are negotiated by the Office of Innovation, Technology & Alliances.
- A collaboration agreement is a contract between organizations that wish to work together but generally do not want to exchange funding. Collaboration agreements are not considered sponsored research, per se, but govern the exchange of equipment, data and inventions. A funded collaboration agreement is sponsored research as the sponsor provides funding and other resources for the collaboration.
- A clinical trial agreement is a contract between two or more parties that defines all of the terms, conditions, expectations, and deliverables associated with one or more University researchers conducting an industry-authored or investigator-initiated clinical trial when that clinical trial is funded by one or more companies. For a study to be classified as a clinical trial by UCSF for purposes of calculating indirect costs, it must conform to the following definition: the controlled, clinical testing of Investigational New Drugs (INDs) or Investigational Devices (IDEs) using either a sponsor- or investigator-developed protocol under a FDA Phase I, II, III, or IV drug study, 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; or ancillary studies at UCSF that support an FDA-approved clinical trial being performed at an outside agency, or under a clinical trial sponsored under the direction of an approved national cooperative consortium. Please note that UCSF's definition of a clinical trial is different from other UC campuses and NIH.
- A material transfer agreement (MTA) is a contract between two parties that defines all the terms, conditions, expectations, and deliverables needed when one or more University researchers sends or receives materials, software or human data from a party (company, non-profit, university, institute, government, individual, etc.) external to the University. Learn more
- A fellowship is a form of grant through which funds are granted (commonly by a university, foundation, government agency, or company) for advanced study or training.
For more information, visit the Office of Innovation, Technology & Alliances (ITA) and Office of Sponsored Research websites.
- How does the type of agreement determine what I am allowed to do with the funds I receive?
Between a contract, grant, and gift, a contract is the most restrictive form of agreement and a gift is the least restrictive.
- A contract is an agreement between two or more parties that defines all of the terms, conditions, expectations, and deliverables for the activity defined in the contract.
- A grant is a form of an agreement that defines the general expectations related to whatever was proposed in the grant; however, as compared to a contract, there are no contractual obligations to deliver under a grant.
- What is the time-table for completion of each type of agreement? What are my responsibilities in completing the agreements?
From the time the sponsor and University investigator decide upon the scope of work and the budget for a proposed project, and all required paperwork (COI, IACUC, CHR, OSR, etc.) is completed, the time required to negotiate and execute a sponsored research or clinical trial agreement is approximately 30-90 days, assuming the sponsor responds in a timely matter and that there are no changes in the scope of the work during the negotiation period. See ITA's Guide to Required Documents for details.
- Which campus offices should you involve for which agreements?
Contact your department's ITA Professional for help with:
- Material Transfer Agreement (MTA) (incoming and outgoing)
- Confidentiality & Secrecy Agreements
- Industry Sponsored Agreements (contracts, grants, collaborations, clinical trials, fellowships)
- Outgoing Licenses
For planned proposals/applications to the SBIR/STTR funding opportunity with deadlines on or after September 5, 2015, UCSF faculty who will participate as subrecipients should contact their assigned Research Services Coordinator (RSC) in Research Management Services (RMS). Subcontract proposals for SBIR/STTR applications with deadlines before September 5, 2015, will be handled by ITA's Industry Contracts Division (ICD). Awards made prior to September 5, 2015, will also be processed by ICD.
For gifts, contact the Research Development Office. For other situations, contact your department or school.
- Once the award or contract is executed, what are next steps and who is responsible?
The principal investigator (PI) is ultimately responsible for all activities under a sponsored agreement. Examples of post-award activities are: reconciling ledgers, approving invoices, getting approvals for compliance issues.
- If I leave the University, can I continue my sponsored research agreement at a different institution?
A sponsored research agreement can be transferred from UCSF to another institution. This takes the approval of the department chair or ORU (Organized Research Unit) director. The award to UCSF must be terminated and the new agreement executed between the sponsor and the new institution. All the results and any discoveries made for the work done at UCSF remains the property of the Regents of the University of California.
Material created at UCSF is the property of the Regents of the University of California. If you want to take research materials that you created at UCSF with you to your new employer, contact the Office of Innovation, Technology & Alliances (ITA) to negotiate a materials transfer agreement (MTA) with your new institution.
- What are Discretionary Accounts and how do they work?
A discretionary account is an unrestricted fund at UCSF that is valuable because it can be used to pay for expenses that fall outside of those typically allowed by federal grants (e.g., business-related entertainment expenses, membership dues, etc.). These accounts can be part of a start-up package, gifts from various donors, or they can be derived from unused portions of fixed priced (only) industry-sponsored agreements.
- How is an industry-sponsored research grant weighted by the University relative to academic grants for career advancement?
The University places great importance on the ability to fund one's own research, so all independent funding is important. Historically, not all funding has been considered equally during consideration for academic advancement. Grants from federal agencies like the National Institute of Health (NIH) tend to be given greater weight than industry-sponsored research agreements, due primarily to the peer-review involved in evaluating a grant proposal. Moreover, the R01 is considered in many quarters to be THE important grant to legitimize an independent researcher's career. This being said, obtaining funding from industry sources will increase your ability to pay salaries and conduct research that will still be important in developing your career. Industry funding could support research that ultimately helps qualify you for an R01 award. Due to the award of NIH funding for the CTSI, there are increasing discussions about faculty hiring and advancement and the need for a broader view of the value of translational and industry-sponsored research.
1.3. Partnership implications
Negotiating scope of work and budgets requires attention to many issues, such as:
- Can the industry sponsor change the direction or focus of the research in midstream?
Yes it can, but you can and should include this issue in your written agreement with the sponsor. If the company requests that the scope of work be altered, that is, they request that the research approach be altered or that a different set of questions be addressed, you should contact the person at the Office of Innovation, Technology & Alliances (ITA) who negotiated your agreement.
- What control do I have over defining benchmarks and milestones for the project?
These should be part of the negotiation. The investigator is not necessarily at the mercy of the company for setting benchmarks and should weigh in on what is considered reasonable progress. Be sure to share the scope of work with your Office of Innovation, Technology & Alliances (ITA) Professional.
- What control do I have over whether a company decides I am not making enough progress and pulls out?
Once the science has been decided, the sponsored research agreement and the way in which it is negotiated are very important with respect to the risk that you take entering into the alliance. It is very important to work closely with your Office of Innovation, Technology & Alliances (ITA) negotiator to work out possible scenarios such as early termination, change of research direction, etc. that may unexpectedly affect your ability to pay salaries.
- Does the agreement cover the limitations, if any, on my present and future research if I collaborate with industry (i.e., impact on my ability/schedule to publish)?
UC policy states that you cannot agree to a contract unless you are able to publish within 30-60 days of the work being completed. There are provisions about the company being able to look at the manuscript (or other forms of public disclosure, such as talks, poster sessions, etc.) and file patents prior to public disclosure, but they cannot prohibit you from publishing. The UCSF contract negotiators have fixed parameters in negotiating publication rights and should make sure that your contract does not contain improper restrictions. You should, however, pay attention to the terms in your contract and ask about any restrictions that you see. Regarding intellectual property rights, the company will get certain rights to the intellectual property and materials you develop, but there are limits to these rights that are carefully negotiated along with the rest of the research agreement.
- When designing a research budget for an industry-sponsored project, should I try to be as frugal as possible?
No, this is not wise. You may feel that you want to minimize the amount of funding that you request to increase the chances that the company will agree, but companies know how expensive research can be, and should understand as long as you write a good budget justification. The most important thing to avoid is to request and receive funding that ends up not completely covering your costs. Then you are stuck: your contract says you will do a certain amount of research and receive a certain amount of money, and any extra costs will have to come from your other accounts (unless you can convince the company to increase the research budget, which is not all that uncommon if you have compelling reasons). Still, paying for this company’s research with federal funds can land you in a heap of trouble, and paying from another industry-sponsored fund raises potential problems with intellectual property concerns. Also, you may wish to impress the company with how well-suited your lab is to do the proposed research, by assuming that no experiment will need to be repeated, but that is bound to backfire. Some animals die of natural causes or get sick and need to be removed from an experiment. Some experiments fail for coincidental or unknown reasons, and sometimes biology just doesn’t behave as you planned that it would, so conditions need to be varied and experiments repeated. Your budget should take a reasonable amount of this uncertainty into account, so by all mean, pad the budget accordingly—and be sure to tell the company exactly what you are doing in the budget justification so that there will be no false impression that you are just trying to get more money. And don’t forget to factor in reasonable percent effort for salaries, future salary/fringe increases, service contracts and maintenance of project-related equipment, and an appropriate portion of the general cost of running your lab. If you end up with extra funds at the end, there’s a good chance you’ll need them for publication costs that come later.
- What special requirements or agreements need to be completed before an industry collaborator can do bench work at UCSF, or vice a versa?
- Are there special rules for protected info/technology if I work with an international company?
U.S. Federal Export Laws are regulations that control the conditions under which certain information, technologies, and commodities can be transmitted to anyone overseas, including U.S. citizens residing in or traveling to a foreign country, or to a foreign national within the U.S., and provide severe penalties for violations of the regulations. Contact the Office of Innovation, Technology & Alliances (ITA) if you plan to pursue research sponsored by a foreign company, transfer information or materials to a foreign person or company, or travel to an embargoed country (Cuba, Iran, North Korea, Sudan, and Syria) with, for example, a personal computer or PDA.
- Are there differences in the way most companies are handled vs. Mission Bay research park companies?
Sponsored agreements with companies located in the Mission Bay research park are negotiated and processed in exactly the same manner as sponsored agreements with any other company. Companies in the Mission Bay research park are able to secure some specific services through UCSF; however, these services are not related to independent or collaborative research under a sponsored agreement.
1.4. Conflict of interest
Conflict of Interest (COI) in partnering with a company can be complicated, and include a wide array of financial concerns. Industry-related conflicts of interest can be different from those you have encountered in other situations. Learn more about Conflict of Interest policy
- How do Conflict of Interest rules limit what I can do?
Investigators who work closely with industry should be aware of the conflict of interest policies in effect at UCSF. A financial conflict of interest refers to a situation in which an investigator has private financial interests that may bias, or be perceived to bias, the design, conduct, or reporting of the investigator's research. To guard against conflicts of interest, federal regulations, state laws, and University policies require all investigators to submit financial disclosures at the time that a research proposal is submitted, annually, when new interests are acquired and/or when new personnel are added to a project.
Under California State Law, the potential for a conflict of interest exists when a faculty member receives research funding from a company or other private entity AND s/he (or his/her spouse, domestic partner or child):
- Receives income or consulting fees over $500;
- Has a direct investment (including stocks or options) in the company sponsor valued over $2000;
- Serves as a director, officer, partner, trustee, or employee, or holds any other management position with that company;
- Travel reimbursement for personal travel (research-related travel, including presentation of results at conferences, is legitimate and can be included in the sponsored research budget;
- Received personal gifts valued at $50 or more;
- Has an outstanding loan with the company.
Under federal regulations, an investigator receiving research funding from the National Institutes of Health, Public Health Service, or National Science Foundation must disclose income over $10,000 annually or 5% equity ownership in any company whose work appears reasonably related to the proposed research. All disclosures are reviewed by the UCSF Chancellor's Conflict of Interest Advisory Committee (COIAC), which may make recommendations to reduce, mitigate, or eliminate the conflict of interest. Learn more about Conflict of Interest policy
- What is UCSF’s policy on an industry sponsor giving gifts to me or to people in my research group, paying for travel, or funding educational programs?
UCSF has adopted stringent policies to avoid the real or perceived existence of a conflict of interest through the receipt of various forms of support and tokens of appreciation. This includes specific definitions of gifts and the conditions under which such support can be accepted. See UCSF Industry Relations Policy
- I have already received research funding from a company, for which the budget included travel to conferences. I have charged the cost of travel to a conference to that account. Is this reportable as travel received as gift or income on the 700-U PI conflict-of-interest form?
Neither; the conflict-of-interest form refers to travel expenses paid directly to you, which is either "income" if it was compensation for work that you did that is considered greater than the value of the travel, or "gift" otherwise. However, travel that was included in your research budget, which was reimbursed to you from a UCSF account based on your industry funding, is a research cost and is not reportable as a conflict of interest. Check "no" to this question on the 700-U form.
- How do Conflict of Interest rules differ between clinical and non-clinical studies?
Any investigator receiving private funding for a clinical study must disclose according to state laws AND eliminate all income/equity/management relationships DURING THE STUDY. An investigator conducting a privately sponsored, non-clinical study must disclose per State laws. The UCSF Chancellor's Conflict of Interest Advisory Committee (COIAC) will determine what, if any, conflict management strategies are necessary. An investigator may (usually) consult for a company sponsoring their research if the topics do not overlap, the study is non-clinical, and all financial relationships are disclosed. The COIAC and the Executive Vice Chancellor determine whether the consulting activities are acceptable. The strict ban applies only to clinical studies.
- What about my lab personnel?
For industry sponsored research, only the principal investigator (PI) is subject to the State Conflict of Interest Regulations under the Fair Political Practices Act. The Laboratory personnel, if listed by name on the Committee on Human Research (CHR) protocol, could undergo a conflict of interest review under the (CHR) COI requirements.
- What about my family (e.g., does the company have to fire my mother)?
Spouses, domestic partners, and children are subject to the same restrictions as the principal investigator (PI). Parents and other extended family are not restricted.
- Can I consult for the company that is sponsoring my research?
Clinical Research: Under UCSF policy, any investigator who participates in a privately sponsored clinical study may not CONCURRENTLY receive any compensation from the sponsor, including honoraria and consulting fees, while the study is ongoing. Furthermore, an investigator may not serve in a decision-making capacity (i.e., member of the Board of Directors, employed in a management position, etc.) with the sponsor during the course of the study.
Basic Research: Under UCSF policy, any investigator who participates in a privately sponsored basic research study may CONCURRENTLY receive compensation from the sponsor, including honoraria and consulting fees, while the sponsored study is ongoing as long as such compensation is not for activities related in any way to the sponsored research. The compensation must be reported to the COIAC, and it will be investigated to confirm that it is not related to the sponsored research.
- Should an industry sponsorship influence the way in which I design my experiments for the project?
If a company is sponsoring your research that explores the potential use of a drug or other product for which the company owns intellectual property, it makes it more important than ever to design blinded experiments as much as possible. Even if the procedural details make it difficult to bias the results of the experiment, the perception from the outside will always be skeptical if you show results that could benefit the company. This should be recognizable to anyone who reads publications like Consumer Reports or the UC Berkeley Wellness Letter: "...the results showed therapeutic benefit but the study was funded by [the company]" (code words for "you can't necessarily trust these results"). If everything is as blinded as possible, even if you don't feel it needs to be, it will reduce the chances of these caveats being raised.
2.0. Industry-sponsored clinical trials
2.1. Conducting an investigator-initiated clinical trial with a compound/device from industry
UCSF generally uses the definition provided by ClinicalTrials.gov. An industry-initiated clinical trial is designed and funded by pharma, biotech, or other private entities. An investigator-initiated clinical trial is designed by the investigator or in collaboration with industry, and might be funded by industry.
- What clinical trial resources are available?
As knowledge and technology advance, performing clinical and translational research involves an increasingly complex regulatory environment. CTSI Regulatory Knowledge and Support Consulting is available to help researchers understand and meet the many regulatory and compliance requirements in the pre-award and post-award process.
- Clinical Research Resource HUB
- CTSI Clinical Research Services
- 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, contact your department's representative at the Office of Innovation, Technology & Alliances (ITA).
- For assistance with submitting committee approval requests to the Committee on Human Research (CHR), IACUC, or any of the Technical Committees, please contact the respective office or your department's research administrator.
- For assistance with Biostatistics, research ethics and design, and more, Consultation Services can help investigators at UCSF and affiliated CTSI institutions meet these challenges successfully and produce research of the highest scientific and ethical standards
- For additional help finding research resources, Talk to a Research Navigator
The FDA offers the following internet resources for answers to questions about investigational device studies, humanitarian devices and other clinical uses of unapproved devices:
- Federal regulations (21 CFR Parts 50, 56, 812, 814, etc) and FDA Information Sheet Guidance for Institutional Review Boards (IRB), Clinical Investigators, and Sponsors
- General information regarding device regulations
- Information on off-label use of medical devices
- Significant risk guidance, including examples of SR (Sponsored Research) and NSR (Non-funded sponsored research) device studies
- Procedural guidance for IRBs requesting assistance from FDA in making the SR/NSR risk determination
- General guidance covering various IDE (Investigational Device Exemption) issues, including Early Expanded Access Policy (see Chapter III)
- Listing of all approved HDEs and HDE (Humanitarian Device Exemption) guidance documents
Contact numbers at the Center for Devices and Radiological Health with respect to IDE, HDE, compliance issues, and complaints are as follows:
- Investigational Device Exemptions/Humanitarian Device Exemption Staff: 240-276-4034. Also, contact this number to find out whether a device study needs an IDE approved by FDA.
- Division of Bioresearch Monitoring, Office of Compliance: 240-276-0125
- Office of Compliance for questions about Custom Devices: 240-276-0125
- If a company funds the research per patient as they are recruited, how do I pay for the initial costs of setting up the clinical trial?
An Industry Clinical Trial Pre-Startup Fee is allowable for two types of industry contracts: clinical trials and other clinical services. The fee covers actual costs that may occur prior to the start of the contract project, and are allowable whether or not a contract is finalized during the negotiation period and applies to the following charges: All start-up effort and material costs including, but not limited to, costs for protocol review, feasibility analysis, budget preparation and negotiation, preparation and submission of human subject protocol applications, Committee on Human Research (CHR) review fee, negotiation and execution of a clinical trial or other clinical service contract, and associated Facilities and Administrative Costs.
- What is a multi-center clinical trial?
A multi-center clinical trial is one that is conducted at more than one medical center or clinic.
- How do conflict-of-interest rules differ for clinical studies?
- Any investigator receiving private funding for a clinical study must disclose according to State laws AND eliminate all income/equity/management relationships DURING THE STUDY.
- An investigator conducting a privately sponsored non-clinical study must disclose per State laws.
- The UCSF Chancellor's Conflict of Interest Advisory Committee (COIAC) will determine what, if any, management strategies are necessary.
- An investigator may (usually) consult for a company sponsoring their research if the topics do not overlap, the study is non-clinical, and all financial relationships are disclosed.
- The COIAC and the Executive Vice Chancellor determine whether the consulting activities are acceptable. The strict ban applies only to clinical studies.
2.2. Protecting human subjects, data and specimens
You must obtain approval from the Committee on Human Research, and file various documents such as a Data Safety Monitoring Plan. Before materials can be transferred from the company, you must also work with the Office of Innovation, Technology & Alliances (ITA) to set up a Material Transfer Agreement (MTA).
- If I am not affiliated with a campus program who will review my protocol?
Any research conducted at UCSF must obtain the Committee on Human Research (CHR) approval.
- Does everyone participating in a trial need to be consented?
Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with information about humans is considered to be human subject research and requires review. All research on human subjects (including the use of bio-specimens, medical charts, and data) must be submitted to the Committee on Human Research (CHR) for review and approval prior to any contact with human subjects or any use of their specimens, records, or data. Depending on the nature of your research, you may need additional approvals. Find assistance and templates
- Do the subjects need to be told that there is industry participation?
Yes, funding sources must be disclosed in the informed consent and CHR application.
- What is a Data Safety Monitoring Plan (DSMP)?
A DSMP is a plan established to assure that each research study has a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of participants and the validity and integrity of the data. The DSMP should indicate specifically whether or not there will be a formal Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC). THE DSMP should contain:
- Study Risk Assessment
- Description of anticipated adverse events and their expected frequency
- Describe the steps you will take to minimize the risks/discomforts to subjects
- Description of safety monitoring
- Describe which research results, if any, will be made available to subjects and/or to their physicians
- Description of how AEs (adverse events) are graded
- Plan for AE reporting
- Describe who will perform the safety reviews: Individual versus Contracted Research Organization (CRO), or a Data and Safety Monitoring Board (DSMB).
- If a Data and Safety Monitoring Board is required, please include specified description.
See the Data Safety Monitoring Protocol Library for example plans
- What is the process to achieve approval from the Committee on Human Research (CHR) and what is the timeline?
- Do I need to develop a tissue or specimen bank?
Learn about specimen management at the Clinical Research Resource HUB.
3.0. Consulting for a company
3.1. Who is allowed to consult
Generally, PIs and academic personnel are allowed to consult for a company.
- Can I consult for a company?
All faculty and academic employees (faculty, specialist series, postdocs) may consult, subject to rules of their departments. Please note that any consulting agreements must be reviewed by your Dean's office and by Risk Management Services.
- Does there need to be an agreement in place to do so?
Yes. It is in the best interest of both you and your client to have a written agreement to avoid confusion, disagreement, and unpleasant surprises at a later date. Because consulting is an activity you do on your own time, the consulting agreement is personal to you and the University will not negotiate it for you. Nonetheless, is it important you do not sign a consulting agreement that puts you in conflict with your obligations to the University. To that end, both you and your client company should review Academic Affairs and/or School of Medicine consulting guidelines.
- Am I limited in the amount of time I can spend in such activities?
Yes. Each School has its own policy, with variations by Department. For example, the School of Medicine limits outside consulting activities to 21 days (168 hours) per fiscal year unless service is provided to governmental agencies. Please contact the Dean’s Office for your School.
3.2. Types of consulting
- What is the distinction between giving professional advice to a consulting firm for an hour and being a consultant for a technology company for an extended period of time?
Consulting typically involves giving expert non-proprietary advice, reviewing data, helping to design experiments, etc., for a biotechnology or similar company. That company is doing the primary research. Such relationships are frequently long-term relationships and are governed by contract. Providing non-proprietary knowledge in a given area to a consulting company that is attempting to learn about the important issues of your field is typically a less formal relationship, frequently a one-time fee-based conversation, and does not require an official agreement. (Any discussions with an outside entity that involve proprietary information are governed by strict University rules; contact Office of Innovation, Technology & Alliances (ITA) for assistance.)
- What is the distinction between consulting and collaborating?
A collaboration is mutually beneficial to both the investigator and the company, an agreement entered into to work on a project together. Consulting involves imparting expert knowledge to a project of interest to the company.
- Can I do both simultaneously with the same company?
This is allowed if the collaborative project does not overlap with the project under consultation. However, if either project is a clinical study, this is not allowed. If no money is exchanged then one can consult and do a collaboration if their consulting does not take place on campus or overlap with the research done on campus.
3.3. Compensation for consulting
It is important to spend some time thinking about what you would like to charge. In addition, you should be aware of a variety of logistical considerations that are described below.
- What is the difference between a consulting fee and an honorarium?
A consulting fee is compensation for consulting based on an official contract between the University and the consultee. It is governed by the Dean's Office compensation plan and cannot be paid directly to the consultant; it must be paid to the University and disbursed to the consultant according to departmental policy. An honorarium is a professional fee paid for services such as giving a talk or providing knowledge.
- Should I request a monthly or hourly consulting fee?
Because consulting is an activity you do on your own time, the consulting agreement is personal to you. The University will not negotiate it for you or advise you about any aspects of it other than its impact on your obligations to the University.
- How do I know what is a reasonable amount to charge for consulting?
Because consulting is an activity you do on your own time, the consulting agreement is personal to you. The University will not negotiate it for you or advise you about any aspects of it other than its impact on your obligations to the University.
- Does payment go to me or UCSF? Does it support salary or research costs?
The payment goes to UCSF initially. The consultant typically has the option of having the fee added to a paycheck or to have it deposited in an account for research support. Various taxes on the level of the School may apply depending on the amount and the situation.
4.0. Using industry technology
4.1. Testing a technology platform
- A company contacts me and offers to loan me a new technology platform to test either in my own laboratory or in the core facility that I direct. Is this okay?
Yes, if a contract defining the terms and conditions for the placement of the equipment on University property and the use of the equipment is executed by the University and the company.
- Do I need an agreement?
Yes; contact the Chief Procurement Officer (415-502-3037).
- Could I recharge for a service on the instrument if it goes in a core facility?
Please contact the Office of Innovation, Technology & Alliances (ITA) to determine whether it is permissible to recharge for use of the equipment or testing performed using the equipment. Serious legal penalties may apply for billing any government program for services if the equipment used was loaned or gifted to the University.
- Can I get education and training on the instrument as part of the deal?
- Can they remove it whenever they want?
No. Placement and removal of the equipment needs to be defined in a contract between the University and the company providing the equipment.
4.2. Contract Research Organizations (CROs)
- How can I find external research services to support drug and device development activities?
Check out the Preclinical CRO Vendor Program for pre-selected key research services for early translational research.
5.0. Licenses, technology assessment, and company formation
5.1. Disclosing and developing an invention
Although you made a new invention, under the prevailing State labor laws, you do not own it. The technology that you created at UCSF belongs to your employer, the Regents of the University of California, and it is managed as an asset of the State of California by UCSF's Office of Innovation, Technology & Alliances (ITA) Technology Management Group. This office has authority from the Regents to make all decisions regarding UCSF intellectual property. Thus the Office is responsible for determining what to do with the invention, including what kind of intellectual property protection to seek, if any, and whether forming a company based on the technology is warranted. It is imperative that you notify ITA about your invention before you describe it in a manuscript, meeting abstract or talk.
- Who will help me find a company who is interested in the invention I made?
If the Office of Innovation, Technology & Alliances (ITA) Technology Management Group determines the invention is a suitable candidate for commercial use and/or commercial development, the Office will develop and implement the necessary marketing strategy using its own information and contacts as well as any information you can provide about potentially interested companies.
- How do I know whether to further develop my invention myself, or with a partner?
Although many University inventions may be patentable, many cannot be licensed without more work being done to establish proof-of-concept. The more value the inventor can build in the invention by advancing it, the easier it will be to license and the more attractive the license terms will be for the University and the inventor (who shares in the resulting license income). The decision to develop your invention yourself or with an industrial partner is a function of whether you have the requisite know-how and resources available to you at UCSF to advance the technology. Partnering with a company can provide access to special expertise, reagents, assays, equipment, know-how, databases, people and funding that can make a significant difference to your technology while at the same time possibly providing an immediate licensee if the partner is sufficiently interested in your technology to exercise its commercial rights provided in the research agreement.
- What are the rules for income from unpatented software or apps?
See the UCSF policy: Campus License Income Distribution Plans for Unpatented Software and Publications Distributed as Apps (pdf 30KB) or contact Joel Kirschbaum with any questions.
5.2. Commercializing technology
Explore these sources of support and guidance:
- Does UC provide support for industry-university collaboration and innovation?
Yes, Research Initiatives offers Proof of Concept Commercialization Gap Grants (PoC Program) to fund innovations and discoveries at the cusp of commercialization that require a final demonstration of their commercial viability. Research Initiatives also oversees the UC Discovery Grant which is not currently available.
NIH funding opportunities for technology development are also available through the UC Center for Accelerated Innovation (UC CAI).
- What resources can I find here on campus?
- Customized expert feedback and advice, with funding to help drive promising early-stage research through the lengthy and complex process of translating ideas into patient benefit: Catalyst Awards for the Development of Diagnostics, Devices, Therapeutics and Digital Health
- UCSF researchers share insights on 5 keys to successful translational research: LaunchPad
- Knowledge, support and connections for scientists and clinicians to become entrepreneurs: Entrepreneurship Center
- Incubators, Startup in a Box, Bridging-the-Gap Awards and more: California Institute for Quantitative Biosciences (QB3)
- Are matching grants available to encourage academic/industry alliances in cases where the company might not be able to fully support the effort?
The NSF Industry-University Cooperative Research Program (IUCRP) may provide matching funding.