COI: Guidance for Investigators

Clinical research, including clinical trials, poses special situations that require close scrutiny. The University is responsible for ensuring that human subjects are fully informed and not placed at additional risk because of financial interests on the part of the investigator(s). In addition to the disclosure requirements for federally sponsored research and privately sponsored clinical trials, individuals who are responsible for the design, analysis, conduct, or reporting of the results of research performed under a human subjects protocol must disclose whether or not they have a financial interest in or association with the sponsor or the company supplying the materials, drugs, or devices for the project.

If a potential conflict of interest is disclosed, the Independent Review Committee (IRC) on Conflict of Interest will determine which management strategies, if any, are appropriate. Strategies for management of potential conflicts of interest range from highly specific conditions for participation in the trial or research project to more abstract assurances of compliance. All are directed at ensuring integrity, protecting human subjects, and maintaining public trust. Since the informed consent document is considered the principal means by which to advise potential human subjects of any risks associated with their participation in a clinical trial protocol or research project, when appropriate, conflict of interest information is included in informed consent documents. For more information regarding the disclosure of potential conflict of interests in research involving human subjects, please refer to Disclosing Financial Interests: Clinical Trials. 

The Independent Review Committee (IRC) on Conflict of Interest strives to manage conflicts of interest by increasing the visibility and transparency of the conflict of interest review process to help assure the public of the integrity of research results. When individuals engaged in research submit manuscripts for publication, they should disclose any financial interests they have which are related to the research. The appropriate disclosure of an investigator's financial relationship with, or interest in, a company must be made in all relevant publications in any form, including electronic publications and presentations.

Researchers may want to consider including disclosure even in internal presentations at UCSD, starting at the level of the department, such as grand rounds or seminar presentations. A relationship with, or financial interest in a company is relevant and should be disclosed if

• The information in the publication or presentation could be perceived as potentially benefiting the company, or
• The company's technology/product is integral to the research being reported and the publication or presentation could be viewed as an endorsement benefiting the company.

For questions regarding disclosure in publications of research results, please refer to the Disclosing Financial Interests: Publication of Research Results.

Conflict of interest issues surrounding equity ownership are most prevalent in investigator start-up companies. Investigators may have significant financial interests, in the form of stock, stock options, or any other investment or ownership interest, in their own start-up companies. 

The Independent Review Committee (IRC) on Conflict of Interest anticipates that investigators involved in the formation of a start-up company may initially hold significant equity in the company. However, since the start-up company may reasonably be expected to benefit from the research funded in the investigator's laboratory, continued significant ownership beyond a brief, initial period is deemed automatically to constitute a conflict of interest that would be difficult to manage.

When an Investigator has financial interests that would reasonably appear to be directly and significantly affected by the sponsored project, the IRC may impose special conditions to manage the conflict of interest to minimize the effect of the financial interest on the design, conduct, or reporting of the sponsored project.

The IRC considers a number of factors in determining a management strategy including: whether or not the investigator's start-up company has scientific employees and facilities; whether the PI's combined roles of investigator, UCSD academic appointee, and company owner gives an appearance that there is insufficient separation between his/her academic research program and the company's business activities; and whether the company is sufficiently capitalized that it is no longer an early-stage start-up company. As soon as a start-up company has real value, and is successful in raising venture capital, the IRC expects the investigator's equity to be diluted. The IRC wants to ensure that investigators understand that it is not acceptable to have a significant financial interest in a company when sponsored research is directly related to the company's interest.

Management positions in a company impose ethical and legal responsibilities to act in the best financial interest of the company, which could result in a conflict with ethical and legal requirements to the University and to the sponsor of a research project. The appearance of a separation of responsibilities, and a real separation in fact, must be maintained.

It may be a conflict of interest for an award recipient to hold a management positionin a company connect or related to the research project. This includes not only titles like president, CEO, etc., but also the title of Chief Scientific Advisor or membership on a Board of Directors (mere membership on a scientific advisory board is often deemed permissible). While serving as a member of a corporate board is not in itself prohibited for University employees, conflict of interest policies are different from conflict of commitment policies in this area.

After review of the conflict of interest situation, the Independent Review Committee (IRC) on Conflict of Interest may determine that to manage the conflict of interest an investigator must step down from a corporate management position to minimize the effect of the financial interest on the design, conduct, or reporting of the sponsored project.

Investigators may consult and sign personal consulting agreements with outside entities as long as such consulting does not:

• Utilize University facilities
• Interfere with teaching and research responsibilities or with time commitments to the University
• Involve students or postdocs whom the faculty members are mentoring or advising
• Take precedence over prior obligations to the University, including obligations associated with intellectual property arising before, during or after the consulting period, and
• Is not prohibited in a plan developed by the Independent Review Committee (IRC) on Conflict of Interest to manage a specific conflict of interest.

However, there are limits on consulting for one's own start-up company, as well as other specific exceptions. Generally, investigators who have, or participate in, a privately sponsored clinical study shall not concurrently receive any compensation from the sponsor, including honoraria and consulting fees, during the course of the study. The IRC recognizes that researchers may believe that their work with human subjects is actually some distance away from the final trials of a specific product. There are occasional instances in which the IRC would agree, however the argument is only acceptable for very clear cases. Typically, such a case involves no treatment of patients but only the use for research of human tissue samples or diagnostic assays that are archival in nature and anonymous to the researchers.

If there is any risk of public misunderstanding and scandal, possibly due to mistaken or unethical reporting, the University must protect itself by enforcing the rule that there is to be "no consulting during human trials." Additional information on consulting is available on the University Interaction with Industry website or from the Office of the President.

Several of the larger federal agencies, in particular the NIH and NSF, have programs that support the research and development activities of small businesses. Under these funding mechanisms, small businesses are encouraged to partner with a research university to perform innovative research and/or to assist in technology transfer from the university.

The basic idea is a partnership between different independent entities and not the merger of the company's research with the research of the academic institution. Over the past few years, the San Diego campus has seen a dramatic increase in SBIR and STTR applications due to the significant funding available from these programs and the enhanced entrepreneurial activity of our investigators.

Some of these SBIR/STTR awards have produced complex situations with regard to financial conflict of interest issues. For example, it is not uncommon for the PI to have a personal business relationship with the small business entity as a founder, scientific advisor, shareholder, officer, etc. Such a situation generates concerns about whether the purpose of the sponsored agreement is to perform the company's immediate business activities. The Independent Review Committee (IRC) will review each situation on a case-by-case basis and where possible, recommend management strategies to manage or eliminate the conflict of interest.

With careful review and endorsement of the Department Chair (or faculty designee), graduate students and postdoctoral scholars may be allowed* involvement in a company in which their dissertation adviser or faculty mentor has a significant financial interest, as long as there are safeguards in place, such as:

1. A dissertation co-chair (with no interest in the same company) has been assigned to supervise the progress of the graduate students;
2. The Department Chair or faculty designee or dissertation co-chair can confirm there is no overlap in scope and the student’s dissertation;
3. Dissertation, or research project being performed by student in the mentor’s lab may not overlap with the invention or mission of the company; and
4. Disclose interest(s) in Kuali COI, as applicable.

In accordance with the UC Patent Policy, all University employees must assign inventions and patents to the University, except those resulting from permissible consulting activities without use of University facilities. As soon as a potentially patentable invention is identified, Office of Innovation and Commercialization should be notified. The Office of Innovation and Commercialization has detailed information on how to make a disclosure of a new technology. When completed, the Invention and Technology Disclosure Form serves as the foundation for your invention disclosure. It documents the circumstances under which your invention occurred and provides the information necessary to evaluate inventorship, desirability of obtaining patent coverage, and obligations to research sponsors outside the University.

The Independent Review Committee (IRC) on Conflict of Interest believes that a rich innovation pipeline plays a pivotal role in a University's ability to commercialize its research. Nevertheless, the core mission of UCSD is education, public service, discovery research and the dissemination of knowledge. University research tends to be oriented toward basic research that addresses long-term, fundamental scientific discovery and knowledge. Still, the campus has developed very strong corporate relationships and, as a result, many companies have been founded either through our researchers, staff and alumni or through intellectual property (IP) generated here.

However, some academic researchers may be conflicted by the recent focus on commercialization, feeling that it might impede research in areas with a lower probability of direct-market applicability which could lead to advances in fundamental scientific knowledge. The members of the IRC represent a range of viewpoints and work to promote an effective compromise.