Conflict of Interest Policy: Other Policy Considerations
This section addresses various items related to the policy. It touches on CCIR Membership, Record Retention, Publication, Students/Trainees, Human Subjects, and Special Considerations for Faculty Start-up Companies.
The CCIR is comprised of one faculty member from each school, the Director of Research Administration, the Sr. Director of Technology Transfer and Industry Collaboration and an attorney from the University General Counsel. Faculty members are invited by the Vice Provost for Research to serve an indefinite term.
The Executive CCIR Subcommittee consists of the Director of Research Administration, Sr. Director of Technology Transfer and Industry Collaboration and the General Counsel to expedite reviews and to act as an initial review committee before bringing an issue to the committee of the whole.
The CCIR Chair submits a quarterly report to the CCIR detailing the actions taken during the quarter. Additionally, the CCIR Chair will bring to the attention any items requiring the CCIR’s review and actionable recommendations.
In the event the CCIR requires a meeting, it can be accomplished by means of being physically present or on a teleconference. A quorum is 51% of the committee.
The OVPR will retain records of all financial disclosures and all actions taken by the University with respect to conflicts of interest.
The University is required to keep all records as follows:
- For grants or cooperative agreements – for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 45 C.F.R. 74.53(b) for different situations
- For research contracts – for three years after final payment or, where applicable, for the other time periods specified in 48 CFR part 4, subpart 4.7.
The University requires in all its contracts for support of research or education that the researchers be free to objectively analyze and publish all results of their work. The University may accept reasonable delays on publication (normally not to exceed 90 days) that allow for the protection of intellectual property, the deletion of confidential information provided by a research sponsor or for the completion of a multi-site clinical trial.
An important part of the training of graduate students and postdoctoral fellows is mentored research. The University and the faculty who oversee student research must insure that the educational interests of these trainees are not compromised by institutional or individual conflicts of interest. Care must be taken to insure that the source of research funding does not cause a change in the training experience. Students and fellows should not be placed in a situation where publication will be unduly restricted or excessively delayed (any delay greater than 90 days will be considered excessive) or where the financial interests of the company or the mentor will influence the direction of the research project. Students must be able to publicly present dissertations and theses and to publish their research.
In a situation where a student is to work on a corporate sponsored research project in which his or her advisor has a financial interest, prior approval from the student’s Department Chair is required. The financial interest must be disclosed to both the Chair and the student prior to beginning the research project. If the Chair approves of the involvement of the trainee in that research and the trainee is a graduate student, the Chair will inform the student’s thesis committee. If the individual is a fellow or a student who does not have a thesis committee, the Chair will work with the CCIR in developing a management plan that will ensure the PI informs, in writing, students and postdoctoral trainees funded from this source about the conflict of interest, and in doing so inform the trainees that should they have concerns, they should contact their Department Chair or the Director of the graduate program in which they are enrolled.
In situations where a faculty member obtains or owns equity in a company that relates to his or her research, it is especially important to be mindful of conflicts of interest and conflicts of commitment. Care should be taken to keep sight of what is the property of the University versus what belongs to the company. The faculty member should assure that time invested in the company does not exceed the amount of time allowed for outside activities under the conflict of commitment policy and does not compromise his or her ability to perform his or her regular duties and obligations to the University, to funding agencies or to students. A faculty member whose company was awarded a SBIR or STTR where the University is the subrecipient, cannot be the Principal Investigator for the company and the University. The faculty member can be the PI for one or the other but not both. University facilities and resources may not be used for the benefit of the company without a written agreement authorizing the use approved by the dean and the vice provost.
Faculty members and staff who own equity in a company should not personally negotiate or attempt to influence the licensing terms that the University offers to that company. An attorney or executive of the company with no connection to the University should be used for that purpose. The needs and interests of students and fellows must be carefully considered. The Office of the Vice Provost for Research will work closely with faculty members who are starting companies and the faculty members’ deans. Normally, a special conflict of interest oversight committee may be convened and meet at least annually as long as the faculty member remains involved with the company. This committee will be a subcommittee of the CCIR and should consist of one member of the CCIR and two individuals who are familiar with the area of research. The subcommittee will report annually to the CCIR. Alternatively, in lieu of the subcommittee, the CCIR Chair can work with the Investigator and submit the plan to the CCIR committee for review. Once the plan is approved and in place, the Chair may ensure annual reports are conducted and submitted to the CCIR.