Promoting Research Objectivity (PRO) FAQs
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Promoting Research Objectivity (PRO) FAQs
- What is a Research-Related Conflict of Interest (COI)?
What is the Promoting Research Objectivity (PRO) committee?
The Promoting Research Objectivity Committee (formerly known as the Conflict of Interest Committee), is responsible for the review and assessment of all financial disclosures related to research projects at UC Riverside, as well as determining any actions required to ensure that real or perceived financial research-related conflicts of interest are managed, reduced or eliminated.
- How are Research-Related COIs and Conflict of Commitment (COC) related?
What is a Financial Conflict of Interest (FCOI)?
In accordance with the University of California Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Public Health Services Sponsored Awards for Research (42 C.F. Part 50, Subpart F and 45 C.F.R., Part 94): The Principal Investigator and all other UCR investigators must disclose their personal significant financial interests (and those of their spouse/registered domestic partner and/or dependent children) related to their institutional responsibilities. This includes the Principal Investigator, Co-Investigators, Senior and Key Personnel, and any other individual who is responsible for the design, conduct, or reporting of research funded by PHS or an agency or organization that follows PHS disclosure requirements (for example, American Heart Association, American Cancer Society, etc.). This Form is to be completed by the Principal Investigator, and those Project Personnel designated by the Principal Investigator as an Investigator, as defined by the 2011 Revised PHS Regulations.
How are FCOI’s managed?
After PRO determines that a financial interest rises to the level of a financial research-related conflict of interest, PRO will create a management plan recommendation. The PRO Committee works with the Investigator to create the management plan that strives to be the simplest effective means of managing the conflict. Each management plan is situation-specific which is why it requires cooperation between the Investigator and PRO.
The PRO Committee submits a recommendation to the VC-RED. The VC-RED will determine whether the management plan is sufficient and if so, the plan is presented to the Investigator. The Investigator will be required to review the plan and sign that they agree to comply and implement the plan.
What are some general principles to keep in mind when starting a company?
- Keep your company activities separate and distinct from UC faculty activities;
- Expect your company to be treated exactly like any other company (the fact it’s partially owned by a UC faculty member does not give it any special privileges.);
- File a disclosure to evaluate potential conflicts and mitigate risk if necessary;
- Not all research-related conflicts are impermissible and most are manageable;
- When human subjects are involved, there will be a higher level of scrutiny;
- Case-by-case analysis and management is crucial;
- When in doubt, disclose to PRO.
Can I start a company?
Yes. UCR's research-related conflict of interest and conflict of commitment policies do not prohibit investigators from starting their own company, however depending on the type of research the investigator conducts, there may be conflict of interest disclosure requirements and approvals required. Please contact PRO for more information.
In the case individuals are looking for information related to these types of start-ups and entrepreneurial activities at UCR, they can be directed to RED’s 'Entrepreneurial Proof of Concept and Innovation Center’ (EPIC) website and staff.
Can I serve on a board of advisors/directors?
Yes, UCR's research-related conflict of interest policy does not prohibit investigators from serving on a Board of Directors, Advisors, or similar. If this position also involves other financial interests such as income or equity interests, the investigator may have additional COI disclosure requirements. If PRO determines that these interests could potentially be a conflict of interest with the research, the Committee will require the investigator to take steps to manage, reduce or eliminate the conflict before the research can proceed. Investigators who are contemplating serving on a board should contact PRO as soon as possible to discuss possible conflict of interest issues related to their research.
Service on a Board of Directors carries with it legal fiduciary responsibility, but generally not management responsibility and hence, is generally permissible. The investigator’s primary commitment is to the University and service on a Board of Directors should not interfere with his/her primary obligations as a faculty member or university employee. For more information on COC, see this page provided by the Office of Academic Personnel.
Can I serve on a scientific advisory board?
Yes, serving on a Scientific Advisory Board is permitted because such positions do not carry, nor are they perceived to carry, management responsibility. The investigator, however, should recuse himself/herself from any discussion or decision to fund his/her own research. If this position also involves other financial interests such as income or equity interests, the investigator will have additional COI disclosure requirements.
Can I participate in research sponsored by a company that licensed technology I invented at UCR?
Yes. However, your participation in the research could be considered a potential research-related conflict of interest if you have a financial or equity interest in the sponsor. If you have financial interests in the sponsor, you may need to disclose and have the paperwork reviewed by PRO.
For a detailed summary of the thresholds, please see the State Law column in the UCR COI Disclosure Chart.
If you do not have a financial or equity interest in the sponsor, you will not need to be reviewed by PRO.
If you have any questions, please reach out and contact us so we may schedule a consultation.
What are some examples of mitigation or management plans to address COIs?
Here are some examples of how to address potential research-related conflicts of interest:
- Public disclosure of significant financial interests;
- Training on research-related conflicts of interest for all personnel involved in the research;
- Monitoring of research by independent reviewers;
- Double-blind study and/or randomized study
- Modification of the research plan to ensure objectivity;
- Have non-conflicted investigators collect data and perform data analyses;
- Remove oneself as the Principal Investigator;
- Disqualification from participation in all or a portion of the research;
- Divestiture of significant financial interests;
- Severance of relationships that create actual or potential conflicts
I serve as consultant to a company and want to test a product from that company. Does having non-conflicted investigators and the study being blinded assist in mitigating the conflict?
Yes, having a non-conflicted investigator and blinding the study will help mitigate the conflict; however, PRO will still need to review all the factors to determine if that is necessary and/or sufficient. As part of the PRO review, these are some but not all of the other factors the PRO will consider:
- Who has supervisory authority of all research personnel involved in the study?
- Are there any research personnel under the supervision of the conflicted individual?
- Is (Are) the non-conflicted investigator(s) junior to the conflicted individual?
- Are students involved and if so, who is supervising them?
- Who’s doing the data analysis, collection, and reporting?
- Are there Human Participants involved?
Depending on the level of risk created from the financial interest and how the study is designed, PRO may require additional measures to protect the objectivity of the research.
May I own stock in a publicly traded company and serve as an investigator on a study for that company’s products?
You could serve as the investigator on a study, however depending on who the sponsor of the study is and the percentage and/or the value of the stock, you may be required to disclose and go through a PRO review. For a more detailed summary of the thresholds, please see the UCR COI Disclosure Chart. If you have this type of situation, please contact us so we may schedule a consultation.
Through the university, I am an inventor on a patent. May I serve as an investigator testing its effectiveness?
Potentially yes, but it depends on the sponsor of the research. It also depends on whether you have a financial interest in the sponsor or one related to the research project, and how you would manage that financial interest. If you have a financial interest in the sponsor or one related to the research, your situation may need to be reviewed by PRO. If you have this type of situation, please contact us so we may schedule a consultation.
I’m a co-founder in a company that would like to provide funds to my lab at UCR through an industry-sponsored research agreement, am I allowed to do that? What should I be concerned about?
It depends. One thing you will need to be concerned about is making sure you do not represent both the university and the company in the industry-sponsored research negotiations or any business transactions. For example, we would probably recommend 1) your company hire a lawyer to represent the company in business transactions with university, or 2) your company include (or add) an individual without any university affiliation so when UC Riverside is working with the company, that person is the company representative.
However, please note that your participation in the research could be considered a potential research-related conflict of interest if you have a financial interest in the company and are the Principal Investigator or Co-Principal Investigator. If you, the Principal Investigator or Co-Principal Investigator of the study, have financial interests in the company, you will need to disclose and have the paperwork reviewed by PRO. If you have any questions, please contact us so we may schedule a consultation.
I’m a consultant to a company that would like to provide funds to my lab at UCR through an industry-sponsored research agreement, am I allowed to do that? What should I be concerned about?
Yes, it is allowable for the company to provide funds to your lab but that could potentially trigger a COI review. If you have a financial interest in the sponsor and you are the Principal Investigator (or Co-Principal Investigator), your disclosures may need to be reviewed and approved by PRO. If you have this type of situation, please contact us so we may schedule a consultation.
I own stock (have equity) in a company that would like to provide funds to my lab at UCR through an industry sponsored research agreement, am I allowed to do that? What should I be concerned about?
Yes, it is allowable for you to own stock or have equity in the company that would like to provide funds to your lab. However, if you do have a financial interest in the company and you are the Principal Investigator (or Co-Principal Investigator), your disclosures may need to be reviewed and approved by PRO. If you have this type of situation, please contact us so we may schedule a consultation.
I have a positive disclosure for my project that will be sent to PRO for review. When will I receive the results of the review, so my study funds can be released?
Depending on the nature of the disclosure, administrative review of submitted forms can take approximately 1 – 2 weeks after all supplemental forms have been submitted. For disclosures requiring full committee review, completion of the process will take approximately 4 – 6 weeks. See the PRO website for additional information on when the PRO committee meets.
When not reporting COIs, what are some of the potential risks?
If you have any concerns regarding COI issues, we strongly encourage you to contact our office immediately. There are significant risks involved for not reporting:
- Compromise of scientific integrity (objectivity of the research);
- Misuse of University facilities;
- Improper direction of student’s or University employee’s work;
- Unbalanced allocation of faculty member’s time and effort;
- Failure to recognize the University’s right to intellectual property and related financial interests;
- Improper channeling of research funds;
- Inappropriate delay or restriction on publications;
- Appearance of impropriety