Research COI
Individual COI
The Conflict of Interest (COI) Office seeks to promote objectivity and maintain the credibility of investigators. “Investigators” include the principal investigator (PI), project director, key personnel and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of a Project as defined in section II. Definitions of Selected Terms of the University’s Policy on Individual Conflicts of Interest and Commitment.
With the size and breath of the University’s research portfolio, Section V.H of the Policy on Individual Conflicts of Interest and Commitment, Research and Sponsored Projects, is the most heavily used section along with its corresponding SOPs.
COI Study Specific Process
- Individuals receive email notification to complete a COI disclosure upon submission of an Office of Sponsored Programs (OSP) proposal (IPF) or IRB application (IRBIS).
- Individual answers the questions on COI disclosure form in order for disclosure to be received into the online AIR (Activities, Interests and Relationships) system.
- Once disclosure is received into the online AIR system, the form is assessed by the system for positive responses.
- If no conflicts are indicated, emails indicating no conflict are sent automatically.
- If information is included about a possible conflict, the form is triaged for review by the COI staff within the Conflict of Interest Office.
- Every disclosure starts with an Administrative Review. Depending on the nature of the potential conflict, the disclosure may go through additional reviews, starting with a COI Chair, the applicable COI Committee or a designated reviewer. Each disclosure is reviewed on a case-by-case basis.
- Determinations are returned for each individual. The status is reflected into the related research system such as IRBIS (human study) or RAMSeS (sponsored project).
Checking “yes” on a conflict of interest disclosure form does not necessarily put an investigator at risk of losing funding. Sometimes it is determined that no conflict exists. At other times the conflicts can be managed through a combination of oversight and disclosure.
Please note that individuals working in a research study might be required to complete several COI disclosures, each associated with different RAMSeS proposals and/or IRBIS applications. Per federal regulations (OSP) and accreditation requirements (OHRE), a COI review is required for each research study or project. Many RAMSeS projects can support multiple IRB applications. While, at the same time, IRB applications can have multiple funding sources in RAMSeS. Therefore a 1:1 relationship between the two systems is rare. While investigators might consider all of it one research study, the University considers the RAMSeS proposals and IRBIS applications independently, and thus more than one COI disclosure may be required for each individual working in a research study.
Automated Reminder Notifications
IRBIS and RAMSeS are configured to send out reminder email notifications once a study-specific disclosure has been initiated.
Checking Status of Individual Research COI reviews
- RAMSeS proposals and awards
- RAMSeS – Compliance Tab/Conflict of Interest (COI) Grid
- IRBIS applications
- IRBIS – Personnel Tab/Conflict of Interest (COI) Grid
Human Studies
Similar any any aspect related to human studies, there is a higher standard for any individual with conflicts to be involved in human studies. There is particular concern regarding the use of licensed intellectual property by inventors or when there is also equity interest held by the investigator which is related to the study or where the results of the study could benefit the company.
Participation as an investigator with a conflict would require at minimum meeting a threshold of Compelling Circumstances as detailed in the Policy. If compelling circumstances threshold is met, additional management requirements are usually determined, including separation from particular study activities. Transparency is the informed consent is a requirement and expected for any human subject study.
Determination Letters
COI determination letters are sent to individuals after the completion of the review, as detailed in the SOPs. If it’s a new conflict, a signed management plan must be obtained from the investigator before the COI determination letter can be sent out.
The COI finalization letter will contain a determination, an acknowledgement of existing management, or text indicating the need for new (or revised) management to be established. Any management terms, such as public disclosure, are included in the letter and are immediately applicable upon transmission to the Investigator via the email. Informed consent text for human studies is included in this letter and is subject to approval by the reviewing IRB.
When a COI Finalization email is sent, the status is reflected immediately in the related research system at OSP or the IRB.
COI Review Completion Required
In accordance with federal regulation and regulatory standards, COI review must be completed before any sponsored project is funded or before an IRB study can move to final review. Accordingly the Offices of Sponsored Programs and Human Research Ethics have “hard stops” built into their related online systems such that studies or projects cannot move forward until all COI disclosures have a completed status.