Conflict of Interest for Kuali IRB
Guidance and reference of Conflict of Interest for Kuali IRB.
Potential Conflict of Interest (COI) Definition
Any Researcher including their spouse or registered domestic partner, and/or their dependent children, participating in human subject research and have a potential conflict of interest, which refers to a situation in which outside interest(s) may compromise, or have the appearance of compromising, a Researcher's professional actions or judgments in the design, conduct, or reporting of their research results must disclose a conflict of interest in Kuali COI. Interest(s) also includes being an inventor of a UC San Diego intellectual property being used in the human subjects study.
Conflict of Interest (COI) in Kuali IRB
All study team members are listed in Study Personnel in Kuali IRB application. Those Researcher’s with a conflict of interest* will need to mark “yes” under the conflict of interest question within Kuali IRB. The Kuali IRB’s potential COI question is not linked to Kuali COI.
The Principal Investigator with support from the study team are responsible to ensure COI disclosure(s) are in place before human subject studies begin.
How to determine the triggering of Kuali COI disclosure for a specific Human Subjects project
Depending on funding source, type of activity and role of an individual on a project, please refer to the applicable table for guidance and instruction:
Federally Funded Projects* |
|||
|---|---|---|---|
|
Role |
Mandatory COI disclosure required? |
Will Kuali COI trigger COI disclosure? |
Kuali COI System Requirements |
|
Principal Investigator |
Yes |
Yes |
Must be listed in “Key Personnel” in KR PD |
|
Co-Investigator |
Yes |
Yes |
Must be listed in “Key Personnel” in KR PD |
|
Senior Key |
Yes |
Yes |
Must be listed in “Key Personnel” in KR PD |
|
Non-Senior Key (i.e., other study team members) |
No |
No |
Do NOT include in KR in PD |
*All PIs, Co-PIs, Co-Is and Senior Key must be in Kuali Research (KR) in Proposal Development (PD). Once added Kuali COI will send an email to the Discloser and their previously assigned Delegates.
Industry and Non-Profit Funded Projects |
|||
|---|---|---|---|
|
Role |
Mandatory COI disclosure required? |
Will Kuali COI trigger COI disclosure? |
Kuali COI System Requirements |
|
Principal Investigator |
Yes |
Yes |
Must be listed in “Key Personnel” must be designated as “Principal Investigator” in KR PD |
|
Co-Investigator |
No |
*If a person has an interest(s) |
**Request for a Manual Project the specific person be created by sending an email to info-coi@ucsd.edu |
|
Senior Key |
No |
*If a person has an interest(s) |
**Request for a Manual Project the specific person be created by sending an email to info-coi@ucsd.edu |
|
Non-Senior Key |
No |
*If a person has an interest(s) |
**Request for a Manual Project the specific person be created by sending an email to info-coi@ucsd.edu |
*Any Researcher including their spouse or registered domestic partner, and/or their dependent children, participating in human subject research and have a potential conflict of interest, which refers to a situation in which outside interest(s) may compromise, or have the appearance of compromising, a Researcher's professional actions or judgments in the design, conduct, or reporting of their research results must disclose a conflict of interest in Kuali COI.
**Do NOT include in KR PD as Kuali COI will NOT trigger a COI disclosure for this role. Once a manual project is created by the COI office then the discloser and their delegates will get an email from Kuali.
Human Subject Researchwithout any external funding source |
|||
|---|---|---|---|
|
Role |
Mandatory COI disclosure required? |
Will Kuali COI trigger COI disclosure? |
Kuali COI System Requirements |
|
Any Study Team Member |
No |
*If a person has an interest(s) |
Request for a Manual Project the specific person be created by sending an email to info-coi@ucsd.edu |
*Any Researcher including their spouse or registered domestic partner, and/or their dependent children, participating in human subject research and have a potential conflict of interest, which refers to a situation in which outside interest(s) may compromise, or have the appearance of compromising, a Researcher's professional actions or judgments in the design, conduct, or reporting of their research results must disclose a conflict of interest in Kuali COI. Interest(s) also includes being an inventor of a UC San Diego intellectual property being used in the human subjects study.
Sponsored Research and Other Related Activities for Kuali COI
There are two ways to trigger a COI disclosure for sponsored research and other related activities:
- The proposal creator enters a proposal in Kuali Research (KR) in Proposal Development (PD)
- Inform the COI office a manual project is required by sending an email to info-coi@ucsd.edu
|
Activity Type |
Kuali COI Mechanism |
Kuali COI System Requirements |
|---|---|---|
|
Sponsored Research |
Kuali Research in Proposal Development |
Must be listed in “Key Personnel” KR PD |
|
Unfunded Agreements |
Kuali Research in Proposal Development |
Must answer the COI question Compliance Questionnaire in KR. If “yes” is marked then Kuali COI will trigger a disclosure request via email. |
|
Health Science Service Agreements |
Manual Project |
Health Science Business Contracting informs the COI office to create a Manual Project in Kuali COI. Kuali COI sends an email to the Principal Investigator. |
|
General Campus Service Agreements |
Kuali Research in Proposal Development |
Must answer the various COI questions in Compliance Questionnaire in KR. If “yes” to gating COI question is marked then Kuali COI will trigger a disclosure request via email. |
|
Gifts |
Manual Project |
Advancement informs the COI office to create a Manual Project in Kuali COI. Kuali COI sends an email to the Principal Investigator. |