Conflicts of Interest in Research
LSUHSC-NO encourages faculty, staff, students, house officers, and other employees to participate in meaningful professional relationships with industry, government, and private entities. These relationships are established for mutually beneficial reasons and many times produce knowledge and intellectual property that will help the community at large. However, these relationships may create financial or non-financial interests that have the potential to create a bias in decisions.
Chancellor’s Memorandum #35 (CM-35) Update 2/26/2018 - The "Conflicts of Interest (COI) in Research" policy seeks to maintain a reasonable balance between competing interests, gives LSUHSC-NO the ability to identify and manage financial and non-financial interests, and minimizes the reporting and other burdens on investigators. This policy meets the federal regulations governing the disclosure and reporting of financial conflicts of interest.
This Policy applies to and requires compliance by all LSUHSC-NO administrators, faculty members (including parttime, gratis, and visiting faculty), students (including post-doctoral fellows), house officers, staff and other employees, as well as immediate family members of these persons, who propose, conduct, report, or approve of the results of research, regardless of funding source.
Non-LSUHSC-NO personnel participating in LSUHSC-NO research must also follow this policy unless they are affiliated with an institution listed on the Federal Demonstration Partnership (FDP) website. The FDP website lists institutions whose authorized official have certified that they are compliant with the PHS Financial Conflict of Interest rules and regulations.
The COI Team Member Form must be submitted with projects (see list below for details) that are routed to the Office of Research Services. Each person identified on the COI Team Member Form must have a current electronic COI form on file in the COI Risk Manager system or must complete an electronic COI form in the COI Risk Manager system. Electronic COI forms must be completed annually and upated within 30 days of discovering or acquiring any new or previously undisclosed Significant Financial Interest or actual or potential Conflict of Interest. COI Risk Manager is the online COI disclosure software that is in compliance with CM-35.
Anyone (including non-LSUHSC-NO personnel) who will propose, conduct, report, or approve of the results of research must be listed on the COI Team Member Form.
A COI Team Member Form must be submitted with the following projects that are routed to the Office of Research Services:
- New Grant Applications
- Renewal Grant Applications
- Supplemental Grant Applications
- New Contracts
- New Subcontracts
- Progress Reports
- Just In Time (JIT) Information (when sponsor has scored application in possibly fundable range - for NIH, a score of 25 or less)
- Contract/Subcontract Amendments
- IRB Applications and Re-approvals
- IACUC Applications and Renewals
- IBC Applications and Renewals
- Change in Personnel
COI Risk Manager Link for LSUHSC Personnel: https://lsu.coiriskmanager.com/
COI Risk Manager Link for Non-LSUHSC Personnel: https://lsu.coiriskmanager.com/login.aspx
COI training is required every four years.
- Conflicts of Interest Training through KDS is required for anyone who is involved in LSUHSC-NO research. Non-LSUHSC-NO personnel must also complete the training if their institution is not listed on the FDP website.
Non-LSUHSC-NO personnel need to be assigned a LSU logon ID to complete the required training in KDS. PI's should contact their business manager and ask him/her to add the non-LSUHSC-NO person to their research collaborators affiliation. If a research collaborators affiliation does not already exist for the department, the business manager should submit a request to Information Security to create a new external affiliation for their department. The business manager should refer to this document when requesting a new external affiliation: https://intranet.lsuhsc.edu/it/security/docs/lsuhsc_extaffreq.pdf
Is there any additional information required?
If you answered “yes” to a question on the electronic COI form, please provide full disclosure on the electronic COI form. Examples of full disclosure are listed below:
- A description of the nature of the activity
- The entity involved
- The amount of remuneration received
- Patent information, if applicable
- The time frame of the activities
- PM-11 and/or PM-67 disclosures, if applicable
What happens once forms are submitted?
Once an electronic COI form has been submitted to the Office of Research Services, it will undergo an initial review. If necessary, it will be reviewed by the Conflicts of Interest Committee. The Committee will determine whether there is a conflict and whether a COI Management Plan must be implemented. If a plan is necessary, the Committee will draft a plan which will be sent to the investigator for review and signature, before being signed by the appropriate institutional officials. For projects that require IRB approval, the mangement plan must also be approved by the IRB.
- NIH Conflict of Interest Policies - NIH and federal policies on reporting Conflicts of Interest
- Responsible Conduct in Research – Conflicts of Interest - General information on Conflict of Interest available from the Office of Research Integrity
- List of all Public Health Service Agencies: https://research.gwu.edu/list-phs-funded-agencies
- Federal Demonstration Partnership (FDP) Website: http://thefdp.org/default/fcoi-clearinghouse/compliant-entities/