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)  Updated 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 (FCOI).

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 FCOI rules and regulations. 

 

COI Risk Manager

COI Risk Manager is the COI disclosure software for LSUHSC-NO. 

Link for LSUHSC-NO Personnel:  https://lsu.coiriskmanager.com/

  • LSUHSC-NO personnel will be logged in automatically if they have an active account in the COI Risk Manager system.
     
  • If you are not logged in automatically AND you received an email notification from the COI Office, please contact the COI Office at COIOffice@lsuhsc.edu.
     
  • If you have not been notified by the COI Office, there is nothing you need to do at this time.  The COI Office will inform you if you need to complete a COI disclosure form.

Link for Non-LSUHSC-NO Personnel:  https://lsu.coiriskmanager.com/login.aspx

  • Non-LSUHSC-NO personnel should use their assigned username and password to access the COI Risk Manager system.
     
  • If you forgot your username and password, please contact the COI Office at COIOffice@lsuhsc.edu.

 

COI Team Member Form  

The COI Team Member Form must be submitted with projects (see list below for details) that are routed to the Office of Research Services.  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.  The COI Office will review the COI team member form to make sure each person listed on the form has been assigned an annual COI disclosure form in the COI Risk Manager system.

Each person listed on the COI team member form must have a current completed annual COI disclosure form on file in the COI Risk Manager system before they can be approved to work on a research project.  COI disclosure forms must be completed annually and updated within 30 days of discovering or acquiring any new or previously undisclosed actual or potential COI.

A COI team member form must be submitted with the following projects that are routed to the Office of Research Services.  Please note that some IRB submissions no longer require a COI team member form (contact the IRB Office regarding this).

  • 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

 

What Happens Once COI Forms Are Submitted?

Once a COI disclosure form has been submitted to the Office of Research Services, it will undergo an initial review by the COI Office to determine whether there may be a COI which must be managed.  Investigators may be required to provide additional information for this review.

If necessary, the COI disclosure form will be reviewed by the COI Committee.  The COI Committee will determine whether there is a COI and if a COI management plan must be implemented.  If a COI management plan is necessary, the COI Committee will draft a plan to reduce, manage, or eliminate the COI.  The COI management plan 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 management plan must also be approved by the IRB.

 

COI in Research Training

COI in Research training is completed in KDS and is required every four years and immediately when any of the following circumstances apply: (i) LSUHSC-NO revises this Policy to substantially change the requirements of Investigators; or (ii) an Investigator is new to LSUHSC-NO; or (iii) an Investigator is in noncompliance with this Policy or with a COI management plan.

  • COI in Research training 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 an 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


To Complete COI in Research Training:

  • If you are ON Campus, click on the link below and enter your Username (LSU logon ID) and Password:  https://intranet.lsuhsc.edu/ctms/kds/home/ .
     
  • If you are OFF campus, go to LSU’s Remote Access Portal at https://remote.lsuhsc.edu/ > Enter your logon credentials and select ‘Web Connect’ from the dropdown menu and Click ‘Sign on’> Select the ‘Knowledge Delivery System (KDS)’ link listed under your ‘Web Bookmarks.’
     
  • If you run into any issues with the training system, please contact Kelly Guth, Compliance Educator, at kguth@lsuhsc.edu or 504-331-5054.

 

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