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 4/11/2017 - 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.
The COI Team Member Form must be completed and submitted with projects (see list below for details) that are routed to the Office of Research Services. Each team member listed on the form will be assigned a COI/SFI form in COI Risk Manager. COI Risk Manager is the online COI disclosure software that is in compliance with CM-35.
If you indicate on the COI Team Member Form that an external institution is listed on the Federal Demonstration Partnership (FDP) website, please provide a printout from the FDP website as evidence of compliance with the PHS FCOI policy for the external institution. Individuals affiliated with an external institution that has a compliant PHS FCOI policy are not required to complete a LSUHSC-NO COI/SFI form.
COI Risk Manager Link for LSUHSC-NO Team Members: https://lsu.coiriskmanager.com/
COI Risk Manager Link for External Team Members: https://lsuexternal.coiriskmanager.com/
COI training is required every four years.
- Conflicts of Interest Training through KDS - for individials with KDS access
- Conflicts of Interest Training for those who do not have KDS access, go to the ORS Training page for self-study course and test.
Which form(s) must be submitted for all study team members?
Conflicts of Interest Attestation Form - COI Attestation forms are required for the following:
- 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, re-approvals, and CIP
- IACUC applications, renewals, and CIP
- IBC applications, renewals, and CIP
Significant Financial Interest Disclosure Form - Significant Financial Interest (SFI) Disclosure forms are required for all Public Health Service (PHS) funded applications or agreements.
PHS agencies include:
- Agency for Healthcare Research & Quality (AHRQ)
- Agency for Toxic Substances and Disease Registry (ATSDR)
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- Centers for Medicare and Medicaid Services (CMS)
- Indian Health Service (IHS)
- National Institutes of Health (NIH) - including all Institutes and Centers within NIH
- Office of the Assistant Secretary of Health (ASH)
- Office of the Secretary
- Program Support Center (PSC)
- Substance Abuse and Mental Health Services Administration (SAMHSA)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
Link to Each PHS Agency's Website: http://www.usphs.gov/aboutus/agencies/hhs.aspx
Is there any additional information required?
If you answered “yes” to a question on the COI Attestation Form and/or indicated an SFI on the SFI Disclosure Form, you must submit documentation in sufficient detail to allow evaluation of the interest. This includes, but is not limited to:
- 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 Conflicts of Interest (COI) and/or Significant Financial Interest (SFI) Disclosure forms have been submitted to the Office of Research Services, they will undergo an initial review. If necessary, they will be reviewed by the Conflicts of Interest Committee. The Committee will determine whether there is a conflict and whether a Resolution/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