Conflicts of Interest in Sponsored Projects
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) - The "Individual and Institutional Conflicts of Interest in Sponsored Projects" 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 all LSUHSC-NO faculty members (including part-time, gratis, and visiting faculty), staff and other employees, house officers, and students (including post-doctoral fellows) who propose, conduct, or report the results of research or other sponsored projects on behalf of LSUHSC-NO, regardless of funding source. Conflict of Interest training is required every four years.
- Conflicts of Interest Training through KDS - for individials with KDS access
- Conflicts of Interest Training - self-study for those who do not have KDS access
Which form(s) must be submitted for all study team members?
Conflicts of Interest Attestation Form - COI Attestation forms should be submitted along with the following:
- New Grant Applications
- Renewal Grant Applications
- Supplemental Grant Applications
- New Contracts
- New Subcontracts
- Progress Reports
- Just In Time (JIT) Information
- Contract/Subcontract Amendments
- IRB applications
- IRB re-approvals
- IACUC applications (department-funded)
- IACUC re-approvals (department-funded)
Significant Financial Interest Disclosure Form - Significant Financial Interest (SFI) Disclosure forms must be submitted for all Public Health Service (PHS) funded applications or agreements at the time of submission to the Office of Research Services.
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 PHS Agencies: 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