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Office of Research Services

LSUHSC-NO Chancellor's Memorandum #35 (CM-35) - Conflicts of Interest in Research

Managing Potential Financial and Non-Financial Conflicts of Interest of Individuals and the Institution

Revised: March 4, 2018

LSUHSC-NO strives to provide the highest quality patient care, an excellent teaching environment for future health care professionals, and a vibrant climate for cutting-edge basic and clinical research. All research activities at LSUHSC-NO must adhere to the highest standards of ethical conduct, protect the rights of human subjects, minimize conflicts of interest, and ensure the public’s continued trust.

LSUHSC-NO encourages its personnel to participate in meaningful professional research relationships with industry, government, and private entities. These mutually beneficial relationships may generate vital biomedical knowledge or intellectual property that may benefit the public.

However, they also may create potential financial or non-financial conflicts of interest, on the part of either individuals or the Institution, that could appear to threaten:

All such potential or actual conflicts of interest related to research must be disclosed in advance of initiation of that research.

Please note that capitalized terms are terms that have specific definitions in the policy. Please refer to CM-35 for those definitions.

What is a Conflict of Interest?

A Conflict of Interest (COI) is any interest, financial or otherwise, of an individual or the institution which may have a potential or actual adverse impact on the objective conduct of a Research Project or Institutional Responsibilities.

What is a Significant Financial Interest (SFI)

One or more of the following Financial Interests of the Investigator, or his/her Immediate Family Member(s), that reasonably appear to be related to the Investigator’s Institutional Responsibilities, including the design, conduct, or reporting of Research Projects which may be sponsored either by an Entity or by the Institution.

  1. Any payment, in cash or in kind, received directly from any publicly traded OR non-publicly traded Entity in the twelve (12) months preceding the disclosure, or the ownership of any equity interest in the Entity as of the date of disclosure; or
  2. Income from intellectual property rights and interests (e.g. patents, copyrights) personally held by the Investigator or his/her Immediate Family Member and not owned or managed by LSUHSC-NO; or
  3. Any travel costs received in the twelve (12) months preceding the disclosure by the Investigator or his/her Immediate Family Member(s), related to the Investigator’s Institutional Responsibilities, which is reimbursed and/or sponsored by an Entity. Disclosure must include purpose of the trip, identity of the sponsor, destination, and duration of travel.

Note that LSUHSC-NO establishes no minimum thresholds for disclosure of a Financial Interest in an Entity:

Significant Financial Interest DOES NOT MEAN any of the following:

  1. Salary, royalties, or other remuneration paid by Institution to the Investigator, if the Investigator is currently employed or otherwise appointed by the Institution; or
  2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the mutual fund's investment decisions; or
  3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, a US institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education; or
  4. Income from service on advisory committees or review panels for a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
  5. Any reimbursed or sponsored travel costs received in the twelve (12) months preceding the disclosure by the Investigator or his/her Immediate Family Member(s), related to the Investigator’s Institutional Responsibilities, which is reimbursed and/or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education.
Dr. Chesterton

Scenario 1

Dr. Chesterton is a pharmacologist. He has a 403(b) plan which includes equity interest in a mutual fund that invests in the pharmaceutical industry as well as several other industries. Would this be considered a significant financial interest?

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Yes
No

What are my responsibilities as a team member of a research project with regard to conflicts of interest or potential conflicts of interest?

A research team member must:

  1. Disclose annually all Significant Financial Interests and all actual or potential Conflicts of Interest,for themselves or for their Immediate Family Members, which have occurred in the preceding twelve (12) months or which are expected to occur in the next twelve (12) months on the COI Risk Manager online form.
  2. Update their COI Risk Manager form within thirty (30) days of discovering or acquiring any new or previously undisclosed Significant Financial Interest or actual or potential Conflict of Interest for themselves or for their Immediate Family Members.
Dr. Jovanka

Scenario 2

Dr. Jovanka is a geneticist who has submitted a new research project. Does she need to submit a new COI form at this time?

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Yes
No

What additional responsibilities do I have if I am the Principle Investigator? on a research project?

The Principal Investigator must:

  1. Submit a COI Team Member Form listing each person who will participate in any conduct or reporting of the proposed Research Project. Each person identified on the COI Team Member Form must have a current COI Risk Manager form on file or must complete a form in the COI Risk Manager system within thirty (30) days of notification by ORS.
  2. Take responsibility for ensuring compliance with this Policy by all Investigators and study team members involved in a Research Project, including any new Investigators or study team members who later join an ongoing Research Project.
  3. Take responsibility for implementing the Conflict of Interest Management Plans developed by the Conflict of Interest Committee (CIC).

Procedures for Disclosure of Individual Conflicts of Interest

  1. At the time of submission of all Research Projects (grant, contract, IRB, IACUC, or IBC), the Principal Investigator must submit a COI Team Member Form which identifies each study team member involved in the proposed Research Project.
  2. COI Team Member Form

    COI Form image

    (Click or tap image for expanded view)

  3. Each person identified on the COI Team Member Form must have a current COI Risk Manager form on file or must complete a form in the COI Risk Manager system within thirty (30) days of notification by ORS. (See #1 and #2 under "What are my responsibilities as a team member of a research project . . ." above.)
  4. Proposed Research Projects may not begin until reviews of all COI Risk Manager disclosure forms have been concluded and, if necessary, the Investigator has accepted responsibility for implementing any Conflict of Interest Management Plans developed by the CIC.

Disclosure of Institutional Conflicts of Interest

Senior Leadership of the Institution shall disclose annually, to the Director, any equity interest valued over $100,000 which they personally hold in an Entity.

For each Research Project submitted to the IRB, the Chair of the IRB shall request the Director to determine whether any potential or actual Institutional Conflict of Interest exists related to the Research Project.

At the time of continuing review of a Research Project, the Director or his/her designee shall determine whether any new Institutional Conflicts of Interest may have developed since the last review, and shall require CIC review and management as appropriate.

Please refer to CM-35 for additional details on Institutional Conflicts of Interest.

Management of Conflicts of Interest

If the Director determines that there may be a COI which must be managed, his/her review and all relevant disclosure information will be transmitted to the COI Committee (CIC), which will be responsible for evaluating all pertinent factors to determine whether a COI exists.

  1. Upon a determination that an Individual or Institutional Conflict of Interest exists, the COI Committee will develop a written COI Management Plan to reduce, manage, or eliminate that conflict.
  2. A COI Management Plan is a written plan developed by the Conflict of Interest Committee and approved by the Vice Chancellor for Academic Affairs to manage an identified Conflict of Interest. The plan may include, but is not limited to the following actions:
  3. A COI Management Plan must be signed by the Principal Investigator, the Investigator with the Conflict of Interest, the Chairperson of the CIC, the Department Head and Dean of the School of the Investigator with the Conflict of Interest, and the Vice Chancellor for Academic Affairs.
  4. Whenever:
    1. a new Investigator or study team member joins an ongoing Research Project and discloses a potential Conflict of Interest, or
    2. an existing Investigator or study team member discloses a new potential Conflict of Interest or a potential Conflict of Interest was not previously reviewed for whatever reason, or
    3. the Institution identifies a previously undisclosed potential Conflict of Interest,

    the Director shall, within sixty (60) days of disclosure, administratively review to assess the particular circumstances and determine whether there may be a Conflict of Interest which must be Managed. If the Director determines that a potential Conflict of Interest may exist, he/she may implement, on an interim basis prior to the CIC’s action, a Plan which may include measures regarding participation in the Research Project between the date of disclosure and completion of CIC review.

Management of COIs Related to Start-up Companies

In some instances, creation of a new company may be the most effective mechanism to commercialize LSUHSC-NO innovations.   A startup company, launched by an LSUHSC-NO employee who invented the technology (“Employee Innovator”), may need to conduct additional research to advance the technology, and may determine that the Employee Innovator is best able to conduct that research.

In such instances, disclosure and development of a COI Management Plan is imperative to clarify allowable research activities and to ensure that such activities occur within the boundaries of institutional policy, applicable law, and public expectation of research integrity. The Employee Innovator must always operate from the principle that his/her primary duties and obligations are to LSUHSC-NO.

For pre-clinical research activities sponsored at LSUHSC-NO by the Employee Innovator’s company, the results will be adjudicated in the wider research field through the peer review process. However, clinical research activities sponsored at LSUHSC-NO by the Employee Innovator’s company require a more rigorous Plan to ensure the Employee Innovator is adequately and appropriately removed from influencing analysis of research results.

Dr. Chaplet

Scenario 3

Dr. Chaplet is a clinical researcher. She is founder and the sole owner of the company WOTAN, Inc. whose purpose is to commercialize her discoveries that have resulted from her work at LSUHSC-NO. Dr. Chaplet continues to conduct research at LSUHSC-NO that is directly related to WOTAN's interests and future. Does this represent a potential conflict of interest?

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Yes
No

Subcontractors

If Research Projects are conducted through a collaborator, sub-grantee, sub-recipient, or subcontractor, LSUHSC-NO shall, by written agreement, ensure that such entity either:

  1. complies with this Policy or
  2. provides written certification that its financial conflict of interest policies comply with applicable federal rules and regulations.

Additional Requirements for PHS-Funded Research Projects

Records

LSUHSC-NO will ensure public accessibility to certain information concerning a SFI disclosed to the Institution which is:

  1. still held by the Investigator; and
  2. determined to be related to a Research Project; and
  3. determined to be a Financial COI which must be Managed according to a written Plan.

Within five business days of receipt of a written request for information concerning a SFI, LSUHSC-NO, through its Office of Research Services, will provide such information as required by applicable law or regulation.

Violations and Sanctions

Violations of this Policy and implementing procedures, including, but not limited to the failure to file timely disclosures, filing incomplete, erroneous or inaccurate disclosures; or failure to comply with prescribed procedures for managing or resolving Conflicts of Interest, will be handled in accordance with applicable LSUHSC-NO policies.

Sanctions may include disciplinary action up to and including termination of employment. Violations may also result in civil or criminal liability.

Dr. Peth

Scenario 4

Dr. Peth is a clinical researcher at LSUHSC-NO. His spouse is a representative of a pharmaceutical company that frequently contracts with LSUHSC-NO to conduct clinical trials. Should Dr. Peth report this relationship as a potential conflict?

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Yes
No

Summary

For all research projects-- Submit a COI Team Member Form to ORS.

Each person identified on the COI Team Member Form must have an ORS-assigned electronic COI form on file in the COI Risk Manager system. (Collaborators from other institutions must document that they are in compliance with their institutions COI policy.)

COI forms must be updated annually and within 30 days of discovering or acquiring any new or previously undisclosed SFI or potential COI for themselves or for their immediate family members.

There is no minimum threshold for individual CoIs or SFIs.

A research project may not begin until the Principal Investigator acknowledges responsibility for implementing any Conflict of Interest Management Plans required by the CIC.

Institutional CoIs are handled administratively.

Important

All research team members are expected to be familiar with all the provisions of CM-35, not just those highlighted in this training. Read the policy in its entirety for complete details!

Conflicts of Interest Website

Any Questions?

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Phone: 504-568-4970

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