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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: July 10, 2017

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 be perceived to threaten the integrity of the design, conduct, or reporting of the research, or the welfare of human research participants. All such potential or actual conflicts of interest related to research must be disclosed in advance of initiation of that research.

Definitions

Conflict of Interest (COI)

Any Financial Conflict of Interest (FCOI), Non-Financial COI, or Institutional COI which may, depending on particular circumstances, have a potential or actual adverse impact on the objective conduct of a Research Project or Institutional Responsibilities.

Any potential COI which may arise in the conduct of research are judged upon the particular circumstances of each situation and do not reflect upon the character of individuals conducting that research

Financial Conflict of Interest

A Significant Financial Interest (SFI) of an Investigator or Immediate Family Member which could, or could have the appearance of, directly and significantly affecting design, conduct, supervision, or reporting of a Research Project.

Investigator

Any LSUHSC-NO employee (whether faculty or staff), student, house officer, key personnel as defined by the NIH Grants Policy Statement, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of a Research Project.

Immediate Family Member

The spouse, significant other, and dependent children of an Investigator.

Institutional Responsibilities

An Investigator’s professional responsibilities on behalf of LSUHSCNO, which may include but are not limited to research, teaching, consultation, professional practice /clinical duties, and service on institutional or non-institutional boards, committees, or panels.

Significant Financial Interest

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.

SFI Exclusions

The term “Significant Financial Interest” does NOT include the following types of financial interests:

Procedures for Disclosure of Individual Conflicts of Interest

Note that LSUHSC-NO has no minimal threshold for an Individual COI.

  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. Each person identified on the COI Team Member Form must complete an Office of Research Services-assigned electronic COI and SFI (if PHS-funded) form in the COI Risk Manager system, disclosing for themselves and their Immediate Family Members all actual and potential Conflicts of Interest related to the Research Project.
  3. In conjunction with required electronic submission of a COI Risk Manager form, each person must submit documentation in sufficient detail to ORS to allow evaluation of the potential Conflict of Interest, including (i) PM- 11 and/or PM-67 disclosure forms as applicable, (ii) a description of the nature of the activity, (iii) a description of the source and amount of money received, (iv) the time frame of related activities and remuneration, and (v) any other information pertinent to the potential Conflict of Interest.
  4. For the duration of a Research Project, each Investigator and study team member involved in a Research Project must update his/her COI Risk Manager electronic forms (i) annually AND (ii) within thirty (30) days of discovering or acquiring any new or previously undisclosed SFI or potential COI for themselves or for their Immediate Family Members.
  5. Each Principal Investigator shall be responsible 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.
  6. Proposed Research Projects may not begin until reviews of all COI Risk Manager disclosure forms have been concluded and, if necessary, COI Management Plans developed by the COI Committee have been transmitted from the Vice Chancellor for Academic Affairs to the Investigator.

COI Team Member Form

COI Form image

(Click or tap image for expanded view)

Procedures for 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 related to the Research Project may exist in the following categories:

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.

Procedures for 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. Depending on the circumstances, 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.

Procedures for 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 may be 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 preclinical 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.

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.

Training

Training on this policy will be conducted through the LSUHSC-NO Office of Compliance Programs’ (OCP) online, KDS system.  Investigators will be notified by OCP when training is required.

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.

Summary

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

Each person identified on the COI Team Member Form must complete an ORS-assigned electronic COI and SFI (if PHS-funded) form in the COI Risk Manager system.

COI and SFI 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 threshold for individual CoIs or SFIs.

Institutional CoIs are handled administratively.

Important

You must read CM-35 in its entirety for complete details!

Conflicts of Interest Website

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