CM-35 –Conflicts of Interest in Research

November 1, 2009

Introduction

It is the objective of the Louisiana State University Health Sciences Center-New Orleans (LSUHSC-NO) to enact policies and procedures that ensure the highest quality patient care possible, an excellent teaching environment for training future health care professionals and an environment that supports transparent medical and scientific research. LSUHSC-NO must ensure that patient care, education, and research are performed under the highest standards of ethical conduct, with integrity and openness, and the rights of human beings are protected.   

In addition, these policies and procedures are to protect the credibility and integrity of the LSUHSC-NO’s faculty and staff so that public trust and confidence in the LSUHSC-NO's sponsored activities are ensured. LSUHSC-NO understands the increasing complexity of relationships between universities, members of their faculty and staff, federal and state governments, private industry, and the non-profit sector.  

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 non-financial interests as well as financial interests that may create a bias in decisions related to a sponsored project such as payments for services, equity interests, or intellectual property rights.  The value of the results of funded research to the advancement of health care must not be compromised by any investigator's financial and/or non-financial interest that could bias the design, conduct or reporting of the research.

This policy seeks to maintain a reasonable balance between these competing interests, give LSUHSC-NO the ability to identify and manage financial and non-financial interests that may bias the research, and minimize reporting and other burdens on the investigators.

Scope:

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 research on behalf of LSUHSC-NO, regardless of funding source. 

This policy only addresses Conflicts of Interest in Research Projects. There are other areas in which financial and non-financial conflicts may arise and other types of conflicts, e.g. conflicts of commitment or other outside activities, which may conflict with LSUHSC-NO obligations.

Policy

An Investigator shall not be permitted to begin any research activity (e.g. design, conduct or reporting of research, educational, or service activities) when there is an actual or potential Conflict of Interest until a written Conflict of Interest Resolution Plan, has been received by the Investigator from the Vice Chancellor of Academic Affairs.

Each Investigator is responsible for determining whether he/she or his/her Immediate Family Member has a potential Conflict of Interest.

Investigators and/or Immediate Family Members should evaluate potential Conflicts of Interest not only at the outset of their research and continue throughout the period of the award, but also when a change occurs in their relationship with an outside entity.  This may occur at the time a new proposal is submitted, when a new relationship is established with an outside entity, or when a prior relationship with an outside entity changes.  

Requirements for Disclosure

Investigators shall disclose (1) those Conflicts of Interest that would reasonably appear to be affected by or to affect their research or educational activities; and (2) any Conflict of Interest in entities whose interest would reasonably appear to be affected by or to affect the Investigator’s performance of his or her LSUHSC-NO duties, activities and responsibilities.  In other words, this means that if an Investigator has a Conflict of Interest, then disclosure shall be necessary if (1) there is a chance that this interest could reasonably appear to affect his or her research, teaching, or other LSUHSC-NO activities; or (2) if there is a chance that his or her research, teaching, or other LSUHSC-NO activities could reasonably appear to affect the interests of the external entity in which the Investigator or Immediate Family Member has a Conflict of  Interest.  In addition, Investigators are encouraged to disclose any other Conflicts of Interest that could present an actual Conflict of Interest, or might be perceived to present a Conflict of Interest.

Each Principal Investigator or Co-Principal Investigator shall be responsible for ensuring that Investigators under his or her supervision who are involved in proposing, conducting or reporting research on the Principal or Co-Principal’s project comply with this policy in identifying and disclosing any potential Conflicts of Interest

If federally funded research is conducted through collaborators, subgrantees, or subcontractors, the Principal Investigator and/or Co-Principal Investigator shall ensure that such entities comply with this policy or provide written certification that their entities comply with federal regulations.

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 and procedures and may result in civil or criminal liability.

If the failure of the Investigator to comply with LSUHSC-NO’s policy has biased the Research, LSUHSC-NO must promptly notify the funding agency and any other application agencies of the corrective action taken. If the awarding agency is PHS, LSUHSC-NO agrees to make information on conflicting interests available and how those interests have managed, reduced, or eliminated

If the funding agency determines that a funded project of clinical research, whose purpose was to evaluate the safety or effectiveness of a drug, medical device, or treatment, was designed, conducted, or reported by an Investigator with a conflicting interest that was not disclosed or managed LSUHSC-NO must require the Investigator to disclose the conflicting interest in each public presentation of the results of the Research.

Procedures

Records

Definitions

Roles and Responsibilities

Procedures for Disclosure of Conflicts of  Interest

Investigators must disclose any Conflicts of Interest of the Investigator and his/her Immediate Family Members, prior to submitting the research proposal.  

This disclosure must be submitted to the Office of Research Services by completion of the Conflict of Interest Disclosure Form, and the appropriate attachments, including but not limited to PM-11 and/or PM-67 disclosure forms.  Conflict of Interest Disclosure Forms must be updated to reflect any new or previously undisclosed Conflicts of Interest.

Appropriate steps shall be taken by LSUHSC-NO to protect the confidentiality of the information provided however, LSUHSC-NO shall make certain Conflicts of Interest information available when required by law, mandated by sponsoring entities or determined to carry out the purpose and administration of this Policy.

All Conflict of Interest disclosures shall first receive an administrative pre-review to assess the circumstances of a potential Conflict of Interest by the Director of Research Services or designee.  Investigators may be required to provide additional information to perform this initial assessment. If the Director determines that a potential Conflict of Interest may exist, the Director shall forward his or her pre-review to the LSUHSC-NO’s Conflict of Interest Review Committee (CIRC), which is responsible for reviewing all Conflict of Interest disclosures and providing recommendations to reduce, manage or eliminate Conflicts of Interest as appropriate.

The CIRC Committee shall include, but is not limited to the following factors in its evaluation of the potential Conflict of Interest:

• Length or nature of the involvement with the Sponsor
• Type of Sponsor, how the Research Project is supported or financed
• Estimated degree of separation between the Research Project's and Investigator’s activities
• The nature of the Conflict of Interest and when and where the relationship commenced
• Whether the conditions of the relationship have changed
• Whether the results of the Research Project are likely to be affected by the Conflict of Interest
• The mechanisms to ensure the integrity of the Research Project such as peer review, other independent research monitors or controls
• The availability of alternatives to avoid the Conflict of Interest
• Risks to the rights and safety of human subjects research
• Rights to the rights and obligations of students, including fellows, participating in the research
• By whom the study is designed
• Is LSUHSC-NO the appropriate site for the Research
• Transparency of relationships

If the CIRC determines that an actual or potential Conflict of Interest exists, then the Committee shall develop a Conflict of Interest Resolution Plan which may impose singularly or in combination any of the following:

• Public disclosure of Conflicts of Interest
• Disclosure to subjects through the consent process
• Review of Research protocol by independent reviewers 
• Monitoring of the Research project by independent reviewers
• Reduction of equity holdings
• Clear separation of Research from paid activities
• Modification or disapproval of the Research plan
• Divestiture of Conflicts of Interest, complete or partial
• Appointment of a non-conflicted Principal Investigator
• Severance of relationships that create actual or potential Conflicts of Interest
• Disqualification of the Investigator with the Conflicts of Interest from participating in all or a portion of the Research

The Plan may also impose other restrictions which the CIRC deems necessary to reduce, manage or eliminate actual or potential Conflicts of Interest.

In certain circumstances, the CIRC may determine that the Investigator has presented compelling circumstances to justify allowing research to proceed despite the presence of a Conflict of Interest.  Whether the circumstances are deemed compelling shall depend upon the following:

• the nature of the science,
• the nature of the Conflict of Interest
• the amount of the Financial Interest,
• how closely the Conflict of Interest is related to the Research,
• the degree to which the Conflict of Interest may be affected by the Research, and
• the degree to which the Conflict of Interest can be effectively managed.

No “compelling circumstances” will be approved which may violate federal regulations or result in actions detrimental to the LSUHSC-NO and the goals of this policy.

If the CIRC determines that there are compelling circumstances the Research should go forward, despite the Conflict of Interest, then the CIRC may allow the research go forward and shall include in the Conflict of Interest Resolution Plan

• The compelling circumstances which support including the conflicted Investigator in the project.
• The stages of the research and the specific activities for which there are compelling reasons for the Investigator’s involvement.
• The activities the Investigator will be allowed to perform.
• Any restriction plan imposed to prevent the conflict from influencing or appearing to influence the outcome of the project and strategy to restrict the time of involvement to a minimum.

Conflict of Interest Resolution Plans involving human subject research studies shall be submitted to the LSUHSC-NO Institutional Review Board for approval. If the IRB determines that the Plan does not satisfactorily protect human subjects, then the Plan may be returned to the CIRC for further consideration, modification and resubmitted to the IRB for approval.  No Conflict of Interest Resolution Plan involving human subject research studies shall be implemented without IRB approval.

Conflict of Interest Resolution Plans must be signed by the Principal and/or Co-Principal Investigator, the Investigator with the Conflict of Interest, the Chairperson of the CIRC, the Department Head and Dean of the school of the Investigator with the Conflict of Interest, the Director of Research Services and the Vice-Chancellor for Academic Affairs.

Records

Records relating to disclosures of actual or potential Conflicts of Interest and determinations of the CIRC shall be maintained by the Vice Chancellor for Academic Affairs for at least three (3) years after the termination or completion of the Research project, or the resolution of any government action or litigation, whichever is later.

The existence of any Conflict of Interest Resolution Plan must be reported as required by law.

Definitions:

A “Financial Conflict of Interest” occurs when an Investigator’s or Immediate Family Member’s Financial Interests compromise or have the appearance of compromising, an Investigator’s professional judgment in proposing, conducting, supervising, or reporting research.

A Financial Conflict of Interest depends on the situation and not on the character of the individual. 

A Financial Conflict of Interest means anything of monetary value and includes the following interests of the Investigator and/or Immediate Family Member or of any foundation or entity controlled or directed by the Investigator or Immediate Family Member.   Financial Interest includes, but is not limited to:

1. Consulting fees, honoraria (including honoraria from a third party, if the original source is a financially interested company), gifts or other emoluments, or “in kind” compensation from a financially interested company (or entitlement to the same), whether for consulting, lecturing, travel, service on an advisory board, or for any other purpose not directly related to the reasonable costs of conducting the research (as specified in the research agreement).
2. Equity interests, including stock options, in a non-publicly traded financially interested company (or entitlement to the same)
3. Equity interest (or entitlements to the same) in a publicly traded financially interested company (see exceptions below)
4. Royalty income or the right to receive future royalties under a patent license or copyright, where the research is directly related to the licensed technology or work;
5. Any non-royalty payments or entitlements to payments in connection with the research that are not directly related to the reasonable costs of the research (as specified in the research agreement between the sponsor and the institution).  This includes any bonus or milestone payments to the investigators in excess of reasonable costs incurred, whether such payments are received from a research sponsor, financially interested company or from the institution.
6. Service as an officer, director, or in any other fiduciary or decision making role for a research sponsor, financially interested company, whether or not remuneration is received for such service.

The term does not include:

1. Salary, royalties, or other remuneration from the LSU system
2. Interests of any amount in publicly traded, diversified mutual funds, (since the Investigator does not control the selection of the investments.)
3. Payments to LSUHSC-NO, or via the LSUHSC to the Investigator that are directly related to the reasonable costs incurred in the conduct of research as specified in the research agreement(s) between the sponsor and the institution.

Please note that the abovementioned exclusions shall not apply if the compensations or transfer of equity interest is conditioned upon a particular outcome in research project.

“Non-Financial Conflict of Interest” occurs when an Investigator’s or Immediate Family Member’s role in the University or other outside activities compromise or have the appearance of compromising an Investigator’s professional judgment in proposing, conducting, supervising, or reporting research or come into conflict with an Investigator’s primary commitment to maintain scientific objectivity.

Non-Financial Interest includes, but is not limited to:

• Conflicts of Commitment regarding Time and Effort
• Using a student to perform services for a company in which the Investigator or Immediate Family Member has an ownership or management role when (1) the student is currently enrolled in the Investigator’s or Immediate Family Member’s class or (2) the Investigator or Immediate Family Member currently supervise(s) the student in an academic capacity; or (3) the Investigator or Immediate Family Member otherwise has the ability to influence the academic progress of the student.

“Conflict of Interest” means any “Financial Conflict of Interest” and/or any “Non-Financial Conflict of Interest”.

“Conflict of Interest Resolution Plan” is a written plan developed by the Conflict of Interest Review Committee and approved by the Vice Chancellor of Academic Affairs designed to eliminate, reduce or manage a specific Conflict of Interest of an Investigator.

“Conflict of Interest Review Committee (CIRC)” is a committee appointed by the Vice-Chancellor of Academic Affairs charged with determining whether a potential Conflicts of Interest exist and if so developing a Conflict of Interest Resolution Plan for Investigators who have reported Conflicts of Interest to the Office of Research Services.

“Investigator” means any LSUHSC-NO Principal Investigators, Co-Principal Investigators, project directors, and any other research personnel, including but not limited to any other LSUHSC-NO  employee, (whether faculty or staff), student, or house officer who contributes to research activity, regardless of funding, and/or status (e.g. faculty key personnel, research associates, technicians, nurse coordinators, administrators, and students).

“Immediate Family Member” means the spouse of the Investigator, dependent children of the Investigator, and any other individual that the Investigator knows or should know maintains Conflicts of Interest that may be impacted by research the Investigator is proposing or conducting. Additionally, any other relationship that a reasonably prudent person might consider as an appearance of a conflict of interest is also included in the definition of “Immediate Family” and should be disclosed as well.

 “Research Project”: means a systematic investigation designed to develop or contribute to generalizable knowledge, including basic and applied research, behavioral, and social research, biomedical research, product development and other scholarly activity.

Roles and Responsibilities Matrix

Attachment:  LSUHSC-NO Conflict of Interest in Research Disclosure Form