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Part A

Policy of Tulane University on Conflicts of Commitment and Interest
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All terms in Bold are defined at the end of this Part A of the Policy.

Principles

Tulane University’s mission is to create, communicate, and conserve knowledge in order to enrich the capacity of individuals, organizations and communities to think, to learn and to act and lead with integrity and wisdom.  Accordingly, the University recognizes that its Faculty and Staff participate in Leadership Roles, such as consulting, serving on boards of companies whether for-profit or non-profit and other Secondary Commitments that benefit the participant and the University, its students, patients and the public at large.  The University, its Faculty and Staff have a shared interest in assuring the institutional integrity of the University as well as the personal and professional integrity of Faculty and Staff members.  The University is committed to maintaining the highest standards of excellence in teaching, research, patient care and welfare.  Because Leadership Roles, Secondary Commitments and Financial Interests may result in conflicts of interest and/or commitment, the University requires all Faculty and Staff to complete a Conflict of Interest and Conflict of Commitment Disclosure Form in accordance with this policy. 

This policy provides guidelines and mechanisms for dealing with potential, actual or perceived conflicts of commitment and interest to ensure that the University and Faculty and Staff members conduct academic and administrative activities in a fair and unbiased manner.  Thus, an integral part of this policy is disclosure by Faculty and Staff members of their commitments, financial interests and activities.  

While this policy governs Conflicts of Interest and Conflicts of Commitment, it does not regulate disputes between two or more Faculty or Staff members, or disputes between one or more Faculty or Staff members and the University.  Such disputes are to be resolved according to the University’s established dispute resolution procedures.

Conflict of Commitment

Faculty and Staff members owe their Primary Commitment to University activities and responsibilities, must act in the institution’s best interests, and must not permit any Secondary Commitments to an outside organization, entity or project jeopardize this Primary Commitment.  A Conflict of Commitment occurs when these efforts for the University are compromised by one or more Secondary Commitments.  For example, a Conflict of Commitment would occur if a Faculty member exceeded permitted time limits on outside consulting, or if, as a result of a Leadership Role in an outside organization, entity or project, an individual’s primary professional loyalty were not to the University.

Conflict of Interest

A Conflict of Interest arises whenever the Faculty or Staff member’s Professional Interests, such as professional obligations or judgment owed to the University and its constituencies are compromised by, or could be perceived as being compromised by, his or her Leadership Roles, Secondary Commitments or Financial Interests.  A Conflict of Interest depends on the situation and not on the character of the individual.  For example, Faculty or Staff who make decisions about purchasing or contracting for goods or services received by the University should not have relationships with, or Financial Interests in, outside Vendors or suppliers that conflict with, or appear to conflict with, their duty to act in the University’s best interests when purchasing or contracting on behalf of the University.  A Conflict of Interest can also occur when the academic work of a Faculty Member could affect a Financial Interest of the University, or of a Faculty or Staff member.  Academic integrity is compromised when the Faculty member modifies his work to augment or shield that Financial Interest, such that the work product does not accurately reflect the Faculty member’s research, beliefs and opinions.  For example, academic integrity may be compromised when a Faculty member prepares the content of a book, article, audit or other report, with knowledge that such content could reasonably be expected to affect a Financial Interest of that Faculty member, one or more other Faculty members, the University, or one or more University officials.

Process

1. Disclosure: All Faculty and Staff must complete on an annual basis (by January 31 of each year) a Conflict of Interest and Conflict of Commitment Disclosure Form A.  This Form A requires the individual to report any and all Leadership Roles, Secondary Commitments and Financial Interests.  In addition, this form requires the individual to report any and all Leadership Roles, Secondary Commitments and Financial Interests that the individual’s Immediate Family may have that could reasonably be expected to affect, or appear to affect, the professional judgment of a Faculty or Staff member.  Faculty and Staff in academic units must submit completed disclosure forms to their department chair or the dean if the unit does not have a departmental chair structure.  Staff in non-academic units must submit disclosure forms to their direct supervisor.  Deans (in consultation with their department chairs where appropriate) and direct supervisors will review and forward (i) the completed Conflict of Interest and Conflict of Commitment Disclosure Form, (ii) a report that includes recommendations concerning the management of any disclosed conflicts, and (iii) a list of the names of individuals who fail to provide a disclosure form to the University’s Conflict of Interest Committee (the “COI Committee”).  Deans and direct supervisors will also forward a copy of the report, and a copy of the list of names of individuals who have not provided the required Conflict of Interest and Conflict of Commitment Disclosure Form, to the Senior Vice President responsible for their unit.  Newly hired or affiliated Faculty and Staff must submit a Conflict of Interest and Conflict of Commitment Disclosure Form within the first three months of employment or affiliation, and must thereafter comply with the annual filing deadline of January 31.
   
   
2. Updating: If at any time over the course of the year one or more Leadership Roles, Secondary Commitments or Financial Interests of a Faculty or Staff member changes in any material way, the Faculty or Staff member must promptly provide an updated Conflict of Interest and Conflict of Commitment Disclosure Form in accordance with the procedures described in Paragraph (1).
   
   
3. Confidentiality:  All financial and other confidential information disclosed by Faculty and Staff to the individuals described in Paragraph (1) will be maintained in strict confidence.  The COI Committee may disclose such information only to other University administrators defined as Designated Officials to carry out the purpose of this Policy.  No other uses or disclosures of the financial and other confidential information of a Faculty or Staff member will be permitted, unless required by law.
   
   
4. Review by the COI Committee:  As promptly as practicable after the January 31 filing deadline, the COI Committee will review the disclosure forms and reports.  The COI Committee may ask that a Faculty or Staff member who has a potential conflict provide additional information or discuss the matter with the COI Committee in person.  The COI Committee will examine disclosed conflicts to assess the degree of risk they carry to Primary Commitments and Professional Interests.  The COI Committee will endeavor to work with the Faculty or Staff member to manage, reduce or eliminate any identified conflicts.  When necessary, the COI Committee will require that a Faculty or Staff member comply with a particular strategy for managing a conflict.
    
5. Compelling and Necessary Exceptions:  The COI Committee may consider “compelling and necessary” exceptions that would allow Faculty or Staff members for whom an actual Conflict of Commitment or Conflict of Interest has been determined to exist to maintain their Leadership Role, Secondary Commitment or Financial Interest with appropriate oversight and controls to safeguard the reputations and integrity of the University and its Faculty and Staff members. 
   
   
6. Management or Elimination of Conflicts of Commitment and Conflicts of Interest:  The COI Committee’s management strategy will be based upon an assessment of the nature, scope and severity of the Conflict of Commitment or Conflict of Interest.  The primary methods of controlling or managing Conflicts of Interest shall include:
   1. Modifying the University employment responsibilities of the conflicted Faculty or Staff member;
      
      
   2. Disclosing the conflicting Leadership Role, Secondary Commitment or Financial Interest to the public, for example, during conference presentations and/or in journals and other publications;
      
      
   3. Reducing the conflict by reducing or altering the Leadership Role, Secondary Commitment or Financial Interest (e.g., partial divestiture or sequestration of one or more Financial Interests, reduction of time spent in furtherance of one or more Leadership Roles or Secondary Commitment);
      
      
   4. Eliminating the conflict by eliminating the Leadership Role, Secondary Commitment or Financial Interest (e.g., total divestiture or sequestration of one or more Financial Interests, resignation from one or more Leadership Roles or Secondary Commitment).
      
      
7. Appeal of COI Committee Decision:  A Faculty or Staff member who disagrees with the COI Committee’s findings or required management strategies may appeal in writing to the Senior Vice President responsible for that Faculty or Staff member’s unit.  A copy of the appeal must be sent to the COI Committee.  The applicable Senior Vice President may agree with the COI Committee’s findings and/or management strategy, or may amend such findings and/or strategy.  The applicable Senior Vice President shall promptly notify the Faculty or Staff member and the COI Committee in writing of the conclusions of his or her review, including the actions that must be taken by the Faculty or Staff member to comply with this policy.  Upon receipt of the applicable Senior Vice President’s written report, the Faculty or Staff member must promptly comply with the actions specified in that report.

Audit and Sanctions for Non-Compliance
At the request of a Senior Officer of the University, a Faculty or Staff member may be audited for the purpose of verifying whether the individual truthfully and accurately disclosed his or her Leadership Roles, Secondary Commitments, and Financial Interests in the annual Conflict of Interest and Conflict of Commitment Disclosure Form (and in any updates thereto), and for the purpose of verifying whether the individual is complying with the actions, if any, that were specified in the written report of the COI Committee (or the applicable Senior Vice President where there has been an appeal).  A Faculty or Staff member who fails to file a completed Conflict of Interest and Conflict of Commitment Disclosure Form with the COI Committee by the annual deadline, or who fails to comply with any other action specified by the COI Committee or applicable Senior Vice President, will be subject to potential sanctions in accordance with applicable University policy and procedures.  These sanctions may include formal admonition or censure; suspension; non-renewal of appointment; and/or dismissal.

1. Conflict of Interest Committee.  The COI Committee will be composed of at least nine (9) members with five (5) members constituting a quorum.  The Committee members collectively should have knowledge in financial investments, legal issues, ethics, and human subjects research.  These members may be drawn from within and outside of the University.  All members of the COI Committee must undergo training in the assessment and management of Conflicts of Interest and Conflicts of Commitment.  COI Committee members will be nominated by the Committee on Research and appointed by the President.  The President shall appoint the Chair of the COI Committee.
   
   The COI Committee shall meet monthly, unless the Chair of the COI Committee determines there is no issue to be considered.  The COI Committee members may participate in a meeting of the COI Committee by means of conference telephone or similar communications equipment if all persons participating in the meeting can hear each other at the same time.  Such participation shall constitute presence in person at the meeting for purposes of a constituting a quorum and taking any action. 
   
   Appointment to the COI Committee is for a period of three (3) years and may be renewed indefinitely at the discretion of the President.  A COI Committee member may be removed by a Senior Vice President of the University only for good cause, which must be fully documented for audit and grievance purposes.  If a COI Committee member has or may have a Conflict of Interest with respect to any of his or her duties on the COI Committee, the COI Committee member will disclose such conflict and recuse himself or herself from such duty.
   
   
2. Designated Officials:  The designated officials of the University for purposes of reviewing, administering and implementing Conflicts of Interest determinations shall be the President, the Senior Vice President for Academic Affairs and Provost, the Senior Vice President for the Health Sciences, the Deans of the Schools of Medicine, Public Health and Tropical Medicine, Architecture, Business, Engineering, Graduate School, Law, Liberal Arts and Sciences, Newcomb College, Social Work, Tulane College and University College, the Director of the Tulane National Primate Research Center, the Senior Vice President for Operations and Chief Financial Officer, the Senior Vice President for External Affairs and the General Counsel.  Chairs of the IRB and other University administrators may be called upon, as needed, by the Senior Vice Presidents or by the COI Committee for specific purposes. 
   
   
3. Financial Interest: Aggregate investments (whether in the form of debt, stock or other equity ownership, options or warrants to purchase stock or other securities or similar instruments) with a value exceeding $10,000 or representing a five (5%) percent or greater interest in any entity, enterprise or trust; royalties on any patent or other intellectual property interests with a value exceeding $10,000, unless paid by Tulane; or income, salary or remuneration in cash or in kind, emoluments, benefits, gifts, honoraria, travel expenses, goods or services with a value exceeding $10,000.  Financial Interest does not include holdings in mutual funds or other equity funds in which the day-to-day control of investments is held by a person not subject to any Tulane University Conflict of Interest policy.
   
   
4. Immediate Family:  Spouse or domestic partner, children (including adoptees) and other dependents.  Because of strict conflict of interest rules required by federal and state law, the definition of Immediate Family for a member of the Tulane University Medical Group and for other healthcare providers is broader than the definition for other Faculty and Staff members.  Members of the Tulane University Medical Group or other health care providers must refer to Part B of this Policy for the definition of Immediate Family.
   
   
5. Leadership Role:  Employment, consulting in any administrative or executive capacity, or serving as (i) a member of a board of trustees, directors or administrators, (ii) an officer or (iii) a member of an advisory committee, advisory board or subcommittee of a board of trustees, directors or administrators, whether compensated or non-compensated.
   
   
6. Professional Interests:  Academic, personal, professional and/or institutional integrity, patient safety and welfare, or any other interest that may be added to this policy from time to time.
   
   
7. Primary Commitment.  The time, energy and loyalty that Faculty and Staff members are required to dedicate to the University.
   
   
8. Secondary Commitment.  Activities that are not part of the Primary Commitment, which include but are not limited to employment, consulting or participation in outside businesses or organizations.  The time, energy and loyalty that Faculty and Staff members dedicate to outside Leadership Roles and other compensated or non-compensated extramural activities.  Secondary Commitments do not include personal activities conducted on holidays, vacations and weekends.
   
   
9. Vendor:  Any individual, business, partnership, corporation or other entity that sells or conveys goods or services to the University, or that arranges for the purchase or sale of goods or services to, for or by the University 
   

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Part B

Policy of Tulane University on Conflicts of Commitment and Interest
For Members of the Tulane University Medical Group and Health Care Providers
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This Addendum shall apply ONLY to members of the Tulane University Medical Group and other health care providers.  For the purposes of this Addendum, a health care provider is a physician or other health care professional or Staff member who orders medical items, supplies (including for example pharmaceuticals) or services for patients or who refers patients to other health care providers or suppliers of medical items, supplies or services.  A physician or other Staff member who performs no patient care services, directly or indirectly, and whose duties encompass no direct or indirect patient care is NOT covered by this Addendum.

By this Addendum, the Policy of Tulane University on Conflicts of Commitment and Interest incorporates federal and state laws requiring that persons making purchasing and/or patient referral decisions not receive any remuneration or payment for making such decisions (often referred to as “anti-kickback” laws) and other laws that prohibit physicians from referring patients to services and facilities in which those physicians and their families hold financial interests (often referred to as the “Stark” laws).  As required by such laws, the definition of Immediate Family in this Addendum shall apply to members of the Tulane University Medical Group and health care providers in lieu of the definition included in the Policy to which this Part B is attached:

“e.       Immediate Family.  Spouse or domestic partner, children and other dependents, natural or adoptive parents, siblings, stepparent, stepchild, stepbrother or sister, father-in-law, mother-in-law, daughter-in-law, son-in-law, brother-in-law, sister-in-law, grandparent, grandchild, and spouse of grandparent or grandchild.”

Applicability

This Part C of the Policy applies to Investigators in research involving human subjects. 

Principles

Federal law and policy require that for federally financed research studies, the university hosting the research gather information related to each Investigator’s Research Financial Interests, as well as Financial Interests that may be affected by the research itself.  Although these requirements originated in a concern for assuring the integrity of federally financed research data, Tulane University is also concerned, as are various professional organizations, with the possible influence of such Research Financial Interests on research integrity and on the safety and welfare of human subjects involved in research protocols, regardless of the source of research funding.  The University’s policy in this regard is consistent with prevailing standards for professional conduct, which require that physicians and other licensed professionals not exercise undue influence over patients and clients and act at all times in the best interests of their patients and clients.  The University is also concerned about Leadership Roles of Investigators in entities that sponsor research.  The University’s policies therefore incorporate those concerns as well.

Consistent with federal laws and the ethical principles of human subjects research, Tulane University seeks to ensure that its Investigators can carry out their responsibilities to protect the rights and welfare of human subjects participating in research projects at the University.  Since the University recognizes that real, potential and apparent Conflicts of Interest may occur during research, this policy is intended to assist Investigators in determining when they have Conflicts of Interest in research, and to guide them in disclosing all potential conflicts and in cooperating with the management or elimination of the conflicts, where necessary.  While this policy governs the Conflicts of Interest of Investigators, it does not regulate disputes between two or more Investigators or between one or more Investigators and the University.  Such disputes are to be resolved according to the University’s established dispute resolution procedures.

Process

1. Disclosure:  All Investigators must complete Form C: Annual Research-Related Financial and Leadership Disclosures (hereinafter “Form C”) of the Conflict of Interest and Conflict of Commitment Disclosure Form.  This form must be submitted to the Investigator’s department chair or dean in accordance with the process described in the Tulane University Policy on Conflicts of Commitment and Interest and must be updated on an annual basis (by January 31 of each year) for as long as the Investigator continues to conduct any research at the University.  Investigators who are newly hired by or affiliated with the University or who have not previously conducted research at the University may submit Form C of the Conflict of Interest and Conflict of Commitment Disclosure Form at any time during the year, provided that such Investigators may submit the form directly to the COI Committee in order to provide it at least three (3) weeks prior to the scheduled meeting date of the University’s Institutional Review Board (“IRB”), at which the IRB will review the Investigator’s research protocol.  Newly hired or affiliated Investigators may not submit any research protocol for review by the IRB before they have submitted Form C to the COI Committee.  Thereafter, such Investigators must comply with the January 31 filing deadline.
   
   Investigators must indicate in Form C any and all Research Financial Interests and/or Leadership Roles they or their Immediate Family1 may have in any research or health care-related organization, including any not-for-profit or tax-exempt health care-related companies or foundations. 2  Investigators must append to the Disclosure Form a copy of every report of their Research Financial Interests that they are required to submit to any Sponsor of research.3  Any report of Research Financial Interests that is sent to a Sponsor of research anytime after the January 31 filing deadline must also be sent without delay to the COI Committee.  
   
   
2. Updating:  If at any time over the course of the year one or more Research Financial Interests or Leadership Roles of an Investigator or an Investigator’s Immediate Family in any research or health care-related organization changes in any material way, the Investigator must promptly notify the COI Committee of that change by submitting a written statement detailing such change(s). 
   
   Investigators must also forward to the COI Committee without delay any amendments or changes that they make to any reports of Research Financial Interests that are submitted to any Sponsor of research.
   
   
3. Confidentiality:  All financial and other confidential information disclosed by Investigators as described in Paragraph 1 above will be maintained in strict confidence.  The COI committee may need to disclose information to other University administrators defined as Designated Officials in this Policy to carry out the purpose of this Policy.  No other uses or disclosures of the financial and other confidential information of an Investigator will be permitted, unless required by law.
   
   
4. IRB Application and Continuing Review Forms:  In the application for IRB approval of the research protocol, and at the time of continuing review of the protocol, each Investigator must attest using the Tulane University Investigator Conflict of Interest Attestation Form that he or she has supplied the COI Committee with a complete Conflict of Commitment and Conflict of Interest Disclosure Form, including Form C (and any required updates thereto), and must indicate whether the research he or she is conducting could be affected by any of his or her Research Financial Interests and/or Leadership Roles.  The IRB staff may not process applications for IRB approval and may not commence continuing review of a protocol until each Investigator has provided this required information.  If, at the time for continuing review of a study, all necessary information has not been provided, no new subjects shall be enrolled in the study.  Unless the IRB determines that it is in the best interests of the previously enrolled subjects to continue the study and their participation, the study shall not be authorized to continue, and shall not be allowed to continue until such time as all information has been provided. 
   
   
5. Review by the COI Committee:  The COI Committee shall meet to consider whether any disclosed Research Financial Interests or Leadership Roles constitute an actual Conflict of Interest in regard to an Investigator’s research.  For this purpose, the COI Committee may ask that the Investigator provide additional information or discuss the matter with the COI Committee in person.  If one or more Conflicts of Interest are identified in this process, then the COI Committee shall examine those conflicts to assess the degree of risk they carry in regard to research integrity and the safety and welfare of human subjects.  The greater the Research Financial Interest or Leadership Role of the Investigator in the research being conducted by that Investigator, the greater the potential risk that the conflicts may inappropriately influence research outcomes and/or subject safety and welfare.  Whenever an Investigator indicates in an IRB or continuing review application that the research may be affected by one or more Research Financial Interests or Leadership Roles held by the Investigator and the Investigator has not disclosed the information to the COI Committee, the IRB will forward the Investigator’s response to the COI Committee for review and resolution. 
   
   
6. Compelling and Necessary Exceptions:  The COI Committee may consider “compelling and necessary” exceptions that would allow an Investigator with an actual Conflict of Interest related to Research Financial Interests or Leadership Roles to conduct research, with appropriate oversight, at the University.  This may be allowed to occur, for example, in circumstances where the Investigator has special expertise regarding the particular drug, device or method under investigation that uniquely qualifies that Investigator to conduct the investigation; where the University has special facilities or equipment that are unavailable at most other institutions in the United States that allow or facilitate the proposed research; and/or where the Investigator or the University is particularly well situated to enroll study subjects because of the patient population of University-affiliated health care providers or of that Investigator himself or herself.
   
   
7. Management or Elimination of Conflicts of Interest:  The COI Committee’s findings and/or management strategy will be based upon an assessment of the seriousness of the Conflict of Interest, and the likelihood that the Conflict of Interest could in fact influence persons to make inappropriate, unfair or unwise decisions in their conduct or oversight of human subjects research.  The primary methods of controlling or managing Conflicts of Interest shall include:

1. Eliminating the conflict by referring the study to non-conflicted Investigators at the University, by divesting or sequestering the conflicting Research Financial Interest or eliminating the Leadership Role, or by referring the study to another site at which Investigators are not conflicted;
   
   
2. Requiring that investments posing a Conflict of Interest in a research study be “frozen” for a designated period of time lasting beyond the termination of the study, with the Investigator allowed neither to sell nor transfer those interests until the end of that time period, thus providing for a forced segregation of the research study and its results from the Investigator’s conflicting Research Financial Interest;
   
   
3. Disclosing the conflicting Research Financial Interest or Leadership Role to Sponsors, research subjects (i.e., during the informed consent process) and/or journals and other publications;
   
   
4. Providing independent monitoring of the subject recruitment and/or informed consent processes;
   
   
5. Requiring independent monitoring and oversight of subject-researcher interactions, data gathering, data analysis, and/or data reporting;
   
   
6. Arranging for review of all adverse events, including review of subject records on a comprehensive, periodic or sampled basis to assure that reports of adverse events have been timely and properly made; and/or
   
   
7. Adopting procedures for a routine periodic updating of information relating to the Conflict of Interest, if it appears that the Conflict of Interest might change in any appreciable way over the course of a research study.

8. Appeal of COI Decision:  The COI Committee shall promptly notify the Investigator and the IRB of its finding(s) regarding whether the Research Financial Interest(s) and/or Leadership Role(s) of the Investigator constitutes a Conflict of Interest, and if so, regarding the method(s) it recommends for managing any such Conflict(s) of Interest.  Investigators who disagree with the COI Committee’s findings and/or management strategy may appeal in writing to the Senior Vice President responsible for that Investigator’s unit.  A copy of the appeal must be sent to the COI Committee.  The COI Committee will promptly notify the IRB of the appeal.  The applicable Senior Vice President may agree with the COI Committee’s findings and/or management strategy, or may amend such findings and/or strategy by, for example, strengthening or weakening the management strategies.  The applicable Senior Vice President shall promptly notify the Investigator and the COI Committee of the conclusions of his or her review.  The COI Committee will forward to the IRB a revised copy of its findings and management strategy should these require amendment as a result of the appeal.  The IRB shall suspend its ultimate determination regarding the study pending the resolution of the appeal.   
   
   
9. IRB Review of the COI Committee’s and/or Senior Vice President’s Findings and Management Strategy:  The IRB shall review the findings and management strategies of the COI Committee, and of the applicable Senior Vice President when there has been an appeal.  The IRB may accept the management strategies, or may strengthen them.  If the IRB elects to strengthen the management strategies, it must document its reasons for doing so and submit a copy of its written report to the COI committee and to the applicable Senior Vice President.  The IRB must promptly notify the Investigator in writing of its determination regarding the Investigator’s real or perceived Conflict of Interest, who must comply with the management strategies as modified by the IRB.
   
   
10. Continuing Review:  At each continuing review, the IRB shall consult with the COI Committee regarding any changes in the Research Financial Interests and/or Leadership Roles of the Investigator, and regarding any changes in management strategies recommended by the COI Committee.

Audits and Sanctions for Non-Compliance

At the request of a Senior Vice President of the University, an Investigator may be audited for the purpose of verifying whether the Investigator truthfully and accurately disclosed his or her Leadership Roles, Secondary Commitments, Financial Interests, including Research Financial Interests in the Annual Conflict of Commitment and Conflicts of Interest Disclosure Form, including Forms B and C (and in any updates thereto), and for the purpose of verifying whether the Investigator is complying with the actions, if any, that were specified in the written report of the COI Committee (or applicable Senior Vice President where there has been an appeal, or IRB where management strategies were strengthened).  An Investigator who fails to file a completed Form C of the Conflict of Interest and Conflict of Commitment Disclosure Form with the COI Committee by the annual deadline, or who fails to comply with any other action specified by the COI Committee or applicable Senior Vice President (as modified by the IRB) will be subject to potential sanctions in accordance with applicable University policy and procedures.  These sanctions may include formal admonition or censure; suspension or termination of the Investigator’s eligibility for grant applications and/or IRB approval; non-renewal of appointment; and/or dismissal.

Additional Definitions & Descriptions Part C

10. Investigator:  Any professional research staff member involved in exercising independent judgment in research design, enrollment, data collection and gathering, data analysis and/or preparation for publication that requires IRB approval.
    
    
11. IRB or Institutional Review Board:  Any board, committee, or other group formally designated by the University to review human subjects research, and which was established and which functions and operates in conformity with Part 46 of Title 45 and Part 56 of Title 21 of the Code of Federal Regulations.  IRB Members are those who comprise the IRB.
    
    
12. Research Financial Interest:  Any investments (whether in the form of debt, stock or other equity ownership, options or warrants to purchase stock or other securities or similar instruments) or interest in a Sponsor, research or healthcare related organization; royalties on any patent or other intellectual property interests, unless paid by Tulane; or income, salary or remuneration in cash or in kind, emoluments, benefits, gifts, honoraria, travel expenses, goods or services received from a Sponsor or research or healthcare related organization.  Research Financial Interest does not include holdings in mutual funds or other equity funds in which day-to-day control of investments is held by a person not covered by any Tulane University Conflict of Interest policy.  Please note that Research Financial Interest has no dollar or ownership thresholds; therefore, any interest related to a Sponsor or to the research must be disclosed, however small.
    
    
13. Sponsor:  The entity that is sponsoring or funding the research and the entity’s affiliates and subsidiaries, and any entity that monitors research, collects or arranges data for research or otherwise performs any services related to or supporting research, including without limitation assisting in applications or responses to the United States Department of Health and Human Services and/or the United States Food and Drug Administration.

Footnotes

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Part D

Policy for Conflicts of Interest of Institutional Review Board Members
and Research Oversight Officials

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All terms in Bold are defined either at the end of the Tulane University Conflict of Commitment and Interest Policy or this Policy.

Applicability

This policy applies to Research Oversight Officials, which includes, but is not limited to, Institutional Review Board (“IRB”) Members and members of other institutional bodies responsible for research oversight at Tulane University.  This Policy defines Research Oversight Officials to include all personnel and staff of any institutional office or body at the University who perform research oversight functions in which they exercise professional or administrative-level discretion

Principles

Federal law requires that IRB Members not have any conflicting interests in the research that they review.  The University is concerned, as are various professional organizations, with the possible influence of such Research Financial Interests on research integrity and on the safety and welfare of human subjects involved in research protocols regardless of the source of research funding.  The University is also concerned with any Leadership Roles that may be held by IRB Members in any entities that sponsor research, or that perform support, marketing, recruitment, data analysis or FDA liaison activities for research.  The University’s policies therefore incorporate those concerns as well.

Consistent with federal laws and the ethical principles of human subjects research, Tulane University seeks to ensure that its Research Oversight Officials can carry out their responsibilities to protect the rights and welfare of human subjects participating in research projects at the University.  Since the University recognizes that real, potential and apparent Conflicts of Interest may occur during research, this policy is intended to assist IRB Members as well as other Research Oversight Officials in determining when they have Conflicts of Interest in research and to guide them in disclosing all potential conflicts and then, as appropriate, cooperating in the management or elimination of the conflicts.  While this policy governs the Conflicts of Interest of IRB Members and other Research Oversight Officials at the University, it does not regulate disputes between two or more individuals, nor disputes between one or more individuals and the University.  Such disputes are to be resolved according to the University’s established dispute resolution procedures.

Because IRB Members and other Research Oversight Officials have primary responsibility for protecting the safety and welfare of human subjects participating in research at the University, it is the policy of the University that IRB Members and Research Oversight Officials, may not review any research protocol in which a decision to approve or disapprove the protocol could affect the IRB Member’s or Research Oversight Official’s or their Immediate Family’s 1 Research Financial Interests.  In particular, IRB Members and Research Oversight Officials may not have Research Financial Interests in any research sponsor or health-care related organization, nor any Leadership Roles in any research sponsor or research-related organization that could affect their review of research.   

1. Disclosure:  All IRB Members and Research Oversight Officials must complete Form D of the Conflict of Interest and Conflict of Commitment Disclosure Form 2   This form must be submitted to the member or official’s department chair or dean in accordance with the process described in the Tulane University Policy on Conflicts of Interest and Conflicts of Commitment and must be updated on an annual basis (by January 31 of each year) for as long as the IRB Member or Research Oversight Official continues to supervise research at the University.  IRB Members and Research Oversight Officials who are newly hired by or affiliated with the University must submit Form D of the Form prior to beginning their research oversight duties, and must thereafter comply with the January 31 filing deadline.  IRB Members and Research Oversight Officials must indicate upon the form any and all Research Financial Interests and/or Leadership Roles they or their Immediate Family may have in any research or health care-related organization, including any not-for-profit or tax exempt health care-related companies or foundations.  IRB Members and Research Oversight Officials must also indicate whether any of their Leadership Roles could affect, or appear to affect, their review of any particular research projects.
    
   
2. Updating:  If at any time over the course of the year one or more Research Financial Interests or Leadership Roles of an IRB Member or Research Oversight Official or their Immediate Family in any research or health care-related organization changes in any material way, the IRB Member or Research Oversight Official must promptly notify the COI Committee of that change by submitting a written statement detailing such change(s). 
   
   
3. Confidentiality:  All financial and other confidential information disclosed by Faculty and Staff to the individuals described in Paragraph (1) will be maintained in strict confidence.  The COI Committee may need to disclose information to other University administrators defined as Designated Officials in this Policy to carry out the purpose of this Policy.  No other uses or disclosures of the financial and other confidential information of a Faculty and Staff member will be permitted, unless required by law.
   
   
4. Review by the COI Committee:  As promptly as practicable after the January 31 filing deadline, the COI Committee will review Form D of the Disclosure Form of the IRB Member or Research Oversight Official to make certain that the IRB Member or Research Oversight Official does not possess any research or health care-related Research Financial Interests, or any Leadership Roles that could affect the Member’s or Official’s review of research.  If the COI Committee concludes that the IRB Member or Research Oversight Official is devoid of any such Research Financial Interests and that the Member or Official does not possess any Leadership Roles that could affect the Member’s or Official’s review of research, then the matter will go no further.  If, however, the COI Committee concludes that the IRB Member or Research Oversight Official possesses one or more Research Financial Interests, and/or that the Member or Official holds one or more Leadership Roles that could affect the Member’s or Official’s review of research, then the COI Committee will promptly inform the Member or Official in writing of its determination and of the remedies that must be taken by the Member or Official to fall into compliance.  A Conflict of Interest will be deemed to exist per se if the IRB Member or Research Oversight Official is an inventor or co-inventor of a product or method in a study undergoing review or continuing review by that Member or Official, and/or where the IRB Member or Research Oversight Official is, or expects to be included as, an author on any publication relating to the study under review. 
   
   
5. Management or Elimination of Conflicts of Interests:  Where an IRB Member or Research Oversight Official is out of compliance with this policy due to one or more Research Financial Interests, the COI Committee will require that the Member or Official reduce every Research Financial Interest in any research Sponsor or health care-related organization to a de minimis level.  The IRB Member or Research Oversight Official has the discretion of selecting how to accomplish this obligation (e.g., partial divestiture of the official’s Research Financial Interests, and/or partial divestiture of the Research Financial Interests of the official’s spouse or dependent children), but the time-frame in which divestiture must occur will be stipulated by the COI Committee, which ordinarily shall not be more than four weeks.  Where an IRB Member or Research Oversight Official is out of compliance with this policy due to one or more Leadership Roles that could affect his or her review of research, the COI Committee will require that the Member or Official either terminate that Leadership Role or recuse himself or herself from the review of any research protocol that could be affected by that role.  While an IRB Member or Research Oversight Official may not review a study that is being funded by a Sponsor in which he or she holds a Leadership Role, Leadership Roles in other research-related organizations will be assessed on a case-by-case basis by the COI Committee.  If a Conflict of Interest is deemed to exist based on the IRB Member’s or Research Oversight Official’s status as an inventor or co-inventor of a product or method in a study undergoing review or continuing review by that Member or Official, or is deemed to exist based on the IRB Member’s or Research Oversight Official’s existing or expected status as an author on any publication relating to the study under review, the remedy will be recusal.
   
   
6. Recusal:  IRB Members and Research Oversight Officials must recuse themselves from reviewing a research protocol whenever they self-identify themselves as possessing a Conflict of Interest in relation to that protocol, and whenever they have been directed to do so by the COI Committee (or the Senior Vice President in the case of an appeal).  In all cases, recusal must occur before the discussion of, and vote on, the research protocol in relation to which the IRB Member or Research Oversight Official has a Conflict of Interest.  Nevertheless, the IRB Member or Research Oversight Official may remain in the room prior to the discussion or vote in order to provide information relating to the protocol, and may, if he or she is an inventor and/or serves as an Investigator on that protocol, present or assist in presenting the protocol to the IRB Members.     
   
   
7. Appeal of COI Decision:  An IRB Member or Research Oversight Official who disagrees with the COI Committee’s findings and/or management strategy may appeal in writing to the Senior Vice President responsible for the research.  A copy of the appeal must be sent to the COI Committee.  An appeal may lie in regard to whether the IRB Member’s or Research Oversight Official’s Leadership Role is likely to affect his or her review of research, but IRB Members and Research Oversight Officials may not contest the terms and conditions of this policy (e.g., they may not contest the prohibition on Research Financial Interests, nor the remedy for such interests).  The applicable Senior Vice President may agree with the COI Committee’s findings and/or management strategy, or may amend such findings and/or management strategy, by for example, strengthening or weakening the management strategy.  The applicable Senior Vice President shall promptly notify theIRB Member or Research Oversight Official and the COI Committee in writing of the conclusions of his or her review, including the actions that must be taken by the IRB Member or Research Oversight Official to comply with this policy.  Upon receipt of the applicable Senior Vice President’s written report, the IRB Member or Research Oversight Official must promptly comply with the actions specified in that report.
   
   

 Audits and Sanctions for Non-Compliance

If required by a Senior Vice President of the University, an IRB Member or Research Oversight Official may be audited for the purpose of verifying whether the IRB Member or Research Oversight Official truthfully and accurately disclosed his or her Leadership Roles, Secondary Commitments and Financial Interests, including Research Financial Interests in the Annual Research-Related Financial and Leadership Disclosure form (and in any updates thereto), and for the purpose of verifying whether the IRB Member or Research Oversight Official is complying with the actions, if any, that were specified in the written report of the COI Committee (or the Senior Vice President where there has been an appeal).  An IRB Member or Research Oversight Official who does not comply with the actions specified by the COI Committee or the Senior Vice President will be subject to potential sanctions in accordance with University policy and procedures.  These sanctions may include: formal admonition or censure; suspension or removal from the IRB or other institutional research oversight body, and/or any other research oversight roles and responsibilities; non-renewal of appointment; and/or dismissal.  
     

1. Investigator:  Any professional research staff member involved in exercising independent judgment in research design, enrollment, data collection and gathering, data analysis and/or preparation for publication.
   
   
2. IRB (“Institutional Review Board”):  Any board, committee, or other group formally designated by the University to review human subjects research, and which was established and which functions and operates in conformity with Part 46 of Title 45 and Part 56 of Title 21 of the Code of Federal Regulations.  IRB Members are those persons who comprise the IRB.
   
   
3. Leadership Role:  Employment, consulting in any administrative or executive capacity, or serving as (i) a member of a board of trustees or board of directors, (ii) an officer, or (iii) a member of an advisory committee, advisory board or subcommittee of a board of trustees or a board of directors, whether remunerated or non-remunerated, in a research Sponsor or research-related organization.
   
   
4. Research Financial Interest:   Any investments (whether in the form of debt, stock or other equity ownership; options or warrants to purchase stock or other securities or similar instruments) or any interest in a Sponsor, research or healthcare-related organization; royalties on any patent or intellectual property interests, unless paid by Tulane; or income, salary or remuneration in cash or kind, emoluments, benefits, gifts, honoraria, travel expenses, goods or services received from a Sponsor or research or healthcare related organization.  Research Financial Interest does not include holdings in mutual funds or other equity funds in which day-to-day control of investments is held by a person not covered by any Tulane University Conflict of Interest policy. 
   
   
5. Research Oversight Official:  Personnel and staff of any institutional office or body at the University who perform research oversight functions in which they exercise professional or administrative-level discretion.   All Designated Officials in the Policy of Tulane University on Conflicts of Commitment and Interest are also Research Oversight Officials.  
   
   
6. Sponsor:  The entity that is sponsoring or funding the research and the entity’s affiliates and subsidiaries, and any entity that monitors research, collects or arranges data for research or otherwise performs any services related to or supporting research, including assisting in applications or responses to the FDA.

Footnotes

*[revisions approved by Senate May 2, 2005; update made to the Faculty Handbook February 6, 2007]

The purpose of this policy is to safeguard the integrity and reputation of Tulane and its faculty, staff, and researchers. It seeks to foster the proper and unbiased conduct of sponsored research and other academic activities by providing guidelines and mechanisms for dealing with actual or perceived conflicts of interest.

The faculty, staff, and administration of Tulane University have a common interest in the success of its academic pursuits, which requires an allegiance based on fairness and trust. Academic enterprises, however, are vulnerable to conflicts of interest. Teaching, research, promotion, the awarding of tenure, and the use of resources must be carried out in ways which are consistent with the pursuit of academic achievement. Any effort or expenditure that is inconsistent with this pursuit threatens the high regard in which Tulane is held by members of scholarly and professional communities, alumni, friends, and the general public.

Faculty and staff members often participate in extramural professional activities, such as consulting and similar activities which can advance the dissemination of knowledge. Conflicts of interest resulting from extramural commitments may, on occasion, threaten to undermine a faculty or staff member's responsible performance of his or her University duties, or the integrity of his or her research. Conversely, there may be circumstances in which pursuit of the University's financial interests threatens a faculty member's academic freedom. These conflicts tend to undermine the supportive relationship between the University and its faculty and staff, and can compromise the University's reputation for integrity and academic excellence. Thus, each faculty or staff member, by virtue of employment, accepts the responsibility to avoid activities or commitments that are inconsistent with his or her University duties, or the integrity of his or her research. In return, the University is committed to respecting the dignity and academic freedom of its faculty and the integrity of its staff.

The University will annually solicit from members of the faculty and staff disclosure of their outside professional activities and other relevant financial involvement in order to determine whether there is a threat to their mutual allegiance. Faculty and staff will disclose any relationships which could reasonably be expected to create the appearance of a conflict of interest. All conflicts of interest, including institutional conflicts of interest, must be resolved or managed in ways that are fair, and that can reasonably be expected to promote mutual allegiance and trust.

Definitions of Conflict of Interest

a. Conflict of Interest   refers to either 1.) Individual Conflict of Interest or 2.) Institutional Conflict of Interest.

1. Individual conflict of interest is conflict which leads, or threatens to lead, to the neglect of academic or institutional duties because of other professional activities, to undermining the integrity of research, or to the improper use of institutional resources for the sake of personal financial gain. A prime example of such conflict is a situation in which the financial interest of an individual or his/her immediate family can lead to improper conduct in research or bias in reporting research results [University policies regarding the extent to which faculty members may commit their time to outside professional activities are stated in the Consulting and Other Extramural Activities section of the Faculty Handbook].

2. Institutional conflict of interest is conflict between financial interests of the university and the scholarly pursuits of a faculty member. The possibility of an institutional conflict of interest is greatest in cases of sponsored research or technology-development agreements in which the University has an interest in developing a technology, yet the pursuit of such an interest would interfere with the faculty member's academic freedom, and particularly his or her freedom to communicate research results [Policies regarding the extent to which the University may share in ownership rights with respect to discoveries and inventions of University employees are stated in the Intellectual Property Policy and Procedures section of the Faculty Handbook].

b. Consulting for purposes of this policy, includes not only the provision of information and expertise on professional matters, but also the holding of extramural management positions and/or board memberships. In accordance with the policies stated above, staff and faculty should pursue consulting activities only to the extent that these are consistent with their University commitments. Required teaching, research, patient care, and other University duties must not be neglected for the sake of consulting.

c. Faculty for the purposes of this policy are as defined in III.A.I, above. Part-time as well as full-time faculty are included, as are those holding regular appointments, research appointments, clinical appointments, adjunct appointments and other special appointments.

d. Clinical Medical Faculty for the purpose of this policy, are those members of the faculty who participate in the Faculty Practice Plan and/or are appointed in clinical departments of the School of Medicine. This policy acknowledges the guidelines and formulae provided in the Faculty Practice Plan for the collection and distribution of income derived from professional consulting by and other outside relationships of members of the clinical medical faculty.

e. Staff are all other employees of the University, whether part-time or full-time, and including temporary as well as permanent employees. A staff employee may have a faculty appointment as well, in which instance the employee is obligated to abide by this policy as it applies to both positions.

f. Immediate Family includes a faculty or staff member's spouse and dependent children (including stepchildren). For purposes of this policy, it is irrelevant whether these family members live in the same household as the faculty or staff member.

g. Equity Interest for purposes of reporting, is ownership, whether directly, indirectly, or beneficially, by a member of the faculty or staff or his/her immediate family member(s), either individually or in aggregate, of a five percent or greater interest in any business entity or trust.

h. Financial Interest for purposes of this policy, includes:

1) equity interest, as defined above, and in general any investment, including but not limited to ownership of stock, stock options, warrants, or any equity, debt, security, or capital holding in a business enterprise; and/or salary, other remuneration, or financial consideration for services as an employee, consultant, advisor, officer, or board member of any business.

2) significant financial interest is a financial interest which exceeds $10,000 or a 5% ownership interest for any one enterprise or entity when aggregated for the faculty or staff member's spouse and dependent children or any other financial interest of a faculty or staff member or his or her immediate family, which could reasonably be regarded as threatening to undermine the proper conduct of research or to lead to bias in reporting research results. In general, a financial interest the value of which is less than $10,000 will be presumed not to pose a conflict of interest.

i. Signature Authority is granted by resolution of the Board of Administrators of the Tulane Educational Fund. A current copy of the resolution can be obtained from the President's office.

Institutional Conflict of Interest:

On occasion disagreements will arise between a faculty or staff member and the University regarding how to proceed with commercial development of a technology derived from his or her research. An institutional conflict of interest might arise from the non-competitive routing of inventions to a company in which the University has equity or royalty interests. Similarly, a conflict might exist if the University were to take a seat on the board of directors of a spin-off company to which it had licensed technology.

Faculty or staff members should use established grievance procedures of the respective colleges and schools when such a disagreement occurs. In situations where there is a conflict between the financial interest of the University and the scholarly pursuits of a faculty or staff member, the University is required to resolve that conflict promptly, and in a way that does not interfere with the academic freedom of the faculty or staff member.

Disclosure Procedures:

On an annual basis, all faculty and staff will disclose their outside professional activities, other significant financial interests and any relationships which could reasonably be expected to create the appearance of a conflict of interest. Disclosures should include financial data from the member's immediate family only when such data are relevant in determining whether the member has a conflict of interest.

In the case of the Tulane University Health Sciences Center, the Senior Vice President for the Health Sciences, the Deans of the Schools of Medicine and Public Health and Tropical Medicine, the Director of the Tulane National Primate Center, and the Senior Vice President for Operations and Chief Financial Officer (hereinafter "designated officials") are designated to solicit, review, maintain and enforce this policy. In the case of the Uptown campus, the President, the Senior Vice President for Academic Affairs and Provost, the Deans of Architecture, Business, Engineering, Law, Liberal Arts and Sciences, Social Work, and University College, and the Senior Vice President for Operations and Chief Financial Officer (hereinafter "designated officials") are designated to solicit, review, maintain and enforce this policy.

The designated officials will review and seek to resolve any potential conflict of interest or significant financial interest. In the event the designated official cannot resolve the potential conflict of interest or significant financial interest, he/she may refer cases to a Conflict of Interest Committee (hereinafter COI Committee).

If a faculty or staff member has identified significant financial interests, outside professional activities, or relationships which could create an appearance of a conflict of interest in areas which could reasonably appear to be affected by the faculty or staff member's research or educational activities, these apparent conflicts of interest will be examined by a COI committee appointed by the designated official. In those instances where the institution is required to inform a sponsor or federal agency of an actual or perceived conflict, it will do so within the time frame specified. The institution will, where appropriate, inform the sponsor or agency of any noncompliance, of the action taken in response to this noncompliance, and the effect, if any, on any sponsored research project.

In addition to the annual disclosure outlined above, faculty and staff are required to update such disclosures on an as-needed basis, such as when there is a significant change in any of the categories of information. The following are instances in which a faculty or staff member must update his/her disclosure:

1. He/she develops or discovers a conflict of interest;

2. There is a change in significant financial interest which could affect research being undertaken.

3. A disclosure is requested by the dean of his/her school for the purpose of implementing a school-specific policy;

4. He/she is involved with a grant or other externally supported project that requires disclosure;

5. A disclosure is required by Federal regulation.

All such updated disclosures shall be forwarded to the designated official. In those instances where there may be a newly arisen conflict, the designated official will refer the matter to the appropriate COI committee.

Faculty/Staff disclosure statements will be maintained in confidence by the designated officials; access by a Conflict of Interest Committee, appropriate University officers, or a Federal agency will be on a need-to-know basis. Such statements will be maintained for one year, except that in those cases where there is a sponsored research agreement, the period will be three years from the award completion date of the agreement or until resolution of any action regarding the records has been reached, whichever is longer.

Disclosures are to be used to determine whether a faculty or staff member has a conflict of interest. A faculty or staff member who refuses to comply with policies and procedures in relation to disclosure will be subject to penalties, as described below. Disclosures are to be made in writing. Members of the Executive Working Group submit their disclosures to the President.

Resolving a Conflict of Interest:

When the appropriate COI committee determines that a possible conflict of interest exists, the committee will work with the faculty or staff member informally to resolve the issue. If a resolution is not possible, the following procedures apply:

1. The report of the COI committee regarding the supposed conflict of interest will be forwarded to the designated official. The designated official, as appropriate, will initiate informal conflict resolution procedures to resolve the supposed conflict of interest.
2. If an agreement on resolving the supposed conflict of interest cannot be reached, the designated official, with the assistance of University Counsel, will prepare a written opinion as to whether a potential conflict of interest exists and, if a conflict of interest or potential conflict of interest exists, what actions must be taken to eliminate or manage the conflict, or reduce the possibility that a conflict might arise in the future.

The University expects the faculty or staff member involved in a relationship in which there is potential or actual conflict of interest to disclose the relationship, and to work with the appropriate University officer to implement plans for resolving the situation promptly. This may result in the liquidation of equity interests or the discontinuation of research. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of interest include: public disclosure of significant financial interests; monitoring of research by independent reviewers; modification of the research plan; disqualification from participation in all or a portion of the research; divestiture of significant financial interests; or severance of relationships that create actual or potential conflicts.

1.  In cases where equity interest brings about a conflict of interest, the faculty or staff member will be expected to divest himself/herself of the ownership, or to discontinue participation in any research that may be compromised by such ownership. The possibility of financial loss to the faculty or staff member, or disruptions to the outside firm, will not be regarded as justification for failing to divest.

2.     Should the faculty or staff member disagree with this opinion, he or she may request a hearing before the appropriate divisional or administrative grievance committee, with recourse to established faculty or staff appellate procedures.

Reporting a Violation

A faculty member, a staff member, or a student may report a situation involving conflict of interest. Such reports should be made to the designated official or to the Office of the General Counsel, regardless of campus. The University is obligated to protect anyone who reports a violation from reprisal. The University will attempt to take responsible and appropriate measures to preserve his or her confidentiality.

Individuals or organizations outside the University community who have evidence of a conflict of interest may also report such situations. These reports should be made to the designated official or the Office of the General Counsel, regardless of campus.

Penalties:

The University reserves the right to assess penalties for those who breach this policy; possible penalties include, but are not limited to, reimbursement to the University for misused resources and/or dismissal from employment. Such penalties may only be assessed, however, consistent with proper procedures set forth elsewhere in this document, and in other relevant policy statements, such as those concerning grievance procedures, intellectual property, and academic freedom, tenure, and responsibilities.

Certification on behalf of the University

Those with Signature Authority of the University may certify to granting agencies that the process of obtaining disclosure statements and reviewing them is current and operational.

Designated Review Official

The designated officials of the University for purposes of reviewing conflict of interest shall be the President, the Senior Vice President for Academic Affairs and Provost, the Senior Vice President for the Health Sciences, the Deans of the Schools of Medicine, Public Health and Tropical Medicine, Architecture, Business, Engineering, Law, Liberal Arts and Sciences, Social Work, and University College, the Director of the Tulane National Primate Center, the Senior Vice President for Operations and Chief Financial Officer, and the General Counsel.

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