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KUMC Individual Conflict of Interest Policy & Procedures

Policy
Purpose: 

To describe KUMC’s procedures for implementation of the University of Kansas Individual Financial Conflict of Interest Policy.   

Applies to: 

All faculty, all unclassified professional staff, and all Investigators as defined below.

Campus: 
Medical Center, Kansas City
Wichita
Salina
Policy Statement: 

Section I. Definitions

A.  Clinical trial: a research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.

B. Covered Persons:  These procedures cover all faculty, all other unclassified academic and professional staff, and all Investigators as defined below. Financial Interests of a Covered Person include those of the Covered Person’s immediate family (spouse and dependent children) and personal household.

C. Equity Interest: includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

D.  Investigator: the project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research conducted under the auspices of the University. Investigators may include, for example, collaborators not employed by the University.

E. Financial Conflict of Interest: a Significant Financial Interest that KUMC reasonably determines compromises or has the appearance of compromising the fulfillment of professional duties; teaching, clinical or scientific judgment; integrity of research data and the research; or the safety and welfare of patients and/or research subjects.  In the case of  research, this includes a Significant Financial Interest that KUMC reasonably determines could directly and significantly affect the design, conduct or reporting of KUMC research.

F. Financial Interest: anything of monetary value received or held by a Covered Person, or such Covered Person’s immediate family (spouse and dependent children) or personal household member, whether or not the value is readily ascertainable, including, but not limited to:

  • salary or other payments for services (e.g., consulting fees, honoraria, or paid  authorships other than scholarly works);
  • any Equity Interests (e.g., stocks, stock options or other ownership interests);
  • any intellectual property rights and interests (e.g., patents, trademarks, servicemarks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
  • Except as otherwise noted in subsection c) below, for Investigators, “Financial Interest” also includes reimbursed or sponsored travel related to an Investigator’s University Responsibilities.  This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed to the Investigator, even if the exact monetary value is not readily available. 

           "Financial Interest" does NOT include:

  • salary, royalties, or other remuneration paid by the University to the Covered Person if the individual is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and  agreements to share in royalties related to such rights;                        
  • income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Person does not directly control the investment decisions made in these vehicles;
  • income or other benefits for certain activities sponsored by or in the service of Governmental or Educational Entities, as follows: seminars, lectures, or teaching  engagements service on advisory committees or review panels reimbursed or sponsored travel.

G. Governmental or Educational Entities: include federal, state, or local government agencies; institutions of higher education as defined at 20 U.S.C. 1001(a); and academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education.

H. Significant Financial Interest: a Financial Interest (as defined below) that reasonably appears to be related to the Covered Person’s University Responsibilities, and consists of:                    

  • An interest in any publicly traded entity, if the value of any Remuneration received from the entity in the twelve months preceding disclosure, and the value of any Equity Interest  as of the date of disclosure, when aggregated exceeds $5,000; or
  • An interest in any non-publicly traded entity, if the value of Remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Covered Person holds any Equity Interest; or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.  As indicted above, this does not include income paid by the University or KUIC on behalf of the University. 

 I. Public Health Service or “PHS: means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the  Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.

J.  Remuneration: includes salary and any payment for services not otherwise identified as salary (e.g., consulting or other fees, honoraria, paid authorship, commissions, etc.)

K.  University Responsibilities:  An individual’s responsibilities on behalf of the University, which may include (but are not limited to), activities such as teaching, research, research consultation, administration, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.

Section II. Oversight

A.  Institutional Official: Federal law requires the appointment of an Institutional Official related to the oversight of conflict of interest. The Vice Chancellor for Administration shall serve as or appoint an Institutional Official in matters related to conflict of interest.

B.  Conflict of Interest Committee (COIC): A committee or committees shall be constituted to review potential individual conflicts of interest, to develop management plans for real or perceived individual conflicts of interest, to advise the Institutional Official on matters related to conflicts of interest, and to serve as a resource to faculty and staff regarding issues to conflict of interest.  Each COIC shall consist of at least five (5) full-time faculty and may include a community member, all of whom shall be voting members. At least three (3) voting faculty members must be present for quorum.  All members shall be appointed by the Institutional Official.  Members of a COIC with jurisdiction over research-related conflicts of interest shall be approved by the Research Advisory Council.  Each COIC will consist of members with appropriate professional expertise and be representative of the schools and campuses.   Office of Compliance staff shall provide committee support.

Section III.  Disclosure Reporting

A.  Disclosures Generally:  At the time of hire and annually thereafter at the time prescribed by KUMC, all full-time and part-time faculty and unclassified staff shall complete a Conflict of Interest Reporting Form. If a Covered Person’s situation related to conflict of interest should change during the time between reporting periods, the Covered Person shall file an ad hoc report within thirty (30) days of discovering or acquiring the change. 

B.  Interests to be Disclosed:  The Conflict of Interest Reporting Form shall require reporting of all Significant Financial Interests (see definition) that reasonably appear related to the Covered Person’s University Responsibilities.  

C.  Investigators:  Investigators not otherwise subject to the foregoing reporting requirement shall still be required to submit a Conflict of Interest Reporting Form prior to submission of a proposal for sponsored research and on an annual basis thereafter.  If any Investigator’s situation related to a conflict of interest changes during the time between reporting periods, the Investigator shall also file an ad hoc report within thirty (30) days of discovering or acquiring the change.   In addition, Investigators shall disclose conflicts of interest as required for IRB applications and on animal care and use protocols, as deemed necessary by the IRB and IACUC.  Prior to entering into sponsored projects or technology licensing arrangements, the  Investigator must affirm that their last Conflict of Interest Reporting Form is complete and accurate and that all ad hoc reports, if any, have been filed.   The University will not submit a research proposal unless the Investigator(s) have submitted the Conflict of Interest Reporting form and all required ad hoc COI disclosures. 

D.  Committee Members:  Individuals who serve on an IRB, IACUC, COIC, Radiation Safety Committee (RSC), Radioactive Drug Research Committee (RDRC) or Institutional Biosafety Committee (IBC) shall report any Significant Financial Interests that might affect, or reasonably appear to affect, the scope of their responsibilities as committee members. IRB, IACUC, COIC, RSC, RDRC and IBC Committee members shall recuse themselves from participating in any deliberations concerning or voting on protocols in which they have a Significant Financial Interest. Each Committee administrator shall poll the Committee members at the beginning of each meeting to determine whether or not members have any potential conflicts of interest that would require recusal and shall document the results in the meeting minutes.

Section IV. Disclosure Review

A. Review of Annual and Ad Hoc Conflict of Interest Reporting Forms:  To avert or mitigate individual conflicts of interest arising from financial or other relationships, Significant Financial Interests reported in the Conflict of Interest Reporting Form shall be reviewed by the Office of Compliance COI staff (“COI Staff”) on an annual basis, as ad hoc reports are submitted and as new research projects arise.  COI Staff will determine whether a conflict of interest likely exists by considering the nature of the KUMC activity, the nature of the Significant Financial Interest and how closely the interest is related to the covered individual’s University Responsibilities.

B. COI Staff are authorized to administratively review and process individual conflicts of interest that present very low risk of potential or perceived bias or lack of objectivity to the relevant research and for which the relevant COIC has already developed, reviewed and approved certain “standard” management terms.  

C. Other likely conflicts of interest (those not subject to administrative review and processing by COI Staff) shall be referred to the COIC with jurisdiction over the matter, to determine whether the conflict of interest should be eliminated, reduced or otherwise managed.  The COIC shall determine whether the Significant Financial Interest is a Financial Conflict of Interest and whether it may be managed effectively or should be eliminated. All such decisions shall be documented and shall be communicated to the Covered Person, his/her supervisor, and as appropriate, to the IRB and IACUC.  The COIC or designee will provide the Covered Individual with an opportunity to confer regarding a determination that a Financial Conflict of Interest exists. 

D.  It shall be the prerogative of the Institutional Official to review Conflict of Interest Reporting Forms at any time and to take action on any report as appropriate to the circumstances with regard to a particular real or perceived conflict of interest.

E.  Appeals Process: A COIC decision and/or action may be appealed by submitting, in writing, a request to the Institutional Official to review the COIC’s decision and/or action. The Institutional Official will review the potential conflict of interest and the COIC’s decision and/or action. The Institutional Official may then refer the matter back to the COIC for reconsideration or the Institutional Official may, after consultation with the appropriate Dean, make an alternate decision and/or action.

F.  Maintenance of Records: KUMC’s Office of Compliance shall cause to be maintained records of Conflict of Interest Reporting Forms and actions taken by the institution with respect to identified conflicting interests for at least five (5) years after completion of the relevant research or five (5) years after the conflict has ended, whichever is longer. 

Section V. Management of Individual Conflicts of Interest

A. Conflict of Interest Management Plans Generally: The COIC, and COI Staff in the circumstances described above, shall make recommendations for the elimination, disclosure or management of a Financial Conflict of Interest identified. The COIC or Dean may also recommend management of a Financial Interest or Significant Financial Interests that the COIC does not consider to be a Financial Conflicts of Interest, to promote transparency and avoid the appearance of a Financial Conflict of Interest

B.  Elements of a Conflict Management Plan.

  • Examples.  Management may include disclosure, recusal, monitoring of the research or other activity by independent reviewers, modification of the research plan, disqualification of participation in a portion or all of the research or activity in question, reduction or elimination of the Financial Interest, severance of the relationship that creates the conflict of interest, or other management plan deemed appropriate to the circumstance by the COIC and/or the COI Institutional Official. 
  • Recusal.   Recusal is not an effective management strategy when the Covered Person would be precluded from fulfilling the responsibilities of his or her position.   In such cases, the best interests of the University may necessitate that the Covered Person divest him or herself of the Financial Interest or vacate the position.  If a KUMC  official  who holds a  Significant  Financial  Interest  in a commercial  research  sponsor becomes aware that he/she  must take an action or participate in a decision that may affect, or reasonably  appear to affect,  the University’s  research,  and the official has not yet been  directed by the  COIC to recuse himself/herself from the matter, the official  must  disclose  the circumstances to his/her superior. The superior may determine that recusal is necessary, may decline to require recusal or may refer the matter to the COIC for resolution.  In any case, the superior shall document his/her recusal determination and forward the documentation to the COIC.  When the superior declines to require recusal, the reviewing COIC should make the final determination as to whether or not recusal is necessary. The COIC shall maintain a central repository of information about all recusal determinations related to KUMC research.

C.  Development and Documentation of a Conflict Management Plan: If the COIC determines that there is a Financial Conflict of Interest that can be managed, the COIC must require and approve a written management plan before any related research goes forward. Development of the Conflict Management Plan should include consultation with the relevant department chair(s), unless it is not appropriate to do so (e.g. if the chair has an institutional conflict of interest).   Copies of final Conflict Management Plans shall be retained in the Office of Compliance.        

D.  Compliance with Management Plans: Covered Persons must fully comply with all management elements set forth in their Conflict Management Plan. A Covered Person with an existing Conflict of Interest Management Plan must submit his or her approved Plan to the IRB and IACUC at the time any protocol is submitted for review.  When required by the terms of a Conflict Management Plan, the Covered Person must also provide documentation demonstrating compliance.  Each School will be responsible for monitoring compliance with Conflict Management Plans.  The Institutional Official and COIC shall have authority to obtain and review documentation for purposes of reviewing compliance with the Management Plan.   

E.  Interim Conflict of Interest Management Plans: Investigators are entitled to expect relatively prompt action regarding Financial Conflict of Interest determinations. If time is of the essence, for example, to comply with the timing requirements imposed by PHS conflict of interest regulations, an interim Conflict Management Plan may be developed by the COI Program Manager in consultation with the Dean. If an interim Conflict Management Plan is created, then a final Conflict Management Plan will be issued after all the steps described above have been completed

 F.  Reporting of FCOI’s to the PHS Awarding Component; Retrospective Review: The KUMC Research Institute, with input from the Office of Compliance and COIC, will report to the PHS Awarding Component the existence of any Financial Conflict(s) of Interest prior to any expenditure of funds under an award and will assure that the conflict(s) have been reviewed and that the conflict(s) have been managed, or eliminated. If a new Financial Interest is disclosed subsequent to the award (either by an Investigator new to the project or by an existing Investigator), the Office of Compliance and the COIC will review the Financial Interest to determine whether the interest is a Significant Financial Interest, whether it is related to the PHS-funded research, and determine whether a Financial Conflict of Interest exists. If a Financial Conflict of Interest exists, a Conflict Management Plan will be developed and an FCOI report will be submitted to the PHS Funding Agency within 60 days from when disclosure is made. Such reporting will be done by the KUMC Research Institute, with consultation from the Office of Compliance and the COIC.

If a Significant Financial Interest is not disclosed in a timely manner or if  KUMC fails to review a previously existing Significant Financial Interest during an ongoing PHS-funded project, the Institutional Official or his or her designee, in consultation with the COIC’s Executive Committee, shall within 60 days of the determination of noncompliance: review the Significant Financial Interest; determine whether it is related to the PHS-funded research; and determine whether a Financial Conflict of Interest exists.  If a Financial Conflict of Interest exists, the Institution will implement, on at least an interim basis, a Conflict Management Plan that shall specify the actions that have been, or will be taken to manage such Financial Conflict of Interest going forward and submit an FCOI report to the PHS funding agency. 

In addition to the FCOI report, the Institutional Official or designee will identify the individual(s) who will, within 120 days of the determination of noncompliance, complete a retrospective review of the Investigator’s research activities and the PHS-funded research project to determine whether any PHS-funded research, or portion thereof, conducted during the time period of the noncompliance, was biased in the design, conduct or reporting of such research.  Documentation of the review shall include the project number, project title, PI, name of the Investigator with the Financial Conflict of Interest, name of the entity with which the Investigator has the Financial Conflict of Interest, reason(s) for the retrospective review, detailed methodology used for the retrospective review, and findings and conclusions of the review.               

Sponsored Projects Administration will update any previously submitted report to the PHS funding agency, specifying the actions that will be taken to manage the Financial Conflict of Interest.  If bias is found, the PHS funding agency will be notified promptly and Sponsored Projects Administration, in consultation with the Office of Compliance, will submit a mitigation report that includes a description of the impact of the bias on the research project and the KUMC’s plan of action or actions taken to eliminate or mitigate the effects of the bias.

G.  Report by COIC to the IRB and IACUC:  In the event that the COIC has recommended management of a Financial Interest or Significant Financial Interest, the COIC or COI Staff shall communicate the COIC’s conclusions, along with any Conflict Management Plan to be implemented, to the IRB or IACUC having jurisdiction over the research. 

 Section VI. Subgrantees, Contractors, Collaborators:

Non-KUMC individuals participating in KUMC research as subgrantees, contractors or collaborators must comply with applicable conflict of interest regulations. To demonstrate such compliance, subgrantees, contractors or collaborators must comply with KUMC’s policy and procedures for reporting and managing conflicts of interest or must certify to KUMC or the KUMC Research Institute in the agreement that they are in compliance with applicable PHS regulations. The agreement must specify time period(s) for the subgrantee, contractor or collaborator to report all identified Financial Conflicts of Interest to KUMC, and such time period(s) shall be sufficient to enable KUMC to provide timely FCOI reports, as necessary to the PHS. 

KUMC must then determine whether or not a Financial Conflict of Interest exists on the part the subgrantee, contractor or collaborator providing assurance of compliance.  If a Financial Conflict of Interest exists, KUMC will work with the subgrantee, contractor or collaborator to develop a relevant Conflict Management Plan to manage, reduce or eliminate the conflict. KUMC will report such conflicts as required by regulation.

Section VII.  FCOI Training

Prior to engaging in PHS-funded research, and no less often than every four (4) years, all PHS-funded Investigators must complete training with respect to this policy and the PHS FCOI rules and regulations.  In addition, PHS Investigators shall complete such training whenever: 1) KUMC revises this policy or related procedures in any manner that materially affects the obligations and responsibilities of the PHS Investigators; 2) a PHS Investigator first becomes associated with KUMC; and 3) KUMC determines that a PHS-funded Investigator is not in compliance with this Policy or any applicable Conflict Management Plan.  

Section VIII.  Public Disclosure of FCOI’s

KUMC will provide sponsors with FCOI information as required by law or sponsor policy.  PHS requires that KUMC respond within five (5) business days to a written request for information about Significant Financial Interests held by senior/key personnel when KUMC has determined that the disclosed Significant Financial Interest is related to the PHS-funded research, and constitutes a Financial Conflict of Interest.  Requests for FCOI information should be sent to the COI Program Manager.  The reporting of FCOI’s to the public will be the responsibility of the Office of Compliance in consultation with the Institutional Official.

 

Consequences: 

Alleged violations of KUMC’s Conflict of Interest Policy and Procedures will be reviewed by the applicable COIC, which will determine whether or not a violation has occurred and will recommend appropriate sanctions.

Sanctions will then be referred to the KUMC Institutional Review Board, Institutional Animal Care and Use Committee, the Institutional Official, and department chair for implementation.  Regarding clinical research, in any case in which the Department of Health and Human Services determines that a PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device or treatment has been designed, conducted or reported by an Investigator with a Financial Conflict of Interest that was not disclosed or managed as required by Federal regulations, KUMC shall require the Investigator(s) involved to disclose the conflicting interest in each public presentation of the results of the research and to request an addendum to previously published presentations. 

Contact: 

Associate Vice Chancellor, Compliance  
913-588-1206
lhoebelheinrich@kumc.edu

Approved by: 
Vice Chancellor for Administration
Approved on: 
Wednesday, May 27, 2009
Effective on: 
Wednesday, May 27, 2009
Review Cycle: 
Annual (As Needed)
Definitions: 

A.  Clinical trial: a research study that involves interaction with human subjects and the concurrent investigative use of drugs, biologics, devices or medical or other clinical procedures, such as surgery.

B. Covered Persons:  These procedures cover all faculty, all other unclassified academic and professional staff, and all Investigators as defined below. Financial Interests of a Covered Person include those of the Covered Person’s immediate family (spouse and dependent children) and personal household.

C. Equity Interest: includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

D.  Investigator: the project director or principal investigator or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research conducted under the auspices of the University. Investigators may include, for example, collaborators not employed by the University.

E. Financial Conflict of Interest: a Significant Financial Interest that KUMC reasonably determines compromises or has the appearance of compromising the fulfillment of professional duties; teaching, clinical or scientific judgement; integrity of research data and the research; or the safety and welfare of patients and/or research subjects.  In the case of  research, this includes a Significant Financial Interest that KUMC reasonably determines could directly and significantly affect the design, conduct or reporting of KUMC research.

F. Financial Interest: anything of monetary value received or held by a Covered Person, or such Covered Person’s immediate family (spouse and dependent children) or personal household member, whether or not the value is readily ascertainable, including, but not limited to:

  • salary or other payments for services (e.g., consulting fees, honoraria, or paid  authorships other than scholarly works);
  • any Equity Interests (e.g., stocks, stock options or other ownership interests);
  • any intellectual property rights and interests (e.g., patents, trademarks, servicemarks, and copyrights), upon receipt of royalties or other income related to such intellectual property rights and interests.
  • Except as otherwise noted in subsection c) below, for Investigators, “Financial Interest” also includes reimbursed or sponsored travel related to an Investigator’s University Responsibilities.  This includes travel that is paid on behalf of the Investigator as well as travel that is reimbursed to the Investigator, even if the exact monetary value is not readily available.    

        “Financial Interest” does NOT include:

  • salary, royalties, or other remuneration paid by the University to the Covered Person if the individual is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and  agreements to share in royalties related to such rights;
  • income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Person does not directly control the investment decisions made in these vehicles;
  • income or other benefits for certain activities sponsored by or in the service of Governmental or Educational Entities, as follows: seminars, lectures, or    teaching engagements service on advisory committees or review panels reimbursed or sponsored  travel.

G. Governmental or Educational Entitiesinclude federal, state, or local government agencies; institution of higher education as defined at 20 U.X.C. 1001(a); and academic teaching hospitals, medical centers, or research institutes affiliated with an institution of higher education.

H. Significant Financial Interest: a Financial Interest (as defined below) that reasonably appears to be related to the Covered Person’s University Responsibilities, and consists of:

  • An interest in any publicly traded entity, if the value of any Remuneration received from the entity in the twelve months preceding disclosure, and the value of any Equity Interest  as of the date of disclosure, when aggregated exceeds $5,000; or
  • An interest in any non-publicly traded entity, if the value of Remuneration received from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Covered Person holds any Equity Interest; or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.  As indicted above, this does not include income paid by the University or KUIC on behalf of the University.        

I. Public Health Service or “PHS: means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the  Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.

J.  Remuneration: includes salary and any payment for services not otherwise identified as salary (e.g., consulting or other fees, honoraria, paid authorship, commissions, etc.)

K.  University Responsibilities:  An individual’s responsibilities on behalf of the University, which may include (but are not limited to), activities such as teaching, research, research consultation, administration, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards. 

Keywords: 
Conflict of Interest, Financial Conflict of Interest, Significant Financial Interest
Review, Approval & Change History: 

02/22/2017: Fixed broken link to Kansas Board of Regents Policy Manual.

09/08/2016: updated link to Vendor Relations policy.

05/06/2016: Removed Date Last Reviewed

04/04/2016: Deleted old link to KUMC Conflict of Procedures (August 10, 2012)

02/15/2016: Revised to change reporting threshold from $0 to $5,000; updated definition of “Family”.

Financial Categories: 
Financial Oversight
Personnel: Administrators Categories: 
Conflicts of Interest
Personnel: Faculty/Academic Staff Categories: 
Conflicts of Interest
Personnel: Staff Categories: 
Conflicts of Interest
Personnel: Student Employees Categories: 
Conflicts of Interest
Research and Sponsored Projects Category: 
Research and Sponsored Projects

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