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Conflict of Interest and Conflict of Commitment Policy

Description: 

Please see the respective SIU SOM policy directly below.

SOUTHERN ILLINOIS UNIVERSITY SCHOOL OF MEDICINE

POLICY ON CONFLICT OF INTEREST AND CONFLICT OF COMMITMENT

 

 

SPECIAL NOTE:  All employees of Southern Illinois University School of Medicine are subject to the policy on conflict of interest and conflict of commitment outlined in this document.  All employees must no less than annually or as required by external agencies certify that their COI/C Disclosure is current and up-to-date, using forms and processes designed for this purpose.  In addition, the employee must also report changes to their financial interests and/or external time commitments as their situation, or that of their family members, change during the year. Review the “Requirements for Disclosure” in the Procedures section of this document as well as guidelines included on the School of Medicine’s Conflict of Interest and Conflict of Commitment intranet website, http:/COI.siumed.edu, for more details.

 

 

 

POLICY STATEMENT

All employees are required to give the School of Medicine their primary professional loyalty and to arrange their financial interests and other non-university activities so as not to conflict or interfere with their commitment to the School of Medicine.  All employees must be alert to the possible effects of their non-university activities on the objectivity of their decisions, on the fulfillment of their obligations to the School of Medicine and its students and other learners, and on the discharge of the School of Medicine’s responsibilities to the general public.   School of Medicine employees must perform their duties free of actual conflicts of interest and commitment and the appearance of such conflicts.

The School of Medicine's Conflict of Interest and Commitment Policy (“Policy”) complements conflict of interest and commitment policies of the State of Illinois, including the State Officials and Employees Ethics Act, the Illinois Governmental Ethics Act, the Illinois Gift Ban Act, the University Faculty Research and Consulting Act, and policies of Southern Illinois University, including the University’s Conflict of Interest policies and University Codes of Conduct and Ethics.  The School of Medicine’s Conflict of Interest and Commitment Policy also incorporates other related policies of the School of Medicine such as the Policies on Industry Relations.

 

INTRODUCTION

Southern Illinois University School of Medicine (“SIU SOM”) encourages its employees to seek and participate in research, to consult widely, and to engage in other activities that may benefit not only the participants but also SIU SOM and the public.  However, while SIU SOM recognizes the benefit of such activities, it is also committed to ensuring that they are conducted properly and not to the detriment of the SIU SOM.

In recent years, the number of faculty and staff engaging in research, in consulting, in community service and/or in other interactions with external organizations has increased substantially. These interests and commitments must not conflict or compromise the atmosphere of free inquiry and public service that SIU SOM considers vital.

This SIU SOM Policy on Conflicts of Interest and Commitment provides:

1.  OVERVIEW

2.  DEFINITIONS

3.  PRINCIPLES

4.  EXAMPLES

5.  PROCEDURES

The Policy makes every effort to balance the interests of the SIU SOM with the interests of individual faculty and staff members.   The COI Committee attempts to identify and then eliminate or manage actual and apparent conflicts of interest or commitment.  The Policy encourages remedies to manage conflicts constructively, but provides for sanctions when the Policy is violated.

 

OVERVIEW

  • A conflict of commitment arises when the external activities, whether compensated or not, of an employee are so demanding of time or attention that they interfere with the individual’s primary responsibilities to the SIU SOM.
  • A conflict of interest occurs when the employee is in a position to advance one’s own economic interests, or that of one’s family members, to SIU SOM’s detriment.  For the purposes of this Policy, a Family Member is defined as a spouse, domestic partner, parent, sibling, child, and any other relative who resides in the same household as the employee. The involvement of SIU SOM learners or other employees in the external activities of the employee must be disclosed, approved in advance, and may require monitoring.
  • Each Department will work with the employee to identify and address conflicts.
  • Potential conflicts and remedies are reviewed by the Conflict of Interest Committee (“Committee”).
  • Management of conflicts will always be the goal, but if remedies mutually satisfactory to the employee and the SIU SOM are not reached, the SIU SOM may prohibit the external activity, subject to appeal.
  • Final responsibility for this Policy rests with the Dean and Provost of the SIU SOM.
  • The confidentiality of disclosures will be maintained as far as possible.

 

DEFINITIONS

Conflict of Commitment:  A conflict of commitment occurs when the external activities of an employee, whether compensated or not, are so demanding of time or attention that they interfere with the individual’s primary responsibilities to SIU SOM. 

The time allowable will vary among individuals, from discipline to discipline, from one type of proposed activity to another, and among employee types, and will be affected by specific departmental needs to meet teaching, research, service, administrative and/or support functions.  Employees are expected to satisfy all of the requirements of their jobs and should not permit outside activities to interfere with the performance of their SIU SOM obligations.

Conflict of Interest:  A conflict of interest occurs when the employee is in a position to advance one’s own economic or reputation interests, or that of one’s family members, to SIU SOM's detriment.

For purposes of this policy, an individual's economic interests include:  his or her interest in obtaining, maintaining or increasing the value of relationships such as outside employment, independent contractor or consulting relationships; management positions, board memberships and other fiduciary relationships with for-profit or not-for-profit organizations; ownership of stock or other securities and other financial interests such as loans; and any other active or passive activity from which the individual receives or expects to receive remuneration.  They also include such interests on the part of the individual's family members.

The economic interests are external economic interests when those interests do not involve SIU SOM as an institution. For example, although employment is an economic interest, an individual's employment by SIU SOM is not an external economic interest; hence, the incentives that derive from the individual's SIU SOM employment do not create conflicts of interest for purposes of this Policy.

As the examples below illustrate, external economic interests create conflicts of interest when they provide an incentive to the individual to adversely affect a SIU SOM decision or other activity (for example, the possibility for personal gain) or when the individual has the opportunity to affect the SIU SOM decision or other activity (for example, because he or she is the decision-maker or the principal investigator for a research project or the employee is a clinician who holds a patent or ownership interest in a pharmaceutical or device company which is used in their clinic practice).

 

PRINCIPLES

The following principles underlie the SIU SOM policy on conflicts of interest and commitment:

1. External activities should not compromise an individual's ability to perform their assigned duties and responsibilities as an SIU SOM employee;

2. An individual should not receive remuneration for the conduct of his or her work duties, research or clinical activity at SIU SOM, or other SIU SOM activity, except through University channels (such as salary);

3. An individual should not perform work duties, conduct research or clinical activity at SIU SOM or carry on other SIU SOM business under circumstances in which a reasonable person would infer that the SIU SOM activity was distorted by the desire for or expectation of direct or indirect financial or reputational  advantage;

4. SIU SOM faculty and staff must not be precluded from publishing their work by agreements with external sponsors or on account of the interest of an external organization in which a faculty mentor or supervisor has an economic interest;

5. SIU SOM facilities and personnel should only be used for SIU SOM's education, patient care, research  and service purposes, except when other uses are specifically authorized in advance by the SIU SOM; and

6. An individual can  participate directly in the negotiation of agreements such as research contracts, license agreements, equipment purchases or other arrangements between the University and an organization in which the individual has an economic interest, but completion and execution of such agreements are to be managed by the appropriate office of the SIU SOM.

 

EXAMPLES

The following examples are intended to illustrate the principles underlying SIU SOM policy.  This is by no means an exhaustive list.  Individuals who have questions about how this Policy applies to a particular activity should seek advice from the SIU SOM Office of Compliance.

 

Examples 1 through 5 below represent actual conflicts of interest or commitment and are inconsistent with SIU SOM policy.  Situations like these are prohibited.

1. A researcher uses his laboratory at SIU SOM to do product-testing research, paid for by a company in which he/she has a financial ownership interest.

2. A clinician makes patient referrals to an entity in which his/her immediate family has a significant ownership interest.

3. An employee directs the purchase of supplies for the University toward a business in which he/she or an immediate family has a significant ownership interest.

4. An employee engages in outside activities (e.g., volunteer work) that, while performed on non-SIU SOM work time, interfere or detract from the individual’s primary obligation to SIU SOM. 

5. A clinician receives a royalty or referral payment for a drug or device which he/she prescribes.

 

Examples 6 through 15 below may represent conflicts of interest or commitment.  These must be disclosed and may be allowed to go forward or continue after disclosure with appropriate safeguards and continuing oversight.

6. A researcher conducts Federal or foundation-sponsored research on a product developed by a company for which he is a consultant.

7. A researcher conducts clinical research on a product developed by him/her and licensed to an external organization in which he/she owns equity or has other direct relations including consulting.

8. A researcher who is a member of a company's scientific advisory board conducts research sponsored by that company.

9. An employee manages a design and construction project involving an architectural firm in which he/she or an immediate family member is a partner.

10. An employee uses SIU SOM resources to conduct research that is sponsored by an entity in which the employee or his/her family member holds a financial interest.

11. An employee serves on the board of directors or a major advisory committee of an external entity that sponsors the employee’s research or provides gift funds for the use of the employee or his/her department.

12. A faculty member utilizes SIU SOM learners (e.g., students, clinical residents) or employees in consulting activities, supported by gift funds, and/or research sponsored by an entity in which the employee has financial interests.

13. A researcher diverts research opportunities from SIU SOM to another academic institution, federal laboratory, business, or consulting entity.

14. A researcher conducts research (other than product evaluation research) sponsored by a large publicly traded company in which he/she has an ownership interest or stocks which would have or may have the appearance of being self-serving for the individual.  

15. An employee earns income from a second job that is performed on non-SIU SOM work time, but which may be in conflict with or perceived as being in conflict with their SIU SOM assigned duties and/or responsibilities because the duties of the second position are similar and related to their SIU SOM position.

 

It is important to understand that the above examples are meant to be only that--examples--and that there are many other situations different in nature and kind from the above.  Individuals who have questions about how this policy applies to a particular activity should seek advice from the SIU SOM Office of Regulatory Compliance.

 

PROCEDURES

Disclosure

An essential step in addressing a conflict of interest or commitment is for the individual involved to make full disclosure of all relevant information.  Disclosure shall be as follows:

Requirements for Disclosure:  All employees of the SIU SOM are subject to the Policy and are required to complete, sign, and submit a disclosure form certifying that their Disclosure is current and up-to-date.  All employees must complete and submit an  Disclosure Form at least annually, and to also make changes to their Disclosure as their situation or that of their family member changes throughout the year.  Employees are required to complete and submit a revised  Disclosure Form within thirty (30) days whenever their financial interests or external activities change.

 The COI/C Disclosure from and instructions can be found at the following site: https://coi.siumed.edu/.

The confidentiality of the disclosures will be respected as far as possible. In particular, the information on the forms will not be shared except with those with a need to know.

 

Review of Disclosures by the Conflict Of Interest Committee

The Committee shall review disclosures to determine if a conflict of commitment or interest exists by appointing an initial reviewer from the Committee.  The initial reviewer will review the disclosure before forwarding it to the full Committee to determine if a conflict of interest or commitment appears to exist. The initial reviewer shall provide a recommendation to the Committee of whether a conflict exists.

The Committee will then determine whether a conflict of interest or commitment exists and, if so, by what means--such as the individual's abstention from the external activity, modification of the activity, and/or the monitoring of the activity by the employee’s department or relevant unit administrator.  If necessary, the Committee will discuss the matter with the individual involved and may also consult with others who may have relevant information. The individual is entitled to meet with the Committee if he or she wishes.

If warranted, the Committee will communicate its decision in writing to the individual, the individual’s supervisor, and the Dean and Provost. The Committee will keep a record of the disclosure and other relevant information.  If the Committee prescribes monitoring of the activity, it will describe specifically how the monitoring shall be performed and what records are to be kept of the process.

If the individual is not satisfied with the decision of the Committee, he or she may appeal as indicated below.

 

Sanctions for Violation of This Policy

Sanctions are warranted for failure to report potential conflicts or to abide by a remedy to manage, reduce, or eliminate the conflict.  Severity of sanctions depends on the extent of the violations of the Policy.  Inadvertent, unintentional, and minor breaches require lesser sanctions, whereas knowing, deliberate, and major violations demand the severest sanctions.  Any sanctions for violations of this Policy shall be carefully examined with due regard for the academic freedom and rights of the employee and the interest of the SIU SOM.  Sanctions may include, but are not limited to:  1) suspension of clinical privileges; 2) suspension of laboratory privileges; and/or 3) other actions as necessary, up to and including termination.  While gross non-compliance with this Policy could constitute due cause for dismissal, this Policy does not abrogate any of the procedural protections afforded by the University, including those associated with tenure.

Sanctions shall be reduced to writing and any associated documents routed through regular reporting channels.  The employee will be afforded an opportunity to respond before the proposed sanction is forwarded to the next administrative level.

 

Appeals

When approval of an external activity is denied by a department chair or unit administrator, an employee shall be afforded the opportunity to appeal in writing to the Committee.  The Committee will then make a decision on the activities.

When approval of an external activity is denied or when a remedy or sanction is imposed by the Committee, an employee shall be afforded the opportunity to respond in writing to the Committee.  The Committee will then either reaffirm, modify, or reverse its decision on the denial, remedy or sanction.

An employee is entitled to make an appeal of a denial, remedy or sanction to the Dean and Provost in matters of conflict of commitment or conflict of interest.  This appeal must be made in writing and within 30 calendar days from the employee’s receipt of notice regarding such action.  The Dean and Provost will provide the final decision on the matter.

 

Conflicts Associated with the Dean and Provost

In situations where the Dean and Provost is personally the subject of the claims of conflict, the Dean and Provost will recuse himself/herself from the process and the Chancellor, SIU Carbondale, will provide administrative oversight for the process.

 

 

Reference and Regulatory Compliance

The Conflict of Interest and Conflict of Commitment Policy complies with the regulations of the Public Health Service of the U.S. Department of Health and Human Services establishing standards that provide a reasonable expectation that the design, conduct and reporting of research funded under Public Health Service grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.  (See Title 42, Part 50, Subpart F, Sections 50.601-50.607). 

 

 

Revised January 2006

Revised March 2006

Revised July 2009

Revised September 2010

Revised January 2012

Revised September 2012