UAB Enterprise Conflict of Interest and Conflict of Commitment Policy

UAB Enterprise Conflict of Interest and Conflict of Commitment Policy

Abstract:
This policy describes the UAB Enterprise's commitment to conducting its activities in ways that promote and maintain public trust and sets forth requirements for employees and other designated individuals in identifying and managing conflicts of interest and conflict of commitment.
Effective Date:
8/24/2012
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff
Keyword(s):
None Assigned
Material Original Source:

University of Alabama at Birmingham Enterprise
 
CONFLICT OF INTEREST AND CONFLICT OF COMMITMENT POLICY
 
August 24, 2012
 
Section 1.  Scope
 
This policy applies to all organizations within the UAB ENTERPRISE: UAB, UAB Hospital Management, LLC, UAB Health System, University of Alabama Health Services Foundation, P.C., Eye Foundation, Inc., University of Alabama Ophthalmology Services Foundation, Valley Foundation, Triton Health System, LLC, VIVA Health, Inc., UAB Educational Foundation, UAB Research Foundation, National Alumni Society of the University of Alabama at Birmingham, and University of Alabama at Birmingham Professional Liability Trust Fund. These organizations are collectively referred to here as “UAB ENTERPRISE,” but each is individually responsible for assessing information and managing actual and perceived conflicts of interest and conflicts of commitment in accordance with this policy. 
 
This policy applies to all employees, including but not limited to faculty and staff.  Certain employees and other individuals who engage in research on behalf of UAB ENTERPRISE, identified by this policy as designated individuals, have additional requirements for disclosing financial interests.  
 
 
Section 2.  Background
 
UAB ENTERPRISE is committed to conducting its activities in ways that promote and maintain public trust.  UAB ENTERPRISE encourages professional interactions, activities, and development that enhance an employee's value to UAB ENTERPRISE; that enhance UAB ENTERPRISE's presence in the local, national, or international communities; and that provide public service.  Nonetheless, in the complex environment of a major urban university and academic medical center, these opportunities may also present potential for, or appearance of, conflicting loyalties and responsibilities.  The purpose of this policy is to implement the goals of the UAB ENTERPRISE Code of Conduct and to provide guidelines to protect UAB ENTERPRISE, its employees, and the public.
 
 
Section 3.  General Principles
 
The UAB ENTERPRISE Code of Conduct requires employees to be aware of the potential for conflicts of interest and conflicts of commitment and to exercise initiative to identify, review, and manage those conflicts appropriately.  All employees are expected to comply with this policy, as well as any other applicable policies or procedures adopted by UAB ENTERPRISE organizations, schools, or departments pursuant to or in furtherance of this policy.   
 
 
Section 4.  Definitions
 
The following defined terms are used for purposes of administering this policy but may be defined differently elsewhere in other UAB ENTERPRISE policies and materials.
 
Conflict of interest – a circumstance in which an individual’s financial, professional, or personal interests affect, or have the appearance of affecting, judgment in exercising a duty or responsibility owed to UAB ENTERPRISE.  Financial conflict of interest related to the design, conduct, or reporting of research is defined separately below.
 
Conflict of commitment – a circumstance in which an employee’s engagement in external or internal activities compromises the ability to carry out his/her primary obligations and commitments to UAB ENTERPRISE.  Because conflicts of commitment generally arise from allocation of time, the primary commitment of employees’ time should be toward their institutional responsibilities, as defined below.
 
Designated individual – any individual, regardless of position, title, or employment, who is:
  • responsible for the design, conduct, or reporting of research (also defined here as an investigator); and/or
  • otherwise designated as such by a UAB ENTERPRISE organization based upon the individual’s role or responsibility.
Dependent – any individual, regardless of his or her legal residence or domicile, who receives 50% or more of his or her support from a designated individual or his/her spouse or who resided with the designated individual or his/her spouse for more than 180 days during a calendar year.
 
Employee – an individual who receives a W-2 from a UAB ENTERPRISE organization as a regular or temporary full-time employee, regular or temporary part-time employee, or irregular employee.  (For purposes of this policy, individuals receiving a W-2 as a student assistant, federal work study, graduate assistant, or credentialed credit course instructor are not included as employees, although they may be considered designated individuals if they are deemed responsible for the design, conduct, or reporting of research.) 
 
Entity – a company, association, organization, institution, or any other type of entity with a separate legal identity, including a for-profit, not-for-profit, or an organization of higher education.  For purposes of reporting financial interests under this policy, it also includes an individual.
 
External activities – activities that draw upon the knowledge, skill, or abilities an employee uses to fulfill his or her institutional responsibilities at UAB ENTERPRISE and that are performed for an entity outside the UAB ENTERPRISE, whether or not for compensation.  Examples of external activities include, but are not limited to, the following: 
  • external employment, including moonlighting and/or locum tenens activities;
  • consulting;
  • lecturing, presenting, or speaking;
  • establishing and/or supporting a start-up company;
  • serving as an expert witness;
  • participating in a board of directors; or
  • participating in a scientific advisory board.

Financial conflict of interest – a reasonable determination made by the UAB Conflict of Interest Review Board (CIRB) and/or Office that an investigator’s significant financial interest is related to and could significantly and directly affect the design, conduct, or reporting of research.

Financial interests – anything of monetary value accepted or owned by an  individual, his/her spouse, or his/her dependents, not held in an investment vehicle such as a mutual fund or retirement account in which the owner does not directly control investment decisions, whether or not the value is readily ascertainable.  Examples of financial interests include, but are not limited to:
  • remuneration for participation in external activities (e.g., salary, consulting and other fees, gifts, honoraria, etc.);
  • acquisition or ownership of stock, shares, or other types of equity interests;
  • options to acquire stock, shares, or other types of equity interests;
  • income arising from stock, shares and other types of equity interests;
  • income from royalties;
  • licensed, optioned, or revenue-bearing intellectual property;
  • acquisition of a license of UAB or other intellectual property; or
  • sponsored or reimbursed travel.
Institutional responsibilities – all activities, duties, and responsibilities performed by an employee in the course of his/her employment or other relationship with UAB ENTERPRISE, including but not limited to scholarship, research, research consultation, teaching, professional practice, administration, contracting or procurement responsibilities, or professional public service activities.
 
Internal activities – activities that draw upon the knowledge, skill, or abilities an employee uses to fulfill his or her institutional responsibilities at UAB ENTERPRISE and that are performed for another UAB ENTERPRISE organization or another unit within the same organization in the UAB ENTERPRISE, the Veteran’s Administration, or Children’s Hospital of Alabama for compensation in addition to the salary and compensation attributable to the employee’s appointments or assignments at UAB ENTERPRISE.
 
Investigator/Responsible personnel – any individual, regardless of title, position, or employment, who is responsible for the design, conduct, or reporting of proposed or active research.  An investigator is also a designated individual. 
 
Professional Public Service Activities – activities listed below that are performed outside the UAB ENTERPRISE and are considered part of an employee’s institutional responsibilities, whether or not separately compensated: 
  • Seminars, lectures, service on advisory committees or boards of directors, or review panels for US federal, state, or local government agencies, institutions of higher education, academic teaching hospitals, medical centers or research institutes that are affiliated with an institution of higher education;
  • Professional studies, services, participation on boards of directors, or participation in manuscript review, grant/contract review, or academic program review for nonprofit/philanthropic entities, professional societies, or professional associations, that are not affiliates of or affiliated with industry or other for profit entities;
  • Seminars, presentations, performances, or board service for civic groups; and
  • Participation on boards of directors with UAB Enterprise affiliated entities.
Research – any activity for which funding is sought and/or received through a grant or cooperative agreement such as a research grant, career development award, center grant, individual fellowship award, contract, infrastructure award (construction, renovation, equipment, etc.) institutional training grant, program project, or research resources award.  The term also includes all work involving human subjects requiring Institutional Review Board review, regardless of funding source.
 
Responsible for the design, conduct, or reporting of research – a designated individual who is responsible for controlling the design, conduct, or reporting of research (also defined here as an investigator):
Design – the development of the strategy and means to test a research question or hypothesis.
 
Conduct – the supervision or management of a study’s execution. This is typically done by the principal investigator (PI) and co-investigators, but also may be performed by other project personnel, such as postdoctoral fellows, graduate students, or other junior researchers. For studies involving human subjects, this includes anyone who is responsible for explaining the study, risk -benefit, and/or alternatives to potential participants, is listed on Form FDA-1572 or device agreement, and/or must complete a sponsor’s conflict of interest form.
 
Reporting – the authorship of publications or reports that describe the results of the study.  Such reports may be to the sponsor of the research or to academic or scientific meetings.
Significant financial interest (SFI) - a financial interest of an investigator, his/her spouse, or his/her dependents that reasonably appears to be related to the investigator’s institutional responsibilities. 
 
  • With regard to any publicly-traded entity, a significant financial interest exists if the value of the financial interest received from the entity in the current or prior calendar year, when aggregated, exceeds $5,000.
  • With regard to any non-publicly traded entity, a significant financial interest exists if:
    • the value of any remuneration received from the entity in the current or prior calendar year, when aggregated, exceeds $5,000; or
    • when the investigator (or the investigator’s spouse or dependents) holds any equity interest (e.g., stock, stock option, or other ownership interest).
  • With regard to intellectual property rights and interests (e.g., patents, copyrights), a significant financial interest exists for any intellectual property licensed, optioned, or that has generated income/revenue.
  • Significant financial interest does NOT include remuneration for professional public service activities, textbook royalties, peer reviewed journal editorship activities for publishing companies, or other related items as determined by the Conflict of Interest Review Board in accordance with federal regulations.
  
Section 5.  Policy Statement 
 
All UAB ENTERPRISE employees are required to: 
  • abide by all requirements outlined in this policy;
  • use UAB ENTERPRISE resources, including confidential or privileged information, only for UAB ENTERPRISE purposes or as allowed by applicable law and policy;
  • seek approval prior to engaging in external or internal activities in accordance with this policy and the procedures of the UAB ENTERPRISE organization with which they are primarily employed;
  • notify unit leadership of any financial interests that relate to their institutional responsibilities in accordance with this policy and the procedures of the UAB ENTERPRISE organization with which they are primarily employed; and
  • adhere to any conflict of interest or conflict of commitment management or monitoring plan prescribed by their leadership.
All designated individuals are required to:
  • abide by the requirements above; and
  • complete formal processes for disclosure of financial interests related to their institutional responsibilities, as described Section 5. Policy Statement C. Disclosure of Financial Interest below.
All chairs, deans, and other employees responsible for approving requests submitted by those they supervise are required to:
  • administer this policy;
  • ensure adequate controls are in place to review and approve external and internal activity requests submitted by employees in their units;
  • determine whether requested external activities are more properly conducted as official UAB ENTERPRISE activities;
  • ensure proper accounting of employees’ time away for purposes of external or internal activities;
  • ensure written financial arrangements are in place for payment of the portions of employees’ salaries attributable to appointments/assignments/work projects performed for other UAB ENTERPRISE organizations;
  • develop and/or monitor conflict of interest and conflict of commitment management  plans; and
  • adopt specific procedures or more restrictive standards, if desired for their units.
 
A.  Use of UAB ENTERPRISE Information and Resources 
 
Employees, by  accepting employment at UAB ENTERPRISE, make a commitment to UAB ENTERPRISE that includes the appropriate and responsible use of UAB ENTERPRISE information and resources, including facilities, personnel, equipment, patents, copyrights, technology, logos, and work product, as well as UAB ENTERPRISE’s more intangible reputation and prestige.  Employees must ensure that their use of UAB ENTERPRISE information and resources, their external and internal activities, and their financial interests do not interfere with, or appear to interfere with, their institutional responsibilities (i.e., their primary obligations to UAB ENTERPRISE). 
 
Employees are prohibited from engaging in activities from which they, their families, or their businesses will gain financially or personally because of the employee's position at UAB ENTERPRISE or because of the use of UAB ENTERPRISE resources or information.  It is the responsibility of the involved employee to inform his or her immediate supervisor of any potential or actual use of UAB ENTERPRISE resources or information in the employee’s external activities or financial interests.  If, through the course of the appropriate review, it is determined that such use exceeds thresholds allowed by law and policy, the employee will be required to contract with UAB ENTERPRISE or otherwise reimburse UAB ENTERPRISE for the fair market value of the use of the resource or information.  
 
 
B.  External and Internal Activities
 
External and internal activities are encouraged.  However, any perceived, potential, or actual conflicts of interest or conflicts of commitment caused by such activities must be administered in accordance with this policy. 
 
UAB ENTERPRISE must ensure that participation in external and internal activities:
  • does not interfere with the performance of other institutional responsibilities as an employee;
  • is compatible with the interests of UAB ENTERPRISE as a public academic institution; and
  • does not violate state law and policy related to use of UAB ENTERPRISE resources or facilities.
Approval of External and Internal Activities
 
All employees must request and receive pre-approval of external and internal activities.  The decision whether to approve an external or internal activity resides with unit leadership. 
  • University faculty and staff members Grade 20 or above in full-time positions and UAB ENTERPRISE employees designated as Investigators (regardless of title, position, or employment), who wish to engage in an external or internal activity, must complete a Request for External Activity Approval.  All other University employees should obtain permission directly from their immediate supervisor.
  • All other UAB ENTERPRISE organizations will designate a process for their employees to engage in external and internal activities in accordance with the standards in this policy. 
Exemptions
 
1. Professional Public Service Activities
 
The following external activities are considered professional public service activities and do not have to be reported or approved, whether or not compensated.  Investigators have special disclosure requirements as outlined in Section D.
  • Seminars, lectures, service on advisory committees or boards of directors, or review panels for US federal, state, or local government agencies, institutions of higher education, academic teaching hospitals, medical centers or research institutes that are affiliated with an institution of higher education;
  • Professional studies, services, participation on boards of directors, or  participation in manuscript review, grant/contract review, or academic program review for nonprofit/philanthropic entities, professional societies, or professional associations, that are not affiliates of or affiliated with industry or other for profit entities;
  • Seminars, presentations, performances, or board service for civic groups; and
  • Participation on boards of directors with UAB ENTERPRISE affiliated entities.
2. Secondary Appointments/Assignments/Work Projects
 
A secondary (or otherwise additional) appointment or assignment or other work project with another UAB ENTERPRISE organization, the Veteran’s Administration, or Children’s Hospital of Alabama in which an employee’s time or effort is shared or which is part of an employee’s job expectations is not considered an internal activity.  In these instances, the organization receiving the services must make appropriate financial arrangements for payment and/or distribution of the portion of the employee’s salary attributable to that appointment, assignment, or other work project. 
 
Considerations
 
Employees are responsible for ensuring that their external activities, and any contracts they sign with external entities for their external activities, are conducted in accordance with UAB ENTERPRISE policies related to disclosure of discoveries and inventions, patents, and use of computer software.  It is the responsibility of unit leadership to exercise judicious oversight and control of external activities so that no UAB ENTERPRISE functions or policies are compromised.
 
Leave for External and Internal Activities
 
Employees must properly account for time spent on external and internal activities.  Time away is allowed at the discretion of a staff member’s supervisor or, in the case of a faculty member, the Director, Chair, and Dean.  Standards for applying leave time, as well as maximum time allowed, for external and internal activities must be managed in accordance with applicable human resource policies of each UAB ENTERPRISE organization. 
 
Conflicts of Commitment
 
All employees are expected to devote their primary professional loyalty, time, and energy to their position at the UAB ENTERPRISE.  Accordingly, external and internal activities must not require such extensive absence as to cause the employee to neglect teaching, research, patient care, or business obligations or become regularly unavailable to students and/or colleagues.  External and internal activities should not create a conflict of commitment with the employee’s institutional responsibilities.  It is possible to have a conflict of commitment even with an uncompensated activity. 
 
 
C.  Disclosure of Financial Interests
 
Employees must fulfill their institutional responsibilities based on sound professional judgment unimpaired by their personal financial interests or relationships.  When participating in or influencing an official UAB ENTERPRISE decision (e.g., purchase of equipment, UAB ENTERPRISE contract for service with an external entity, approval or administrative control of research, etc.), employees are required to notify their chair, administrator, or any relevant committee of any financial interests or personal relationships the employees, their spouse, or their dependents have that may or may be perceived to influence that decision.  Such notification of financial interests should take place prior to any official action, but no forms, other than those described elsewhere in this policy, are required for submission.  Based on their notification, appropriate action may be taken to manage the actual, potential, or perceived conflict of interest between the employees’ institutional responsibilities in this regard and their personal financial interests, ranging up to recusal from the decision. 
 
In addition to any required approvals related to external and internal activities, designated individuals are required to submit formal disclosures of financial interests.  Individuals responsible for the design, conduct, or reporting of research, also known as investigators, must submit a Disclosure of Interests, which will be processed through the UAB Conflict of Interest Review Board as described below in Section 5. Policy Statement D. Research.  Others designated by their employing UAB ENTERPRISE organization must follow the instructions for submitting formal disclosures provided to them at the time they are so designated.
 
 
D.  Research
 
UAB ENTERPRISE is committed to promoting objectivity in research.  The aim of this policy is to provide an expectation that the design, conduct, and reporting of research will be free from bias resulting from financial interests held by investigators.   All investigators are expected to comply with any applicable laws, regulations, and UAB ENTERPRISE policies pertaining to financial conflicts of interest.  This includes but is not limited to the timely disclosure of financial interests, completing requisite training, and, as applicable, compliance with UAB Conflict of Interest Review Board (CIRB) rules and management plans.
 
For all projects seeking or receiving extramural funding (including any grant/contract application processed by the UAB Office of Sponsored Programs (OSP)) and all work involving human subjects requiring Institutional Review Board review, regardless of funding source, participating UAB Investigators are expected to comply with UAB Policy, CIRB rules, and the NIH rule  “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors” (42 CFR Part 50 and 45 CFR part 94).  Each investigator is required to disclose to UAB ENTERPRISE all financial interests related to his/her institutional responsibilities that are owned or held by him/her, his/her spouse, or his/her dependents prior to the application for research and within 30 days of discovering or acquiring new financial interests.  Investigators must update any such disclosed financial interests not less than annually while involved in research. 
 
Although no prior approval is required, Investigators’ disclosures must include any financial interest exceeding $5,000 acquired from any one entity in the previous 12 months for their participation in the following professional public service activities:
  • Professional studies, services, participation on boards of directors, or  participation in manuscript review, grant/contract review, or academic program review for nonprofit/philanthropic entities, professional societies, or professional associations, that are not affiliates of or affiliated with industry or other for profit entities; and
  • Seminars, presentations, performances, or board service for civic groups.
The CIRB considers Investigators’ approved external activities to be a disclosure of financial interest when the amount of remuneration from any activity or multiple activities for any one entity in the current and prior calendar year reaches the significant financial interest thresholds defined in Section 4.
 
The CIRB is responsible for identifying and reviewing significant financial interests for the current and past calendar year to determine if any such interests are financial conflicts of interest related to research.  The CIRB must manage and report any identified financial conflict of interest.  Management of an identified financial conflict of interest requires development and implementation of a management plan, which may include but is not limited to reducing or eliminating the conflict of interest.  The CIRB must also conduct non-compliance reviews and institute corrective actions as indicated.  The CIRB must review significant financial interests related to the research of external consultants, subgrantees, and subcontractors that do not have policies meeting NIH regulations.
 
School Deans and the Dean and Associate Deans of the Graduate School are responsible for ensuring that reasonable protections are in place for any student, fellow, or trainee involved in activities in which a supervisor has disclosed a conflict of interest or conflict of commitment situation.
 
 
Section 6.  Disciplinary Action
 
Violations of this policy are grounds for disciplinary action up to, and including, discharge.
 
 
Section 7.  Implementation
 
The Provost, Vice President for Financial Affairs and Administration, and CEO of the UAB Health System are responsible for overall implementation of this policy.  The Vice President for Research and Economic Development is responsible for the development and enforcement of procedures to implement the portions of this policy related to research.