Library Document Details

Institutional Conflict of Interest Policy

Abstract:
This policy states UAB's commitment to the highest standards of integrity by identifying and managing conflicts between financial or fiduciary interests held by the institution or institutional officials and the ethical conduct of research.
Effective Date:
4/20/2011
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff
Material Original Source:
Policy Reference Manual

University of Alabama at Birmingham

INSTITUTIONAL CONFLICT OF INTEREST POLICY

April 20, 2011


Purpose
 

The University of Alabama at Birmingham (hereinafter “UAB,” “Institution,” or “University”) is committed to the highest standards of conduct in research, teaching, clinical care, professional practice, business transactions, and other activities that support its core missions.  Relationships with the commercial sector play an important role in supporting UAB’s missions.  However, these relationships should not compromise UAB’s integrity or unduly influence decisions in any activity within UAB. 
 

Applicability
 

While Institutional conflicts of interest may affect other business of the University, this policy addresses only activities related to research.  

 

Policy
 

It is the policy of UAB that, in pursuing its mission, research must be conducted free of improper influence resulting from Institutional conflicts of interest.  Potential conflicts of interest between the Institution’s primary missions or objectives and its financial interests must be identified, reviewed, and properly managed or eliminated.  Such ICOIs are not inherently unethical; however, they may introduce risks to the integrity of the Institution.

 

Definitions

 

For purposes of this policy, the following definitions apply:

Institutional conflict of interest (ICOI): Institutional conflict of interest involving research is defined as a situation in which the financial investments or holdings of UAB or the personal financial interests or holdings of Institutional Officials might affect or reasonably appear to affect institutional processes for the design, conduct, reporting, review or oversight of research.

Institutional conflict of interests may be created by gifts, payments, royalty income, equity, and other benefits from or interests held in for-profit organizations.  Institutional financial interests also are created by financial and/or fiduciary interests of Institutional Officials or in instances in which the Official has oversight responsibilities that influence or may be perceived to influence decisions related to the research. 

 

Institutional Official: An Institutional official is an individual with direct authority over allocation of institutional resources, assignments of graduate students, trainees, funding, space, salary, or promotions for faculty who are conducting research.

For purposes of this policy, Institutional Officials include: 

  • University President;

  • University Provost;
  • University Vice Presidents;
  • Deans; and
  • Other senior administrators, as determined by the University Compliance Officer in consultation with the University President.

General Standards and Requirements 

Reporting Requirements
Outlined below are reporting requirements for Institutional Officials and Institutional financial interests.

This policy mandates that Institutional Officials report financial and/or fiduciary interests as designated below to the Conflict of Interest Review Board (CIRB) staff in the University Compliance Office, so that ICOIs are identified and addressed in accordance with this Policy. 

Reporting Institutional Official’s Financial and/or Fiduciary Interests
The following financial and/or fiduciary interests of Institutional Officials and their spouses and dependent children must be reported annually and updated within 20 working days after financial and/or fiduciary interests change: 

  • Equity and/or ownership interests in publicly-traded for-profit organizations of an amount exceeding $10,000 in the value of its stock.  Not included are:  1) equity or ownership interests in mutual funds; and 2) equity or stock holdings for which the Institutional Official has no role or influence over trading decisions;
  • Equity (including stock, options, warrants, and the like), ownership, or founders' interests in non-publicly traded companies;
  • Any fiduciary interest, such as service on the board of directors of a for-profit organization; and
  • Income, including royalty, equity, consulting fees, or other payments from for-profit organizations that, in the aggregate, exceeds $10,000 per year from each organization.

Reporting Institution’s Financial Interests
The following financial interests of the Institution must be reported no less than quarterly in accordance with procedures coordinated by the University Compliance Office:

  • Equity and ownership interests worth more than $100,000 in any publicly-traded, for-profit organization, except for interests held in the Institution’s endowments, and those interests where Institutional Officials have no role in trading decisions;
  • Equity and ownership interests of any amount in any for-profit organization that is not publicly traded, except those interests where Institutional Officials have no role in trading decisions;
  • Gifts of $100,000 or more from any for-profit organization or philanthropic unit associated with a for-profit organization (see "Philanthropy" below); and
  • Payments, including royalty payments, resulting from technology transfer, licensing, and business activities such as Institutional consulting or service agreements that, for each arrangement, have the potential to exceed $100,000 per year.  Clinical care income and tuition income are not included as Institutional interests. 

Review Responsibility   
 

ICOIs related to research not involving human subjects are reviewed by the Conflict of Interest Review Board (CIRB).  
 

ICOIs related to human subjects research are reviewed by the Institutional Conflict of Interest (ICOI) Committee.  The committee is appointed by the University President and consists of seven members, three of which must be considered independent, having no financial relationship with UAB and not being influenced by interests of UAB.

 

All reviews must consider whether the financial and/or fiduciary interests reported in accordance with this policy have the potential to appear to affect any of the following: 

  • Safety of human research subjects;
  • Safety of patients; and
  • Integrity of research.

The standards and evaluation criteria do not vary by funding or regulatory oversight; additionally, the same standards apply to reviews of the financial interests of the Institution and of the financial and/or fiduciary interests held by Institutional Officials. 
 

Making Recommendations  

 

The review of a specific ICOI case may result in one of three recommendations:  

  • No ICOI.  The arrangement does not represent a significant actual, potential, or perceived ICOI that needs to be managed;
  • Manageable ICOI.  The arrangement can be managed with required changes.  In cases determined by the ICOI committee to be manageable, it will recommend one or more management measures.  These may include, but are not limited to: 1) effective recusal from decision-making regarding the proposed arrangement by the financially-interested Institutional Official and disclosure of the recusal to the appropriate individuals implementing the recusal; 2) reduction in the magnitude of the financial and/or fiduciary interest (generally to below the thresholds outlined above); 3) disclosure of the financial interest in relevant publications, presentations, human subject consent forms, clinical procedure or other consent forms, educational material, etc.; 4) oversight by a disinterested senior individual or committee;  and/or 5) other measures as deemed appropriate; or
  • Unmanageable ICOI.  The arrangement is not manageable and either the activity may not proceed or the financial interest must be eliminated or reduced.  In cases judged to be unmanageable, eliminating or reducing the financial interest is preferable to prohibiting the proposed activity.  The reviewing bodies and the Institution should generally give precedence to activities that carry out Institutional missions over conflicting financial interests.  

In all cases reviewed, the CIRB and the ICOI Committee must retain documentation of the review in accordance with established guidelines.

 

All recommendations of the ICOI Committee are presented to the University President for a decision.  The University President makes a determination, and such determination is communicated by the President or the President’s designee to:  1) the individuals affected; 2) the Chair of the ICOI Committee; and 3) the Office of the IRB and the Chair of the IRB.  The IRB of record will have final authority to decide whether the interest and its management, if any, allows the human subjects research to be approved.

Philanthropy  

Gifts, pledges, and solicitation of gifts to UAB are important to its missions.  However, no charitable donation is allowed to be contingent upon the outcome of any research or business transaction conducted at or by the Institution.  The Institution hereby affirms that it will not solicit or accept gifts that in any way limit the ability of its investigators to conduct and/or report the results of research in accordance with the highest scientific, medical, professional, and ethical standards.  Nor will the Institution solicit or accept gifts (including gifts to support research) that are contingent upon any particular business or purchasing decision(s).  All gifts to the University must be handled in accordance with the institutional Fund Raising and Gift Acceptance Guidelines and should be forwarded to the Gift Records Office for processing and record-keeping purposes.  Faculty and staff members are accountable for adhering to institutional gift policies. 
 

In some cases, the Institution may enter into arrangements involving the donation of all or a portion of capital equipment, with the expectation that the equipment will be used for research or patient care.  Such arrangements are appropriate, provided they do not limit the professional independence of faculty and staff. 
 

Institutional Investment Assets, including Endowment   
 

The Institution’s endowment includes assets received from philanthropy, investment, and other sources.  The Institution hereby affirms that the individuals charged with managing the investments and endowments of the Institution will not communicate with Institutional Officials or Institutional researchers concerning the conduct and interpretation of ongoing or planned research performed at the Institution for the purpose of influencing investment decisions.  Maintaining this robust "firewall" is essential for ensuring that the core activities of the Institution are not affected, or perceived to be affected, by the Institution’s interest in maximizing the value of the endowments.  If an individual becomes aware of a situation in which there appears to be a conflict of interest involving philanthropic gifts, solicitation of gifts, or management of the endowments, the individual must notify the University Compliance Officer who will ensure a review of the arrangement is conducted, and if necessary, refer the matter to the ICOI Committee. 
 

Implementation 
 

The University Compliance Office is responsible for procedures to implement this policy.