Guidance on Developing Your Conflict of Interest Management Plan

Two Situations that Require Conflict of Interest (COI) Management Plans

  • The faculty member assigns students, postdoctoral fellows, or other trainees or employees to projects of interest to or supported by a business (through sponsored research or a contribution) in which they, an immediate family member, or an associated entity has a financial or business interest (other than royalty income).
  • The faculty member or his or her department receives University-supervised sponsored research support or contributions (in dollars or in kind) from a business in which they, an immediate family member, or an associated entity has a financial or business interest.

Conflict of Interest (COI) Management Plan Outline

  1. Describe the external relationship [Significant Financial Interest Disclosure form]
  2. Identify areas of potential COI [data integrity; undue influence on students/postdocs]
  3. Develop strategies to guard against COI affecting data or behavior and draft in a plan
    1. Full disclosure to:
      1. Students and advisees [see appended sample]
      2. Others on the project
      3. Journal editors [see appended sample]
      4. Review panels
      5. Sponsors
    2. Ensure research integrity
      1. Disinterested, expert independent review of research plan and data
      2. Consider assigning PI role to disinterested faculty member
    3. Safeguard students
      1. Insulate from financial pressure
      2. Provide an ombudsman for students
    4. Consider diivestiture / removing the COI situation

Components of a Good Management Plan

Full Disclosure of Financial/Business Interests

Full, appropriate disclosure of relationships to interested parties is a part of every Conflict Management Plan.

  • The faculty member must make full, appropriate disclosure on financial or business interests with an external entity to all interested parties, including:
    • students and advisees;
    • others working on the professional activity in question;
    • journal editors;
    • program committees and review panels;
    • all sponsors, including sponsors of related research and particularly federal sponsors to comply with federal policy.
  • Disclosure letters should explicitly state the nature of relationships regarding any financial and/or business interests, pertinent licensing agreement(s), the relationship between intellectual property and the licensing agreement, etc.
  • Example disclosure statement(s) are useful to include in the management plan. 

Ensure Research Integrity

In some cases, the nature of the research activity may eliminate the potential for conflict of interest. If so, explain why.

In most cases, particularly those with strong applied or proprietary interest or with high potential economic impact for a company or industrial sector, the objectivity of research may be questioned in the following areas:

  • Problem definition and research design
  • Data integrity and confidentiality
  • Data analysis
  • Reporting results

In such cases, a Conflict Management Plan should suggest steps that the faculty member thinks should be taken in these areas to ensure confidence in the objectivity of the results. These should include standard procedures in their discipline, which they should briefly summarize. They should also include additional steps, such as:

  • Review of the problem formulation, research design, data analysis, and results by a disinterested party who is fully aware of the business or financial interest that creates a potential conflict. This should include:
    • periodic review of the research activity;
    • and may include written reports to the COI Committee.
  • Concurrent replication at another site where researchers do not have a business or financial interest.
  • Assignment of another faculty member as principal investigator of the project

Safeguards for Students Engaged in Directed Research Activities

All students engaged in directed research must be insulated from commercial pressures stemming from situations with potential conflicts of interest.

Unimpeded progress of graduate students toward their degrees and professional goals is part of the University’s mission. However, this may conflict with the desire of research sponsors and/or faculty with interests to:

  • shape the research so that it serves proprietary rather than scholarly or students’ career goals or
  • delay publication for an unreasonably long period

Management plans should suggest ways to insulate students from such pressures.

  • Provide students with full disclosure, in writing, of the professional activities and relationships with external entities prior to initiating research responsibilities.
  • Create solutions with the student advisee
  • Inform students that the Department Chair or an alternative ombudsman is available for consultation at any time
  • Consider the impact of potential conflicts of interest from the students' perspective prior to engaging students/advisees as employees in an external entity
  • Anticipate potential issues related to students' examination committees
  • Arrange independent review of student projects by the Department Chair or, in some cases, designate other faculty members as thesis co-advisors.
  • Advise students to consider a balance of interests when selecting thesis committees and make appropriate suggestions for outside members.

Managing Potential Conflicts of Interest by Divestiture or Removing the Situation

  • The researcher is replaced as principal investigator by an independent researcher with no relevant financial interest.
  • The researcher removes himself or herself as students' primary advisor.
  • The researcher resigns from a board or executive position.
  • The researcher recuses himself or herself from company board deliberations involving his or her own research.
  • The researcher divests equity in a company which is sponsoring his or her research.

     

Sample Disclosure Statements

TO JOURNALS

(Name) (has financial and/or business interests in) (is a consultant to) (receives funding from) a company that may be affected by the research reported in the enclosed paper. S/He has disclosed those interests fully to the University of Mississippi, and has in place an approved plan for managing any potential conflicts arising from (that involvement).

OR

This research is sponsored by (company A) and may lead to the development of products which may be licensed to (company B), in which (professor name) has a business and/or financial interest. S/He has disclosed those interests fully to the University of Mississippi, and has in place an approved plan for managing any potential conflicts arising from this arrangement.

TO STUDENTS

For your information, I serve as (a consultant to) (a board member of) (an executive officer of) COMPANYNAME. I also receive research grant funding from (company name) investigating (briefly describe the research area). This relationship has been identified as having the potential to create a conflict of interest with my responsibilities as a faculty member. I have fully disclosed these interests to the University of Mississippi, and I have in place an approved plan for managing any potential conflicts arising from this involvement.

I understand that your work on the project, (insert project name), should be for academic reasons to further your studies and your professional career endeavors. If at any time you have any concerns about whether your work is inappropriately focused toward my outside relationship(s), or that your ability to publish has been impeded in any way, I encourage you to contact the Department Chair or (alternative advocate for the student) (include names and phone numbers, if not evident).

I look forward to continuing to serve as your advisor and you can continue to count on my utmost support of your work.