1. COI Management Planning A guide and tutorial to assist with the development and drafting of a Conflict of Interest Management Plan

2. What is COI Management Plan? A comprehensive COI Management Plan is a written proposal for proactively managing potential conflicts of interest. A written plan demonstrates the intent to comply with LSUHSC-Shreveport policy.

3. What Goes into a COI Management Plan? A comprehensive COI management plan should include: I. Full disclosure and description of the external relationships (listed on the COI annual disclosure form) II. Identification of any area(s) of potential COI III. Strategies to manage, reduce or eliminate COI and thereby help prevent COI from influencing data or performance

4. COI Management Plan A proposed plan should clearly describe and fully explain the nature of the relationship(s) involved and how the actions proposed will help the faculty and staff avoid perceived or actual conflicts of interest. A management plan should be written in common terms, using language that would be easily understood by a lay person.

5. Developing Your Management Plan I. Full Disclosure – It has been stated that full disclosure is the “antidote” to conflict of interest. With every COI management plan, there should be a full disclosure of relationships that may cause an actual or perceived conflict of interest.

6. I. Full Disclosure  COI Management Plans should explicitly disclose the nature of the relationships regarding any significant financial and/or business interests, licensing agreement(s), the relationship between intellectual property and the licensing agreement, etc.

7. I. Full Disclosure Full disclosure should be made to all interested parties, including : Students Journal editors Program committees and review panels All sponsors Any others working on the project

8. Developing Your Management Plan II. Identification of the area(s) of potential conflict of interest - A conflict of interest is seen to exist when a person is performing two overlapping roles and when the responsibilities, obligations, and privileges of one role may influence or appear to influence that person’s responsibilities and obligations in the other role.  The identification of a conflict of interest is first and foremost the identification of potentially conflicting roles. It is not an identification of impropriety.

9. Common Situations for a Potential Conflict of Interest Conflicts of Interest (COI) generally occur in the following circumstances:  A faculty member assigns students, postdoctoral fellows, trainees or colleagues to projects in which they, or a family member, has a financial or business interest (other than royalty income).  A faculty member receives sponsored research support or contributions (in dollars or other equity) from a business in which they, or an immediate family member has a financial or business interest

10. II. Identification of Potential COI  LSUHSC-Shreveport Policy prohibits the use of University funds, facilities, or personnel to complete work related to outside consulting agreements without prior approval and arrangements for the reimbursement of direct and indirect costs. Include a statement acknowledging either: Verification that no University funds, facilities or personnel will be involved in a project with an external entity, OR Documentation of prior approval with reimbursement for direct and indirect costs

11. Developing Your Management Plan III. Develop management strategies to manage, reduce or eliminate any perceived or actual conflicts of interest. Management strategies are developed and implemented to address conflicts of interest and to assure that the Investigator may satisfy his/her research obligations in an objective manner and to avoid and/or mitigate concerns of bias. Management strategies that may be considered in addressing conflicts range from no action required other than disclosure, to that of disqualification of the Investigator from participating in the project.

12. III. Development of Management Plan  In some cases, particularly those projects with strong applied or proprietary interest or with high potential for economic impact for a company or industrial sector, the objectivity of research may be questioned in one or more of the following areas: Problem definition and research design Data integrity and confidentiality Data analysis Reporting results In such cases, a COI 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.

13. Ensuring Academic Integrity One of LSUHSC-Shreveport’s primary priorities is to ensure the integrity of the academic research endeavor. Therefore, it may be efficacious to consider the following possibilities: Periodic peer review, including possible periodic written reports to the COI Committee Conduct the study at another site where researchers do not have a business or financial interest Suggest other faculty members as a principal investigator or monitor of the project Use of a third party organization to analyze data Recuse oneself from authorship

14. Management Techniques with Students, Trainees, and Colleagues  Some issues to consider when working with students, trainees, and/or colleagues: What conflicts may arise from a student, trainee, or colleague participating in research project conducted by senior or supervising faculty? What conflicts could occur when students, trainees, or colleagues are allowed to work in newly-formed companies involving conflicted faculty who have positions of authority over the students, trainees, or colleagues? What conflicts may develop should a student, trainee, or colleague working on a project have access to senior faculty who are not involved with the research project to ensure independent review of any questions or concerns they have about the research?

15. Management Techniques with Human Subjects  Some concerns to consider when drafting a conflict of interest management plan that involves human subjects include, but are not limited to: Should a conflicted individual be involved in subject recruitment? Should a conflicted individual be allowed to participate in subject selection, including prescreening for inclusion/exclusion criteria? Should a conflicted individual be allowed to participate in the consenting process?

16. Management Techniques with Human Subjects (continued) Should a conflicted individual be allowed to participate in the clinical treatment of subjects, separate from the research interventions or procedures? Should a conflicted individual be allowed to participate in a clinical evaluation of subjects during the research, separate from the research interventions or procedures, including adverse/unanticipated event evaluation and reporting?

17. Management Techniques for Financial Interests  There are different strategies available for eliminating, reducing, or managing financial conflicts. Some possibilities to consider are: The principal investigator with financial interests is replaced by an independent researcher with no relevant financial interest Divestiture of the respective interest(s) The researcher is removed as the students' primary advisor The researcher resigns from a board or executive position The researcher abstains from company board deliberations involving his or her own research

18. Special Considerations for Start-Up and Small Ventures  Especially in projects that involve human subjects research, risks are associated with the participation of a conflicted individual in activities of an outside entity that is the source of the conflict with the particular research project, particularly a new or small venture. To address the role of the individual in the outside entity when the individual is performing research related to the entity, the following should be considered: Abstaining from participating in Institutional negotiations with the company, except as the Institute directs Abstaining from serving on boards of directors Abstaining from serving as an officer Abstaining from serving as a member of a scientific advisory board Abstaining from serving as a member of a speakers’ bureau Abstaining from serving as a consultant Prohibition of disclosure of institutional confidential information Prohibition of receiving research grant support from companies founded by the conflicted individual

19. Special Considerations for Conflicted Administrators and Supervisors  For the purpose of protecting both the integrity and objectivity of its employees, and to create a workplace environment based in equity and fairness, some of the following options may be useful to consider in cases of conflicted individuals who have administrative or supervisory roles: Recusal of the conflicted administrator from institutional decisions related to the outside entity that is the source of the financial conflict Periodic written disclosure of the conflict to all faculty, staff and students under his or her supervision Research oversight committees Appointment of an independent individual to oversee the high-level administrative decisions to prevent preferential treatment or misdirected resources

20. Examples of COI Management  Case I Dr. John Smith in the Entomology department has an ongoing relationship with Bug Blasters Business, which pays $11,500 annually for consultations and project planning. Additional compensation is received for presentations given for training purposes. Bug Blasters would like to offer Dr. Smith a grant to study a new promising roach sterilizing agent that would require additional staff and students for research.

21. Potential Conflicts for Case I  What are the potential conflicts of interest that could arise from the situation with Dr. Smith? Financial Interests Assignment of students Interpretation of results

22. Suggested Management Techniques  A peer faculty member will review the grant proposal to ensure that it is scientifically sound  The Dean of Graduate Studies will review student assignments to ensure the students’ academic goals are being met  Disclosure of financial interest will be made to students and to journals when the results are ready to be published

23. Examples of COI Management  Case II Dr. Ima Geak of the technology department at LSUHSC-Shreveport created a database for the Office of Sponsored Programs and Technology Transfer and has obtained an exclusive license from LSUHSC-S to market the program. Dr. Geak creates a company to sell the database program, which was developed using the Institution’s resources as well as some external support that was donated to the department. Dr. Geak also assigns one of his graduate students the task of improving performance and marketability of the software.

24. Potential Conflicts for Case II  What are the potential conflicts of interest that could arise from the situation with Dr. Geak? Financial interest Assignment of students Commitment of time

25. Suggested Management Techniques  The Dean of Graduate Studies will review the student’s assignments to ensure academic goals are given priority  Disclosure of financial interest will be made annually whenever other conditions are present  A PM-67 form will be completed and submitted to the OSPTT  A written agreement will be drafted for Dr. Geak designating how much University time will be allotted to the software development

26. Contact Information Phone: (318) 675-5416 Fax: (318) 675-7015 Email: jtoup1@lsuhsc.edu

27. Thank You! Thank you for reviewing the COI Management Plan tutorial. Please let us know if you have questions.