University of Missouri System

Academic Affairs

Conflict of Interest for the University of Missouri System

Conflict of Interest Policy Guidelines

An Analysis of COI Policies and Procedures at Other Institutions

Policy Issue Guidelines

1. Written COI policy is required for all institutions receiving federal funding via various agencies. However, the type and depth of the policies vary widely from institution to institution. Some are extremely brief and say little more than that faculty and staff should behave ethically at all times, while other are extremely proscriptive and detailed.
2. Approximately half of the institutions reviewed have revised their COI policies in the last three or four years. The rest of the institutions revised their COI policies in the mid-1990’s following the COI directives from the PHS.
3. The number of COI policies varies for institution to institution. Many have a single policy that covers all possible areas of conflict. Other institutions have multiple policies, one for each category of possible COI. The most common choices have been one policy covering all possible areas or two policies one covering the more business related COI and a second covering the more academic areas of COI.
   1. The vast majority of COI have a statement of general principles that outline the institutions philosophy on how it views the conflict of interest that can and do arise. Most of the recently revised COI policy have statements that COI is inevitable and is not seen as the faculty or staff doing something wrong. These COI must be disclosed and managed were possible. A few COI policies discourage or strongly discourage any COI or the appearance of any COI.
   2. Most policies clearly define the monetary thresholds needed for disclosure and management. These levels vary from any thing of value to the levels noted in the PHS guidance to other levels deemed appropriate by the institution.
   3. All policies reviewed described the importance of disclosure of COI, review of the disclosure, management of the COI, and approval of the action to be taken to deal with the COI.
   4. Some of the COI policies describe a specific role for the IRB while other policies do not address the role of the IRB in COI at all.
4. Most of the COI policies clearly define what types of financial interest are included or excluded from consideration when determining Significant Financial Interest. This deals with issues related to royalties, consulting fees, honoraria, stock options, equity holdings, administrative positions within the company, etc.
5. Most of the policies have a definition of terms section that defines all significant terms used within the policy.
6. Conflict of commitment is handled differently depending on the institution. Some institutions have a separate Conflict of Commitment policy that addresses issue of faculty and staff time and its impact on their primary employer (the institution). Other institutions have a portion of their COI policy that addresses conflict of commitment. While other institution do not deal in a direct way the issues of conflict of commitment.
7. Most of the COI policies deal with Significant Financial Interest in both research as well as other functions of the institution. As stated above the level of financial interest maybe the same for research and other functions or it may be different. This difference seems to arise either for historic reasons, difference in date of inclusion, or due to guidelines from outside the institution.
8. COI disclosure was a primary point in all the policies. The disclosure or assurance form varied depending on the institution. The person to receive the completed form also varied a great deal. The range was from the persons immediate superior to a central office administrator or a central committee.
9. The disclosure forms were in all cases reviewed. They may be reviewed by only one administrative individual, multiple administrative levels, a committee, or an administrator and a committee. Coordination between multiple reporting levels varied greatly. Multiple reporting and review levels were used only by a few institutions. Most of the institutions that used multiple levels had recently revised their policies.
10. Some institutions included their implementations plan in their policy. Others had a separate implementation plan or guidance, while others had no specific plan that could be found.
11. Most appeals process went through already existing faculty and/or staff grievance policies. Others had specific appeals only for COI at the next higher administrative level working up the chain of command. Others used their conflict of interest committee as the group to handle appeals.
12. Most organizations did not state specific sanctions. Other institutions listed a range of possible sanctions. Other institutions stated that non-compliance with COI policies was a serious matter and would be dealt with as such.
13. Most institutions had some plan for managing COI that arose. Institutions had many different approaches to management plans. Who wrote the management plan varied for the person with the COI, their immediate supervisor, the Dean, the central office administrator (Provost, Vice Provost for Research, etc.), or the COI committee. The management plans were reviewed also by various individuals or groups depending on the institutions. The range was for the immediate superior to the Provost, Chancellor, President, Vice Provost for Research, or the conflict of interest committee. The types of management ranged from public disclosure, independent monitoring, modification of the research plan, disqualification from the project, divestiture of the financial interest, or severance of the relationship.
14. A small number of institutions defined all of the individuals or group that would be involved in the COI policy processes. Most institutions defined the main individuals and groups.
15. Most institutions did not seem to have an integrated plan where different units could work together to identify and manage conflicts.
16. Evaluation language was not included in most of the policies. In the couple that did have some evaluation language, the group to review the COI policies was identified and the process to be used, but timing was not stated.
17. Most institutions did not have explicit Institutional Conflict of Interest Policies. The few that did were the institutions that had reviewed and updated their COI policies in the last few years.

Disclosure Guidelines

1. All institutions had at a minimum some type of annual reporting of either activity or conflict.
2. Most but not all institutions had a procedure for updating COI reporting when situations changed. Some institutions (about 1/3) required reporting and approval prior to the faculty or staff taking part in the activity. The other institutions reported the change in activity and dealt with it after the fact. The exception to this was with federal grant which most institutions required reporting of COI on form required for submission of the grant.
3. As was mentioned above who receives the activity report, COI assurance or COI disclosure varied from institution to institution. This ranges for the direct supervisor to a designated central administrator to the COI committee. About ¼ of the institutions have reporting at multiple levels.
4. A small number of institutions reporting all COI to all granting agencies where funding is being requested. Other institutions report COI only to those granting agencies that require COI disclosure.
5. All institutions require faculty report of COI. Not all institutions require reporting of COI for all trainees, staff, and student. However, a substantial minority do include all employees.
6. Most institution that did not have a Medical School did not mention a role for the IRB even though the may conduct some human subject research. Some institutions that do have Medical School did not have a role for their IRB that could be found in their policies. Other institutions had very prominent roles for their IRB is deciding the impact of COI on the approval of human subject research.

Implementation and Review

1. All institutions do have reporting forms for activities, assurances, or disclosures. The forms are individual and fit the institutions needs and culture. The specific forms for each institution can easily be found on their web sites.
2. Some institutions have specific universal reporting dates. Others have specific reporting dates by unit. Others stated annual without a schedule. The most specific had a complete timeline for all step including reporting, review, declaration, management plan writing, plan review, and implementation.
3. About half of the institution did not mention education of faculty, staff, trainees, and students. Others had frequently asked questions. Others had written educational material. This was a weakness in all of the policies reviewed.
4. About 1/3 of the institutions require the individual reporting to sign on the form acknowledging that they have read and understand the policy.
5. Most institution had a procedure for updating the reporting when the individual status changed requiring new reporting. Some institutions required the reporting and approval prior to allowing the change taking place. Other institutions required reporting, but not approval prior to the change. Other institutions required reporting, but this could be done during a specified time after the change.
6. Most institution had a clearly designated COI officer. Who this was varied a great deal. It ranged from Chancellor, President, Vice President for Academic Affairs, Vice President for Administration, Vice President for Research, Provost, Vice Provost for Research, and the Chief Legal Officer.
7. About ¼ of the institutions required reporting and review at multiple administrative levels.
8. Most institutions had COI committees. Some had Ad Hoc committees that they formed as needed, while other have standing committees. The committee membership ranged from mostly faculty to mostly administrative. The responsibilities of the committee also varied. Some reviewed disclosures and determined conflict. Others wrote the management plans. Others reviewed the management plans. Others managed the plans written by others that they approved. Others acted as mediations group when differences between faculty and administration group arose.
9. Most institution used administrative chain of command in reviewing reporting and management plans.
10. No institution reviewed used their internal auditors to monitor their COI policies and procedures.
11. Most institutions used their existing grievance policies for dispute resolution. Other institutions allowed appeal to the next highest administrative level, while others allowed appeal to the COI committee.
    

- Peter Wilden