Research@UIC > Conflict of Commitment and Interest > COI statement for PAFs

COI Statements for PAFs

A conflict of interest is a function of the situation, and does not imply improper behavior. Potential and actual conflicts of interest must always be disclosed. Once disclosed, potential or actual conflicts of interest should be managed, reduced, or eliminated.

For situations in which the elimination of the potential conflict of interest is desired (e.g. where reduction or management is insufficient to protect the objectivity of the research), several options are possible. For example, the conflicted individual may elect to cease consulting for the study sponsor or to divest his/her ownership interests in the company sponsoring the study. The conflicted individual may choose not to participate in the study, and have the study conducted by an independent investigator.

For situations in which the reduction or management of the potential conflicts of interest is desired, we suggest your PAF statement cover 5 main areas. The amount of detail depends on the situation. If there is more than one conflicted person and the potential conflicts are similar, they may make a joint statement, or each may make her/his own statement. If there are multiple individual statements, they must be coordinated.

Begin by stating which COI statements generated the “yes” response. (i.e., "Professor X has responded yes to question X.")
Describe the nature of the conflict. Professor X is conflicted because he owns the company granting the award, or serves on the Speakers Bureau for the sponsor, etc. Details of the nature of the relationship should be provided.
Describe the conflicted person’s role and function in the study. What will she/he be doing?
Provide justification as to why the conflicted person should be involved in the study. (special skills, knowledge, techniques, resources, etc)
- Indicate what conflict management techniques are in place to minimize the potential impacts of potential or actual conflicts of interest. If the conflicted person has an approved Conflict Management Plan, it should be referenced here, along with the key management techniques noted (external reviewer, etc.) The statement should indicate whether any new conflicts are introduced (i.e., conflicts not discussed in the Conflict Management Plan), and if so, what they are and how they’re being managed.
- Independent review as a conflict management technique. In some cases, having some oversight of the sponsored research project can help ensure that the results are not biased toward the study sponsor.
  - The reviewer can be, but need not be, someone from within the UIC community, but the reviewer should not serve as a consultant for the sponsor.
  - The reviewer should not have a university reporting line to the conflicted person, nor be one of his/her research collaborators.
  - Some people using this conflict management technique have included with their PAF an explanation similar to the following:
    
    The department seeks to allow Professor X to be a PI on a contract to UIC from Company Y provided the following additional review safeguards are implemented. Dr. […], of the […] is authorized to sign the release of test data after performing appropriate checking to ensure that the tests are done with accepted scientific or engineering procedures, and that the data are not prejudiced in any way toward the sponsor. Dr. […] has no financial interest in Company Y, and has agreed to serve in this role. The reviewer will indicate his/her review and approval of the test data in a document that will be signed and dated and given to the Department Head, who will keep a copy on file in the department.

If the conflicted person is not the PI, and the PI is not conflicted, a description of the overall responsibility of the PI compared to that of the conflicted person can help demonstrate that the conflicted person has less opportunity to affect the design, conduct, or reporting of the research.
If this research involves human subjects research, the IRB has final authority regarding whether the conflict management techniques are appropriate or if additional safeguards are needed to protect the rights and welfare of the subjects. The conflict must be disclosed to the IRB. Your statement should say that you will disclose the conflict to the IRB and agree to follow all IRB recommendations regarding conflict management. Many protocols already include practices or mechanisms which help reduce or manage conflicts of interest, and if so, they should be noted in this response. These mechanisms include but are not limited to the following:
- Double-blind or triple-blind design
- Conflicted person will not solicit informed consent (will conflicted person identify potential research participants but then direct these people to a non-conflicted individual for the consenting process?)
- Implementation of an independent DSMB or data monitoring board
- Monitoring board has a priori rules (e.g., safety and efficacy) for stopping the study
- Independent review (as described above)
- Multi-center trial. (What percent of the total study population will be enrolled at UIC? Will it be no more than 10% of the national projected enrollment?)
- Protocol involves standard level of care
- Disclosure of conflict in consent form
- Disclosure of conflict in publications, presentations, etc.
- Disclosure of conflict to other research personnel (e.g., co-investigators, fellows, students)
- Conflicted person not involved in data collection
- Conflicted person not involved in data entry
- Conflicted person not involved in data analysis
- Dataset given to independent statistician for comparison
- Analysis of existing data (are the data de-identified?)
- Minimal risk to research subjects
- Investigator-initiated study
- Increased frequency of continuing review by IRB
- Non-conflicted individuals involved in study development (design, conduct, analysis)

If you have any questions, or if your situation is different or not covered by these guidelines, please contact the COI office at coi@uic.edu or (312) 996-4070.