RCOI Program Manager Vail Health Hospital, United States
Background: The HRPP lacked the ability to capture and monitor COIs related to human subjects research on an ongoing basis. The research COI (RCOI) office built electronic forms that cross communicate with the IRB, outcomes of annual disclosures, management plans, annual monitoring, and ancillary COI reviews of IRB submissions.
Program
Description: The RCOI Office built into the IRB’s electronic submission system a research conflict of interest platform that cross communicates with IRB submissions. The research conflict of interest platform included an annual COI disclosure form, electronic management plan form, and annual monitoring form. Also, within the IRB submission forms, an ancillary conflict of interest review was built into the submission process. With each IRB submission, the RCOI Program Manager conducts an ancillary review of the study submission in relation to each study team member’s annual COI disclosure for relatedness. The submission is then flagged with the COI outcome, so the IRB knows whether to anticipate a management plan in relation to the study. Likewise, the management plan form includes review pathways so the IRB committee can weigh in on appropriateness of plan in relation to the study.
Program
Assessment: Prior to implementation, the HRPP only identified 3 conflicts of interest that required management plans in 5 years; and had no process for continued monitoring. Building the electronic process took about 6 months to build, test, and publish. Since implementation of the electronic process in July 2022, 42 conflicts have been identified and managed. Since then, 1 management plan has been revised due to changes seen in a study amendment, while another 8 have been discontinued due to changes seen in a study amendment. Upon submission of an updated annual COI disclosure form, 3 management plans have been discontinued and 2 have been further revised. Furthermore, 6 management plans have been discontinued upon notification of study closure. The remaining 25 active management plans continue to be monitored on an annual basis. Thus far with monitoring, no findings of non-compliance have been identified. Also, no IRB submissions have been approved prior to the approval of the management plan from the RCOI Committee.
Limitations: Our organization is small, with only 140 active protocols. It is currently unknown if this process is effective with a larger research portfolio. For larger organizations, where COI and IRB offices are not as intertwined, additional hurdles in implementing a review process like ours may require extensive changes in policies and procedures; as well as a change in submission platforms, if their current electronic system does not have similar customizable capabilities.
Discussion: Long-term assessment of the system is needed to ensure that reviews and communication remain efficient with a growing research portfolio; thus far, it looks promising. Many organizations' COI and IRB offices are siloed causing communication restraints between them. Also, COI correspondence is often captured through a variety of mediums – email, word documents, and some electronic forms. Building and adopting an electronic platform like ours that houses all COI documentation in one place and communicates relevant outcomes to partnering offices, will improve efficiency in office operations, enhance compliance oversight and outweigh any hurdles in implementation.
