Original Effective Date 1/1/2007
Last Revised Date 3/20/2020
Washington University (WU) monitors compliance with FCOI management plans to verify management plan activities have been appropriately implemented in accordance with the prescribed strategies in the following circumstances or as required by the CIRC:
- All research involving human subjects
- When the significant financial interest (SFI) being managed involves non-public equity
- When students or trainees are involved in the research
- All research is funded by an agency adhering to Public Health Services (PHS)regulations
Monitoring is conducted on an ongoing basis until the completion of the research project, when applicable, in accordance to PHS regulations (42 CFR Part 50 and 45 CFR part 94). Monitoring of management plans occurs as prescribed below.
1. Monitoring for compliance with FCOI management plans
Monitoring includes, when applicable, but may not be limited to the following activities:
a. Verifying appropriate disclosure
i. In publications
ii. In presentations
iii. In consent forms
iv. To all individuals involved in the research
b. Confirming/Verifying:
i. For students/trainees, a co-advisor is appointed
ii. The financial interest remains under the appropriate threshold for the duration of the study and through the first publication
iii. HSR QA/QI monitoring was completed
iv. Oversight of the research was performed
v. Independent data analysis was performed
c. Confirming/Verifying the conflicted individual’s role has been modified
i. For students/trainees, removal of the conflicted individual from the thesis advisory committee
ii. Removal from the informed consent process
iii. Removal from determining enrollment criteria
iv. Removal from analyzing data and/or obtaining data
v. Removal from serving as the PI/PD
vi. Removal of the conflicted individual from the design, conduct, and reporting of the research
2. Roles and Responsibilities
a. The COI Program monitors for compliance and documents the activity
b. The covered individual and/or principal investigator, as appropriate, responds to requests related to monitoring for compliance
c. The CIRC Chair(s) reviews the monitoring reports provided by the COI Program and determines if the individual is compliant with WU’s policies and processes governing research conflicts of interests
3. Potential non-compliance
If there is potential non-compliance with a management plan, the Procedures for Assessing Non-Compliance and Sanctions for Non-Compliance is followed.