Policies, Procedures and Guidelines

Monitoring Procedures

Washington University (WUSTL) shall monitor compliance with FCOI management plans related to Public Health Services (PHS)-funded research on an ongoing basis until the completion of the PHS-funded research project, in accordance to PHS regulations, 42 CFR Part 50 and 45 CFR part 94. Monitoring of management plans for PHS-funded research will occur as prescribed below.

1. Monitoring for compliance with FCOI management plans
For PHS funded research, monitoring will include, 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. HR 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 Research Ethics and Compliance Office will monitor for compliance and document the activity

b. The covered individual and/or principal investigator, as appropriate, will respond to requests related to monitoring for compliance

c. The CIRC Chair(s) will review the monitoring reports provided by RECO and determine if the individual is compliant with WUSTL’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 will be followed.