Policies, Procedures and Guidelines

Monitoring Procedures

Originally effective: January 1, 2007
Last updated: April 26, 2018

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:

  1. All research involving human subjects
  2. When the significant financial interest (SFI) being managed involves non-public equity
  3. When students or trainees are involved in the research
  4. 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 Research Ethics and Compliance Office 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 RECO 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.