Page 34 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: A002 SOP Title: Conflict of Interest
5.4 Manage & Maintain
The institution is responsible for managing and maintaining the COI for PHS funded or various other funding agencies of research. Industry trials for FDA regulated research are responsible for managing and maintaining COI for the covered individual involved.
As part of “promoting objectivity in research,” the institution must manage and maintain an updated management plan in Table 5.4 below:
Table 5.4
The value of the financial interest in specific intervals.
A description of how the SFI relates to the PHS-funded research and the basis for the institution’s determination that the SFI conflicts with the research.
Requirements of a COI Management Plan
Role and responsibilities of the covered individual.
Conditions of the management plan.
Management plan is designed to safeguard the objectivity of the research.
Confirmation of the Investigator’s agreement to the management plan.
Management plan will be monitored to ensure Investigator compliance.
Other information as determined necessary.
5.5 Decline
If an acceptable management plan cannot be identified, the covered individual must make a decisions regarding whether they will keep their outside interest and decline participation in the institution or with research. Once a decision has been reached, the covered individual should inform the relevant parties of their decision.
6. STANDARDS/FORMS/TEMPLATES TO BE USED
Conflict of Interest
Recognize Disclose Review & Report
Enforce annual completion of COI by all covered individuals
Provide new or changed COI requirements issued in their annual reviews to the institution
Review updated regulations
Provide information through updated policies and training resources
Utilize information made available in relevant policies and training
Oversee completion and documentation of COI training by all covered individuals
Stay current on all COI required training
Enforce annual completion of COI by all covered individuals
Require all newly acquired COI to be disclosed at the time they are acquired
Report any newly acquired COI within 60 days of becoming aware of them
Review all submitted COI for relatedness to the study
No
Is COI a
significant, Yes
financial COI?
Annual updates on management of COI must be reported
Receive more detail if needed from direct supervisor
Develop retrospective review to determine whether the COI influenced research that was conducted during the period of noncompliance with the COI policy
Sign and complete form
Must be submitted priori to spending or renewal of awarded funds
Evaluate interests and identify potential for COI
Receive COI form from direct supervisor during onboarding process
Review the relevant policy and ask any questions while evaluating current and potential interests
Make copies of signed job description and file sccordingly
COI needs updates?
Yes
Address any additional queries and provide any additional information
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Direct Covered CHST Institution Governing Supervisor Individual Agencies