Management of CoIR
Management StrategiesIn cases where an employee's disclosed activity is permitted but requires implementation of certain management plans, options for resolution and a mechanism for reporting back to those with oversight responsibility must be developed. Because each disclosed conflict is likely to be unique, deans, directors, and department chairs have considerable discretion in suggesting management strategies to the Conflict of Interest in Research Committee. Consultation with others who have experience and expertise in a particular area is encouraged (e.g., compliance officers, administrative officials, the Legal Department, Human Resources).
Based on current national guidance, OHSU's Conflict of Interest in Research Committee has developed management plan guidelines for participation in clinical trials where the investigator has a significant financial interest.
Essential goals for conflict management include:
- Compliance with federal, state, and local laws and regulations
- Protection of confidentiality
- Protection of reputation (OHSU, employee, department)
- Protection of OHSU's interests
- Least obtrusive measures
- Expeditious response
- Means for verification
- Amenable to internal and external review/audit
Possible options for managing conflicts include:
- Public disclosure of all relevant information
- Reformulation of the relationship
- Modification of the workplan
- Use of a disinterested third party in key decision-making roles
- Close monitoring
- Divestiture of relevant personal interests or relationship
- Termination or reduction of involvement in the relevant work
Questions to consider when managing an employee's disclosed conflict include:
- Has all relevant information concerning the employee's activities been acquired?
- Do the employee's relevant financial interests exceed predetermined thresholds of acceptability, as determined by OHSU policy or the executive level of the employee's school or institute (i.e., Dean or Director)?
- Do the employee's external commitments exceed permissible levels, as determined by the executive level of the employee's school or institute (i.e., Dean or Director)?
- Is there any indication that the employee's outside commitments have biased or otherwise interfered with the quality/quantity of his/her duties to OHSU?
- Is there any indication that the employee has improperly favored any outside business or appears to have an incentive to do so?
- Has the employee inappropriately represented OHSU to an outside business?
- Does the employee appear to be subject to incentives that might lead to inappropriate bias or impropriety in the conduct of research?
- Could the employee's circumstances represent violation of federal, state, or local laws or regulations?