Conflict Of Interest
It’s All About the Overlap
The regulation of personal financial Conflict of interest (FCOI) has been the subject of increased scrutiny in the popular press and regulation by lawmakers and agencies. Institutions must be organized and responsive to authorities and regulators while not stifling the entrepreneurial relationships and activities that promote translation of new scientific knowledge into products and services available for the public benefit.
C3Authority can assist universities, and small business with understanding what they need to do to be compliant with FCOI regulations and also how to do it effectively and efficiently. C3Authority can assist universities with consideration and implementation of policies and procedures related to the trending area of Institutional Conflict of Interest (ICOI) as well.
How We Can Help You
Personal Financial Conflict of Interest
- Review of FCOI policies and procedures for compliance with sponsor policies, federal and state laws and regulations
- Assistance with integration of FCOI processes into other institutional sponsored project, technology transfer, and compliance systems
- Multidimensional assessment and evaluation of COI issues and requirements prior to proposal submission
- Assistance with review of individual situations and disclosures of research team members and recommendations for management of related FCOIs
- Service as an unbiased reviewer of FCOI situations and proposed management plans
- Review of and assistance with FCOI issues for consortia, research centers, and public/private collaborations and agreements
- Assistance with FCOI review of clinical trials and FDA regulated research
- Assistance with development of FCOI compliance solutions for small business awardees, collaborator(s) or subcontractors under federal grants and contracts
- Assessment of and solutions for university’s monitoring of subcontractor FCOI compliance
- Review of impact of FCOI situations on data and intellectual property ownership and control, and publication and development of risk mitigation strategies
- Review of consulting and other engagement agreements between companies and university employees
- Evaluation of an organization’s FCOI systems, procedures, and personnel requirements compared to best practices
- Assistance in FCOI risk assessment and strategy development
Institutional Conflict of Interest
- Review of institutional objectives and risk profile
- Assessment of ICOI issues and solutions
- Serve as an unbiased reviewer of ICOI situations and proposed management plans
- Assistance with ICOI situations involving organizational decision-makers
- Assistance with ICOI situations involving human subjects
- Evaluation of an organization’s ICOI systems, procedures, and personnel requirements compared to best practices
During and Post Award Review and Troubleshooting
- Amicable response to Sponsor inquiries, concerns
- Thoughtful response to agency audits
- Assistance with mitigation plans and effects of alleged policy violations
- Assistance with public response to identified FCOI and ICOI situations
- Recommendations for monitoring compliance with FCOI and ICOI management plans and suggestions for corrective action, if necessary
Processes, Procedures, Training
- Assistance with determination of institutional risk profile and tolerance
- Assistance in FCOI and ICOI monitoring, compliance, and reporting activities
- Training on FCOI, ICOI, interpretation and application of policies, federal terms and regulations for Committees, faculty, and staff
- Updates and information on current and changing FCOI and ICOI laws, rules, guidelines, and regulations
- Evaluation of COI administration systems, procedures, and personnel requirements compared to best practices
- Assist in developing COI “Unit”, and its systems, procedures, and personnel requirements
- Development and evaluation of your organization’s COI Committee(s)
- Development of COI Project Specific oversight subcommittees for high volume or complex researcher portfolios
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