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STANDARD OPERATING PROCEDURE Research Administration SOP No: A002 SOP Title: Conflict of Interest
within 60 days of becoming aware of the new interest. Annual updates on COI are also required.
4.3 Review & Report
All disclosed COI must be documented. Significant, financial COI must be reviewed and reported by the institution on the following points:
1) The relatedness of the significant, financial COI to an investigator’s PHS- supported research.
2) The potential impact of the significant, financial COI on the design, conduct or reporting of the research.
All reports must be submitted prior to spending the awarded funds.
4.4 Manage & Maintain
The U.S. FDA 21 CFR 54 requires that the sponsor obtain disclosure of all financial disclosures for all research investigators. The sponsor is responsible for the upkeep and management of all financial disclosures and their respective management plans.
The management plan may be implemented in the following ways in order to minimize
the impact of the potential COI:
1) Disclose the COI in presentations, publications, and all other public forums that disseminate the information.
2) Reducing or removing the covered individual from the primary oversight of the research.
3) Reducing or removing the financial interest from the covered individual.
4) Affirmation of the management plan from the institution on the part of the investigator or covered individual.
4.5 Decline
If the institution cannot develop a satisfactory management plan, it may be in the best interest of all parties that the covered individual decline their involvement altogether.
5. SPECIFIC PROCEDURE 5.1 Recognize
Compliance with the updated policies and regulations on COIs are a requirement of the both institution and covered individual. In order to fulfil this responsibility, it is important for the institution to be vigilant of new mandates amidst all relevant, governing agencies. Additionally, the institution must increase awareness for all new regulations and make such information available to all covered individuals in order that potential COI can be recognized.
Governing Agencies of Research & CHST Institution
1) All governing agencies must provide new or changed COI requirements issued in their annual reviews to the institution.
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