COI is a set of conditions, in which professional judgment concerning a primary interest (patient's welfare or the validity of research) tends to be or appears to be unduly influenced by a secondary interest (financial or non-financial gain).
The payments made thereof do not include payments for the conduct of the clinical trial of the product under consideration or clinical trials of other products, under a contractual arrangement, but do include other payments made directly to the investigator or to an institution for direct support of the investigator and institution.
Financial interest related to the research means financial interest in the sponsor, product, or service being tested, or competitor of the sponsor or product or service being tested.
Compensation affected by the outcome of clinical studies means compensation that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest.
COI of interest in clinical research extends to all stakeholders. Principal investigator (PI), ethics committee (EC), and the institution.
Main Area of Concern is the Industry-sponsored research.
In case of sponsored research, if immediate family members of the PI or of institutional heads, and/or human research protection programme (HRPP) board are a part of the board of directors, and/or medical advisors, and/or ethics committee members, and/or who have financial interests and/or who hold major share in the sponsor company should be probed and should be declared before the acceptance of the research protocol.