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These flashcards cover key concepts and definitions related to conflicts of interest (COI) in research, based on lecture notes.
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Conflict of Interest (COI)
A situation where a professional's judgment may be unduly influenced by secondary interests, such as financial gain.
Financial COI
A situation in which financial considerations may compromise, or appear to compromise, an investigator’s judgment in conducting or reporting research.
Non-Financial COI
Interests that do not involve financial elements but can influence an investigator's obligations, such as professional recognition or personal beliefs.
Disclosure
The act of revealing financial or personal interests that may affect research integrity.
Consequences of COI
Potential negative outcomes including loss of objectivity, degradation of scientific integrity, and exploitation of trainees.
Types of Financial COI
Financial interests that include stocks, payments, employment relationships, intellectual property rights, and benefit arrangements.
Institutional COI
Potential conflicts arising within institutions related to financial interests, research obligations, and policy-making.
Clinical Research Enterprise
The network including physicians, institutions, industries, and regulatory bodies involved in conducting clinical trials.
Jesse Gelsinger Case
A notable case illustrating significant problems in clinical trial integrity and ethics, leading to regulatory scrutiny.
Informed Consent
An ethical requirement that participants understand and agree to the conditions of a study, including any potential conflicts of interest.
Types of COI
Includes individual, organizational, financial, and non-financial aspects that can influence research outcomes.
Regulatory Body Roles in COI
Functions of regulatory bodies include reviewing, approving, and overseeing research to prevent conflicts of interest.