3.4.3 Personal Conflict of Interest in Medical Research: What Is It? What Can Be Done About It?
Trudo Lemmens, LicJur, LLM, DCL
- To understand the concept of conflict of interest in the context of medical research
- To understand why conflicts of interest have to be addressed
- To learn what types of remedies exist to deal with conflicts of interest
Dr. Reed is an academic researcher with over 400 publications. He is on the advisory boards of professional organizations as well as pharmaceutical companies. He holds a Chair in Cardiology at the University of Port Hope. He obtained a contract from the pharmaceutical company Selaserom to conduct a phase 3 double-blind randomized controlled trial comparing Selaserom's drug Lovrux with another hypertension drug in the University of Port Hope's General Hospital. Dr. Reed has been paid as an expert consultant during the development of Lovrux. The contract provides a lump sum of $9,000 per patient to Dr. Reed and his team for all administrative and research-related costs, payment for research equipment and a half-time salary for a research coordinator. Dr. Reed will receive stock options in Selaserom. The contract stipulates that blood samples and clinical data will be analyzed at the General Hospital's research laboratory and that the data will be forwarded to Selaserom's research unit, which will keep the randomization codes. Selaserom will organize the final analysis and will coordinate, in collaboration with Dr. Reed, all public communications related to the project.
- What is a conflict of interest?
- How can we identify conflicts of interest in medical research?
- What are the primary professional obligations of researchers?
- What types of financial conflicts of interest exist in medical research?
- How can the professional obligations to conduct research and to protect the integrity and well-being of human subjects be affected by these financial interests?
- What remedies are there to deal with conflicts of interest?
- What conflicts of interest affect Dr. Reed?
- How should Dr. Reed's conflicts of interest be dealt with?
There is a growing recognition, resulting in part from various empirical studies, that financial conflicts of interest can impact on the design, conduct, analysis and reporting of clinical research. It is also increasingly recognized that disclosure of conflicts of interests is not sufficient to deal with the potential impact on the protection of research subjects and the integrity of research. Dealing with such conflicts is complex, and various institutional and regulatory measures have been developed to address the problem. Researchers, institutions, governmental agencies and REBs have to work together to reduce the potential negative impact of conflicts of interests.
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