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Research Ethics Boards (REB’s) exist to protect the safety of research subjects. However, they provide guidelines only, and often guidelines are ambiguous. REB’s may be private entities, and thus may be vulnerable to pressure.
Patients may also feel some pressure to agree to enroll in a study strictly because of the nature of the physician-patient relationship. Patients place great trust in their doctors, but they may be afraid that refusing to take part in a study may cause their doctor to have negative feelings towards them. They may agree to take part simply to keep their doctor “happy.” Another concern is that financial inducements may hamper physician’s decision-making. For example, a doctor who was being rewarded financially for every patient who completed the study might be inclined to keep a patient in the study even if they suffered untoward symptoms. There are internationally developed guidelines that are meant to provide guidelines in clinical research; some examples are the Helsinki Declaration, International Guidelines for Biomedical Research Involving Human Subjects, and Good Clinical Practice for Trials on Pharmaceutical Products (World Health Organization). What are some considerations that can mitigate some of the aforementioned conflicts of interest? Above all, patients should be made aware of any potential conflict of interest and also have the right to know exactly how the physicians are being rewarded by the drug company. Additionally, patient confidentiality should be protected as much as possible and patients should be made aware of how information about them may be shared. In this way, physicians can participate in research trials without compromising patient trust and safety. Reference Puttagunta, P., Caufield, T., Grenier, G. (2001).Conflict of Interest in Clinical Research: Direct Payment to the Investigators for Finding Human Subjects and Health Information.Health Law Review, 10(2) ---
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Posted by Dr. Shaheen Lakhan