Ethical Considerations In RCTs With Diabetic Patients

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Author(s): 
Farah Siddiqui, DPM

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Desmond Bellsays: June 7, 2011 at 8:29 pm

Great topic and well written article. Thank you for your contribution.

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DR DPMsays: June 22, 2011 at 9:52 am

Clinical research is always a timeless dilemma that is ample fodder for medical ethics. First of all, the purpose of clinical research trials (RCTs) is to meet the best interests of the patient more so than the individual interests of the physician scientist. It is never the other way around. If it was the other way around, nightmares like science fiction TV shows ("The Incredible Hulk" pilot episode in 1977 is the number one example) would occur. A "clinical experiment gone wrong" has myriad of negative consequences for all involved, more so for the physician scientist. Whether the physician scientist is an MD, PhD (Dr. David Banner), a DO, PhD, a DPM, PhD, or a MD, DO, or a DPM, the physician scientist must adhere to the well being of the patient.

Secondly, I feel that putting the patient in the placebo group for the duration of the clinical research project is fine ethically, despite the negative trade-off of potential possible minimum treatment quality (i.e, an inferior medicine). Informed consent should involve informing the patient he or she has a 50% chance of being in the placebo group, therefore receiving the minimum or inferior treatment. That is the only information the patient should know if the patient volunteers in a clinical research experiment.

Thirdly, the above two paragraphs involve a fine line of many gray areas. That is where the ample fodder for medical ethics come in. Each patient has his or her own unique potential moral dilemma once he or she participates in the clinical research project. So, if there are 2,500 patients involved in a clinical research project, then there are 2,500 unique potential moral dilemmas the physician scientist must tackle. The gist of the matter is this: first, where do physician scientists draw the line in terms of conflict of interest between the physician scientist and the patient. Secondly, how does one reconcile this conflict of interest with the informed consent?

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