Explain the ethical dilemma generated by randomized clinical trials, as expressed by Samuel and Deborah Hellman.
Physicians – duty to beneficence (do good for the patientResearchers – duty to reach scientific conclusions and discover resultsClinical trials can put a patient in a control group where they don’t get the best care/treatment.
Randomized clinical trials (RCTs) are considered the gold standard for testing the efficacy and safety of medical interventions. However, some ethical issues are raised by Samuel and Deborah Hellman in their article “Of Mice but Not Men.” The ethical dilemma generated by RCTs lies in balancing the investigational and therapeutic interests of the trial participants and the scientific interests of the researchers.
The first issue is the use of a placebo group. Randomization to a placebo group means that some participants will receive no intervention or a standard of care intervention rather than the experimental intervention being tested. This means that they may not receive the benefit of an effective treatment, which could put their health at risk. However, the use of a placebo group is necessary to establish the true efficacy of the investigational intervention.
The second issue is related to the human subjects used in RCTs. Samuel and Deborah Hellman note that there is a potential conflict of interest because the investigators may have financial or other interests that influence their decisions about how to conduct the trial. Additionally, the trial participants may be vulnerable and may not fully understand the risks and benefits of participating in the trial. This conflict of interest could lead researchers to take shortcuts during the study design, enrollment, and monitoring process that could put the safety of the participants at risk.
Finally, the results of RCTs may have public health implications. However, they may not be applicable to all patients as the study population may not fully represent the diversity of the general population. Therefore, it is necessary to be cautious when extrapolating the results of RCTs to the general population, especially in view of social and economic differences.
In summary, the ethical dilemma generated by randomized clinical trials is balancing the interests of individual participants and the scientific community with the safety and potential benefits of investigational interventions. Researchers must ensure proper study design, conduct, and monitoring of clinical trials to ensure full informed consent and safety for the participants while maintaining the validity of the research conducted.
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