Ethically, the health care professional has a responsibility to provide the best care (beneficence), minimize harm, respect for persons (informed consent), and treat people equally (justice). Does the act of enrolling a person in a randomized clinical trial counter these obligations? What are the implications for the patients in the placebo group? What are the implications for the patients in the experimental groups? Consider the following:
A new cancer drug has been developed and is ready for clinical trials. The researcher has received IRB approval and informed consent is obtained. This new drug appears to be much more effective than the standard protocol. A randomized clinical trial is conducted with 50 patients assigned to the experimental group (the new drug) and 50 patients assigned to the control group or usual treatment (standard protocol). In the course of the clinical trial, the patients in the control group experience a significant increase in mortality rates compared to the experimental group.
A) Write a potential hypothesis for this study and identify the variables (independent and dependent)
B) Should the research study be stopped? Why or why not?
C) Is there a favorable balance between benefit and harm?
D) What would you recommend from an ethical perspective? Support your position.
E) Find a peer reviewed research study that is a clinical trial for a drug and briefly summarize it, noting the the reference in the APA format.