Question

Please respond in your own words, interpreting the concept, and answering the prompt utilizing the language your learned in Epidemiology 101 this semester. I conducted an RCT, where I placed 125 people in treatment A, 125 people in treatment B, and 125 people in the placebo group. The Principal Investigator (PI) for my research project just called me to tell me that I violated the ethics code in the assignment of treatment options. What may I have done wrong? (Must use Epi terms for full credit.) _________________________________________________ ________________________________________________________________

Answer 1

I conducted an RCT, where I placed 125 people in treatment A, 125 people in treatment B, and 125 people in the placebo group. The Principal Investigator (PI) for my research project just called me to tell me that I violated the ethics code in the assignment of treatment options. What may I have done wrong?

Answer- RCTs is randomized controlled trials, in clinical research, use of RCT is the best procedure to evaluate the safety and efficiency/efficacy of any new treatment.

In your research you have used 125 people in treatment A, 125 people in treatment B, and 125 people in the placebo group. What may I have done wrong- using placebo controlled trials

Use of placebo-controlled trials (PCT) are not ethically accepted everywhere (except few clinical research trials). Use of PCT is considered very rigorous method of clinical research. A clinical research always requires a balance between rigorous methods of evaluating the efficacy of any drug treatment with protection to the treatment subject (Human). Ethically, use of placebo trials in randomized controlled trials (RCTs) are permitted only (1) when no drug/treatment has been proven effective in the case study, (2) when there is no risk to human subjects on withholding treatment, (3) when in clinical research study there is treatment that compels requirement of a placebo control.

There is ethical concern in permitting the use of PCTs when a confirmed effective treatment exists. Subsequently randomizing human subjects to a placebo trial exposes them to the possible problems of non-treatment.