Hello,
I'm currently writing an essay for a university assignment on whether a, presumably hypothetical, clinical trial is ethically justified. I see that the second of the 4 questions that the National Institutes of Health (NIH) prompts you to answer/think about when defining if a study is a clinical trial is: "Are the participants prospectively assigned* to an intervention**?" (https://grants.nih.gov/ct-decision/index.htm)
The question is then further broken down by explaining that "prospectively assigned" refers to a pre-defined process (e.g. randomisation).
The essay question I have reads as follows: An investigator plans to conduct a clinical trial in remote parts of Brazil and Mexico. The trial involves giving children with suspected cutaneous leishmaniasis (a parasitic infection) a newly developed drug treatment over a 3 week period and then collecting a series of samples from them, including stool samples. What ethical issues does this scenario raise, and are they acceptable?
If a researcher is looking to do a clinical trial on children in the rural parts of Mexico and Brazil, I imagine the sampling method here would come under the non-probability sample method purposive sampling (https://www.scribbr.co.uk/research-methods/sampling/) -- Does this still fit what "prospectively assigned" refers to, even if the subjects for the trial aren't randomly chosen?
Also, I'm guessing that the question Are the participants prospectively assigned to an intervention? in full means to ask, 'Are the participants, that have been selected by a method of sampling, assigned to an intervention treatment for the disease the trial is investigating?'
Sorry that this wasn't written very succinctly, it's my first time asking a question on the website and I've only begun my second year of university, so I'm still coming to understand various terminologies.
Hi,
The whole trial is Ethically unviable, so the rest of the questions do not arise.
"..giving children with suspected cutaneous leishmaniasis (a parasitic infection).."
This would be tantamount to a criminal act of causing harm to an individual
Follow these Ethical Guidelines:
https://clinicalcenter.nih.gov/recruit/ethics.html
Mainly the ethical principles, ae beneficence, nonmaleficence, autonomy, and justice.
It may not be as clear cut as Bhogaraju Anand says. Factors to consider are:
1. Is there an established treatment/Standard of Care (SoC) for the disease?
2. If yes, is the investigator looking for additional benefit by adding the experimental therapy to the established therapy?
3. Is there a control group receiving only the established therapy/SoC?