Question

The researchers want to test the effects of xyz drug on pregnant women for their diabetic issues. The drug has been approved globally for the treatment of thyroid problem in women, but it is not approved for any other use in any country. More than 400 women were enrolled in the study without their knowledge or consent to take part in clinical trials conducted at five or more centres across the country. Participants were not fully informed about the risks of the trials and received misleading and confusing explanations. Consent forms were not fully read and informed consent was not taken. Participants were told that they had to complete the trial and cannot leave or withdraw from the experiment. Moreover, the researchers used the demographic information of the participants in another study which they conducted one year later.

What ethical rules have been violated by the researchers in the above study? Why is it important to take informed consent from the participants before beginning any trail? (150-200 words)

Answer 1

Answer:

The goal of the informed consent process is to provide sufficient information to a potential participant, in a language which is easily understood by him/her, so that he/she can make the voluntary decision regarding “to” or “not to” participate in the research study.

Explanation:

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