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?

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?

Vocaloid · Answer

Please do not copy-paste my response. In research studies involving human participants, it's important that the participants fully understand the study, what it involves, what the risks are, how their data will be used, etc. We call this idea "informed consent". Informed = given the knowledge they need to understand the study, and consent = agreement. It is unethical to involve people in studies without their full, informed consent. I'll identify one major issue with this study, and let you identify the rest: "Participants were not fully informed about the risks of the trials and received misleading and confusing explanations." ---> this means that the participants were not given sufficient information to understand the possible negative outcomes of this study, and thus have not consented to the risks. this is especially important in drug trials where people are taking treatments which could have long-term/permanent health consequences. some recommended reading to help you with this assignment: https://www.apa.org/news/press/releases/2014/06/informed-consent#:~:text=%E2%80%9CInformed%20Consent%2C%20psychologists%20inform%20participants,withdrawing%3B%20(4)%20reasonably%20foreseeable https://ccts.osu.edu/content/informed-consent-research

858 · Answer

Thankyou.