You attend a local health fair organized by several health care research companies. You notice that a company is distributing a trial drug to other attendees at one of the booths. When you approach one of the researchers, you are offered a waiver to sign for participation in the trial.
1.What ethical or legal parameters should the researchers have considered prior to distributing the trial drug at the health fair?
2. If you were on the translational research team, what steps would you have taken to maintain ethical and legal guidelines?
Answer preview
Upholding ethical and legal guidelines in clinical research is critical to promote the safety and rights of participants involved. In the case scenario, distributing a trial drug in a health fair organized by researchers show that the participants have not willingly decided to participate, which raises the question of their safety and rights. The healthcare researchers should have considered the ethical parameter of patient’s rights and safety, encompassed by participants’ informed consent. According to Moorcraft et al. (2016), participant’s informed consent in the fundamental right of patient autonomy refers to the voluntary willingness to participate in a clinical trial after having all relevant information about the test. The researchers should have
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