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Qualitative Research Module 2
Qualitative Research Module 2
STEM 11
QUALITATIVE RESEARCH
Most people agree that individuals should be able to choose whether or not to
participate in research in order for it to be ethical. This is accomplished
through an informed consent process in which individuals (1) are accurately
informed of the research's purpose, methods, risks, benefits, and alternatives,
(2) comprehend this information and how it relates to their own clinical
situation or interests, and (3) make a consensual intention to engage.
SUMMARY:
According to government data, 4,967 people died in clinical trials and research in
India between 2005 and 2017. For the past six years, a lawsuit to improve the
regulation of these trials has been dragged through the Supreme Court
unresolved. The trials take advantage of rule flaws and lax oversight, as well as
India's large population of poor people who are frequently unaware of their rights
as trial subjects. Following a Supreme Court interim order, the government made
it mandatory for companies to obtain written informed consent from each subject
prior to a trial in 2013. In practice, however, this is rarely the case. What is more
common, according to Mr. Nidhi, is the type of experience Pradeep Gehlot had.
His story is part of the non-legal profit's case. He claims that 32 people died, and
that 1,833 children and 233 mentally ill people were enlisted in trials against
their will. The state government discovered 81 "serious adverse events" during
clinical trials involving over 3,000 people.