8. In an efficacy study, a clinical study was conducted on a…
8. In an efficacy study, a clinical study was conducted on a new drug that was believed to lower blood pressure levels among participants with uncontrolled high blood pressure (HBP) in one of the villages in the Eastern Cape. Local health care workers (HCWs), were hired to recruit potential participants who were offered incentives in the form of food parcels and amounts of R1, 000. Upon sponsor initiated audit, it was found that an informed consent (IC) had been sought from the participants, with risks and benefits clearly stated, however, the IC form was written in English. There was no documentation of the drug approval by the Drug Regulating Authority. Preliminary data analysis also revealed that nearly two-thirds of the participants were over the age of 60 years and had a primary level of education. Furthermore, the Induna of the village had been awarded an amount of R5, 000 for approval. Please explain how the following ethical principles were not upheld. Where possible provide two points for each ethical principle. 8.1 Informed consent (2) 8.2. Autonomy (2) 8.3. Anonymity and confidentiality (2) 8.4. Non-maleficence (2)
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