Resources | Q Give up? | Hint Identify the ethical issue posed by each clinical

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Resources | Q Give up? | Hint Identify the ethical issue posed by each clinical trial. In 1932, an experiment was initiated at Tuskegee institute to study the effects of syphilis in African- American men if left untreated. The men were not told of the real purpose of the clinical trial and those afflicted with syphilis were not told of their diagnosis. Rather, they were led to believe that they were being treated for "bad blood, a colloquial term used to describe an assortment of ailments. The men were incentivized to participate in the trial with offers of free doctor visits and treatments. The experiment continued for 40 years and when syphilis treatment became available during the study timeframe, the treatment was witheld. In 1999, Jessie Gelsinger, a patient in a gene trial being conducted at the University of Pennsylvania, passed away shortly after taking the experimental therapy developed for a rare, genetic metabolic disorder. The researchers had previously told Jessie and his family that the trial was safe without disclosing that other human participants had incurred adverse reactions and two animals had died during the pre-clinical stage of the trial. A pharmaceutical executive and his wife were found guilty of altering results data yielded from clinical trials held from 1994 to 1995 for an experimental drug for psoriasis and skin cancer. The husband and wife altered test results to make the drug look more effective in order to increase the stock price. They were also found culpable of delivering mistatements to the Food and Drug Administration. Suppose a biostatistician at a research hospital is working on a clinical trial for a new treatment for atrial tibrillation. He tracks vitals and health metrics for the heart patients in the test group as well as in the control group, who receive a sandard beta blocker. A colleague at a university asks to view the data from this clinical trial for a larger seale report that she is putting together. The biostalistician provides a version of the data lile from the clinical trial that is not de-identilied to his colleague Answer Bank

Explanation / Answer

1. The ethical issue posed in the first clinical trial is that of Informed consent. It is a voluntary expression of a well informed competent subject to participate in the clinical trial.

Here,in the given case, the real purpose of the study and diagnosis given were not revealed to the participants.

The consent of these men is not valid until they have a proper understanding the risks and benefits of the treatment and the type of procedure adopted and most importantly the purpose of the research.

2. The ethical issue in the second case is that of both informed consent(decieving the participant about the trial being safe, which in actual has found to have claimed lives of many) and issues regarding protection of the patient and their exploitation.

3.The ethical issue here is publication bias or reporting bias whereby the false impression of a treatment's effectiveness is given.

4.The ethical issue here is protection of the identities of all the research participants.

There is violation of the privacy laws:Allow the data on a clinical trial to be used or disclosed for any secondary purpose only after the data being appropriately de-identified is of utmost significance ethically.

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