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 Thusband 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 fibrillation. He tracks vitals and health metrics for the heart patients in the test group as well as in the control group. who receive a standard beta blocker. A colleague at a university asks to view the
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 Thusband 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 fibrillation. He tracks vitals and health metrics for the heart patients in the test group as well as in the control group. who receive a standard beta blocker. A colleague at a university asks to view the
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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
Thusband 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 fibrillation. He tracks vitals and health metrics for the heart patients in the test group as well as
in the control group. who receive a standard beta blocker. A colleague at a university asks to view the
Transcribed Image Text:data from this clinical trial for a larger scale report that she is putting together. The biostatistician
provides a version of the data file from the clinical trial that is not de-identified to his colleague.
Answer Bank
Confidentiality breach
Data integrity violation
Informed consent violation
U.S. Public Health Service Syphillis Study, http://www.cdc.gov/tuskegee/timeline.htm (accessed December 6, 2016).
Ten Years Later: Jessie Gelsinger's Death and Human Subjects Protection, 2009, http://www.thehastingscenter.org/ten-years-later-jesse-gelsingers-death-and-
human-subjects-protection/ (accessed December 8, 2016).
National News Briefs; Couple Sentenced for Faking Test Results, 2000, (accessed December 8, 2016).
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