Read the following true scenario: From: White, M. Why Human.
Read the following true scenario: From: White, M. Why Human… Read the following true scenario:From:White, M. Why Human Subjects Research Protection Is Important. Ochsner Journal Mar 2020, 20 (1) 16-33; DOI: 10.31486/toj.20.5012Ellen Roche was a healthy 24-year-old laboratory technician at the Johns Hopkins Asthma and Allergy Center. She volunteered to take part in a 2001 lung function physiology experiment in which normal pulmonary function in healthy volunteers would be manipulated by inhalation of hexamethonium, a compound that interferes with normal nervous system interaction with the lungs to mimic a mild asthma attack. Although it had been used in the 1950s to treat hypertension, hexamethonium fell into disuse as more effective drugs became available, and the FDA withdrew approval in 1972. Of note, hexamethonium was never approved as an inhaled medication. Roche was the fourth patient to receive hexamethonium in the trial. At least one previous subject had had mild persistent respiratory symptoms that the investigator dismissed as a cold. Roche became very ill, with significant pulmonary abnormalities presenting within 24 hours. The symptoms progressed to multisystem organ failure, and she died within a month.The ensuing investigation turned up several concerns:The literature search relied on PubMed and one contemporary textbook of pulmonary medicine to explore the potential use of hexamethonium for the purpose proposed in the research plan. Neither source revealed any indication of concerns, although other databases and older textbooks warned of significant pulmonary complications associated with hexamethonium.No request was made to determine if the FDA required an investigational new drug application, even though the medication was no longer approved and had never been approved as an inhalational drug.The consent form referred to hexamethonium as a medication but failed to mention that FDA approval had been withdrawn.A few subjects included in previous studies used inhaled hexamethonium with no mention of problems in the subsequent publications, but two subjects did have significant difficulties that were not reported as the investigator did not consider them related to the drug.The hexamethonium used in the study was of chemical grade and was not prepared as a pharmaceutical agent. Match the ethical concern with the Belmont principle that it violates. Some answers may be used more than once, others may not be used at all.Which one is what?The consent form referred to hexamethonium as a medication but failed to mention that FDA approval had been withdrawn. (Non- maleficence, justice, Beneficence, Respect for person) The hexamethonium used in the study was of chemical grade and was not prepared as a pharmaceutical agent. The FDA withdrew approval of the drug in 1972, and even then hexamethonium had never been approved as an inhaled medication. (Non- maleficence, justice, Beneficence, Respect for person)The research subject worked for the research center and her boss had suggested that she might be a promotion if she participated (Not true, I made up this part for the purpose of this exercise).(Non- maleficence, justice, Beneficence, Respect for person) The research subjects were all selected from low wage workers in the university, and offered $500 to participate (Not true, I made this up for the purpose of this exercise.) (Non- maleficence, justice, Beneficence, Respect for person) Health Science Science Nursing NURS 422
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