First Response
Reporting the unethical practices committed by Principal Investigator and study coordinator to the official demonstrates compliance with science guidelines. Patients should have informed consent about the medication they are receiving and understand the procedures employed. Informed consent shows respect and dignity. Therefore, it is the duty of Lilly and the PI to inform the patients that FDA does not approve the drugs administered. This will allow the patients to understand the risks and benefits of the treatment prior medication process. Clinicians need to engage with patients in making the decision of experimental drugs as stated by Baer, e t al . (2011). This is necessary to show the likelihood of risks against benefits. Doing this not only helps the patients but the entire university professional.
Furthermore, randomization methods applied goes against ethical health practices and should be reported to the administration. Administering experimental drug to healthy patients gives them the advantage on clinical outcomes than the less healthy. Besides, clinical trials are meant to evaluate the effectiveness of an individual drug to the sick patient and not giving the least sick ones and then comparing the outcomes with sicker patients given a placebo. These unethical malpractices combined with falsification of data need to be reported to officials.
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Response Two
Informed consent is aimed at protecting human subjects’ during clinical experiments. According to the law, participants need to be informed the risks and benefits for them to participate voluntarily in the experiment. The study carried out on testing the drugs did not obtain effective legal permission from the patients before giving out the medicine. In case the drug greater than minimal risks to the patients, the Principal Investigator could have provided the explanation for any compensation or medical treatments in case of adverse effects. The principal investigator is responsible for ensuring effective informed consent is attained and filed correctly for all participants. Though the role was delegated to the study coordinator, the principal investigator still bears all the responsibilities of ensuring experiments are administered in a free consent manner.
Despite the fourth authorship requirements, it is necessary to disclose the unethical practices in the University of Questionable Studies. This is done for the best interest of the whole public because the experimental results did not meet ethical concerns in health studies. As a result, the drugs which are not approved by FDA may harm other patients in the hospitals. Disclosing the information will not promote unethical practices in giving misleading health information ( Chitty and Black, 2011). However, forming anonymous article may show misconducts in journal practices because the author was not part of the study team in formulating the hypothesis, organizing statistical analysis, and interpreting the results.
References
Baer, A. R., RN, BSN, Devine, S., CCRP, & Catalano, R., PharmD. (2011, March). Clinical Investigator Responsibilities. Journal of Oncology Practice, 7(2), 121-128. doi:10.1200/JOP.2010.000216
Chitty, K. K., & Black, B. P. (2011). Professional nursing: concepts & challenges. Jones & Bartlett Publishers.
