Nursing Simulation Process Assignment

Running head: NURSING SIMULATION
Discussion post- Jan Klein, RN
Name of the Student
Name of the University
Author Note

NURSING SIMULATION1
Introduction- Time and again it has been established that the five basic ethical
principles encompass beneficence, non-maleficence, and minimizing harm, not using
deceptive practice, obtaining informed consent, and maintaining confidentiality (Metcalf &
Crawford, 2016). As a clinical research coordinator (CRC), it is imperative to stand up to the
principal investigator under circumstances when the ethical standards of a research are being
violated. This activity will elaborate on a research simulation and will also elaborate on the
ethical principles of research.
Discussion- In the research simulation activity, I played the character of Jan Klein,
who was a registered nurse (RN) and the CRC. The clinical research was begun only after
taking informed consent from the participants, and on observing discrepancy in study subject
medical record, in addition to their clinical characteristics, the events were reported to the
supervisor, with the aim of preventing any kind of research misconduct. The first ethical
challenge was related to absence of an IRB approval for conducting the melanoma multi-
center trial. Under the regulations of the FDA, an IRB is a suitably established group that has
been officially nominated to evaluate and monitor biomedical research concerning human
subjects. In agreement with FDA guidelines, an IRB has the ability to approve, necessitate
alterations in (to secure endorsement), or reject research (Blackwood et al., 2015). Thus, IRB
approval was required in order to ensure that only systematically and ethically
legal research had been executed. On having questions about the research, efforts were also
taken to search them online, in order to resolve any queries about the purpose and
methodology of the research. Even when Wendy Casper, a patient, and her son wanted to
skip the procedure of giving informed consent, owing to poor health status, voluntary
agreement was only taken after the subject demonstrated adequate understanding about the
investigation and its risks (Wolf, Clayton & Lawrenz, 2018).