When playing the simulation as Jan Klein, RN, it is important to address research-related ethical issues from a nurse’s perspective. She performs a role of a clinical research coordinator and cooperates with a principal investigator (“The research clinic,” n.d.). It is possible to learn certain aspects associated with realizing ethical principles in research. Firstly, it is important to serve as an advocate for subjects to guarantee they understand the purpose and specifics of a study. Thus, the effective enrollment of subjects is possible only when all of them or their official representatives provide a signed informed consent form (Schmidt & Brown, 2019). Secondly, it is important to guarantee that the protocol is followed concerning the exclusion and inclusion criteria of subjects to avoid the falsification of data. It is necessary to follow the protocol in all the cases and even oppose a principal investigator when he lacks knowledge on the ethical issue.
Although it is possible to assume that there are some gray areas in the field of research ethics, it should be perceived as clear and require following regulations and protocols strictly. The reason is that if there are some exceptions, there are risks of receiving incorrect or falsified data and critically negative effects for patients. For example, Jan Klein could ignore ethical protocols and avoid reporting the issues related to the principal investigator’s actions to her supervisor. As a result, the completed trials could have false results because of following inefficient eligibility criteria and including dropped subjects (“The research clinic,” n.d.). The findings of the effectiveness of a specific treatment regimen could be invalid and unreliable, but that treatment could be used in practice, leading to negative outcomes for patients. Thus, Jan Klein should have demonstrated her skills as a leader and an advocate for subjects and patients to prevent causing harm as a result of inappropriately conducted clinical trials.
References
The research clinic. (n.d.). The Office of Research Integrity. Web.
Schmidt, N. A., & Brown, J. M. (2019). Evidence-based practice for nurses: Appraisal and application of research (4th ed.). Jones & Bartlett Learning.