In the research simulation activity, which character(s) did you play? Jan Klein, RN a clinical research coordinator (CRC) What did you learn about ethical principles in research?

In the research simulation activity, which character(s) did you play? Jan Klein, RN a clinical research coordinator (CRC) What did you learn about ethical principles in research?

Research involving human subjects is regulated by the Institutional Review Board (IRB), a regulatory body that oversees the research to ensure that the rights and welfare of research participants are maintained. Before any research involving human subjects can be conducted, IRB has to be consulted to approve the study. One of the major ethical principles in research is informed consent. It involves providing comprehensive information to the participants before deciding whether they want to enroll in the study or not. While some participants may not be attentive and might prefer to skip the process, it is the role of the CRC to ensure that all the information is given and the participant understands the benefits, risks, and the treatments in the research before they are allowed to sign the informed consent form. Any irregularities observed by the CRC should be reported to the supervisors for further investigations. The CRC should also ensure that all research team members are aware of the purpose of the study, protocols to be followed, such as inclusion and exclusion criteria, regulatory requirements, acceptable standards of practice, and other factors (The Office of Research Integrity, 2021).

Are ethics in research clear cut, or do you think there are some gray areas?

            Research ethics are clear-cut since there are established protocols, guidelines, and support systems to ensure that studies, including human subjects, adhere to specific regulations. For example, when Dr. Sowers, the PI, approaches Klein to include a patient into the first phase of the study, she insists that IRB has not yet approved the study protocol and response of Dr. Sowers indicates he is aware of the step only that he is trying to ignore it. This indicates the ethics are regulations are clear. Annie Bailey, also CRC, is captured reading the updated guidelines on new protocols, which confirms that ethics in research are clear without grey lines. Also, there are established lines of reporting whenever a CRC notes irregularities. For example, when Klein suspected data falsification, she was required to report it to the regulators, who then investigated the issue to confirm whether the research adhered to the set guidelines. The several support systems placed at every research project stage show that ethics are clear cut in research (The Office of Research Integrity, 2021).