A clinical study involves different people, such as the principal investigator, the research co-coordinator, and the research assistant, and institutions, such as the institutional review board (IRB) (Office of Research Integrity, n.d.). Each individual and institution has clearly defined roles to ensure harmony during the study. The overall effectiveness of the study, however, depends on the decision making of the principal investigator. The research coordinator, the research assistant and the IRB chair are also essential to the proper performance of a research.
The principal investigator (PI) as the expert at the study site must ensure that the study is conducted based on good research practices. The PI can delegate specific roles to the research coordinator and the research assistant. The oversight roles, however, remains with the PI, who should ensure that all the involved staff abides by the research guidelines and protocols set up by the IRB. If there are any protocols or procedural violations, the PI as the lead investigator should identify and follow the established ethical guidelines to resolve them (Office of Research Integrity, n.d.). It is unethical for the PI to collaborate with other research staff to alter study outcomes or data without the knowledge of the IRB (Office of Research Integrity, n.d.). If there are any problems that may affect the study, the PI has the responsibility to examine the issues and if there is any reason to terminate or suspend the study, the PI should follow the established protocol and inform all the parties.
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The research coordinator and the research assistant are all supervised by the PI. The coordinator and the assistant, however, must still comply with the established ethical guidelines. For example, they must ensure that the research data is gathered and reported accurately (Office of Research Integrity, n.d.). If the data has issues, they may attempt to resolve the issue by working with the data management team, the IRB and the PI.
The IRB, on the other hand, should ensure that the study conforms to the established ethical guidelines. Since the IRB monitors the study, it has the responsibility to identify the critical issues that violate its ethical regulations, and it has the authority to disapprove a study if the violation is critical.
In conclusion, a clinical study involves different experts to ensure that all the ethical guidelines are followed. I believe that any problems that emerge due to ethical violation can be identified before the study is published if all parties fulfill their responsibilities.
Reference
Office of Research Integrity. (n.d.). The Research Clinic. Retrieved September 9, 2018, from https://ori.hhs.gov/TheResearchClinic
