I played the role of Dr. Richard sowers in the simulation activity. From the simulations, there are several lessons I learned regarding the roles played by a principal investigator. The first decision I made in the simulation was regarding the IRB approval before starting the trials. My first choice was to begin enrollment of subjects before IRB approval in which Jan Klein, RN, the Clinical research coordinator was against, but after compulsion, she agrees. The next decision was regarding filling the consent form since we did not have IRB approval. IRB approval is crucial since it ensures ethical standards are adhered to during the study (Vitak et al. 2017). I chose the option of signing the consent form without filling the date. A study protocol and consent form must be approved by an IRB before trials to enroll subjects starts.
Explaining how a study works to the test subjects is essential since it gives room for the participants to ask questions and get full disclosure for the test. Jan was unable to educate the patient on how the trial works; however, I decided to let Jan do her job not to intervene with the process. According to Brown (2016), ethical professionalism requires researchers to disclose full details of the tests, including any risks associated with the study. The next was on the acquisition of subjects for trial, which was a challenge due to exclusion inclusion criteria; I made the decisions to help Jan make the numbers. Jan has poor recording habits; therefore, the data on patients was inconclusive; hence I decided to encourage her to guestimate to fix her mistake, which resulted in the fabrication of data. The audit reports reveal gross misconduct in enrolling the study before approval, recruiting participants not suited for the study, backdating of subject consent forms, and fabrication of data. The decisions I made above were terrible since my mistakes led to two lawsuits against the hospital, two of my subjects who did not meet the inclusion-exclusion criteria threshold died, and their families filed lawsuits. Furthermore, I was suspended together with my staff and put on compulsory paid leave.
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I decided to repeat the simulation using the same decision above. However, on whether to encourage Jan to guestimate to fix her errors or work with her to document the protocol deviations and leave the missing information blank in the research chart, I chose the latter. Though embarrassing, it is good that she decided to be honest and acknowledge her mistake. Hence this eliminated the thought that CRCs have to do whatever they have to do, which is often incorrect. However, it yielded the same negative results as above.
In the next simulation, I followed the same steps as above, making similar decisions until the point where I had to choose whether I should help Jan to make the number work or take off subjects of the study based on inclusion-exclusion criteria. I decided to take the participants off the investigation to comply with inclusion-exclusion standards. According to Wallach, Gonsalves & Ross (2018), researchers need to adhere to inclusion-exclusion criteria. Adherence to inclusion-exclusion rules shows the careful consideration of the characteristics of subjects to minimize the likelihood and scale of harm to patients during clinical trials. Also, it helps to maintain the integrity and reproducibility of the study data. Regarding the poor data recording habits of Jan, which made her loose vital patient information, I decided to work with her to document the protocol deviations and leave the missing information blank in the research chart. However, the net cascading effects of the decisions I made in the previous steps led to similar adverse results, which led to lawsuits, death, and suspension.
I decided to correct my mistakes and took other simulations that were based on making ethical decisions. I went back to fix my choice on enrolling subjects for trial study, and this time I decided to wait for IRB approval before the commencement of the study. Though waiting for IRB approval delayed the investigation, we managed to see it through, and Jan started consenting. In the next step, since the subject did not understand Jan's explanation of how the study works, I decided to intervene with Jan's consent. The effect is that Jan explains profoundly to the subject, and the participants now understand the study requirements. Given the inclusion-exclusion criteria, I decided to take the participants off the research because of the way they were responding to the current medication. I then choose to work with Jan to document the protocol deviations and leave the missing information blank in the research chart. The IRB come to review the audit; the process went well though it was very exhausting. The next decision was to build my relationship with the sponsor to continue having donations for my study. I had to make decisions on what other patients I can get for the study, and I decided to keep plugging on and let the investigation speak for itself. In the end, I managed to achieve the life status proponent of the research integrity Model PI. I managed to navigate through the challenges of a principal investigator successfully.
Based on my previous encounter with Jan Klein, the clinical coordinator, I have managed to appreciate the roles of a principal investigator and a research coordinator towards the success of a study. Both a PI and CRC can affect research study based on the decisions they make. For instance, Jan Klein played a crucial role in the emergence and execution of the use of falsified data in the research. The P.I had the decision to either guestimate to fix her errors or work with her to document the protocol deviations and leave the missing information blank in the research chart and the decision made may have both negative and positive effects on the research as discussed above. Also, the CRC can affect the investigation if they approve for the P.I to proceed with studies without IRB approval.
References
Brown, D. (2016). Ethics and professionalism in the workplace. Retrieved 7 December 2019, from http://www.indianapolisrecorder.com/business/article_36d05298-7b96-11e6-8226033c365dab07.html
The Research Clinic. (2020). The Research Clinic. Retrieved from https://ori.hhs.gov/research-clinic
Vitak, J., Proferes, N., Shilton, K., & Ashktorab, Z. (2017). Ethics regulation in social computing research: Examining the role of institutional review boards. Journal of Empirical Research on Human Research Ethics , 12 (5), 372-382.
Wallach, J. D., Gonsalves, G. S., & Ross, J. S. (2018). Research, regulatory, and clinical decision-making: the importance of scientific integrity. Journal of clinical epidemiology , 93 , 88-93.
