Master's Report: Analysis of Clinical Trial Misconduct Cases

This report examines clinical trial misconduct, focusing on two case studies involving a research assistant and a clinical research coordinator. The cases highlight instances of fabrication and falsification, as well as breaches of inclusion/exclusion criteria and informed consent. The report discusses the impact of these misconducts on research integrity and patient safety. It then details the lessons learned regarding the consent process, the role of the Clinical Research Coordinator (CRC), and patient enrollment requirements. Finally, the report outlines how these lessons can be applied to future practice, emphasizing the importance of thorough literature review, adherence to inclusion/exclusion criteria, IRB approval, and promoting ethical conduct among coworkers. The conclusion underscores the significance of research integrity and the measures needed to prevent misconduct, ultimately improving research quality and patient safety.

Running head: CLINICAL TRIAL MISCONDUCT
CLINICAL TRIAL MISCONDUCT
Name of the student
Name of the university
Author note:

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Introduction:
Research misconduct in clinical trials has been a common phenomenon in recent years.
Such cases potentially harm patients who are enrolled in the trials. These misconducts include
fabrication and falsification (Resnik, Rasmussen & Kissling, 2015). This paper will discuss such
clinical trial misconduct with the assistance of one case study in the following paragraphs.
Discussion:
Clinical trial misconduct:
The first situation of case study involves clinical trial misconduct where Megan Boyle, a
research assistant was forced by the principal investigator regarding the recruitment of the
patient and funding. Consequently, she fabricated the responses and got caught. Two prime
misconduct observed in this case scenario include Fabrication and Falsification. According
to PHS Policies on Research Misconduct, fabrication is defined as manipulation of data or results
and recording or reporting them (Ori.hhs.gov, 2019). On the other hand, Falsification is defined
as manipulation of the research materials which further influence the research report. The impact
of both research misconducts is that both are the most serious offenses which challenge the
credibility of the research and research effort (Www.arc.gov.au 2019). Consequently, when these
researches would be included in the clinical field it may threaten the safety of the population.
The second situation of case scenario involves Jan Klein who is a clinical research
coordinator where she was forced to break the rules by recruiting the patients in the trial which
was not approved by IRB. The two research misconducts in the case scenario includes no

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adhering to inclusion and exclusion criteria of clinical trials and not providing adequate details to
the patients. The inclosing and exclusion criteria are designed for ensuring patients safety,
appropriateness of the result and minimization of the participant withdrawal (Resnik, Rasmussen
& Kissling, 2015). In this case, the lack of these criteria reduce the external validity of the
research by questioning the safety of the patients and reducing the appropriateness of the
research. On the other hand, not providing details to participants is considered as a clinical
misconduct which can subject participants to potential harm.
Lesson from both of the scenario:
After a thorough analysis of the video on clinical misconduct, I have learned the steps of
the consent process. Consent is considered as the voluntary permission which provides the
participants with a purpose and procedure of the research, potential risks and rights of the
participants. The consent of the participants is taken for ensuring the confidentiality of the
participants (Tam et al., 2016). I have understood the importance of a Clinical Research
Coordinator role in clinical trials. The prime role of CRC is to ensure the integrity of a research,
regulatory and acceptable standard of a research and include exclusion and inclusion criteria in
the research. CRC should be competent enough to adhere to study protocol and provide details to
the participants for avoiding the ethical issues. Lastly, I have gathered an understanding of the
requirements of enrolling patients in clinical trials. Before conducting research, the study
protocol and consent form must be approved by IRB so that subjects can be enrolled. No subject
can be enrolled without consent and they must meet the inclusion criteria to be part of the
clinical trial. This not only improves clinical trials but also restore the validity of the research
(Clark et al., 2018).

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Implementation of the lesson in future practice:
As discussed above, after conducting n depth analysis of the video, I have gathered the
understanding of the process of consent, the role of Clinical Research Coordinator and
enrollment process. In the future, when a similar situation will arise, I will conduct an in-depth
literature review for gathering an adequate understanding of the research and research procedure.
I will design adequate inclusion and exclusion criteria for the research for improving the quality
of the research. I will ensure that every participant will meet the inclusion criteria and I will
approve the study protocol and consent from IRB. Lastly, I will encourage my coworkers for
adhering to the study protocol and ensure that no research misconduct such as fabrication,
plagiarism, and falsification impact the accuracy of the research.
Conclusion:
On concluding it can be said that research misconduct is a common phenomenon which
impacted the quality of the study. The potential impacts of these include wrong interventions and
patient safety issues. The two case studies highlighted potential clinical misconducts which
further impacted the research accuracy. In this context, I have gathered the understanding order
to improve quality of the research, the coordinator must approve study protocol and consent form
by IRB, design exclusion and inclusion criteria and coordinator must adhere to the protocol by
ensuring that no misconduct is taking place.

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References:
Clark, L. T., Watkins, L., Piña, I. L., Elmer, M., Akinboboye, O., Gorham, M., ... & Puckrein,
G. (2018). Increasing diversity in clinical trials: overcoming critical barriers. Current
problems in cardiology.
Ori.hhs.gov (2019). PHS Policies on Research Misconduct | ORI - The Office of Research
Integrity. [online] Ori.hhs.gov. Available at: https://ori.hhs.gov/phs-policies-research-
misconduct [Accessed 22 Sep. 2019].
Resnik, D. B., Rasmussen, L. M., & Kissling, G. E. (2015). An international study of research
misconduct policies. Accountability in research, 22(5), 249-266.
Tam, N. T., Huy, N. T., Thoa, L. T. B., Long, N. P., Trang, N. T. H., Hirayama, K., &
Karbwang, J. (2015). Participants’ understanding of informed consent in clinical trials
over three decades: systematic review and meta-analysis. Bulletin of the World Health
Organization, 93, 186-198H.
Www.arc.gov.au (2019). ARC Research Integrity Policy | Australian Research Council. [online]
Arc.gov.au. Available at: https://www.arc.gov.au/policies-strategies/strategy/arc-
research-integrity-and-research-misconduct-policy [Accessed 22 Sep. 2019].