Clinical Trial Misconduct

Running head: CLINICAL TRIAL MISCONDUCT
CLINICAL TRIAL MISCONDUCT
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CLINICAL TRIAL MISCONDUCT
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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