Clinical trials are essential for the development of new treatments, as well as ways to
detect and prevent disease. After multiple events of human rights violations, the need
for guidelines to control clinical research was prominent and consequently, the Good
Clinical Practice (GCP) procedures were shaped. Nevertheless, there have been
numerous instances of research misconduct, which is the mistreatment of research
subjects or conscious manipulation of scientific data.
Three cases that represent different types of research misconduct are examined in the
present thesis. The aim of the study is to analyze these types of misconduct and make
suggestions to efficiently detect and prevent them. The first case shows how
Institutions can deviate from GCP in order to maintain their reputation. The second
case highlights the hidden danger of mistakes or misconduct that can arise in urgent
situations that require scientific results to be published quickly. Finally, the third case
analyzes the promotion of experimental treatments as safe, thus misleading patients
and their caregivers for personal profit and fame.
The suggestions following the above analysis are presented in this thesis and begin
with highlighting the importance of the monitor’s training, resourcefulness and
responsible conduct of on-site or remote visits. Furthermore, physicians should be
adequately trained and tested in GCP, Bioethics and Biolaw before obtaining their
degrees or medical licenses. The Ethics Committees also play a crucial role and their
members should strictly adhere to applicable regulations, independently of potential
external factors that may try to convince them otherwise. On a national level, ethics or
regulatory bodies should frequently perform audits and inspections to detect potential
misconduct in different stages. Finally and if all else fails, harsher sanctions including
the threat of imprisonment should be considered in an effort to discourage even the
most determined individuals.
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