Human Subjects in Clinical Trials: Ethical Considerations and Concerns
Performing a medical examination is a time and resource-intensive course. Critically,
participant identification and maintenance are vital to lowering the cost and amount of time spent
on clinical research. Conducting quality research plays a significant role in assessing the clinical
and cost-effectiveness of healthcare systems and processes, while subject recruitment of
adequate participants is a pillar for an efficient research process to test hypotheses with awash
with confidence and non-discriminatorily. Various guidelines, such as the Good Clinical Practice
(GCP) have been proposed to guarantee that medical research is steered scientifically and
ethically. These regulations seek to protect the integrity, rights, and confidentiality of participant
human subjects (W & Al-Sayed, 2018). With a history of horrific and unethical research, for
instance, the German clinician's trials at Nazi war cantonment during World War II, scientific
research units have championed compliance to the ethical principles approved globally. In this
regard, numerous committees and organizations have adopted different stipulations and
documents that advocate for compliance with ethical principles, evidence-based research,
benefits to outweigh risks, and a concise description of the appropriate protocol. Besides,
obtaining informed consent from subjects or their guardians and affirming confidentiality are
vital components of scientific human subject research. Moreover, proper and accurate data
documentation is vital for the credibility of a study. The accessibility and availability of research
findings are vital to determining the suitability and eligibility of research. Adhering to the GCP
stipulations is vital for actualizing scientifically and ethically apt research (World Health
Organization, 2020). Nonetheless, there is a need for further research to model the existing
guidelines to enhance the recruitment process and protection of human subjects in clinical trials.
HUMAN SUBJECTS IN CLINICAL TRIALS 3
References
W, A., & Al-Sayed, M. (2018). Human subjects in clinical trials: Ethical considerations and
concerns. Journal of Translational Science, 4(6). doi:10.15761/jts.1000239
World Health Organization. (2020). Ethical standards and procedures for research with human
beings. Retrieved from https://www.who.int/teams/health-ethics-
governance/governance/research