Abstract:

This paper examined the ethics of Clinical Research and the protection of potential and enrolled human subjects. Clinical research is a lengthy and costly process. Subject recruitment and retention are an essential step to help lowering the cost and the length of clinical trials. Good quality research is crucial for determining the clinical and cost effectiveness of health care systems, at the same time recruitment of sufficient participants is a cornerstone for good quality research that tests hypotheses with confidence and minimizes bias. In this paper, I had the opportunity to highlight some ethical concerns and considerations that are related to recruiting human subjects in clinical research. The purpose of ethical guidelines is both to protect patient volunteers and to preserve the integrity of the science. This report serves as guidance for biomedical and behavioural researchers to find a summary of the basic ethical principles to protect human subjects basically: beneficence, justice, and respect for individuals.

The existing literature on the subject was reviewed all along to contextualize the study. I have used observation during the field trips and hands on knowledge of recruiting human subjects carried in my job. The process of informed consent is crucial in achieving these principles. In order to protect human subjects, the informed consent process involves the verbal discussion with the possible subject along with the paper document. Finding revealed that by placing some people at risk of harm for the good of others; clinical research has the potential to exploit patient volunteers. Undue inducement could be eliminated by careful assessment of risks, paying attention to eligibility criteria, collecting an informed and voluntary consent of research subjects. We should continually strive to bring in interactive learning opportunities for clinical researchers, ethics committee members, scientists, biomedical researchers and all other personnel involved in clinical development and translational research.

Keywords: Clinical Research, Good Clinical Practices, Ethics, Informed Consent, Potential Subjects Protection.

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