Ethics in Life Sciences and Research

Abstract

Ethics of clinical research deals with norms and values defining what ought and ought not to be done in the context of clinical trials to protect the rights, safety, and well-being of the study participants. As a result of past unethical approaches, protection for human subjects has been strictly regulated, introducing three fundamental ethical principles: respect for person, beneficence and non-maleficence, and justice. Many believe that informed consent is the sufficient and necessary step point to make clinical research ethical. However, to be ethical a clinical research must satisfy seven specific requirements underpinning the three general principles (social or scientific value, scientific validity, fair subject selection, favorable risk/benefit ratio, independent review, informed consent, and respect for enrolled participants). In this regard, RECs/IRBs have been established to protect patients’ dignity and well-being while promoting the potential benefit of ethical research, even if presenting with large variation in practice across different countries. In the clinical research setting, the primary ethical dilemma is that only those individuals enrolled in a clinical trial are asked to face burden or risk as research subjects to benefit others and society with a range of unique ethical problems featuring the design and conduction of RCTs. Dealing with individuals who serve as human subjects, the chance of exploitation must be minimized, and the respect must be pursued in accordance with ethical principles and the rigorous methodology of clinical research. This chapter aims to highlight ethical principles, concerns, and considerations surrounding the clinical research setting while discussing the legislative and organizational role of research committees.