ABSTRACT

This chapter focuses on how biomedical research has come to be regulated, in response to the major scandals revealed after the Second World War. Since fully informed and free consent is often very difficult to ensure in research, there is a strong responsibility on ethics committee to assess fully the balance of risks and benefits in every research protocol. Another area of ethical dilemma in research arises when information is discovered that was not part of the research aim, and when this 'incidental finding' could have great relevance to some of the research participants. A clinical trial involves the use of patients as research subjects and normally employs the classic research method known as the randomized clinical trial (RCT). Another very contentious area in biomedical research is the use of animals to determine the safety and effectiveness of products before trials are begun on human subjects.