Ethics and regulation of clinical research

Abstract

Clinical research is established by providing samples and/or data based on the patient's goodwill. So, researchers are responsible for not wasting their samples and data, and conducting research requires ethics, social significance, and scientific validity. Researchers are required to attend seminars. And, researchers must prepare a "research plan" prior to research and be examined by the ethics review committee. In order to obtain consent, it is a general rule to obtain sufficient explanation and free will consent from the patients. If it is impossible to obtain consent in a study that uses existing samples and information obtained in clinical practice or another study, it can be conducted by opt-out.