How are the rights and welfare of a study participant protected?
Clinical research studies are conducted by qualified medical staff and physicians. Additionally, various worldwide agencies have regulations to protect clinical research participants and standards for how studies are conducted. For example, an independent review board / ethics council (IRB / IEC) reviews each study protocol and associated materials. This review is conducted to make sure the study is scientifically and ethically sound. The IRB / IEC oversees the processes that the clinic uses for informing you about clinical research studies, including why the study is being done, what will happen during the study, risks involved and previous study results that may impact an individual’s willingness to participate.