Are trials regulated in any way?
Clinical trials are highly regulated by national or international authorities because the experiments are done in humans. The main goal of this regulation is to protect people participating in clinical trials, to ensure that patients are informed of the possible risks and benefits of participating, and also to make sure that a relevant conclusion can be drawn at the end of the clinical trial to avoid that a study has to be repeated. An institutional review board, sometimes called ethical committee, will check if everything is in order to ensure patients’ safety and confidentiality. They will check if the information provided to participants is complete and understandable. Depending on the national laws, such a board includes scientists, doctors, lay-persons and a clergy member.
