Who regulates clinical trials?


In order to obtain an approval for a clinical trial, a company has to submit to national Health Authorities a so-called "study protocol" in which all the details of the study are described. This protocol is reviewed by an Ethics Committee, whose role it is to carry out research in the respect of dignity, rights, safety and well-being of the people who take part in medical research and also by the the Irish Medicines Board (IMB). If the IMB and the Ethics Committee have not approved a protocol, then the study cannot go ahead. Any change to the protocol must also be approved by the Ethics Committee. An Ethics Committee must have at least 5 members and is composed of health care professionals and investigators as well as members of the public. The World Medical Association has also developed the so-called "Declaration of Helsinki". This sets the ethical standards for research involving human beings, human material or identifiable data. Most investigators will state that their clinical trial protocol has been developed in line with these ethical principles. In addition to this, The Food and Drug Administration (FDA) in the USA, The European Medicines Agency as well as multiple legislative texts at European Union level have very specific rules laid out to protect patients involved in clinical trials.