Multicentre clinical trials: the value of collaboration
02/09/2024
10/07/2023
Biomedical research is essential for advancing scientific knowledge and improving the quality of life for society, but it must always ensure the protection of participants. Throughout history, numerous experiments were conducted on humans, some of which involved egregious atrocities committed in the name of science. This concern led to the development of various ethical codes and norms that are periodically updated and serve as guidelines for all researchers.
The first ethical code addressing research with human subjects was established after the Nuremberg trials, which judged the crimes and abuses against humanity committed during the German Third Reich. The Nuremberg Code of 1947 included the requirement of obtaining informed consent from study participants. In 1974, the U.S. National Research Act came into effect, referencing for the first time the concept of an institutional ethics committee as a protective mechanism for participants.
In 1964, the Declaration of Helsinki was published, encompassing the right to participant confidentiality, the protection of vulnerable individuals, the development of a written protocol outlining the study design and methods, the obligation to prioritize the interests of the subject above those of science and society, and the truthfulness in reporting results. Later, in 1979, the Belmont Report was published, establishing three fundamental principles of research: respect for persons (the principle of autonomy), beneficence, and justice.
The Ethics Committee of the Barraquer Ophthalmology Centre is an independent and multidisciplinary body that safeguards the rights, safety, and well-being of patients participating in research projects, ensuring compliance with current codes, norms, and laws.
Mònica Martí Orpinell, Technical Secretary of the Research Ethics Committee for Medicines.