Ethics in Clinical Research

Dr. Humberto Reynales MD. MSc. PhD

Ethics are one and must be lived consistently, regardless of the place or time of the situation. In ethics there should be no gray tones: one is ethical or not. You cannot be ethical at times or when it is convenient or not convenient. You cannot be ethical at work and not be ethical at home or in the community. Ethical action should always be the guide in any situation that arises. The foregoing is valid in health research with human beings, be it basic, epidemiological, clinical, applied, social, etc.

The focus of these notes is to review existing tools to get research done ethically. It is not intended to describe the events known to many about the outrages and atrocities committed in WWII by the Nazis; as well as many others that have occurred in other countries and times, and that have generated declarations, reports and codes such as Helsinki, Nuremberg and Belmont. But even if there are rules, processes, laws, advice or recommendations, it can only be guaranteed that research in humans is ethical if each of those who participate in it decides to do it in the right way.

In clinical research, defining it as the process by which a new molecule, of chemical or biological synthesis, is evaluated for its efficacy and safety, indicated for the prevention or treatment of a disease, ethical aspects have great relevance, since The results of the studies will lead to important decisions being made regarding the approval or not of the use of the molecule under study in humans. And this is a critical point, where the lack of ethics can have serious and negative consequences, for example, if the results were biased by fraud.

In clinical research, it is important to consider the responsibility of the different actors such as: ethics committee, researcher, research team, sponsors, research subjects and the Government as a regulatory entity, represented in Colombia by the Ministry of Health and the Invima. These responsibilities are clearly defined in international regulations (ICH-GCP) as well as in the Colombian one (Decree 2378 of 2008 and Regulation 8430 of 1993, among others).