Some common mistakes in the ethical considerations of research projects

Clinical research, that is, research conducted with human beings, is a product of the 20 th century.In the first half of that century, humanity learned that there must be an appropriate design, with a rigorous methodology, developing statistical tests and, later, qualitative methods.In the second half of the century, it was learned that it is not enough for a research protocol to be impeccable from a theoretical and methodological standpoint: it must also meet ethical requirements.In the second half of the century, it became clear that a research protocol must not only be flawless from a theoretical and methodological perspective but must also adhere to ethical standards.Those who conduct research with human beings are usually very clear about the scientific quality of the research protocol.However, the regulatory aspect is often less known and, therefore, less understood.Hence, the most common mistake is probably confusing the ethical and legal regulatory systems.When this happens, which is quite frequently, legal documents are consulted to meet enforceable requirements, but not to act ethically.It ends up being more of an administrative act than an ethical one.In the Mexican context, it is common to consult the Regulations of the General Health Law on Health Research (RLGSMIS, particularly title two, and especially Articles 17, which addresses research risks, and Articles 20, 21, and 22, which address Informed Consent); since it is quite an old document, there are many aspects that are considered different from the ethical standpoint.