After almost 10 years of processing, Law No. 14,874/2024 was finally approved, establishing ethical and scientific requirements applicable to research involving human beings, as well as creating the National System of Ethics in Research involving Human Beings.
Based on regulations yet to be issued by the Head of the Federal Executive Branch, the National System of Ethics in Research involving Human Beings will be segmented into:
National Research Ethics Body, which will be responsible for, among others:
edit regulatory standards on research ethics;
accredit and accredit the CEP of each institution (Research Ethics Committee); and
act as an appeal court for decisions issued by each CEP; and
The Research Ethics Review Board, which will be represented by each CEP, will be a collegiate body linked to the institution conducting the research, whether public or private, with an interdisciplinary composition, composed of members from the medical, scientific, and non-scientific fields, with an advisory and deliberative capacity, which will act independently and autonomously to ensure the protection of the rights, safety, and well-being of research participants. It will be responsible for:
safeguard the well-being of research participants through the ethical analysis, review and approval of research protocols and their amendments;
analysis, review and approval of the methods and materials used during each research; and
document the free consent of the participants, as well as clarification of the terms and conditions of the research.
All clinical research involving human beings must follow the procedures established by law and in the regulations to be issued, which include the prior analysis to be carried out by the CEP and, on appeal, by the National Research Ethics Committee.
In general terms, the market already complies with many of the guidelines established by law to protect participants in clinical research involving human beings, but with some new features, such as social control through the participation of representatives of the research participants, for example.
It is important to highlight that the new legal framework must be applied to any and all research with human beings, which includes medicines, products, techniques and
procedures, medical devices and therapies.
Among the positive points is the definition of the sponsor’s duties and responsibilities, with a clear assignment to compensate and provide health care to the research participant for any damages suffered as a result of their participation in the research. The sponsor’s right of recourse against the researcher should be defined in the contract if the damages are caused by an error during the research.
The Protocol to be examined by the CEP must also clarify to the participant the continuity of supply after the completion of the study, as well as the possibility of interruption by the sponsor, in the cases provided for by law.
Finally, the law establishes that the health surveillance agency will have a period of 90 days to analyze requests for clinical trials, and that, if the agency remains silent, the trial may begin.
The new law will come into effect at the end of August 2024. By then, regulations are expected to define the details to be observed by the sector.
