Brasília – The National Health Council (CNS) has issued Recommendation No. 15/2025 calling for greater parity and expanded social oversight in the regulatory framework governing research involving human subjects, including clinical trials. The position was approved during the council’s 372nd ordinary meeting and seeks to influence amendments to Decree No. 12.651/2025, which regulates Law No. 14.874/2024 and establishes the National System of Research Ethics with Human Beings (INAEP).

According to the council, the proposed composition of INAEP creates an imbalance by allocating a majority of seats to government and research institutions while limiting representation from social control within the Brazilian Public Health System (SUS). The CNS argues that insufficient participation from civil society increases the risk of conflicts of interest and may weaken protections for participants in clinical research.

Source: CNS