By: Adriana Pérez, Ruth Olivares y Olga Torres
On November 2, 2021, the Ministry of Public Health and Social Assistance published on its website the REGULATION OF CLINICAL TESTS IN HUMANS, which was approved by Ministerial Agreement 206-2021, entering into force on October 30, 2021.
The purpose of this regulation is to establish the requirements for the development of clinical trials on human beings in the country and the basic ethical principles, these being respected for persons, beneficence, and justice. Its importance is in the fact that it modifies and qualifies several aspects already contemplated in previous regulations and establishes others, always taking into account that each clinical trial to be carried out with human beings must obtain authorization from the Research Ethics Committee and the Department of Regulation and Control of Pharmaceutical and Related Products.
The standard states that trials must adhere to the ethical tenets contained in the Declaration of Helsinki, as revised in 2016, the Belmont Report, and the internationally accepted Standards of Good Clinical Practice.
This standard incorporates and standardizes aspects of testing such as:
- Protection and consent of participating subjects
- Criteria for authorization by Research Ethics Committees
- Clinical trial requirements
- Ethics for pharmacogenetics studies
- Amendments, dossiers, progress report requirements, publication of clinical trials
- Site, products, surveillance and safety
Failure to comply with the regulations will result in the cancellation of the test without prejudice to any civil or administrative actions that may be applicable.