The well-kept secret of Latin America that made headlines with its pioneer medical and recreative cannabis regulation, setting the basis for hundreds of millions of dollars in investments, is going a step further and has just revamped its clinical research regulation.
Decree 159 approved on June 3 seeks to make clinical research more attractive by defining clear approval paths and timelines and guarantees that all IRBs will be certified. What’s new:
1- introduces the concept of “multicentric trials that require a unified resolution” and includes here all multicentric international trials. The ruling exempts IRBs from issuing an opinion about the protocol, IRBs will only accept or reject the study on the basis of ethical aspects and will leave to the National Ethic Committee to comment on the protocol itself. This simplified path reduces evaluation time at the IRB and avoids having multiple reviews and comments on the protocol.
2- All IRBs will be accredited by the National Ethic Committee ensuring a national standard and criteria.
3- The Ministry of Health (MOH) will only have a surveillance role and protocols will only be submitted to the MOH for registration purposes. The MOH will only control that all formal aspects have been completed and all documentation provided.
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