Clinical trials in Venezuela require institutional ethics-committee approval (timing varies by study; we confirm it per protocol) on first-in-human and early-phase studies. The approval is part of the Spanish submission package INHRR (Instituto Nacional de Higiene “Rafael Rangel”) reviews: investigator brochure, informed consent, insurance, and ethics-committee approval. bioaccess® coordinates ethics review and the INHRR file as one timeline — not two queues.
Every clinical trial in Venezuela needs institutional ethics-committee approval before it starts. Institutional ethics review on first-in-human and early-phase studies runs alongside MPPS / INHRR work; timing varies by study, and we confirm it per protocol.