The National Institute for Food and Drug Surveillance (Invima) indicated that on August 1 it carried out Inspection, Surveillance and Control (IVC) actions at the International Vaccine Center and/or Malaria Vaccine and Development Center (MVDC), finding that the Activities associated with clinical studies involving human beings are not approved by the regulatory entity.
“In accordance with the powers of Invima and according to current regulations, after the IVC work, a health security measure consisting of the ‘Total suspension of activities related to clinical research in humans’ was applied,” indicated Invima.
National Institute for Food and Drug Surveillance (Invima). | Photo: COLPRENSA ©
“During the inspection, clinical study documents were found that have not been evaluated or approved by this institute prior to its start and, consequently, the legal and technical requirements established by health regulations are not met; as well as clinical study documents that have not been evaluated or approved by Research Ethics Committees certified in Good Clinical Practices by this institute”.
Studies were found that do not have the express manifestation of voluntary participation by the subjects investigated and that can be verified by signing informed consents.
Among the findings, as reported by Invima, is the existence of information from publications in indexed journals with results of studies carried out on human beings that were not approved by Invima, and in which, in addition, the name of a committee is evidenced. for which no support was found for their participation in the evaluation and approval of said studies.
Invima found that in some studies, the main investigator is not a doctor. Similarly, some sub-researchers do not have a medical record in the Single Registry of Human Talent in Health. (Reference image).
The study participants were offered a payment of 250,000 pesos for their participation in the studies, an activity that goes against the postulates indicated in Resolution 8430 of 1993, which indicates that the participation of the subjects must be ( …) “of free choice and without any coercion” (…)
“It was evidenced in the design of these studies the existence of possible conflicts and practices that go against national and international ethical regulations, taking into account that healthy participants are premeditatedly exposed to a pathology under study, in order to subsequently measure the immunogenicity of the vaccine, without taking into account the control of the risks and the procedures established in the Good Clinical Practices for this type of interventions”.
It could be confirmed that for these studies there was not an adequate transfer of information to the respective ethics committees, which would allow adequate monitoring of safety and ethical aspects that are the responsibility of these research governing bodies.
“During the procedure, it was not possible to inspect 100% of the documentation requested by this institute, because the center officials who attended it argued that they were in the custody of the principal investigator, who was not available to attend the visit.” , assured the Invima.
The Invima will continue with the pertinent investigations according to its powers and will make the respective transfer to the investigative and/or control entities that may take place. (Reference image).
It is worth noting that the Institute will continue with the pertinent investigations according to its powers and will make the respective transfer to the investigative and/or control entities as appropriate.
“Our entity reiterates its commitment to public health and the safety of people who participate in clinical studies in the country, guaranteeing the development of research under ethical principles in which respect for human dignity and the protection of human rights must prevail. and well-being of the participants”, concluded the Invima.
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2023-08-06 12:42:33
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