Science and Technology
publicado em 15/06/2013 às 09h53:00
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Brazil has new rules for human research

Resolution of CNS defines the rights of volunteers and opens the possibility of financial reward, with a deadline for ethical review

 
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Resolution published this week by the National Health Council (CNS) defines, for the first time, the rights of volunteers and opens the possibility for financial reward participants, currently prohibited in Brazil.

The resolution reinforces the privacy of information of the volunteers, the mandatory reimbursement of expenses, such as transportation and food, and the possibility of abandoning research when you want. Are also provided in case of side effects, compensation and health care during and after the search. Information about the research must be passed in an accessible and appropriate to culture, age and socioeconomic status of the participant.

Regarding the suspension of the prohibition of payment of financial reward to volunteers, the measure covers research Phase 1, when drugs are tested on a small group of healthy people, and bioequivalence studies, which facilitate the registration of new generic.

"The intention is to broaden participants' safety and accelerate the development of health technologies in the public interest",
To expedite the review of the studies, the regulation sets a maximum period of 60 days to the ethical evaluation of projects and 20 days for review, if the researcher has to make changes in the original design. Clinical research strategies for the Unified Health System (SUS) will have priority. The new rules give garantiras both the researchers and the participants volunteers. Now, with clear principles and criteria, we will have more transparency, security and agility scientific activities of this kind, says Secretary of Science, Technology and Strategic Inputs of the Ministry of Health, Carlos Gadelha.

According to the chairman of the National Health Council (CNS), Maria do Socorro de Souza, the resolution follows the principles of Research Ethics Committees (SPC) and the National Commission for Ethics in Research (Conep) and emphasizes the rights of participants research. The intention is to broaden participants' safety and accelerate the development of health technologies in the public interest, he says.

Another breakthrough that brings the resolution is the establishment of risk classification to different research methodologies. Thus, less invasive studies have faster analysis. It would not be fair to refer to the same criteria of analysis, studies involving only questionnaires to others who volunteer receives medicines, says Secretary Gadelha.

With information the Ministry of Health

Source: Isaude.net
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