General
publicado em 10/12/2012 às 18h00:00
   Dê o seu voto:

Under pressure, CNS must approve changes in clinical trials with humans

Regulations can be approved on Tuesday. Is expected to act as council for final approval of the document

 
font size
A-
A+

Some pieces of information on this page may have been automatically translated. Makernews is not responsible for the irregularities resulting from these translations. When in doubt,      consult the original text.



The National Commission on Research Ethics (CONEP) provides that the National Health Council (CNS), both linked to the Ministry of Health approves, on Tuesday (11), new legislation regulating clinical research in human volunteers in Brazil.

The final document, which contains the consolidated proposals for the improvement of Resolution 196/1996, is on the agenda of the last meeting of the year of collegiate CNS.

The expectation of the coordinator of Conep, Gisele Saddi Tannous, is that the National Board of Health acts as the approval of the final document. "From there, the new version of the 196 goes to publication," said Gisele the Journal of Science. This prediction is supported by the executive secretary of Conep, Eline Jonas. "The expectation is that we ended the year with the approved Resolution 196," he predicted. "Efforts are for this."

If the prediction is confirmed approval of the document tomorrow, Gisele believes the reform legislation of clinical research with human beings volunteers will be published in January 2013 in the Official Gazette. Before that, the final version will pass the scrutiny of Legal Counsel (Conjur) of the Ministry of Health

<b> pressure from the scientific community </ b>

The initiative is a positive reaction to pressure from the scientific community who pleads agility in the approval of the 196 modifications and scientific development in the country. On Monday (3), the Brazilian Society for the Progress of Science (SBPC), the Brazilian Academy of Sciences (ABC) and the National Academy of Medicine (ANM) sent a letter to Health Minister Alexandre Padilha, asking agility the approval of new standards of clinical research with humans.

To the presidents of SBPC, Helena Nader, ABC, Jacob Palis, and the ANM, Marcos Moraes, approval of changes by CNS is a pressing need to modernize and allow greater efficiency and competitiveness of national science. "In the current language, the Resolution 196 implies enormous damage to our scientific and technological development, including clinical trials unfeasible phase 1 and 2 in our country," said the letter signed by three.

<b> News </ b>

Among the major changes of the new 196 set, according to Gisele, a standard operating to improve the conduct of research projects with human volunteers. The norm, for example, will establish the monitoring system of analysis of clinical studies and ensure the shortening of the process of analysis - a key demand of scientists.

The proposal, according to Gisele, to provide "accreditation" (a kind of certification) for Research Ethics Committees (ECs) to avoid duplication of analysis in research protocols, should shorten the process by which more than 100 days in the final opinion projects. The publication of the operational guideline is parallel to Resolution 196 and the process of "accreditation" should be completed in 2013, Gisele. "The CEP to provide satisfactory performance in the analysis will only shorten at least 180 days in the process of analyzing research projects," estimates.

According to Gisele, the objective of the operational guideline is to make "logic" Resolution 196 giving versatility to the system of research analysis. According to her, the operational rule represents a "breakthrough" in the qualification of EPCs. "Today we have around 640 ethics committees that are quite heterogeneous with respect to their qualifications," he explained.

"The legislation in force seizes processes because it requires duplication of bureaucratic documents, considerably lengthening the final opinion of studies, for example, to the discovery of new medicines"

Yearning <b> scientists </ b>

As the doctor understands Rubens Belfort, member of the National Academy of Medicine, agility approval of changes in the 196 is necessary to unlock the research and development of technology in the country, both clinically and surgically.

According to Belfort, the legislation in force seizes processes because it requires duplication of bureaucratic documents, considerably lengthening the final opinion of studies, for example, to the discovery of new medicines. Moreover, such delays, the doctor said, prevents the creation of new patents. He recalls that the protocols of clinical research are the analysis of EPCs, the Conep and ANVISA, the process by which a lab arrives to wait two years, more or less, to obtain the approval of a project.

"When you get the approval of a clinical trial with human volunteers in Brazil has given up the lab conducting research in the country because Western Europe, USA and even Argentina already went ahead," laments Belfort. "We Brazilians lost the opportunity to do research and see the drug tested in Brazil." Nevertheless, he criticizes the fact that the drug results from a research approved in another country, be approved later to be sold in Brazil.

With the amendment of Resolution 196, Belfort believes that Brazil may hold the world "a progressively greater space" to develop new products for health, both medical and surgical. Thus, producing innovative technologies and attract new technologies to be incorporated into our industries. "Today, Brazilian legislation hinders both the national and the international industry," he said. "The damage, however, is the largest national because the international has more breath: can swap Brazil for Argentina or South America to the Middle East. Brazilian industry generally has no leg to leave Brazil."

Across <b> </ b>

Betting also the approval of the 196 changes tomorrow, the executive secretary of Conep, Eline Jonas acknowledged the delay in analysis of research protocols in Brazil. "It is better to sin and listen to science than do the reform hastily," he said.

She said, however, that the improvement of this process also involves changing the position of the researchers themselves. "If you lack in design document that was filed and the document to be accessed this delay will delay the final report of the research," he explained. "This is a two-way effort."

Demonstrating optimism with the changes of the 196, Eline believes, however, that changes in legislation - such as the contemplation of the areas of humanities, service improvement and advancement of EPCs in the conduct of research projects - should meet the needs of the community scientific.

The sources of Conep insisted that changes to the current legislation of clinical research with humans is the result of a public consultation a year ago with a Brazilian company that made suggestions and contributions to the improvement of existing legislation.

Source: SBPC
  • Share this pageShare this page
  • Share this pageCorrect
  • ShareShare
  • AlertAlert
Reduced link: 
  • You are recommending this story: Under pressure, CNS must approve changes in clinical trials with humans
  • Fill in the following form to send your recommendation to your friend:

  • You are suggesting a correction for this story: Under pressure, CNS must approve changes in clinical trials with humans


Receba notícias do iSaúde no seu e-mail de acordo com os assuntos de seu interesse.
Seu nome:
Seu email:
Desejo receber um alerta com estes assuntos:
Clinical research    Resolution 196    Academy of Sciences    ABC    National Academy of Medicine    ANM    Brazilian Society for the Advancement of Science    SBPC   
Comments:
Comment
Leave your comment
Close
(Required fields are marked with an *)

(Your email address will never be published or shared.)

Enter the letters and numbers below and click in the button "send"

  • Twitter iSaúde
advertising
Informe Saúde printed version

Recommend the portal
Close [X]
  • You are recommending this story: http://www.isaude.net
  • Fill in the following form to send your recommendation to your friend:

RSS news from the portal  iSaúde.net
Get the newsletter of the portal  iSaúde.net
Recommend the portal iSaúde.net
News from  iSaúde.net in your blog or website.
Get news on the subject of your interest.
© 2000-2011 www.isaude.net Todos os direitos reservados.