{"id":538511,"date":"2025-01-14T14:17:44","date_gmt":"2025-01-14T17:17:44","guid":{"rendered":"https:\/\/revistapesquisa.fapesp.br\/?p=538511"},"modified":"2025-01-14T14:17:44","modified_gmt":"2025-01-14T17:17:44","slug":"new-rules-for-research-involving-human-beings","status":"publish","type":"post","link":"https:\/\/revistapesquisa.fapesp.br\/en\/new-rules-for-research-involving-human-beings\/","title":{"rendered":"New rules for research involving human beings"},"content":{"rendered":"

At the end of August, new legislation will come into force regulating scientific studies involving human beings in Brazil. The federal law, which was passed by the government on May 28, seeks to speed up the approval of research proposals, including clinical trials of new drugs and treatments. Brazil\u2019s Ministry of Health is still working on the regulatory framework that will be implemented. The new law promises to decentralize and accelerate the analysis of research proposals, which will be carried out in one single process, with research ethics committees (RECs) at hospitals and universities given more autonomy than they have today. At the same time, existing mechanisms that allow for societal participation in reviewing proposals may be reduced.<\/p>\n

The law, which covers all fields of knowledge, establishes a nationwide ethics system for research involving humans, made up of ethics committees based at research institutions and a national body, which will be overseen by the Ministry of Health. The current system\u2019s composition is almost identical, but with different responsibilities. Today, in addition to being reviewed by RECs, all proposals considered high risk, such as projects involving human genetics or new drugs, or that are coordinated or sponsored from abroad, must also be evaluated and approved at a federal level by the National Research Ethics Commission (CONEP), run by the National Health Council (CNS). Under the new rules, these proposals will only need to be reviewed by accredited RECs. The new national body will evaluate any appeals against REC decisions and will be responsible for training, accrediting, and supervising RECs.<\/p>\n

Deadlines similar to those already stipulated by recent CNS resolutions will continue to apply \u2014 30 working days for ethical analysis of a study after approval of the documentation by an REC, and 90 days for the Brazilian Health Regulatory Agency (ANVISA) to authorize the import of any drugs needed through a parallel review of the substances to be used in the research. The whole process should be shorter thanks to the removal of the CONEP assessment stage, which currently adds another 60 days. \u201cThe RECs will have more autonomy in this new framework. This is important because they are an integral part of the culture of their institution \u2014 they really understand the hospital or academic environment,\u201d says pharmacist and biochemist Fernando de Rezende Francisco, executive director of the Brazilian Association of Clinical Research Organizations (ABRACRO).<\/p>\n

Dr. Paulo Hoff of the S\u00e3o Paulo State Cancer Institute (ICESP) and Rede D’Or S\u00e3o Luiz in S\u00e3o Paulo says the two levels of approval led to unnecessary delays. \u201cThere have been improvements in recent years, led by CONEP. But the process could be more efficient,\u201d says Hoff, who spoke before the committees analyzing the bill in National Congress due to his role as a research scientist and member of the Brazilian Society of Clinical Oncology (SBOC). According to the Industry Association for Pharmaceutical Clinical Research (INTERFARMA), it took an average of 215 days for a clinical trial to be approved in Brazil in 2018, while the average times taken in Argentina and the USA were 113 days and 32 days respectively. \u201cWe are the eighth biggest pharmaceutical market in the world, but we are 20th<\/sup> when it comes to those that initiate the most clinical research. We have great potential to grow,\u201d says Renato Porto, executive president of INTERFARMA.<\/p>\n

The current system, known as CEP\/CONEP, was created in 1996 and is run by the CNS, an independent body linked to the Ministry of Health, with many representatives of civil society involved.<\/p>\n

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L\u00e9o Ramos Chaves\u2009\/\u2009Revista Pesquisa FAPESP | Eduardo Cesar\u2009\/\u2009Revista Pesquisa FAPESP<\/span>Projects considered high risk, such as those involving new medicines, will be analyzed by accredited RECs onlyL\u00e9o Ramos Chaves\u2009\/\u2009Revista Pesquisa FAPESP | Eduardo Cesar\u2009\/\u2009Revista Pesquisa FAPESP<\/span><\/p><\/div>\n

The new law will establish a new national body that will perform the role currently fulfilled by CONEP, managed by the Ministry of Health\u2019s department of science and technology, with no involvement of the CNS. This potential change, which would reduce societal control over the system, has been the subject of questions and criticism. \u201cIn our opinion, this part of the new law is a big mistake,\u201d says La\u00eds Bonilha, a professor at the Federal University of Mato Grosso do Sul (UFMS) and current head of CONEP. \u201cThis is not the best approach for this process, the primary function of which is to protect the interests of research participants. By moving away from societal control and into areas with conflicting interests, there is a greater chance that conflicts of interest will arise,\u201d she adds.<\/p>\n

She believes the new body, which is yet to be fully defined, should be CONEP itself. \u201cWe propose that the CNS should retain this responsibility. In our interpretation of the law, this would be possible,\u201d emphasizes Bonilha.<\/p>\n

Bioethics specialist Ronildo Alves dos Santos, head of the Ribeir\u00e3o Preto School of Nursing\u2019s REC at the University of S\u00e3o Paulo, says the new law has both benefits and drawbacks. \u201cWe finally have legislation that deals with ethics in research involving humans in Brazil,\u201d he states. \u201cThe great loss is the lack of participation by society as a result of the removal of the CNS from the system,\u201d he notes. Another negative point, according to Santos, is the number of \u201cresearch participants\u201d \u2014 representatives of volunteers who take part in clinical trials \u2014 required to sit on ethics committees. \u201cCurrently, CONEP requires at least two per committee, but the new law will reduce this number to just one,\u201d he says.<\/p>\n

The final bill was subject to two presidential partial vetoes, and it could still be overturned by Brazil\u2019s National Congress. The first change was to remove a requirement that the public prosecutor be informed whenever Indigenous people participate in clinical trials, after it was argued that the rule makes it difficult for Indigenous people to take part in trials. The second veto related to post-trial medication and treatment provided to patients when a study is suspended or completed. The bill originally stated that participants would receive treatment at the expense of the trial funder for five years after the study. After this period, if the product is on the market, it would be provided by a private health insurance plan or Brazil\u2019s public health system (SUS). \u201cNo patient would be left without treatment,\u201d says ABRACRO\u2019s Rezende. After the line-item veto, the current rule of providing treatment indefinitely will be maintained. \u201cPeople who participate in clinical research have the right to access their benefits for as long as they need them. There are cases where people have rare diseases and often only survive thanks to these treatments,\u201d points out Bonilha.<\/p>\n

When sought for comment by Pesquisa FAPESP<\/em>, the Ministry of Health stated that the regulations to be established when the new law is passed are still under development. \u201cFor now, until the law comes into force, the CEP\/CONEP system continues to function as normal,\u201d adds Bonilha.<\/p>\n","protected":false},"excerpt":{"rendered":"New law set to come into force at the end of August will allow trials to be approved by a single body","protected":false},"author":684,"featured_media":538512,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[166],"tags":[247,232,260],"coauthors":[2721],"class_list":["post-538511","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policies-st-en","tag-medicine","tag-pharmacology","tag-public-health"],"acf":[],"_links":{"self":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/538511","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/users\/684"}],"replies":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/comments?post=538511"}],"version-history":[{"count":3,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/538511\/revisions"}],"predecessor-version":[{"id":540723,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/posts\/538511\/revisions\/540723"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media\/538512"}],"wp:attachment":[{"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/media?parent=538511"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/categories?post=538511"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/tags?post=538511"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/revistapesquisa.fapesp.br\/en\/wp-json\/wp\/v2\/coauthors?post=538511"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}