10/29/2025 | Faculty of Medicine UFMG

https://www.medicina.ufmg.br/brasil-moderniza-pesquisa-clinica-e-amplia-oportunidades-para-universidades-e-pesquisadores/ 

The Secretary of Science, Technology, Innovation and the Economic-Industrial Complex of Health of the Ministry of Health, Fernanda De Negri, explains what changes in the country after the regulation of the Human Research Law.

The Federal Government regulated the Human Research Law (No. 14.874/2024) at the beginning of this month. According to the Ministry of Health, the new legal framework would guarantee legal certainty, expand the protection of participants, and encourage the production of knowledge and the development of new technologies.

The measure could triple investments in Brazil, valuing the work of universities and the more than 900 Research Ethics Committees (CEPs), fundamental to ensuring the ethical integrity and transparency of studies. Between 2023 and 2024, the country registered 254 clinical studies and invested more than R$ 1.8 billion in strategic areas of health, such as vaccines, precision medicine, and oncology. With the new regulation, the Ministry expects to double this number.

To understand the impacts of the law and the perspectives for the science and technology system in health, the Ministry of Health interviewed the Secretary of Science, Technology, Innovation and the Economic-Industrial Complex of Health of the Ministry of Health, Fernanda De Negri:

Secretary, we know that there was a study of other research ethics standards used in other countries to inspire Brazilian legislation. What does this law represent for the future of science and innovation in health in Brazil?

It represents a historic step. Following the Covid-19 pandemic, countries such as China, the United Kingdom, members of the European Union, India, Canada, and the United States re-evaluated their regulatory frameworks for clinical research, seeking to increase competitiveness, stimulate innovation, and facilitate access to new technologies.

Brazil is among the top 20 countries in the global ranking of clinical studies, but participates in less than 2% of worldwide clinical research. We have the potential to be among the 10 most relevant countries in the world in this area, and the expectation is that the new legislation will boost this growth.

Now, our country has a modern legal framework that converges with international standards, reinforcing the protection of participants, scientific autonomy, and legal certainty for the development of new therapies and medicines.

This means better conditions to attract clinical studies, train researchers, expand knowledge production, and reduce dependence on foreign technologies. Ultimately, it is a law that places Brazil among the countries with the most robust and participatory ethical systems in the world.

Many life-saving innovations, such as medicines, vaccines, and therapies, reach the population after undergoing clinical research. How does the regulation of this law contribute to access for those who need it?

With research conducted here, and direct monitoring by Anvisa (Brazilian Health Regulatory Agency), product registration can be faster, and therefore treatments will reach Brazilians sooner. This legislation benefits, for example, patients with cancer, rare diseases, and neurological diseases, who often waited for studies conducted outside the country to access new medications.

It clearly establishes responsibilities, rights, and duties for all involved actors, institutions, and research participants. With this, Brazil now has a more modern, predictable system aligned with international best practices.

What are the main changes brought about by the Law?

The new law consolidates principles established by the CEP/Conep system (Brazilian National Ethics Committee), such as respect for human life and ethical integrity in scientific research, in addition to establishing faster deadlines for the analysis of projects, both in the Ethics Committees and in the National Health Surveillance Agency (Anvisa). The State, through the National Ethics in Research Authority (Inaep), will now be responsible for regulating the ethical review of research in Brazil, a function previously performed by the National Health Council (CNS) and the National Ethics in Research Commission (Conep).

Coordinated by the Secretariat of Science, Technology and Innovation and the Economic-Industrial Health Complex (Sectics), Inaep will issue regulations on research ethics, accredit and support Research Ethics Committees, and act as an appeals body in the review of projects.

The composition will be pluralistic, with strong participation from the National Health Council (CNS), the scientific community, selected through a public call for proposals, where experience in Ethics Committees will be valued. Representatives from the Ministries of Health, Education, Science, Technology and Innovation, Anvisa, and the Confederation of Research Support Foundations (Confap) will also participate. Research participants may also be part of the Instance.

This diversity and the institutional strengthening of research ethics make the Brazilian system more modern and transparent.

You mentioned faster deadlines for project analysis. What are the new project evaluation deadlines?

Yes. In practice, these changes represent greater access to new medicines, vaccines, and other health treatments for our population, in addition to attracting investments to Brazil.

The new model reduces the project evaluation process by the Research Ethics Committees (CEPs) from 180 to 30 days. The evaluation by the National Health Surveillance Agency (Anvisa) will be up to 90 business days. Strategic research for the SUS (Brazilian Unified Health System) and cases of health emergencies will be evaluated in up to 15 business days.

In addition to the 30-day deadline, what changes for the functioning of the Research Ethics Committees?

The CEPs are the heart of research ethics in Brazil, and this regulation recognizes the work that the teams have been doing for decades, guaranteeing more support and institutional stability. These Committees remain fundamental and are integrated into the National Research Ethics System, acting autonomously and responsibly, following the norms and guidelines established by INAEP and the legislation, including with regard to meeting the 30-day deadline for analyses.

The more than 900 Brazilian CEPs will be more qualified, with the monitoring and support of INAEP, which acts in a consultative, normative, and supervisory capacity. From an analysis point of view, INAEP will only act as an appeals body, eliminating the need for double evaluation in other cases. The Research Ethics Committees (RECs) will be classified as accredited and certified. Certified RECs will be authorized to conduct ethical evaluations of low and medium-risk studies. Accredited RECs will be authorized to analyze high-risk research.

In the composition of the positions at INAEP, public selection processes will prioritize prior experience in Research Ethics Committees, recognizing the trajectory and contribution of these professionals to strengthening the national ethical system.

We know that research participants will now have the continuity of treatment guaranteed by law for up to five years after the end of the research. This is the result of an action by the National Congress, which overturned President Lula's veto. What about the rights of research participants?

Following guidelines already established by the National Health Council (CNS) and the National Research Ethics Commission (Conep), the protection of participants is reinforced.

In cases of serious diseases with no therapeutic alternatives, patients who show proven benefit will have the continuity of treatment guaranteed for up to five years after the end of the research, according to a plan approved by the REC.

The provision of the medication may be terminated in situations such as the participant's decision, cure, emergence of a therapeutic alternative, lack of benefit, or occurrence of a serious adverse reaction.

The legislation also defines specific rules for research with vulnerable groups, such as children, pregnant women, indigenous peoples, and people deprived of liberty, ensuring differentiated ethical treatment, additional safeguards, and greater safety.

There was also a clear definition of the responsibilities of researchers, sponsors, and institutions, strengthening the ethical and legal commitment to the integrity of the participants. The sponsor is responsible for compensating for any damages resulting from the research.

Participation in studies is conditional on the express authorization of the volunteer, or their legal representative, through the Informed Consent Form (ICF), written in simple and accessible language.

The document must be resubmitted to the Research Ethics Committees (RECs) whenever there is new information that may alter the decision to participate. The participant can withdraw their consent at any time, without needing to provide a reason.

Brazil has a population of 214 million people and great genetic and cultural diversity. What is the country's role in the global clinical research landscape, and what has the Ministry of Health been doing to strengthen this role?

Our country has unique conditions to attract investments, generate qualified jobs, and strengthen science and national sovereignty. By encouraging research with Brazilian participants, we ensure that medicines and treatments are developed in a way that is more appropriate to the profile of our population and the needs of the SUS (Brazilian Unified Health System).

In this sense, the Ministry of Health has been working to improve the regulatory environment, strengthen research ethics, and increase direct investment in this field. Between 2023 and 2024, more than R$ 1.8 billion was allocated to studies in vaccines, precision medicine, oncology, and other strategic areas of health.

We have also adopted measures to expand national research, such as public calls for proposals, a transparent method for contracting studies. In 2024, R$ 263.8 million was invested in 336 scientific projects involving various higher education institutions.

The Ministry of Health has also increased annual investments to approximately R$ 500 million, in addition to investing R$ 643 million in new technological platforms, such as Messenger RNA and cell therapy, aimed at the development of biopharmaceuticals, biologics, intelligent medicine, and digital health, strengthening the Health Economic-Industrial Complex and expanding the country's scientific and productive autonomy.