On April 23, 2024, the Federal Senate approved the final consolidated text of Bill No. 6,007/23, which aims to establish a legal framework for research with human beings in Brazil, and establishes the National System of Ethics in Clinical Research with Human Beings.

After 7 years under discussion in the National Congress,  the text initiated in the Federal Senate was revised by the  Brazilian House of Representatives at the end of 2023, having been approved in this House in the form of a substitute (Bill No. 7.082/17).

Check below the main aspects involving the current regulation of clinical research in Brazil and the final text approved on an urgent basis.


In practical terms, Brazil already has a structured clinical research system that includes the National Health Council (CNS), the National Research Ethics Commission (Conep), and Institutional Review Boards – IRBs (Comitês de Ética em Pesquisa – CEPs) established in hospitals, research centers, and academic institutions.

Bill No. 6.007/23, however, intends to provide a legal foundation for applicable regulations and oversight of public and private institutions conducting research with human beings in Brazil.

According to the approved text, research with human beings includes the handling of their data, information or biological material, directly or indirectly. It can be divided into three categories:

  • Scientific, technological or innovation research – Study that interacts with human beings (individually or collectively), in a direct way, without the objective of registering the product under research.
  • Clinical research – A set of scientific procedures developed in a systematic manner with the aim of:

- evaluating the action, safety and efficacy of drugs, products, techniques, procedures, medical devices or health care for preventive, diagnostic, or therapeutic purposes;

- verifying the distribution of risk factors, diseases or conditions in the population;

- Assessing the effects of factors or states on health.

  • Clinical Trial – Its purpose is to discover or confirm the clinical, pharmacological, or any other pharmacodynamic effects of the investigational drug, to identify any reaction to the product, or to study its absorption, distribution, metabolism, and excretion, to analyze and verify the action, safety, and efficacy of the investigational

In these cases, research protocols will be subjcet to a prior ethical analysis, which form now on will be carried out in a single instance by Institutional Review Boards, putting an end to the double review carried out by Conep, which today still occurs in specific cases.

In addition, the text established a maximum period of 30 days for deliberation by the IRBs, except when it comes to research of strategic interest to the SUS, whose deadline for issuing an opinion will be 15 days.

Main changes in Bill No. 6.007/23the final text

The Federal Senate promoted about 60 amendments to the substitute text proposed by the House of Representatives, in its most of editorial nature.

The main modification concerns the financial responsibility of the research sponsors in Brazil.

The version approved by the House of Representatives provided that, in the case of research sponsored by governments, national or international government agencies, or non-profit institutions, the collaborating Brazilian institution could assume and exempt the responsibilities of one or more sponsors from the obligation to indemnify and provide health care for any damages caused. However, said provision was fully removed by the Senate.

Other highlights are:

  • Exclusion of the possibility of having Independent Institutional Review Boards;
  • Reestablishment of the National System of Ethics in Clinical Research with Human Beings (SNEPCSH), composed of a national ethics body (current CONEP) and a local ethics analysis body (IRBs);
  • The National Research Ethics Commission (current CONEP) will now integrate the Ministry of Health, having the competence to regulate, supervise, and carry out the ethical control of research;
  • The research with pregnant women will be mandatorily preceded by similar research with women outside the gestational period, except when the pregnancy or the unborn child is the fundamental object of the research;
  • Studies with biological materials of human origin should avoid discrimination and stigmatization of individuals, families, or groups, regardless of the benefits obtained from the research;
  • Exclusion of the possibility of having an IRB to waive the requirement of prior individual informed consent for future use of biological data and materials in case of new research of relevant social value or deemed unfeasible without waiver;
  • Clinical trials may be initiated within 90 days from the submission of the request for approval to Anvisa, regardless of the Agency's manifestation, provided that the ethical protocol has been approved;
  • Elimination of the "researcher/investigator-sponsor" player, under the justification that such a figure could lead, in practice, to the exemption of responsibilities on the part of the sponsor.

Criteria for Post-Study Provision

Access of the investigational drug post-study may be interrupted on the following situations:

  • decision of the research participant or legal representative;
  • cure of the disease or introduction of a satisfactory therapeutic alternative;
  • absence of benefit from the continued use of the investigational drug to the research participant, considering the risk-benefit ratio outside the context of the clinical trial or the emergence of new evidence of risks related to the safety profile of the investigational drug;
  • an adverse reaction that makes it impossible to continue the investigational drug;
  • impossibility of obtaining or manufacturing the investigational drug for technical or safety reasons - provided that the sponsor provides an equivalent or superior therapeutic alternative existing on the market;
  • after 5 years from the commercial availability of the investigational drug in Brazil; or
  • availability of the product in the SUS.

The text will be analyzed by the President of the Republic, who may sanction it with or without veto. Subsequently, complementary regulations on operational topics are expected to be published, such as:

  • availability of information about the research on a publicly accessible website;
  • definition of standard operating procedures and best practices;
  • rules for biobanks and biorepositories;
  • mandatory clauses for clinical research contracts;
  • definition of special groups;
  • procedures for suspension or termination of IRBs;
  • monitoring rules for research;
  • definition of information and procedures for ethical analysis by the IRBs;
  • creation of a national registry of volunteers in bioequivalence studies;
  • requirements for the design and implementation of a post-study supply program or continuation of the experimental treatment;
  • specificities of research in the humanities and social sciences;

The Life Sciences & Health practice  can provide more information on the topic.