On April 6, 2026, Resolution No. 1/2026 of the Collegiate Body of the National Research Ethics Authority (INAEP) was published in the Official Gazette of the Union (DOU), establishing its provisional Internal Regulations. This is one of the matters provided for in the new legal framework for research involving human subjects (Law No. 14.874/2024 and Decree No. 12.651/2025) subject to regulation by the authority.

In addition, on April 2, 2026, Public Consultation No. 1/2026 was published, submitting to public participation the proposed Resolution setting forth the guidelines for the establishment of biobanks of human biological material and associated information, intended for scientific research, within the scope of the National Research Ethics System for Research Involving Human Subjects (SINEP).

The INAEP Internal Regulations


INAEP is the authority that succeeds the former National Research Ethics Commission (CONEP), with technical and decision-making independence, and its purpose is to protect the rights, integrity, and dignity of research participants, as well as to foster the development of scientific activities in compliance with ethical standards.

Among INAEP's competencies, the following stand out: (i) the development and issuance of rules on research ethics; (ii) the accreditation and certification of Research Ethics Committees (CEPs); (iii) the oversight and supervision of CEPs; and (iv) acting as an appellate body for decisions issued by such committees.

The Internal Regulations establish the governance structure of INAEP, which shall be coordinated by Meiruze Sousa Freitas, pursuant to Ministry of Health Ordinance No. 264/2026. The collegiate body constitutes a consultative and deliberative body, and its deliberations require an absolute-majority quorum, with a minimum of 17 sitting members. In the event of a tie in deliberations, the INAEP Coordinator shall cast the deciding vote.

The main deadlines established are as follows:

  • Review of matters: A review period shall be granted for the duration of one ordinary meeting or for a period of up to five (5) calendar days in the case of meetings held by electronic means;
  • Ratification of ad referendum decisions: An ad referendum decision shall be submitted for ratification at the first subsequent meeting or within a maximum of thirty (30) days, whichever occurs first;
  • Availability of minutes: Within up to ten (10) business days after approval;
  • Filing of appeals: An administrative appeal to INAEP, as the second and final instance, may be filed against the decision set forth in the CEP opinion within thirty (30) business days from the date of the decision;
  • Publication of appeal decisions: The final decision on the administrative appeal shall be published within up to thirty (30) business days from the submission of the appeal;
  • Reporting on matters and submission of proposals: The designated rapporteur shall have up to forty-five (45) business days to submit the proposal to the Collegiate Body. In appeal matters, the rapporteur shall indicate within up to two (2) business days whether he or she is qualified to serve;
  • Disclosure of agendas: The agenda for each public session shall be disclosed with a minimum advance notice of ten (10) business days.

It is worth highlighting the requirement that draft normative acts shall be submitted to a Public Consultation prior to the final deliberation by the Collegiate Body, except in specific cases of waiver, such as acts of an internal administrative nature, of a transitional character, or of low regulatory impact.

The Internal Regulations also set forth the procedure for administrative appeals, providing that appeals to INAEP, as the second and final instance, may be filed against decisions issued by CEPs.

The Internal Regulations are already in effect but are of a provisional nature and shall be reviewed and updated by the Collegiate Body within up to sixty days after the date of investiture of the members who are specialists in the field of ethics in research involving human subjects. The selection process for such members has already had Public Notice SCTIE/MS No. 1 published by the Secretariat of Science, Technology, and Innovation in Health on March 26, 2026.

Public Consultation on Biobanks of Human Biological Material


Public Consultation No. 1/2026, open until June 1, 2026, addresses the guidelines for the establishment of biobanks and biorepositories of human biological material and associated information, intended for scientific research. The proposed rule covers, among other topics:

  • The rights of participants, such as free access to information, anonymity, the withdrawal of consent at any time, and genetic counseling;
  • The rules governing free and informed consent, including the possibility of broad consent for biobanks;
  • The requirements for the transfer of human biological material within Brazil and abroad;
  • The various configurations of biobanks (centralized institutional, decentralized, inter-institutional, network, and consortium);
  • The ethical review of protocols by CEPs accredited by INAEP.

The proposal also expressly prohibits the commercialization of human biological material, subject to the exception of charging amounts for cost recovery. There is no express mention in the text regarding the revocation of CNS Resolution No. 441/2011. The draft Resolution and the documents that supported its preparation are available on the Brasil Participativo electronic portal.

The Life Sciences and Health practice group can provide further information on the topic.