INAEP: Public Consultation on new guidelines applicable to biobanks
Public Consultation No. 1/2026 has been published by the National Research Ethics Authority (Instância Nacional de Ética em Pesquisa – “INAEP”), inviting public participation on the proposed new guidelines applicable to biobanks of human biological material, within the scope of the National System for Research Ethics Involving Human Beings (Sistema Nacional de Ética em Pesquisa com Seres Humanos – “SINEP”).
This initiative (i) is part of the implementation of Brazil’s new regulatory framework for research involving human participants, established by Law No. 14,874/2024 and Decree No. 12,651/2025, which transferred to INAEP competencies previously held by the National Commission for Research Ethics (Comissão Nacional de Ética em Pesquisa – “CONEP”) and (ii) seek to consolidate and update previously fragmented regulations, particularly National Health Council’s Resolution No. 441/2011 and Ministry of Health’s Ordinance No. 2,201/2011, in alignment with the new legal framework.
The draft resolution submitted for public consultation represents the continuation of a process initiated in 2023 under CONEP. The text was initially approved unanimously by CONEP’s board in 2024 and was subsequently reviewed and resubmitted by INAEP under the new institutional arrangement.
The draft addresses, in a structured manner, key issues such as:
- (i) the strengthening of research participants’ rights, with an emphasis on ownership of biological material, the right to withdraw consent, and the possibility of recontact;
- (ii) the regulation of broad consent for future uses;
- (iii) detailed rules on governance, traceability, and national and international sharing of biological material; and
- (iv) the prohibition of undue commercial exploitation of human biological material.
The proposal introduces the concept of an accredited Research Ethics Committee (Comitê de Ética em Pesquisa – “CEP”), concentrating the ethical review of biobanks within committees that demonstrate adequate technical and operational capacity. It also expressly aligns the regulatory framework with the principles of the Brazilian General Data Protection Law and with international ethical standards, such as the World Medical Association’s Declaration of Taipei, thereby enhancing regulatory predictability and harmonization.
Contributions may be submitted until June 1, 2026, exclusively through the government platform.
Impacts on Industry and Research Institutions
If approved, the resolution is expected to have significant implications for sponsors, research institutions, biobank managers, and companies in the pharmaceutical, biotechnology, and medical devices sectors.
Key anticipated effects include greater specialization in ethical review, increased governance and transparency requirements, and enhanced clarity regarding conditions for future use, international transfer of human biological material, and cost reimbursement mechanisms. At the same time, the new regulatory framework has the potential to strengthen legal certainty and support the sustainability of large-scale research initiatives, particularly in fields involving innovation and international scientific cooperation.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to address any questions you may have at lifesciences@soutocorrea.com.br.