09/02/2026 | Priscila Torres | BioRed Brasil

https://www.bioredbrasil.com.br/nova-conep-e-o-controle-social-como-imperativo-etico/

An Intersectoral Commission on Research Ethics is beginning to take shape within the National Health Council (CNS). It seeks to reclaim the role of social oversight—within the constraints imposed by a 2024 law that puts Brazilians participating in clinical trials at risk. What will its role be?

On August 12, 2026, during its 381st Ordinary Meeting, the National Health Council (CNS) approved the establishment of a new Intersectoral Commission on Research Ethics (Conep). The CNS Plenary voted to retain the name "Conep"—with only one abstention—out of respect for the contributions of the former National Commission on Research Ethics. For nearly 30 years, that body was responsible for providing guidance and reviewing the ethical aspects of research involving human subjects through the CEP/Conep System and "Plataforma Brasil" (Brazil Platform), a unified national research registry adopted in 2012.

The meeting highlighted the development and consolidation of the Brazilian model of social oversight, characterized by democratic participation and a commitment to human dignity. A key milestone in this history was CNS Resolution No. 1/1988, which mandated prior approval of research projects by Research Ethics Committees (CEPs). In 1996, CNS Resolution No. 196 consolidated the CEP-Conep system, which subsequently gained international recognition for its participatory and pluralistic nature (CNS, 2026).

Over the past few decades, the National Commission on Research Ethics (Conep) has coordinated, trained, and supported Research Ethics Committees across the country, strengthening participant protection and aligning social oversight with scientific rigor. By 2025, the structure encompassed over 900 CEPs and involved approximately 16,000 people within the system. Between 2012 and 2025, over 1.3 million users, 1.1 million projects, and nearly 42,000 institutions—including approximately 2,000 foreign ones—were registered. At its peak, the *Plataforma Brasil* received an average of nearly 2,700 new projects daily, highlighting the scale and reach achieved by the Brazilian research ethics system (CNS, 2026).

Disruption and resumption of social oversight
Between 2024 and 2025, the Brazilian research ethics system underwent a complete overhaul via Law No. 14.874/2024 (Brazil, 2024). This legislation stripped the National Research Ethics Commission (Conep) and the National Health Council (CNS) of their responsibilities, establishing instead the National Research Ethics Body (Inaep), regulated by Decree No. 12.651/2025.

This was not merely a case of replacing a Commission with a Body; there was a significant shift in the structural relationship with Research Ethics Committees (CEPs). It marked the end of an era defined by the leading role of social oversight, shifting the entire system under the command of the Executive Branch—specifically, the Ministry of Health (MS).

Although the CNS participates in the new Body, the loss of representation is evident. The Council holds only six of Inaep’s 33 seats; the entity has effectively emerged as an instrument of an influential elite, standing in contrast to an ethics framework rooted in shared social oversight (Rodrigues Corrêa Filho, 2025).

Against this backdrop—and recognizing that social oversight could not be exercised solely from within Inaep—the CNS issued Resolution No. 803 on March 12, 2026 (Brazil, 2026). This resolution established a Working Group (WG) tasked with drafting a proposal to create the Council’s own Intersectoral Commission on Research Ethics (Conep). The Working Group (WG) featured equal representation from the three segments comprising the Council: users, workers, and management.

Over a four-month period, the WG worked intensively to propose a new model capable of restoring the role of social oversight—within the legal limits imposed by the new framework—while fulfilling its social mission and meeting the expectations of civil society, particularly research participants.

The proposal presented to the CNS Executive Board is grounded in constitutional values, public administration principles, and the UNESCO Universal Declaration on Bioethics and Human Rights. It was evaluated by specialized technical advisors to prevent overlap or conflicts between the mandates of the new Conep and Inaep, thereby initiating a new phase in the effort to preserve social participation and protect research participants.

Mandate and composition of the new Conep
Under the resolution approved by the CNS plenary, Conep’s responsibilities will include monitoring and supporting the formulation of public policies regarding ethics in research and care, as well as monitoring and evaluating their implementation. It will foster intersectoral dialogue among agencies, institutions, entities, and social movements related to the subject matter, and conduct or provide advisory support for studies, opinions, technical notes, guidelines, and recommendations to inform CNS deliberations.

It shall conduct and/or provide guidance for training and continuing education activities in health—specifically on topics related to its field of operation—aimed primarily at research participants and other interested parties. It is responsible for monitoring ethical and bioethical aspects of healthcare within the SUS (Unified Health System), identifying any shortcomings revealed by this monitoring. It must also receive reports of proven or suspected rights violations, while ensuring the confidentiality of data and information.

The new Conep is further responsible for ensuring appropriate case referrals and monitoring the resulting inquiries or investigations through to their conclusion and resolution. It advocates for and strengthens the role of research participants and/or communities involved in ethical reviews. It champions and expands social participation across bodies, institutions, entities, and social movements active in the health sector and other areas impacting the social determinants of health, including research.

Its duties also include contributing to the strengthening of social oversight and of the institutions, entities, and social movements participating in the SUS. This involves raising awareness and building capacity to protect individuals participating in research projects at all stages—including those involving healthcare—and preserving the institutional memory of the CNS's (National Health Council) contributions to the field of research ethics.

The new Conep will also feature a Technical Chamber to assist in driving three fundamental lines of action:

– Line of Action I – Training and continuing education: Operating from the perspective of social oversight to propose, advise on, monitor, and execute educational activities, either directly or through institutional partnerships.

– Line of Action II – Research and healthcare ethics observatory: Prioritizes listening, dialogue, and coordination with municipal and state councils, ethics and bioethics organizations, and movements advocating for the rights of research participants and patients. It seeks to strengthen ties with institutions operating in the specific localities where research and actual patient care take place. – Axis III – Record of the contribution of social oversight to ethics and bioethics: To recover, record, and preserve the history of the former CEP/CONEP system, building a historical and documentary archive that enhances current practices. Furthermore, this axis aims to document the present and future activities of the newly approved Intersectoral Commission on Research Ethics.

Thus, it is evident that the new CONEP does not conflict with the duties of the INAEP as set forth in the Law and the regulating Decree. In fact, the new CONEP expands its scope to include ethics in care delivery, recognizing that—given the convergence of information and biotechnology—all users of health services are potential, and increasingly actual, research participants. Discussions on research ethics require the inclusion of bioethical perspectives. This entails reflecting not only on data usage but also on the health interventions that generate such data, thereby encompassing ethics within healthcare itself. Therefore, social oversight must be exercised freely and independently to safeguard research participants, as well as users and patients of the SUS (Unified Health System).

Next steps and future challenges
The months following the publication of the approved resolution will be intense. The new CONEP must have its composition—proposed by forums representing users, workers, and management—approved during an ordinary meeting of the CNS Plenary. This process adheres to the operating rules for intersectoral commissions, in accordance with CNS Resolution 765/2024 (BRAZIL, 2024), which governs the approval of the CNS Internal Regulations.

Once duly constituted, the Commission will propose the public call for the composition of the Technical Chamber and, ultimately, draft its Work Plan, which will also be submitted to the CNS Plenary for review. Ad-hoc members and invitees—whether from the health sector or the human and social sciences—will be considered, with the aim of expanding and strengthening the role of research participants. The new Conep will be (re)built just as it was 30 years ago—with democracy, social participation, justice, ethics, innovation, and boldness—without compromising the defense of autonomy, human dignity, equity, human rights, and social justice. We know there are many lingering questions, but there is one certainty: social oversight emerges strengthened and increasingly committed to health and democracy.

References:

BRAZIL. Decree No. 12,651, of October 7, 2025. Regulates Law No. 14,874, of May 28, 2024, which provides for research involving human beings and establishes the National System of Ethics in Research Involving Human Beings. Brasília, DF: Presidency of the Republic, 2025. Available at: Decree No. 12,651/2025 – Planalto. Accessed on: Aug. 25, 2026.

BRAZIL. Law No. 14,874, of May 28, 2024. Provides for research involving human beings and establishes the National System of Ethics in Research Involving Human Beings. Brasília, DF: Presidency of the Republic, 2024. Available at: Law No. 14,874/2024 – Planalto. Accessed on: Aug. 25, 2026.

BRAZIL. Ministry of Health. National Health Council. CNS establishes new Intersectoral Commission on Research Ethics (Conep). Brasília, DF: National Health Council, Aug. 13, 2026. Available at: National Health Council. Accessed on: Aug. 25, 2026.

BRAZIL. Ministry of Health. National Health Council. Resolution No. 803, of March 12, 2026. Provides for the creation of the Working Group to establish the Intersectoral Commission on Research Ethics (CONEP) of the National Health Council (CNS). Brasília, DF: National Health Council, 2026. Available at: CNS Resolution No. 803/2026. Accessed on: Aug. 25, 2026.

BRAZIL. Ministry of Health. National Health Council. Resolution No. 765, of December 19, 2024. Provides for the approval of the Internal Regulations of the National Health Council. Brasília, DF: National Health Council, 2024. Available at: CNS Resolution No. 765/2024. Accessed on: Aug. 25, 2026.

UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION (UNESCO). Universal Declaration on Bioethics and Human Rights. Paris: UNESCO, 2005.

RODRIGUES CORRÊA FILHO, Heleno. Inaep: the influential elite ethic versus the ethic shared with social control. Saúde em Debate, [S. l.], v. 49, no. 147, Oct./Dec. 2025. Available at: https://saudeemdebate.org.br/sed/article/view/11286. Accessed on: Aug. 24, 2026.

Source: Outras Palavras.