10/23/2025 | Thiago Modenesi | Vermelho

https://vermelho.org.br/coluna/lgpd-e-pesquisa-clinica-o-potencial-estrategico-do-nordeste/ 

With expanding centers of excellence and competitive costs, the Northeast is establishing itself as a new frontier for ethical and safe clinical research under the General Data Protection Law

The implementation of the General Personal Data Protection Law (LGPD – Law No. 13,709/18) represented a fundamental regulatory milestone for Brazil, bringing the country into line with international privacy standards. In the healthcare sector and, more specifically, in the world of clinical research, the law brought a new paradigm, imposing rigor in the treatment of sensitive information and requiring a thorough review of processes.

In this context, understanding today's legal challenges and exploring regional opportunities, with an emphasis on Northeast Brazil, is essential for national scientific and technological advancement, particularly at a time of growing public and private investment and economic effervescence.

Health data is classified by the LGPD as “sensitive personal data,” which means it is subject to an even higher level of protection. In practice, any operation involving this data, from patient registration at a clinic to participation in a complex clinical trial, must observe principles such as having a specific purpose, in which data can only be collected for a specific purpose and informed to the data subject, necessity and minimization, where only data strictly necessary to achieve the purpose may be collected, and, finally, consent, as a rule, the processing of sensitive data requires the free, specific, informed, and unambiguous consent of the data subject.

In clinical research, these principles unfold into complex practical requirements. The Free and Informed Consent Form (FICF), already a central piece of research ethics for some time, must now incorporate the provisions of the LGPD. It must clearly and accessibly inform the purpose of the research and how the data will be used, with whom the data may be shared (sponsors, CROs, regulatory authorities), how long the data will be stored, and the rights of the participant, including the right to revoke consent and request the deletion of their data, subject to the legal requirements for maintaining records.

In addition to consent, the LGPD provides other legal bases for the processing of sensitive data in research, such as compliance with legal or regulatory obligations (such as the submission of data to Anvisa) and the conduct of studies by research bodies, ensuring, whenever possible, the anonymization of data.

There are many practical legal challenges in clinical research, and here we list some of them:

1.⁠ ⁠Anonymization vs. Pseudonymization: anonymization (an irreversible process that makes it impossible to identify the data subject) is the safest way to protect privacy. However, in clinical research, it is often necessary to track data for patient safety or validation of results, using pseudonymization (replacing the identifier with a code). Managing this balance is a constant technical and legal challenge;

2.⁠ ⁠International Data Transfer: many clinical trials are sponsored by multinational companies, requiring the transfer of data outside Brazil. The LGPD requires that the destination country offer an adequate level of protection or that specific safeguards be adopted, such as standard contractual clauses. This requires careful legal analysis for each study;

3.⁠ ⁠Cybersecurity: the centrality of digital data in modern research requires robust investments in information security to prevent leaks and cyberattacks, which can result in millions in fines and irreparable reputational damage;

4.⁠ ⁠Governance and Responsibility: the law establishes the role of the Controller (the sponsor or research institution) and the Operator (clinics, laboratories). A clear definition of roles, responsibilities, and the implementation of a Privacy Governance Program are imperative for compliance.

Here, it is worth highlighting the Northeast and its potential as a strategic opportunity. While the large centers in the Southeast concentrate most of the country's research infrastructure, the Northeast region emerges with unique and strategic potential, which can be amplified by strict adherence to the LGPD.

The Northeast is a region with expanding Centers of Excellence, including university hospitals and renowned teaching and research institutions (such as IMIP/PE, Hospital São Rafael/BA, and several federal universities) that already have consolidated Research Ethics Committees (CEPs) and are adapting to the requirements of the LGPD. Investing in this local infrastructure is more efficient and generates regional development.

In this region, operating costs are more competitive, and conducting clinical research in the Northeast can be significantly less expensive than in the large centers of Rio-São Paulo, without compromising scientific quality. This attracts sponsors and makes the region an attractive hub for investment in Research & Development.

And by strengthening trust through the LGPD, the transparent and rigorous adoption of the LGPD by institutions in the Northeast can become a competitive advantage by demonstrating an unwavering commitment to privacy and ethics. These institutions build a relationship of trust not only with local participants but also with international sponsors who seek safe and predictable regulatory environments.

The LGPD is not an obstacle to clinical research, but rather a pillar for its ethical and sustainable evolution. It forces managerial maturity and transparency that ultimately protect participants, institutions, and scientific integrity.

For the Northeast, this moment is a window of opportunity. The region has all the conditions to become a national hub of clinical research excellence, provided there is a coordinated effort between research institutions, the federal government, state governments, and the private sector to train professionals (researchers, lawyers, research staff) in the LGPD as it applies to health, invest in technological and cybersecurity infrastructure, and promote the region nationally and internationally as an innovative and reliable hub for conducting clinical studies.

By embracing the LGPD not as a mere obligation but as a strategic advantage, the Northeast can not only attract investment and foster socioeconomic development but also ensure that its population actively participates in and benefits from the advances in medicine of the future, with due protection for their most fundamental privacy.