INAEP Issues Technical Guidance on Single Ethical Review for Multicenter Research
The National Research Ethics Authority (INAEP) has issued its Technical Guidance on Single Ethical Review for Multicenter Research, providing important clarifications regarding the implementation of Brazil’s new clinical research regulatory framework.
The document comes amid ongoing discussions among regulatory authorities, sponsors, CROs, research institutions, and Research Ethics Committees (RECs) concerning operational questions that remained following the entry into force of the new rules governing the conduct of clinical research in Brazil.
Background
Historically, ethical review of multicenter research in Brazil was conducted on a decentralized basis, often resulting in inconsistent interpretations among RECs, duplicative reviews, and significant delays in study activation.
Under Brazil’s new regulatory framework, a single ethical review model was introduced, whereby one REC assumes responsibility for the ethical review of multicenter studies. While this change represents a significant step toward streamlining the system, a number of practical aspects relating to its implementation continued to generate uncertainty among stakeholders.
Against this backdrop, the Technical Guidance consolidates INAEP’s interpretation of the new framework and provides important operational guidance for the implementation of the single ethical review model.
Key Clarifications
Among the most relevant points addressed in the document are the following:
- Single ethical review: The Guidance reaffirms that the ethical review of multicenter research must be performed by a single REC responsible for the centralized ethical assessment. RECs affiliated with participating sites may not reassess the scientific, methodological, or ethical merits of the protocol, issue competing determinations, raise new deficiencies, or require modifications to documents that have already been approved. Their role is limited to local oversight and participant protection functions.
- Administrative nature of participating site authorization: Institutional authorization is intended to formalize a site’s agreement to host the research and to confirm that it has the necessary administrative, clinical, and operational capacity to conduct the study. As such, it constitutes an administrative authorization that may be provided in parallel with the ethical review process.
- Use of contracts as evidence of institutional authorization: The Guidance confirms that no specific form is required for institutional authorization. Clinical trial agreements, cooperation agreements, accession agreements, or other equivalent documents may satisfy this requirement, provided they demonstrate the institution’s agreement to participate and its capacity to support study conduct.
- Use of a single ICF template: According to the Guidance, separate informed consent forms are not required for each participating site where differences are limited to administrative or site-identification information. A single consent form template may therefore be used across study sites in such circumstances.
- No amendment submission required for administrative changes: Changes involving telephone numbers, addresses, institutional contact information, logos, headers, footers, or other administrative and formatting updates do not require submission as protocol amendments. Instead, they may be processed through a simplified notification procedure, provided such modifications do not affect the approved ethical content or alter participants’ understanding of the study’s risks, benefits, or procedures.
- Centralized submission of study documents to the reviewing REC: Amendments, serious adverse event reports, protocol deviation or violation notifications, periodic reports, and other study oversight documents must be submitted to the REC responsible for the single ethical review. Local RECs may receive such information for awareness and local oversight purposes but are not authorized to conduct parallel ethical reviews or issue competing determinations regarding the protocol.
Practical Implications
The Guidance reinforces the core principles underlying Brazil’s new regulatory framework and helps standardize the interpretation of the rules applicable to multicenter research. In particular, it reaffirms the authority of the Ethics Committee responsible for the single ethical review while clarifying the administrative role of participating institutions and local RECs.
Although the document is non-binding and intended as interpretive guidance, it is expected to reduce inconsistent requirements among research sites, provide greater regulatory predictability for multicenter studies conducted in Brazil, and alleviate operational bottlenecks that persisted following implementation of the new framework.More broadly, INAEP’s position represents an important step toward the effective implementation of the new system, promoting greater legal certainty for sponsors, CROs, research institutions, investigators, and other stakeholders across the clinical research ecosystem.
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