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Published on 25/12/2025

Portuguese Consent and Cultural/Ethical Considerations SOP

Department	Clinical Research
SOP No.	CS/ANVISA-CONSENT/183/2025
Supersedes	N.A.
Page No.	1 of 22
Issue Date	28/08/2025
Effective Date	05/09/2025
Review Date	05/09/2027

Purpose

The purpose of this SOP is to define standardized procedures for developing, translating, and administering Portuguese language informed consent forms (ICFs) and ensuring that cultural and ethical considerations are addressed in clinical trials conducted in Brazil. It aligns with ANVISA, CONEP, and ICH GCP requirements, ensuring participants are provided with accurate and understandable information.

Scope

This SOP applies to all clinical trials conducted in Brazil where participants require informed consent in Portuguese. It covers translation, back-translation, cultural adaptation, ethics submissions, site responsibilities, subject re-consent, and record-keeping. It is applicable to sponsors, CROs, investigators, and translation vendors involved in Brazilian clinical trials.

Responsibilities

• Sponsor: Ensures Portuguese ICFs are available, approved by CONEP, and implemented before trial initiation.
• Principal Investigator (PI): Conducts the consent process, ensures participant comprehension, and maintains signed ICFs at the site.
• Clinical Research Coordinator (CRC): Assists PI in the consent process, maintains records, and ensures participants are provided with subject-facing documents in Portuguese.
• Regulatory Affairs (RA): Submits Portuguese ICFs and supporting documentation to ANVISA and CONEP.
• Quality Assurance (QA): Verifies accuracy of translations and ensures inspection readiness.
• Translation Vendor: Provides certified translations and back-translations for ICFs and subject materials.

Accountability

The Sponsor is accountable for ensuring that consent documents are available in Portuguese and ethically sound. The PI is accountable for ensuring participant comprehension and that signed ICFs are properly documented.

Procedure

1. Translation of Informed Consent Documents

1. Engage certified medical translators for Portuguese translation of ICFs and subject materials.
2. Perform back-translation into English to confirm accuracy and consistency with original documents.
3. File Certificate of Translation Accuracy in TMF.

2. Cultural and Ethical Adaptation

1. Ensure consent documents use culturally sensitive language and avoid medical jargon.
2. Adapt terminology to align with Brazilian cultural norms and literacy levels.
3. Engage Ethics Committees (CONEP) to review cultural appropriateness of translated ICFs.

3. Informed Consent Process

1. Provide subjects with Portuguese ICFs prior to trial enrollment.
2. Allow sufficient time for subjects to read, discuss, and ask questions.
3. Ensure comprehension by asking subjects to explain trial risks and procedures in their own words.

4. Ethics and Regulatory Submissions

1. Submit Portuguese ICFs to CONEP and ANVISA along with the protocol package.
2. File ethics approval letters and acknowledgment receipts in TMF and ISF.

5. Re-Consent

1. Implement re-consent procedures in Portuguese when protocol amendments significantly impact subject rights, safety, or trial procedures.

6. Archiving

1. Maintain signed ICFs, translation logs, and approval documents in TMF and ISF.
2. Archive consent-related records for 15 years or as per Brazilian requirements.

Abbreviations

• ANVISA: Agência Nacional de Vigilância Sanitária
• CONEP: Comissão Nacional de Ética em Pesquisa
• ICF: Informed Consent Form
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• RA: Regulatory Affairs
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. Translation Requirement Log (Annexure-1)
2. Certificate of Translation Accuracy (Annexure-2)
3. Consent Process Documentation Log (Annexure-3)

References

• ANVISA — National Health Surveillance Agency
• CONEP — National Commission for Ethics in Research
• ICH E6(R2) Good Clinical Practice

Version: 1.0

Approval

Prepared By	Checked By	Approved By
Name: Rajesh Kumar Date: 20/08/2025 Signature: __________	Name: Sunita Reddy Date: 22/08/2025 Signature: __________	Name: Dr. Meera Iyer Date: 28/08/2025 Signature: __________

Annexures

Annexure-1: Translation Requirement Log

Date	Document	Status	Reviewer
05/08/2025	Portuguese ICF v1.0	Completed	Rajesh Kumar

Annexure-2: Certificate of Translation Accuracy

Document	Translator	Date	Reviewer
Portuguese ICF v1.0	Maria Silva	06/08/2025	Sunita Reddy

Annexure-3: Consent Process Documentation Log

Date	Subject ID	Consent Version	Witness (if applicable)	PI/CRC Signature
15/08/2025	BRA-201	ICF v1.0 (Portuguese)	João Pereira	Dr. Ana Costa

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
28/08/2025	1.0	Initial SOP for Portuguese consent and cultural/ethical considerations.	New SOP created for compliance with ANVISA and CONEP requirements.	Head of Clinical Research

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