Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
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Timeline of Review
Trial Initiation
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Required Elements
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Children/Minors
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Investigational Products
Definition of Investigational Product
Manufacturing & Import
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Definition of Specimen
Import & Export
Consent for Specimens
Brazil
QUICK FACTS
Clinical trial application languagePortuguese
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredNo
Age of minorsUnspecified
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
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SUMMARY

Overview
As per the LawNo9.782, ResolutionNo9, and Ord650/2014, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in Brazil. ANVISA grants permission for clinical trials to be conducted in Brazil in accordance with the provisions of ResolutionNo466, ResolutionNo9, and Ord650/2014.

ANVISA is attached to the Ministry of Health (MOH), which grants it authority to regulate food and drug laws in Brazil. Ord650/2014 states that the agency is ruled by a Collegiate Board of Directors composed of five (5) members, and it oversees five (5) directorates. In addition, ANVISA also has two (2) main offices: the Advisory Council and the Ombudsman office. The Advisory Council monitors the Collegiate Board’s activities and responds to public inquiries, and the Ombudsman serves as an independent body for the public to directly communicate any complaints. See Ord650/2014 and Additional Resource (C) for more details on ANVISA’s organizational structure.

As delineated in Ord650/2014, within ANVISA’s directorate framework, the General Management of Medicines (Gerência-Geral de Medicamentos (GGMED)) operates within the General Managers of Organizational Processes (Gerências-Gerais de Processos Organizacionais) to manage drug registration. It also oversees the Office of Clinical Research Coordination on Drugs and Biologicals (Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos (COPEC)), which is housed within the Office of Efficacy and Safety Evaluation Management (Gerência de Avaliação de Segurança e Eficácia (GESEF)). COPEC is responsible for the analysis and registration of new drugs and clinical trial protocols.

Contact Information
ANVISA
Setor de Indústria e Abastecimento (SIA)
Section 5, Special Area 57, Lot 200, Block D, 1st Basement
Brasília (DF)
CEP: 71205-050

Phone: 0800-642-9782
Fax: (61) 3462-5772
Clinical Research Office Email: Pesquisaclinica@anvisa.gov.br

ADDITIONAL RESOURCES

(A) (Website) ANVISA – Brazilian Health Surveillance Agency – The Agency (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) ANVISA – Organizational Chart (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(C) (Website) ANVISA – Clinical Research (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Legislation) Law N. 9.782, of January 26, 1999 (LawNo9.782 - Portuguese/Português) (January 26, 1999)
Presidency of the Federative Republic of Brazil, House Civil Cabinet Subcommittee for Legal Affairs, Federative Republic of Brazil

Relevant Section: Chapter II (Article 3)

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter I

(3) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I and II) and Chapter III (Section I)

(4) (Regulation) Ordinance No 650, Of 29 Of May 2014Approves and Promulgates the Internal Regulations of the National Health Surveillance Agency - ANVISA and Other Measures (Ord650/2014 - Portuguese/Português) (May 29, 2014)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Annex I (Title III (Chapter I), Title V (Chapter III (Section II), and Title VI (Chapter IX))

Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with the LawNo9.782, ResolutionNo9, and Ord650/2014, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is responsible for reviewing and approving clinical trial applications for registered and unregistered drugs. The scope of ANVISA’s assessment includes all clinical trials (Phases I-IV) for the following:

  • New therapeutic indication
  • New method of administration
  • New concentration
  • New pharmaceutical form
  • Expansion of use
  • New dosage
  • New associations
  • Any post-registration change requiring clinical data, including registration renewal

As stated in ResolutionNo9, ResolutionNo466, and the PANDRH-GCPs, the institutional ethics committee (EC) (known as a Comitê de Ética em Pesquisas) (CEP)) must review and approve all clinical trial applications prior to ANVISA initiating its review and approval process. Applications with coordination or sponsorship originating outside of Brazil require an additional EC review by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP). Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval. Per ResolutionNo9, ANVISA’s approval of a clinical trial application is not dependent upon CONEP’s approval. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

Clinical Trial Review Process
As delineated in Ord650/2014, ANVISA’s Office of Clinical Research Coordination on Drugs and Biologicals (Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos (COPEC)) is responsible for conducting the review of clinical trial applications. ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). Per ResolutionNo9 and Additional Resource (A), upon receipt of the DDCM, ANVISA has 90 calendar days to evaluate the application. If ANVISA fails to issue a response in 90 days after receipt, clinical development can begin as long as all of the ethical approvals have been obtained.

As per OSNo001/2013, in the instance of a multicenter clinical trial, the principal investigator (PI) is required to submit a list of the participating institutions and the associated protocols as part of the research protocol package sent to the CEP for review.

ADDITIONAL RESOURCES

(A) (Website) Published New Standards for Clinical Research (Portuguese/Português) (March 3, 2015) (Last Updated June 25, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) Global Health Regulatory Requirements DatabaseBrazil: Drugs (Updated November 18, 2014)
Global Health Technologies Coalition

(C) (Website) ANVISA – How ANVISA Evaluates the Registration of New Drugs in Brazil (January 20, 2005)
ANVISA, Ministry of Health, Federative Republic of Brazil

(D) (Website) ANVISA – Considerations and Definitions for Clinical Research (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(E) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Legislation) Law N. 9.782, of January 26, 1999 (LawNo9.782 - Portuguese/Português) (January 26, 1999)
Presidency of the Federative Republic of Brazil, House Civil Cabinet Subcommittee for Legal Affairs, Federative Republic of Brazil

Relevant Section: Chapter II (Article 3)

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 -  English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III) and Chapter III

(3) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter IX, Chapter X, and Chapter XI

(4) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.3), Chapter 3 (Section 3.1), Chapter 4 (Section 4.3), Chapter 5 (Sections 5.5 and 5.6), and Chapter 6 (Sections 6.10 and 6.11)

(5) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2.3 and 3

(6) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

(7) (Regulation) Ordinance No 650, Of 29 Of May 2014Approves and Promulgates the Internal Regulations of the National Health Surveillance Agency - ANVISA and Other Measures (Ord650/2014 - Portuguese/Português) (May 29, 2014)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Annex I (Title VI (Chapter IX))

Regulatory Authority > Regulatory Fees
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SUMMARY

Overview
As stated in ResolutionNo9 and ResolutionNo222, applicants are responsible for paying a Proof of Deposit Health Surveillance Rate (TFVS) fee to submit a clinical trial application to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA). While the fee amount is not currently available from official sources, Additional Resource (A) states that the current fee is $6,000 USD.

ANVISA’s fee expires after six (6) months for the first study site approved; the applicant must pay an additional $6,000 USD for each new site included following this expiration as per Additional Resource (A). Additional Resource (A) also states that total costs can vary between $900 USD and $14,200 USD.

ADDITIONAL RESOURCES

(A) (Website) Global Health Regulatory Requirements DatabaseBrazil: Drugs (Updated November 18, 2014)
Global Health Technologies Coalition
Washington, DC

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter III (Section II)

(2) (Regulation) Resolution – RDC No. 222 of 28 December 2006 (ResolutionNo222 - Portuguese/Português) (December 28, 2006)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter IV

Ethics Committee > Ethics Committee
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SUMMARY

Overview
As per ResolutionNo466 and OSNo001/2013, Brazil has a centralized registration process for ethics committee (ECs) and requires institutional level EC approval for each trial site. The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) serves as the central body that reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body for the Ministry of Health (MOH).

As indicated in ResolutionNo466 and OSNo001/2013, the EC system as a whole is known as the “CEP/CONEP System”. CONEP coordinates the network of institutional ECs, known as Committees of Ethics in Research (Comitês de Ética em Pesquisas) (CEPs). It is responsible for EC (CEP) accreditation and registration, and it prepares ethical guidelines and standards for the protection of human research participants. CONEP was originally established as a statutory body in 1996 under Resolution 196/96. This resolution was repealed in December 2012 and replaced by ResolutionNo466. Each institution that conducts biomedical research is required to have an EC (CEP) that is responsible for reviewing clinical trial applications. In addition, applications with coordination or sponsorship originating outside of Brazil must also be approved by CONEP, unless the co-sponsor is the Brazilian Government. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval.

OSNo001/2013 also indicates that the development and submission of research, as well as the implementation and disclosure of CEP and CONEP opinions, must occur through the Plataforma Brasil. According to Additional Resource (E), Plataforma Brasil was created by the MOH to provide a national and unified registry for research involving human participants. The platform represents the review and approval processes of both the CEP and CONEP. Research applications can be tracked from submission to final approval by the CEP, and when necessary, by CONEP.

CONEP Composition
Please refer to Ethics Committee topic, Authorizing Body subtopic.

EC (CEP) Composition
As per the PANDRH-GCPs, an institutional EC (CEP) must have at least five (5) members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. By comparison, the OSNo001/2013 and the OMREC require the EC (CEP) to be composed of a minimum of seven (7) members having proven expertise in research. The OSNo001/2013 also requires at least 50% of the members to have this research experience. The PANDRH-GCPs, the OSNo001/2013, and the OMREC also indicate that the EC (CEP) should be multidisciplinary, represent a balanced gender and age composition, and consist of members embodying community interests and concerns. The OSNo001/2013 and the OMREC also state that not more than half of its members should belong to the same professional category. In addition, as per the PANDRH-GCPs, in communities where minority ethnic populations predominantly reside, the EC (CEP) should include a member, alternate, or consultant from that group. The EC (CEP) may also designate alternate members whose functions are delineated in the EC’s (CEP’s) standard operating procedures (SOPs).

Additional criteria for EC (CEP) membership is available in Section 3.2 of the PANDRH-GCPs, Section 2.2 of the OSNo001/2013, and Section 2 of the OMREC.

Terms of Reference, Review Procedures, and Meeting Schedule
As set forth in the PANDRH-GCPs and the OMREC, each EC (CEP) must have written SOPs, including a process to be followed for conducting reviews. The SOPs should include information on EC (CEP) composition, meeting schedules, frequency of reviews, requirements for initial and ongoing evaluation of the research study, and requirements for notifying the investigator and the institution of results related to the study’s initial and ongoing evaluation.

Per the PANDRH-GCPs and the OMREC, the majority of committee members must be involved in the review and approval process, and the necessary quorum must be obtained to approve or deny permission to conduct a study as specified in each EC’s (CEP’s) SOPs. As per ResolutionNo370, the registration and appointment terms of EC (CEP) members are valid for three (3) years, and may be renewed at the end of that period.

The PANDRH-GCPs also state that the EC (CEP) must retain all relevant records (e.g., SOPs, member lists, member affiliations and occupations, documents presented, meeting minutes, and correspondence) for three (3) years after the study’s conclusion, and make them available to the regulatory authorities upon request.

For detailed EC (CEP) procedures and information on other administrative processes, see Sections 3.3 and 3.4 of the PANDRH-GCPs and the OMREC.

ADDITIONAL RESOURCES

(A) (Website) National Commission for Ethics in Research (CONEP) (Portuguese/Português) (Current as of October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(B) (Website) National Health Council (Portuguese/Português) (Current as of October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(C) (Website) Bylaws of CONEP/CNS (Portuguese/Português) (June 6, 2001)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Article 1

(D) (Report) Brazilian R&D Status and Brazilian System for Ethical Analysis of Scientific Protocols Involving Human Subjects (2011)
Lopes, Aníbal Gil
European Group on Ethics in Science and New Technologies, Bureau of European Policy Advisers, European Commission

Relevant Section: CEP/CONEP System Role and Responsibilities

(E) (Website) Plataforma Brazil (Portuguese/Português) (Current as of October 19, 2015)
Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter VII

(2) (Guidance) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 3 (3.2, 3.3, 3.4, and 3.5)

(3) (Regulation) CNS Resolution No. 370, of March 8 2007 (ResolutionNo370 - Portuguese/Português) (March 8, 2007)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter I.4

(4) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 1 and 2

(5) (Guidance) Operating Manual for Research Ethics Committees (4th Edition revised and updated) (OMREC - Portuguese/Português) (2008)
National Commission for Ethics in Research, National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Sections 2, 3, and 18

Ethics Committee > Scope of Review
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SUMMARY

Overview
According to the regulations in ResolutionNo466, the PANDRH-GCPs, and OSNo001/2013, the primary scope of information assessed by the institutional ethics committees (ECs) (Committees of Ethics in Research (CEPs)) and the National Commission for Ethics in Research (CONEP), also known as the CEP/CONEP System, relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As delineated in ResolutionNo466 and the PANDRH-GCPs, the CEP/CONEP System must pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these populations). The CEP/CONEP System is also responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. It must act in the interests of the potential research participants and the communities involved, evaluating the possible risks and expected benefits to participants, confirming the suitability of the investigator(s), facilities, and methods, and verifying the adequacy of confidentiality and privacy safeguards. See Chapter III in ResolutionNo466 and Chapter III in the PANDRH-GCPs for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As per ResolutionNo466, the PANDRH-GCPs, ResolutionNo9, and OSNo001/2013, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) and the EC (CEP) must approve a clinical trial application prior to the sponsor initiating the trial. Applications with coordination or sponsorship originating outside Brazil require an additional EC review by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP), unless the co-sponsor is the Brazilian Government. In addition to conducting international project reviews, per ResolutionNo466, CONEP is required to review certain studies involving human genetics, human reproduction, invasive therapeutic procedures, indigenous populations, genetically modified organisms, embryonic stem cells, and the establishment and operation of biobanks for research. See ResolutionNo466 for specific details on CONEP project review requirements.

As delineated in ResolutionNo466, the PANDRH-GCPs, and OSNo001/2013, the principal investigator (PI) is responsible for submitting an application to the EC (CEP) and the CONEP, if applicable, for review and approval. The application must be made via the online Plataforma Brasil.

ANVISA is not required to wait for CONEP’s approval once it finalizes its own approval of a clinical trial application (referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)) in ResolutionNo9 and the G-DDCM Manual). Per ResolutionNo9 and Additional Resource (B), upon receipt of the DDCM, ANVISA has 90 calendar days to evaluate the application. If ANVISA fails to issue a response in 90 days after receipt, clinical development can begin as long as all of the ethical approvals have been obtained. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

The PANDRH-GCPs, ResolutionNo9, and OSNo001/2013 also state that the EC (CEP) must review and approve any protocol amendments prior to those changes being implemented. In addition, the EC (CEP) has a continuing responsibility to monitor the approved trial(s) to ensure ethical compliance throughout the study duration.

There is no stated expiration date for an EC (CEP) approval in ResolutionNo466, the PANDRH-GCPs, ResolutionNo9, or OSNo001/2013. However, in the event that an EC (CEP) revokes its approval of a clinical protocol, it must record its reasons for doing so and immediately communicate this decision to the investigator and ANVISA.

ADDITIONAL RESOURCES

(A) (Website) Plataforma Brazil (Portuguese/Português) (Current as of October 19, 2015)
Ministry of Health, Federative Republic of Brazil

(B) (Website) Published New Standards for Clinical Research (Portuguese/Português) (Last Updated June 25, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Introduction, Chapter II, Chapter III, Chapter IV, Chapter VI, Chapter VII, Chapter IX, Chapter X, and Chapter XI

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.3), Chapter 3 (Sections 3.1, 3.3, and 3.4), Chapter 4 (Section 4.3), Chapter 5 (Sections 5.5 and 5.6) and Chapter 6 (Sections 6.10, 6.11, and 6.23)

(3) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section II), Chapter III (Section II, Article 38 (VIII), and Chapter V (Article 47)

(4) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(5) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: 2

Ethics Committee > Ethics Committee Fees
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SUMMARY

Overview
According to ResolutionNo466 and OMREC, the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP)) does not permit ethics committees (ECs) to charge a fee to review clinical trial protocols. CONEP states that financing to support ethical reviews should come from a specific scientific committee budget designated within each institution.

However, Additional Resource (A) states that some of the ECs charge an administrative fee ranging from $250 USD to $1,200 USD.

ADDITIONAL RESOURCES

(A) (Website) Global Health Regulatory Requirements DatabaseBrazil: Drugs (Updated November 18, 2014)
Global Health Technologies Coalition
Washington, DC

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter VII

(2) (Guidance) Operating Manual for Research Ethics Committees (4th Edition revised and updated) (OMREC -  Portuguese/Português) (2008)
National Commission for Ethics in Research, National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Section 2

 

Ethics Committee > Authorizing Body
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SUMMARY

Overview
The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) is the central statutory body responsible for the registration, audit, and accreditation of institutional ethics committees (ECs), known as (Committees of Ethics in Research (Comitês de Ética em Pesquisas) (CEPs)) in Brazil. As per ResolutionNo466 (which repealed Resolution 196/96), OSNo001/2013, and ResolutionNo446, CONEP was created by the Ministry of Health (MOH) to provide ethical oversight of clinical research and to safeguard the rights and welfare of human participants involved in clinical studies. CONEP reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body to the MOH.

As delineated in ResolutionNo466, OSNo001/2013, and ResolutionNo446, CONEP’s core responsibilities center on:

  • Examining the ethical aspects of research involving human participants
  • Analyzing and monitoring research protocols, and issuing opinions on applications with coordination or sponsorship originating outside Brazil, unless the co-sponsor is the Brazilian Government, and applications related to specialized research areas (i.e., human genetics, human reproduction, vaccines, and human biological materials)
  • Preparing and updating relevant ethical standards
  • Registering, auditing, accrediting, and training ECs
  • Monitoring CEP processes
  • Promoting and participating in educational EC activities


CONEP Composition
As per OSNo001/2013 and ResolutionNo446, CONEP is an independent and multidisciplinary organization consisting of 30 appointed members and five (5) alternate members. The members represent a balanced gender composition; eight (8) members must equally represent various segments of the MOH’s NHC. In addition, according to Additional Resource (D), five (5) members must have a background in ethical research and health, and eight (8) members must represent the theological, legal, health management, and other related professions. CONEP also has a coordinator and an Executive Secretariat that is selected by the NHC Conselho Nacional de Saúde (CNS). See ResolutionNo466, OSNo001/2013, ResolutionNo446, and Additional Resource (D) for detailed information on CONEP composition and responsibilities.

Registration, Auditing, and Accreditation
As per ResolutionNo466, ResolutionNo370, SP006REC, OSNo001/2013, and ResolutionNo446, all ECs (CEPs) must be registered and accredited by CONEP. Accreditation is carried out by CONEP’s Executive Secretariat who performs a documentation review to ensure compliance with the requirements idelineated in ResolutionNo370. Accreditation is granted for three (3) years. In order to apply for renewal, an EC (CEP) must follow the same procedures as in its initial application. The renewal application must be submitted within the window of 60 days before to 60 days after the accreditation’s expiration date. See ResolutionNo370 and SP006REC for additional details on CONEP’s accreditation process.

ADDITIONAL RESOURCES

(A) (Website) National Commission for Ethics in Research (CONEP) (Portuguese/Português) (Current as of October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(B) (Website) National Health Council (Portuguese/Português) (Current as October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(C) (Website) CONEP Members (Portuguese/Português) (Current as of March 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

(D) (Website) Bylaws of CONEP/CNS (Portuguese/Português) (June 6, 2001)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I and Chapter II (I)

(E) (Report) Brazilian R&D Status and Brazilian System for Ethical Analysis of Scientific Protocols Involving Human Subjects (2011)
Lopes, Aníbal Gil
European Group on Ethics in Science and New Technologies, Bureau of European Policy Advisers, European Commission

Relevant Section: CEP/CONEP System Role and Responsibilities

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter VII, Chapter IX, and Chapter XIII

(2) (Regulation) CNS Resolution No. 370, of March 8 2007 (ResolutionNo370 - Portuguese/Português)  (March 8, 2007)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: I (1, 2, and 4) and II

(3) (Guidance) Standard Procedures No. 006 – Evaluation of Research Ethics Committees (SP006REC - Portuguese/Português) (January 10, 2009)
National Health Council, Ministry of Health, Federative Republic of Brazil

(4) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: 2.3

(5) (Regulation) Resolution No. 446, 11 August 2011 (ResolutionNo446 - Portuguese/Português) (August 11, 2011)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Introduction, Section I, Section VII, and Section IX

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
As delineated in ResolutionNo9 and the PANDRH-GCPs, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) requires the sponsor, his/her designated contract research organization (CRO), or the sponsor-investigator to obtain ANVISA approval, and to ensure that the principal investigator (PI) obtains ethics committee (EC) approval from his/her institution (known as a Comitê de Ética em Pesquisas (CEP)). Per ResolutionNo466, the PANDRH-GCPs, and OSNo001/2013, the PI is responsible for submitting an application to the CEP/CONEP system via the online Plataforma Brasil to his/her institutional EC (CEP), and, if applicable, to the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) for review and approval. Applications with coordination or sponsorship originating outside of Brazil require additional EC review by CONEP, unless the co-sponsor is the Brazilian Government. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval.

ResolutionNo9, ResolutionNo466, and the PANDRH-GCPs indicate that the institutional EC (CEP) must review and approve all clinical trial applications prior to ANVISA initiating its review and approval process. Per ResolutionNo9, ANVISA’s approval of a clinical trial application is not dependent upon CONEP’s approval. ResolutionNo9 and the G-DDCM Manual also state that a clinical trial application is referred to as a Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE).

As per OSNo001/2013, in the instance of a multicenter clinical trial, the PI is required to submit a list of the participating institutions and the associated protocols as part of the research protocol package sent to the CEP for review.

Delivery Address for Clinical Trial Application
ANVISA
Setor de Indústria e Abastecimento (SIA)
Section 5, Special Area 57, Lot 200, Block D, 1st Basement
Brasília (DF)
CEP: 71205-050

Clinical Research Office Email: Pesquisaclinica@anvisa.gov.br

Assembly and Number of Copies
As per ResolutionNo9, applicants must submit one (1) hard copy of the clinical trial application and one (1) electronic copy on CD-ROM in Adobe Acrobat PDF, Microsoft Word, or OpenDocument file format. The electronic documents should also have text searching capability. Additional Resource (B) provides links to ANVISA’s clinical research application forms.

Clinical Trial Application Language Requirements
According to OSNo001/2013, G-DDCM Manual, and Additional Resource (C), the clinical trial application and associated documents (including the protocol, investigator brochure, informed consent form, and sponsor and institutional declarations), as well as all documentation provided to the CONEP/CEP System, must be translated into Portuguese.

ADDITIONAL RESOURCES

(A) (Website) Plataforma Brazil (Portuguese/Português) (Current as of October 19, 2015)
Ministry of Health, Federative Republic of Brazil

(B) (Form) Clinical Trial Application Submission Forms (Portuguese/Português) (Current as August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(C) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (Version 1) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III), Chapter II (Section I), and Chapter III (Sections I and II)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.3), Chapter 3 (Sections 3.1 and 3.3), Chapter 4 (Section 4.3), Chapter 5 (Sections 5.5 and 5.6), and Chapter 6 (Sections 6.10, 6.11, and 6.23)

(3) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter IX, Chapter X, and Chapter XI

(4) (Guidance) Operating Manual for Research Ethics Committees (4th Edition revised and updated) (OMREC - Portuguese/Português) (2008) (4th Edition revised and updated)
National Commission for Ethics in Research, National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter 9 (9.1)

(5) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(6) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)

ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
In accordance with ResolutionNo9 and the PANDRH-GCPs, the sponsor, his/her designated contract research organization (CRO), or the sponsor-investigator must apply to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA), and ensure that the principal investigator (PI) applies to his/her institutional ethics committee (EC) (known as a Comitê de Ética em Pesquisas (CEP)) to conduct a drug-related trial. ANVISA’s approval of a clinical trial application is dependent upon obtaining proof of the EC’s (CEP’s) approval. The clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). Applications with coordination or sponsorship originating outside Brazil also require an additional EC review by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP), unless the co-sponsor is the Brazilian Government. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval.

ANVISA Requirements
As per ResolutionNo9 and the G-DDCM Manual, the following documentation must be submitted to ANVISA in the clinical trial application (DDCM):

  • Clinical Trial Application Form (see Additional Resource (A))
  • Proof of Deposit Health Surveillance Rate (TFVS) as per ResolutionNo222 (tax payment imposed on individuals and companies engaged in clinical research)
  • Drug development plan
  • Investigator’s Brochure (IB)
  • Summary of investigational product’s (IP) safety aspects based on previous research in humans
  • Information on any discontinued development or withdrawal of IP
  • IP dossier
  • Specific dossier for each clinical trial to be conducted in Brazil
  • Clinical research protocol
  • Ethics in Research Committee (ERC) (also known as a CEP) opinion issued for the first clinical trial center
  • Proof of clinical trial registration with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) or other registry recognized by the International Committee of Medical Journal Editors (ICMJE)

See ResolutionNo9 and G-DDCM Manual, for detailed ANVISA application submission requirements.

EC Requirements
As per OMREC and OSNo001/2013, the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) requires applicants to submit the following documentation to the CEP/CONEP system via the online Plataforma Brasil:

  • Cover Sheet for Research Involving Humans (see Additional Resource (D))
  • Clinical research protocol
  • Statement of Commitment from Principal Investigator (PI)
  • Informed Consent Form (ICF) (See Informed Consent topic for additional information)
  • Research budget
  • PI and other researcher(s) CVs
  • Project schedule for research project

See OMREC and OSNo001/2013 for detailed CEP/CONEP system submission requirements.

Clinical Protocol
As delineated in the PANDRH-GCPs, OMREC, and OSNo001/2013, the clinical protocol should include the following elements:

  • Protocol summary
  • Sponsor or authorized representative name and contact information
  • PI CV and contact information
  • PI statement of responsibility
  • IP description (See Investigational Products topic for detailed coverage of this subject)
  • Form, dosage, route, method, and frequency of administration; and treatment period
  • Summary of potential risks and known benefits to research participants
  • Trial objectives and purpose
  • Trial design, random selection method, and blinding level
  • Participant selection/withdrawal
  • Participant treatment
  • Safety evaluation
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Statistics and methods to track trial data
  • Sponsor specifications for direct access to source data/documents
  • Quality control/quality assurance procedures and practices
  • Ethical considerations
  • Data management and record maintenance
  • Financing and insurance details
  • Publication policy

For complete protocol requirements, refer to the PANDRH-GCPs, OMREC, and OSNo001/2013.

ADDITIONAL RESOURCES

(A) (Form) Clinical Trial Application Submission Forms (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) National Commission for Ethics in Research (CONEP) (Portuguese/Português) (Current as of October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(C) (Website) Plataforma Brazil (Portuguese/Português) (Current as of October 19, 2015)
Ministry of Health, Federative Republic of Brazil

(D) (Website) International Clinical Trials Registry Platform (ICTRP) (Current as of October 19, 2015)
World Health Organization, Geneva, Switzerland

(E) (Form) Cover Sheet for Research Involving Humans (Portuguese/Português) (October 1999)
National Commission for Ethics in Research, National Health Council, Ministry of Health, Federative Republic of Brazil

(F) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (Version 1) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil


REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III), Chapter II (Section I), and Chapter III

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter II (Section 2.3), Chapter III (Sections 3.1 and 3.3), Chapter IV (Section 4.3), Chapter V (Sections 5.5 and 5.6), and Chapter VI (Sections 6.10, 6.11, and 6.23), and Chapter VIII

(3) (Regulation) Resolution – RDC No. 222 of 28 December 2006 (ResolutionNo222 - Portuguese/Português) (December 28, 2006)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter IV

(4) (Guidance) Operating Manual for Research Ethics Committees (4th Edition revised and updated) (OMREC - Portuguese/Português) (2008) (4th Edition revised and updated)
National Commission for Ethics in Research, National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter 9 (9.1)

(5) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(6) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
As stated in ResolutionNo9, ResolutionNo466, the PANDRH-GCPs, and OSNo001/2013, the institutional ethics committee (EC) (known as a Comitê de Ética em Pesquisas (CEP)) must review and approve all clinical trial applications prior to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) initiating its review and approval process. Applications with coordination or sponsorship originating outside of Brazil require an additional review and approval by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP), unless the co-sponsor is the Brazilian Government. CONEP coordinates the network of institutional ECs (CEPs) in Brazil. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval. Per ResolutionNo9, ANVISA’s approval of a clinical trial application is not dependent upon CONEP’s approval. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

ANVISA Approval
Although there are no official timelines specified in the regulatory documentation, according to Additional Resource (A), ANVISA’s review and approval process typically takes an average of four (4) to eight (8) weeks. ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). Additional Resource (A) states that prior to submitting a clinical trial application (DDCM) to ANVISA, the required documentation must be translated into Portuguese. Once the DDCM is submitted, ANVISA’s evaluation process is usually divided into two (2) phases: the first involves ensuring that all the required documentation for the clinical trial application is included; the second is the technical review of the application. As discussed in the Regulatory Authority topic, Regulatory Authority subtopic, ANVISA’s technical analysis is conducted by the Office of Clinical Research Coordination on Drugs and Biologicals (Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos (COPEC)). COPEC’s assessment consists of a scientific examination of the clinical protocol, the investigator’s brochure, and the informed consent form as delineated in ResolutionNo9. Sponsors can make requests by email (protocolo.clinico@anvisa.gov.br). See Additional Resource (C) for detailed submission information.

EC Approval
As delineated in OSNo001/2013, the institutional EC (CEP) is required to issue an initial report 30 days from the date the protocol documents are fully accepted for review. The CEP’s review of the protocol documentation for completeness should be accomplished within 10 days following submission.

Per ResolutionNo9, ResolutionNo466, the PANDRH-GCPs, and OSNo001/2013, the EC (CEP) must review and approve all clinical trial applications prior to ANVISA initiating its review and approval process. As earlier stated, CONEP must also review applications for which sponsorship or coordination originate outside of Brazil, unless the Brazilian Government co-sponsors the project. OSNo001/2013 indicates that the CONEP must issue its initial report for this additional review within 60 days from the date the documentation was accepted. CONEPs review of the protocol documentation for completeness should be accomplished within 15 days following submission. ANVISA and CONEP may conduct their reviews in parallel. ANVISA is not required to wait for CONEP’s approval once it finalizes its own approval of a clinical trial application. Refer to OSNo001/2013 for detailed information on CONEP’s review timeline. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for additional submission requirements.)

ADDITIONAL RESOURCES

(A) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) Global Health Regulatory Requirements DatabaseBrazil: Drugs (Updated November 18, 2014)
Global Health Technologies Coalition
Washington, DC

(C) (Website) ANVISA – How ANVISA Evaluates the Registration of New Drugs in Brazil (Portuguese/Português) (January 20, 2005)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III) and Chapter III (Sections I and II)

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter IX, Chapter X, and Chapter XI

(3) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.3), Chapter 3 (Section 3.1), Chapter 4 (Section 4.3), Chapter 5 (Sections 5.5 and 5.6), and Chapter 6 (Sections 6.10 and 6.11)

(4) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(5) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with ResolutionNo9 and the PANDRH-GCPs, a clinical trial can only commence after the sponsor, his/her designated contract research organization (CRO), or the sponsor-investigator receives permission from the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA), and ensures that the principal investigator (PI) obtains ethics committee (EC) approval from his/her institution (known as a Comitê de Ética em Pesquisas (CEP)). ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). Applications with coordination or sponsorship originating outside Brazil require an additional review and approval by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP), unless the co-sponsor is the Brazilian Government. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval. No waiting period is required following the applicant’s receipt of these approvals.

In addition, as per ResolutionNo9, the sponsor or his/her designated CRO is required to obtain an import license for the shipment of the investigational product (IP) to be used in the trial. (See the Investigational Products topic, Manufacturing & Import subtopic for addtional information). As stated in the PANDRH-GCPs and ResolutionNo9, all investigators must possess appropriate qualifications, training, and experience. The trials should be conducted in compliance with the PANDRH-GCPs, ResolutionNo466, and ResolutionNo9. In addition, all clinical trials must be conducted in a laboratory complying with the Organisation for Economic Co-operation and Development’s Good Laboratory Practices as mandated by Brazil’s National Institute of Metrology, Quality and Technology (INMETRO).

The PANDRH-GCPs also states that before the trial begins, the sponsor or his/her CRO must sign a formal legal agreement or contract with each participating institution(s). As per the PANDRH-GCPs, if a sponsor decides to engage a CRO to conduct the trial, a letter of agreement should be submitted to ANVISA. (See the Sponsorship topic, Commencement of a Trial subtopic for more details).

As delineated in ResolutionNo9, it is mandatory for all applicants to register their clinical trials with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) or other registry recognized by the International Committee of Medical Journal Editors (ICMJE).

Clinical Trial Agreement
As delineated in the PANDRH-GCPs, the sponsor or his/her CRO must sign an agreement or contract with the participating institution(s) and the investigator. In addition, if a sponsor decides to engage a CRO to conduct the trial, a letter of agreement should also be submitted to ANVISA as specified in the PANDRH-GCPs and ResolutionNo9.

EC Confirmation of Review and Approval
ResolutionNo466, the PANDRH-GCPs, and ResolutionNo9 mandate that the sponsor obtain confirmation of EC review and approval from the investigator(s) or institution(s) prior to the trial’s commencement. The PANDRH-GCPs also state that the sponsor must receive the following information prior to the trial’s commencement:

  • EC member profiles (names and addresses)
  • Documented approval of EC’s favorable opinion
  • Copy of EC recommendations in case it has based its approval on change(s) in any aspect of the study (e.g., protocol modifications, written informed consent form, or any other written information or other procedures)

The sponsor should also obtain documentation and dates relating to any EC re-evaluations, re-approvals, withdrawals, or suspensions of approval from the investigator. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Clinical Trials Registry
As delineated in ResolutionNo9, it is mandatory for all applicants to register their clinical trials with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) or other registry recognized by the International Committee of Medical Journal Editors (ICMJE).

Data Safety and Monitoring Board
According to ResolutionNo9, an Independent Safety Monitoring Committee should be established to systematically and evaluate aggregate adverse event/adverse drug reaction data.

ADDITIONAL RESOURCES

(A) (Website) INMETRO – CGCRE as the Brazilian Compliance Monitoring Authority for the Principles of Good Laboratory Practices – GLP: Background and Adherence to OECD (Portuguese/Português) (Current as October 19, 2015)
National Institute of Metrology, Quality and Technology (INMETRO), Ministry of Development, Industry and Foreign Trade, Federative Republic of Brazil

(B) (Website) INMETRO – GLP Monitoring (Portuguese/Português) (Current as of October 19, 2015)
National Institute of Metrology, Quality and Technology (INMETRO)
Ministry of Development, Industry and Foreign Trade, Federative Republic of Brazil

(C) (Document) OECD Principles on Good Laboratory Practice (GLPs) (as revised in 1997) (1998) (OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring – Number 1)
Environment Directorate, Organisation for Economic Co-operation and Development

(D) (Website) International Clinical Trials Registry Platform (ICTRP) (Current as of October 19, 2015)
World Health Organization, Geneva, Switzerland

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter IX, Chapter X, and Chapter XI

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III), Chapter II (Section I), Chapter III (Sections I and II), and Chapter VII (Section I)

(3) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.3), Chapter 3 (Section 3.1), Chapter 4 (Section 4.3), Chapter 5 (Sections 5.1, 5.5 and 5.6), and Chapter 6 (Sections 6.2, 6.10, and 6.11)

(4) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

Overview
In accordance with the PANDRH-GCPs and ResolutionNo9, the following definitions provide a basis for a common understanding of Brazil’s safety reporting requirements:

  • Adverse Event/Experience (AE) – Any adverse medical occurrence in a research participant to whom a drug product was administered, and which does not necessarily bear a causal relationship to the treatment
  • Adverse Drug Reaction or Adverse Reaction (ADR) – All harmful unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any unfavorable occurrence that at any dose: results in death, is life-threatening, requires or extends patient hospitalization, results in persistent or significant disability, or is a birth defect or congenital anomaly
  • Unexpected Adverse Drug Reaction – One whose nature or severity is inconsistent with the applicable product information (i.e., the investigator’s brochure for an unapproved investigational product (IP), or package insert/summary of the characteristics of an approved product)


Reporting Requirements for AEs/ADRs
Investigator Responsibilities
As specified in ResolutionNo9, the investigator must inform the sponsor within 24 hours of all SAEs/SADRs occurring during the study. The PANDRH-GCPs also states that the immediate reports should be followed promptly by detailed, written reports in which the participants are identified by unique code numbers. AEs/ADRs identified in the protocol as critical to safety evaluations should also be reported to the sponsor. In the event of a participant’s death, the investigator must provide the sponsor and the ethics committee (EC) (known as a Comitê de Ética em Pesquisas) (CEP)) with any additional requested information (e.g., autopsy reports and terminal medical reports).

Sponsor Responsibilities
As per ResolutionNo9, the sponsor should ensure all relevant information pertaining to fatal or life-threatening SAEs/SADRs is documented and electronically reported to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) no more than seven (7) days after first knowledge. Any additional information should be included in the application up to eight (8) calendar days from the notification date. All other AEs/ADRs whose causality is possible, probable, or definite for the products under investigation should be reported to ANVISA within 15 calendar days from the date of first knowledge by the sponsor.

The PANDRH-GCPs states that the sponsor is also required to notify all concerned investigator(s), institution(s), and ANVISA of findings that could adversely affect participant safety, impact the conduct of the trial, or alter the ethics committee’s (EC’s) (CEP’s) approval of the trial. In addition, ResolutionNo9 specifies that the sponsor must submit to ANVISA annual safety update reports on the development of the IP. The annual report must be filed within a maximum of 60 calendar days starting from the date that ANVISA’s approves the clinical trial application (also referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)).

Form Completion & Delivery Requirements
The Form for Reporting SAEs in Clinical Research and Drug Products For Health (Formulário para Notificação de Eventos Adversos em Pesquisa Clínca de Medicamentos Produtos para saúde) (Additional Resource (A)) should be used to complete SAE/SADR reports. Additional Resource (C) provides a link to the electronic form. The form must be submitted via ANVISA's computerized system, the National Notification System for Sanitary Surveillance (NOTIVISA).

The forms should be sent to:

NOTIVISA (National Notification System for Sanitary Surveillance)
ANVISA
Setor de Indústria e Abastecimento (SIA)
Section 5, Special Area 57, Lot 200, Block D, 1st Basement
Brasília (DF)
CEP: 71205-050

For questions regarding submitting AE/ADR reporting forms to NOTIVISA, contact ANVISA’s clinical research department at pesquisaclinica@anvisa.gov.br.

Data Safety and Monitoring Board
According to ResolutionNo9, an Independent Safety Monitoring Committee should be established to systematically evaluate and aggregate AE/ADR data.

ADDITIONAL RESOURCES

(A) (Form) Form for Reporting SAEs in Clinical Research and Drug Products For Health (Portuguese/Português) (Current as of October 19, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) Questions and Answers About the Operation of NOTIVISA (Portuguese/Português) (Current as of October 19, 2015)
NOTIVISA (National Notification System for Sanitary Surveillance), ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Answer No. 4

(C) (Website) ANVISA – Notifications to the National Health Surveillance - Notivisa Notifications to the National Health Surveillance – Notivisa (Portuguese/Português) (Current as of August 4, 2016)
NOTIVISA (National Notification System for Sanitary Surveillance), ANVISA, Ministry of Health, Federative Republic of Brazil

(D) (Website) ANVISA – National Notification System for Sanitary Surveillance – NOTIVISA (Portuguese/Português) (Current as of October 19, 2015)
NOTIVISA (National Notification System for Sanitary Surveillance), ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 5 (5.11), Chapter 6 (6.5, 6.16, and 6.17) and Chapter 9

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III) and Chapter VII

Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

Overview
In accordance with the PANDRH-GCPs, ResolutionNo9, and ResolutionNo251, the investigator and the sponsor share responsibility for submitting progress reports on the status of a clinical trial. The sponsor is responsible for submitting a final report.

Interim/Progress Reports
As per ResolutionNo9, the sponsor must file periodic reports to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA). ResolutionNo9 also states that the sponsor is responsible for submitting annual clinical trial protocol monitoring report(s) to ANVISA. The report(s) should contain the following information for each clinical trial protocol, in tabulated form, exclusively from Brazilian centers:

  • Trial title
  • Protocol code
  • Participant(s) status
  • Number of participants recruited by center
  • Number/description of deviations and protocol violations by center
  • Description of all adverse events/adverse drug reactions occurring by center

The annual report should be submitted to ANVISA in the form of a secondary petition attached to the respective protocol to which it is linked. The report should be filed within 60 calendar days from the annual anniversary date of the beginning of the trial in Brazil.

The PANDRH-GCPs and ResolutionNo251 also require the investigator to submit half-yearly reports to the ethics committee (EC).

Final Reports
As specified in the PANDRH-GCPs, upon the trial’s completion, the investigator or the institution should provide the sponsor with all required reports, present the EC with a summary of the trial’s outcome, and supply any additional report(s) required by ANVISA. ResolutionNo9 states that the sponsor should submit a final report to ANVISA. The final report must be filed within 12 months of the clinical trial end date. (See Chapter VII, Section II of ResolutionNo9 for detailed final report requirements).

ADDITIONAL RESOURCES

(A) (Form) ANVISA – Final Report Template (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 5 (5.10 and 5.13)

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter VII

(3) (Regulation) National Health Council Resolution No. 251, Dated 7 August 1997 (ResolutionNo251) (Portuguese/Português) (August 7, 1997)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: III.2

Sponsorship > Definition of Sponsor
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SUMMARY

Overview
As per ResolutionNo466, ResolutionNo9, and the PANDRH-GCPs, a sponsor is defined as an individual, company, institution, or organization that supports research through the initiation, management, or financing of a clinical trial.

ResolutionNo9 states that a sponsor can authorize a contract research organization (known as a Contract Clinical Research Organization (CRO) in Brazil) to carry out certain work and obligations regarding the trial. As delineated in ResolutionNo9, any trial-related responsibilities to be transferred and assumed by a CRO should be specified in a written agreement or contract. In addition, a CRO can only submit a clinical trial application on the sponsor’s behalf when the sponsor has no headquarters or subsidiary in Brazil.

As delineated in ResolutionNo9, when a clinical trial is developed by a sponsor-investigator, the institution with which the individual is linked is the primary sponsor. The primary sponsor may delegate responsibilities to the researcher, who will be responsible for conducting the clinical trial at the institution, and the sponsor-investigator will serve as the secondary sponsor.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter II (11)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 9

(3) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 –English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III), Chapter II (Sections I and III), and Chapter III (Section I)

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with ResolutionNo9 and the PANDRH-GCPs, the sponsor, his/her designated contract research organization (CRO), or the sponsor-investigator must apply to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA), and ensure that the principal investigator (PI) applies to his/her institutional ethics committee (EC) (known as a Comitê de Ética em Pesquisas (CEP)) to conduct a drug-related trial. ANVISA’s ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE). As per ResolutionNo9, DDCM submissions to ANVISA can only be made by a CRO when the sponsor has no headquarters or subsidiary in Brazil.

To complete the clinical trial application package (DDCM), the sponsor, the designated CRO, or the sponsor-investigator must submit ANVISA’s Clinical Trial Application Form (see Additional Resource (A)). In addition to the completed application, ResolutionNo9 indicates that the sponsor must also provide the following:

  • Clinical research protocol
  • Proof of Deposit Health Surveillance Rate (TFVS) as per ResolutionNo222 (tax payment imposed on individuals and companies engaged in clinical research)
  • Drug development plan
  • Certified copy of the clinical agreement (contract or statement) that has been written, dated, and signed by the sponsor or his/her CRO
  • Ethics in Research Committee (ERC) (also known as a CEP) opinion issued for the first clinical trial center
  • Investigator’s Brochure (IB)
  • Summary of investigational product’s (IP’s) safety aspects based on previous research in humans
  • Information on any discontinued development or withdrawal of IP
  • IP dossier
  • Specific dossier for each clinical trial to be conducted in Brazil
  • Proof of clinical trial registration with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) or other registry recognized by the International Committee of Medical Journal Editors (ICMJE)


(See the Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements.)

ADDITIONAL RESOURCES

(A) (Form) Clinical Trial Application Submission Forms (Portuguese/Português) (Current as August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Website) National Commission for Ethics in Research (CONEP) (Portuguese/Português) (Current as of October 19, 2015)
National Health Council, Ministry of Health, Federative Republic of Brazil

(C) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III), Chapter II (Section I), and Chapter III (Sections I and II)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 6 (6.10)

(3) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(4) (Guidance) Operational Standard No. 001/2013 (OSNo001/2013) (Portuguese/Português) (September 30, 2013)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

(5) (Regulation) Resolution – RDC No. 222 of 28 December 2006 (ResolutionNo222 - Portuguese/Português) (December 28, 2006)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter IV

Sponsorship > Insurance
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SUMMARY

Overview
As set forth in the PANDRH-GCPs, the sponsor is responsible for providing insurance coverage for any unforeseen injury to research participants. Before the clinical trial begins, the sponsor should also provide insurance or indemnify the investigator and the institution against claims arising from malpractice or negligence.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 6 (6.8.1)

Sponsorship > Compensation
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SUMMARY

Overview
As specified in the PANDRH-GCPs and ResolutionNo466, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. The sponsor must also ensure that participants who suffer any trial-related injuries are provided with free medical treatment for such injuries.

As per ResolutionNo466, participants may also be compensated for travel expenses incurred while participating in the trial.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter V (7)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 6 (6.8.2)

Sponsorship > Quality, Data & Records Management
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SUMMARY

Overview
As stated in ResolutionNo9 and the PANDRH-GCPs, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, the PANDRH-GCPs, and other applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed.

The sponsor must also obtain the investigator(s) and the institution(s) agreement to:

  • conduct the trial in compliance with the PANDRH-GCPs, applicable regulatory requirement(s), and the protocol agreed to by the sponsor and approved by the ethics committee (EC) (known as a Comitê de Ética em Pesquisas) (CEP))
  • comply with data recording and reporting procedures
  • permit monitoring, auditing, and inspection
  • retain essential documents until the sponsor informs them that they are no longer needed


Electronic Data Processing System
When using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance, and that he/she maintains SOPs for using these systems. Refer to the PANDRH-GCPs for detailed information on electronic trial data systems.

Record Management
As set forth in ResolutionNo9, the sponsor should maintain the clinical trial data on file, physical or digital, for a period of five (5) years after the last approval of a request for registration in Brazil. ResolutionNo9 and the PANDRH-GCPs also state that the sponsor should retain clinical trial data, physical or digital format, for at least two (2) years in the case of discontinuing the investigational product’s clinical development, completion of the application for registration is not achieved, or, after the last approval of a marketing application, until there are no pending or contemplated marketing applications. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

Audit Requirements
As part of its QA system, ResolutionNo9 and the PANDRH-GCPs notes that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with his/her own SOPs, the auditor observations are documented, and data is available as needed for the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) review. No specific timeframe is provided for the audit process.

Premature Study Termination/Suspension
The PANDRH-GCPs state that if the sponsor chooses, or is required to terminate a study, the investigator(s) should promptly inform the institution, and the investigator or institution should also immediately inform the EC and provide a detailed explanation of the termination or suspension.

Multicenter Studies
In the event of a multicenter clinical trial, the sponsor should ensure that all investigators conduct the trial in strict compliance with the protocol, the ANVISA, and the EC (CEP).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter II (Section I)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 5 (5.12.3), Chapter 6 (6.1, 6.5, 6.19, 6.5.10, 6.6.4, and 6.23.1)

Sponsorship > Site/Investigator Selection
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SUMMARY

Overview
As set forth in the PANDRH-GCPs, the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure. Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. The sponsor must also sign an agreement or contract with the participating institution(s). If a multicenter trial is going to be conducted, the sponsor must organize a coordinating committee or select coordinating investigators.

(See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional information on clinical trial application requirements).

Data Safety and Monitoring Board
According to ResolutionNo9, an Independent Safety Monitoring Committee should be established to systematically evaluate aggregate adverse event/adverse drug reaction data.

Foreign Sponsor Responsibilities
As specified in the PANDRH-GCPs and ResolutionNo9, the sponsor may transfer his/her study related duties and functions to a contract research organization (CRO). However, he/she is ultimately responsible for the study data’s quality and integrity. Any study related duties, functions or responsibilities transferred to and assumed by a local representative or CRO must be specified in writing. Other duties, functions, or responsibilities not specifically transferred shall be deemed to have been retained by the sponsor. However, as per ResolutionNo9, a CRO can only submit a clinical trial application on the sponsor’s behalf when the sponsor has no headquarters or subsidiary in Brazil.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 5 (5.6.2), Chapter 6 (6.2.1, 6.5.1, 6.5.2, 6.6)

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter II (Section I) and Chapter VII (Section I, Subsection I)

Informed Consent > Documentation Requirements
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SUMMARY

Overview
In all Brazilian clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the PANDRH-GCPs, ResolutionNo466, and the G-ClinRes.

As per the PANDRH-GCPs, ResolutionNo466, and the G-ClinRes, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) and provided to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on contents to be included in the form.)

The PANDRH-GCPs and the G-ClinRes state that the investigator, or his/her designated representative, must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). As delineated in ResolutionNo466, PANDRH-GCPs, and the G-ClinRes, the ICF content should be briefly and clearly presented orally, and in writing, and in a manner that is easy to understand, commensurate with the comprehension level of the research participants, and without coercion or unduly influencing a potential participant to enroll in the clinical trial. When drafting and presenting the ICF, special consideration must be taken with regard to the participant’s culture, traditional values, intelligence, and education. The participant, and his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Re-Consent
According to the PANDRH-GCPs, the G-ClinRes, ResolutionNo9, and the G-SubmissionAmdts, any change in the ICF due to a protocol modification or an alteration in treatment modality, procedures, or site visits, should be approved by the EC, and submitted to ANVISA before such changes are implemented. The participant and/or his/her legal representative(s) or guardian(s) will also be required to sign the revised ICF.

Language Requirements
Additional Resource (A) state that the clinical trial application and associated documents (including the protocol, investigator brochure, ICF, and sponsor and institutional declarations), as well as all documentation provided to the ECs, must be translated into Portuguese. The PANDRH-GCPs and the G-ClinRes also require the ICF to be presented orally and in writing at a level that the participant is able to understand.

Documentation Copies
The PANDRH-GCPs and the G-ClinRes state that the participant and/or the participant’s legal representative(s) or guardian(s), and the investigator(s) must sign and date the ICF. Where the participant is illiterate, and/or his/her legal representative(s) or guardian(s) is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness.

Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant and/or his legal representative(s) or guardian(s) should also receive a copy of any updates to the signed and dated ICF.

ADDITIONAL RESOURCES

(A) (Report) Regulatory Cultures and Research Governance (2013)
Manville, Cal; Hackett, Petal Jean; Gunashhekar, Salil; Jones, Molly Morgan
RAND Europe

Relevant Section: Chapter 3 (3.1.2)

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.6), Chapter 3 (3.1.8), Chapter 4 (Sections 4.1, 4.2, and 4.3), and Chapter 5 (Section 5.5), Annex 3

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter II (Section 2) and Chapter IV (Sections 1 and 2)

(3) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

(4) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter V

(5) (Guidance) Submission Manual for Modifications, Amendments, Suspensions and Cancellations (v.1) (G-SubmissionAmdts - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: 2. Amendments to DDCM (Modificações ao DDCM)

Informed Consent > Required Elements
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SUMMARY

Overview
As delineated in the PANDRH-GCPs, prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) approval for the written informed consent form (ICF), and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

The PANDRH-GCPs and the G-ClinRes, state that information about the research study should be presented in easily understandable and unambiguous language in both written and oral form. The potential research participant, and/or his/her legal representative(s) or guardian(s), should be given sufficient time to inquire about the details of the research study and have all questions answered to his/her satisfaction.

No Coercion
As per the PANDRH-GCPs, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant and/or his/her legal representative(s) and/or guardian(s) to waive or to appear to waive his/her legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence.

ICF Required Elements
Based on the PANDRH-GCPs and ResolutionNo466, the ICF should include the following statements or descriptions, as applicable:

  • The study purpose, the procedures, and duration of the trial
  • The participant’s responsibilities
  • Experimental aspects of the study
  • The approximate number of participants in the study
  • Any expected risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
  • Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point
  • Treatments available to participants, how they are administered, and the probability of receiving every treatment
  • Compensation and/or treatment available for the participant in the case of trial-related injury
  • The disclosure of specific appropriate alternative procedures or therapies available to the participant
  • The probability for random assignment to each treatment
  • Any expenses the participant needs to pay to participate in the trial
  • Confidentiality of records identifying the participant will be maintained, and permission given to monitors, auditors, the EC, and the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) to access the participant’s medical records to verify the procedures or trial data, without violating the participant’s confidentiality, insofar as the applicable laws and regulations permit
  • That participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
  • Contact information for the sponsor and investigator in the event of participant problems or trial-related injuries
  • Foreseeable circumstances under which the investigator(s) may remove the participant without his/her consent
  • The consequences of a participant’s decision to withdraw from the research, and procedures for orderly withdrawal by the participant
  • That the participant and/or his/her legal representative(s) or guardian(s) will be notified in a timely manner if significant new findings develop during the course of the study which may affect the participant's willingness to continue


See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Population subtopic and the Specimens topic, Consent for Specimens subtopic for further information.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 (Section 2.6), Chapter 3 (3.1.8), Chapter 4 and Chapter 5 (Section 5.5), Annex 3

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter III and Chapter IV

(3) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

Informed Consent > Compensation Disclosure
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SUMMARY

Overview
In accordance with the PANDRH-GCPs, and the G-ClinRes, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial.

Compensation for Participation in Research
As specified in ResolutionNo466 and the G-ClinRes, compensation to participants is prohibited other than to provide transportation costs and meals to the participants and their legal representative(s) during the trial.

Compensation for Injury
As per ResolutionNo466, the G-ClinRes, and the PANDRH-GCPs, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter 2 (Sections 18 and 21), Chapter 4 (Section 3(g)), and Chapter V (Section 7)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 4 (Section 4.4)

(3) (Guidance)Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

Informed Consent > Participant Rights
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SUMMARY

Overview
In accordance with ResolutionNo466 and the PANDRH-GCPs, Brazil’s ethical standards promote respect for all human beings and safeguard the rights of research participants, including the right of their autonomy, culture, beliefs, and values. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Informed Consent topic, and the subtopics of Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw
As set forth in the ResolutionNo466, the PANDRH-GCPs, and the G-ClinRes, the participant, or his/her legal representative(s) or guardian(s), should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information
As delineated in the ResolutionNo466, the PANDRH-GCPs, and the G-ClinRes, a potential research participant, and/or his/her legal representative(s) or guardian(s), has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality
As per the ResolutionNo466, the PANDRH-GCPs, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The PANDRH-GCPs also state that it is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal
The PANDRH-GCPs states that the research participant, and/or his/her legal representative(s) or guardian(s), should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or to appeal against a violation of his/her rights. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare
ResolutionNo466 and PANDRH-GCPs clearly state that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 2 and Chapter 4

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter III and Chapter IV (Sections 1, 2, and 3)

(3) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

Informed Consent > Special Circumstances/Emergencies
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SUMMARY

Overview
The PANDRH-GCPs and the G-ClinRes make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances, including medical emergencies.

Medical Emergencies
As per the PANDRH-GCPs, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of his/her legal representative(s) or guardian(s) should be obtained. If the prior consent of the participant or his/her legal representative(s) or guardian(s) cannot be obtained, the ethics committee must provide documented approval in order to protect the participant’s rights, safety, and well-being, pursuant to the applicable regulations. The participant or his/her legal representative(s) or guardian(s) should provide consent as soon as possible.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 4 (Section 4.3.19)

(2) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

Informed Consent > Vulnerable Populations
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
As per the PANDRH-GCPs and the G-ClinRes, in all Brazilian clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The PANDRH-GCPs, ResolutionNo466, and the G-ClinRes, characterize vulnerable populations as those who are relatively (or absolutely) incapable of protecting their own interests due to a lack of autonomy, intelligence, education, resources, strength, or other necessary attributes. These participants may include those with incurable diseases, people in convalescent homes, the unemployed or indigent, patients in emergency situations, ethnic minorities, homeless people, seasonal workers, refugees, minors, and those who cannot give their consent.

The ResolutionNo466 and PANDRH-GCPs specify that ethics committees (ECs) must pay special attention to protecting participants who are from vulnerable populations. If the EC regularly evaluates studies involving vulnerable populations, it should consider including members or consultants who know or have had experience working with the group in question. The G-ClinRes also states that vulnerable groups should not be included unless the research is necessary to promote the health of the population represented, and this research cannot instead be performed on legally competent participants.

See the Informed Consent topic, and the subtopics of Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these vulnerable populations.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 3 (Section 3.1 and 3.2.10) and Chapter 9

(2) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

(3) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter II (25),Chapter III(2(j)), and Chapter IV (6(a))

Informed Consent > Children/Minors
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
The applicable regulatory requirements do not specify the age of minors.

As per PANDRH-GCPs, ResolutionNo466, and the G-ClinRes, when the research participant is a child, the informed consent form must be signed by the child’s legal representative(s) and/or guardian(s). All pediatric participants, however, should be informed to the fullest extent possible about the study in language and terms that they are easily able to understand.

As stated in the G-ClinRes, children should only participate in clinical studies when their participation is necessary to promote the health of the population represented, and this research cannot be performed on other legally competent participants.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 4 (Section 4.3.17)

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter 4 (Section 6)

(3) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
As per ResolutionNo466 and the PANDRH-GCPs, any Brazilian clinical studies involving women of childbearing age or who are pregnant, require additional safeguards to ensure that the research assesses the risks and benefits as well as any potential impact on fertility, pregnancy, the embryo or fetus, labor, lactation, and the newborn. The research must be approved by the ethics committee prior to conducting the study, and the research must be deemed justifiable for the benefit of its participants.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Annex 3

(2) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter III(2(r))

Informed Consent > Prisoners
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
According to the PANDRH-GCPs, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. ResolutionNo466 also states that freedom of consent must be guaranteed to those research participants who are fully competent, but are exposed to specific constraints or have restricted autonomy. These participants must have the freedom to decide whether or not to participate without any fear of reprisal.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter IV (Section 6)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 9

Informed Consent > Mentally Impaired
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
According to ResolutionNo466 and the G-ClinRes, the ethics committee must approve the participation of research participants who are mentally or physically incapable of giving consent, and sufficient justification must be provided for involving this population in a study. As delineated in the PANDRH-GCPs, consent should only be provided once the participant is informed about the study, to the extent that he/she is able to understand it, and if able, should sign and date the written informed consent in person. The participant’s legal representative(s) or guardian(s) must also be present during the informed consent process and sign and date the informed consent form.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter 4 (Section 6)

(2) (Guidance) Guidance for Participants in Clinical Research (G-ClinRes - Portuguese/Português) (December 2012)
ANVISA, Ministry of Health, Federative Republic of Brazil

(3) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 4 (Section 4.3.17)

Investigational Products > Definition of Investigational Product
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Last content review/update: October 18, 2015. Submit updates or comments.
SUMMARY

Overview
As delineated in the PANDRH-GCPs and ResolutionNo9, an investigational product is defined as a dosage form of an active ingredient or placebo that is being tested or used as a reference (also known as a comparator) in a clinical trial. The PANDRH-GCPs states that this includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, or when it is used to gain further information about an approved use.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 9

(2) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter I (Section III)

Investigational Products > Manufacturing & Import
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
According to ResolutionNo9, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) is responsible for authorizing the manufacture of investigational products (IPs) in Brazil. ANVISA approves the manufacture of an IP as part of its review and approval of the clinical trial application.

Per ResolutionNo9, ANVISA is also responsible for authorizing the import of IPs. The sponsor may apply for an import license at the same time that he/she submits the clinical trial application to ANVISA. ANVISA issues a Special Bulletin (SB), a Specific Special Bulletin (SSB), or a Document for Importation of Product(s) under investigation by the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). An SB is an authorizing document ANVISA issues upon review and approval of the DDCM and can be used for IP import/export requests; an SSB is an ANVISA document issued to permit the sponsor to import/export an IP while his/her DDCM is still awaiting review and is within ANVISA’s 90-day approval window; a Document for Import of Product(s) under investigation by the DDCM is issued in the case of non-manifestation of the DDCM. The sponsor is required to present one of these ANVISA documents at the location where IPs for import or export are unloaded. (See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III), Chapter III (Section I) and Chapter IX

(2) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Investigational Products > IMP/IND Quality Requirements
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with ResolutionNo9 and the PANDRH-GCPs, the sponsor is responsible for providing investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

IB Content Requirements
Additional Resource (B) states that the IB has to provide coverage for the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and postmarketing experiences)
  • Summary of data and guidance for the investigator(s), and
  • Bibliography
  • See Annex 2 (Section 7.5) of Additional Resource (B) for detailed content guidelines.


The sponsor is also accountable for supplying the IP, including the comparator(s) and placebo, if applicable. As defined in the PANDRH-GCPs, he/she must ensure that the products are manufactured in accordance with the Good Manufacturing Practices as laid down in ResolutionNo17. (See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

ADDITIONAL RESOURCES

(A) (Guidance) Questions and Answers on the Resolution RDC No. 17/2010 on Good Manufacturing Practices (Portuguese/Português) (October 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.13, and 7.5 (Appendix 2)

(C) (Document) Questions and Answers RDC 09/2015 (Version 1) (Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter III (Sections I and II)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 6 (6.6.3, 6.12.2, 6.13.1, 6.13.2,6.13.3, 6.13.4, 6.13.5, 6.14, and 6.5.11), Annex 5 (1)

(3) (Regulation) RDC Resolution No. 17 of 16 April 2010 (ResolutionNo17 - Portuguese/Português) (April 16, 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

Investigational Products > Labeling & Packaging
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in Brazil must comply with the requirements set forth in ResolutionNo9, the PANDRH-GCPs, G-IPLabel, and Additional Resource (A). The G-IPLabel states that for an IP to be used in a clinical trial, it must be properly labeled in the official language of the country in which the product is to be used. As set forth in ResolutionNo9 and G-IPLabel, the following labeling information must be included on the primary package label (or any intermediate packaging), and the outer packaging:

  • Name, address, and telephone number of the sponsor, contract research organisation (CRO), or investigator
  • Pharmaceutical dosage form, route of administration, quantity of dosage units, and in the case of open trials, the name/identifier and strength/concentration
  • Batch and/or code number to identify the contents and packaging operation
  • Trial reference code allowing identification of the trial, site, investigator, and sponsor (if not given elsewhere)
  • Trial participant identification number/treatment number and where relevant, the visit number
  • Investigator name (if not already included above)
  • Instructions for use (reference may be made to a leaflet or other explanatory document intended for the trial participant or person administering the product)
  • “For exclusive use in clinical trial”
  • Storage conditions
  • Expiration date (use by date, expiration date, or re-test date as applicable), in month/year format and in a manner that avoids any ambiguity
  • “KEEP OUT OF REACH OF CHILDREN”

In addition, the PANDRH-GCPs and Additional Resource (A) state that the IP be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. (See Investigational Products topic, Product Management subtopic for additional information on IP labeling requirements).

ADDITIONAL RESOURCES

(A) (Guidance) Handbook for Good Clinical Practice – ICH (Portuguese Brazil) (Harmonized tripartite version) (Portuguese/Português) (January 1997) (Harmonized tripartite version)
International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 5.13.1

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter II (Section I) and Chapter III (Section I)

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Section: Chapter 6 (6.13.1)

(3) (Guidance) Product Labels for Clinical Research (G-IPLabel - Portuguese/Português) (Current as of August 12, 2013)
ANVISA, Ministry of Health, Federative Republic of Brazil

Investigational Products > Product Management
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with ResolutionNo9 and the PANDRH-GCPs, the sponsor is responsible for providing investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) obtained through the earlier research phases, including preclinical, toxicological, safety, efficacy, and adverse events data. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
As delineated in ResolutionNo9 and the PANDRH-GCPs, the sponsor must also supply the investigator(s)/institution(s) with the IP(s), including the comparator(s) and placebo, if applicable. The sponsor should not supply either party with the IP(s) until the ethics committee (EC) (known as a Comitê de Ética em Pesquisas) (CEP)) approves the clinical trial application (known as the Drug Clinical Development Dossier (DDCM)), and the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) issues a Special Bulletin (SB), a Specific Special Bulletin (SSB), or a Document for Importation of Product(s) under investigation by the (DDCM). An SB is an authorizing document ANVISA issues upon review and approval of the DDCM and can be used for IP import/export requests; an SSB is an ANVISA document issued to permit the sponsor to import/export an IP while his/her DDCM is still awaiting review and is within ANVISA’s 90-day approval window; a Document for Import of Product(s) under investigation by the DDCM is issued in the case of non-manifestation of the DDCM. The sponsor is required to present one of these ANVISA documents at the location where IPs for import or export are unloaded.

Per ResolutionNo9 and the PANDRH-GCPs, the sponsor must ensure that the qualitative information and specifications include the following:

  • IP product quality and stability over the period of use
  • IP manufactured according to good manufacturing practices (GMPs) as per ResolutionNo9 and ResolutionNo17
  • Proper coding, packaging, and labeling of the IP(s)
  • IP use record including information on the quantity, loading, shipment, receipt, dispensing, handling, reclamation, and destruction of the unused IP
  • Acceptable storage temperatures, conditions, and times for the IP
  • Written procedures including instructions for handling and storage of the IP, adequate and safe receipt, dispensing, retrieval of unused IP(s), and return of unused IP(s) to the sponsor
  • Timely delivery of the IP(s)
  • Establishment of management and filing systems for the IPs

Refer to ResolutionNo9 and PANDRH-GCPs for detailed sponsor-related IP requirements.

Record Requirements
Per the PANDRH-GCPs, the sponsor is required to maintain records that document shipment, receipt, disposition, return, and destruction of the IPs. He/she must also maintain a system for retrieving IPs and documenting this retrieval, and maintain a system for the disposition of unused IPs. Finally, the sponsor should maintain sufficient samples from each batch and keep a record of their analyses and characteristics for reference so that, if necessary, an independent laboratory could reconfirm the same data.

The sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed.

As set forth in the PANDRH-GCPs, sponsor-specific essential documents should also be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the IP’s clinical development.

ADDITIONAL RESOURCES

(A) (Guidance) Questions and Answers on the Resolution RDC No. 17/2010 on Good Manufacturing Practices (Portuguese/Português) (October 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

(B) (Guidance) Handbook for Good Clinical Practice – ICH (Portuguese Brazil) Harmonized tripartite version) (Portuguese/Português) (January 1997)
International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: Annex 2 (7.5)

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Sections I, II, and III), Chapter II (Section I), Chapter III (Sections I and II), Chapter IX, and Chapter X

(2) (Guidance) Good Clinical Practices – Document of the Americas (PANDRH-GCPs) (Portuguese/Português) (March 2005)
IV Pan American Conference on Drug Regulatory Harmonization, Pan American Health Organization, Dominican Republic

Relevant Sections: Chapter 6 (6.6.3, 6.12.2, 6.13.1, 6.13.2,6.13.3, 6.13.4, 6.13.5, 6.14, and 6.5.11), Annex 5 (1)

(3) (Regulation) RDC Resolution No. 17 of 16 April 2010 (ResolutionNo17 - Portuguese/Português) (April 16, 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

Specimens > Definition of Specimen
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
As per OrdinanceNo2201, a specimen is defined as any biological material such as organs, tissues, and body fluids, obtained from a single participant at a particular time.

OrdinanceNo2201, ResolutionNo55, ResolutionNo441, ResolutionNo20, ResolutionNo9, and Additional Resource (A) also define a specimen as human biological material or a biological product. Human biological materials or biological products are defined as complex molecules of high molecular weight derived from biological fluids, tissues, animal, biotechnological procedures, or manufactured using a biological process (e.g., DNA recombinant technology). The biological products approved for registration by the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) include the following:

  • Allergens
  • Monoclonal antibodies
  • Biopharmaceuticals (classified into medicinal products derived from biological fluids or tissues of animal origin, and drugs obtained by biotechnological procedures)
  • Blood products
  • Probiotics
  • Vaccines
  • Antibodies
  • Monoclonal antibodies
  • Medicines containing microorganisms live, attenuated, or killed

Please refer to ResolutionNo55 for more specific definitions for selected terms including blood products, monoclonal antibodies, adult stem cells, embryonic stem cells, germ cells, and hematopoietic progenitor cells.

ADDITIONAL RESOURCES

(A) (Website) ANVISA – Biological Products (Portuguese/Português) (Current as of August 4, 2016)
ANVISA, Ministry of Health, Federative Republic of Brazil

REQUIREMENTS

(1) (Regulation) Ordinance No. 2201 of 14 September 2011 (OrdinanceNo2201 - Portuguese/Português) (September 14, 2011)
Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Article 3 (VII and IX))

(2) (Regulation) Board Resolution - RDC No. 55 of 16 December 2010 (ResolutionNo55 - Portuguese/Português) (December 16, 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (I (Article 2)) (II), and (III (Article 4))

(3) (Regulation) CNS Resolution No. 441 of 12 May 2011 (ResolutionNo441) (Portuguese/Português) (May 12, 2011)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Article 1 (III)

(4) (Regulation) Resolution No. 340, 8th July 2004 (ResolutionNo340) (Portuguese/Português) (July 8, 2004)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: (Section II)

(5) (Regulation) Resolution – RDC No. 20 of 10 April 2014 (ResolutionNo20 - Portuguese/Português) (April 10, 2014)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter I (Section III)

(6) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III) and Chapter III (Section I)

Specimens > Import & Export
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Last content review/update: October 19, 2015. Submit updates or comments.
SUMMARY

Overview
As delineated in ResolutionNo9 and ResolutionNo55, the sponsor or his/her designated contract research organization (CRO) must obtain approval from the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) (ANVISA) to import human biological materials into Brazil.

The sponsor may apply for an import license at the same time that he/she submits the clinical trial application to ANVISA. ResolutionNo9 and the G-DDCM Manual state that the clinical trial application is referred to as the Drug Clinical Development Dossier (Dossier de Desenvolvimento Clínico de Medicamento (DDCM)). ANVISA’s approval of the DDCM is known as a Special Notice/Bulletin or a Comunicado Especial (CE).

ANVISA issues a Special Bulletin (SB), a Specific Special Bulletin (SSB), or a Document for Importation of Product(s) under investigation by the DDCM. An SB is an authorizing document ANVISA issues upon review and approval of the DDCM and can be used for investigational product (IP) import/export requests; an SSB is an ANVISA document issued to permit the sponsor to import/export an IP while his/her DDCM is still awaiting review and is within ANVISA’s 180-day approval window for biological products; a Document for Import of Product(s) under investigation by the DDCM is issued in the case of non-manifestation of the DDCM. The sponsor is required to present one of these ANVISA documents at the location where IPs for import or export are unloaded.

ResolutionNo20 also states that the procedures for the import and export of human biological material should be determined by the biological material type and the mode of transport. Regardless of the mode of transport or material type, transport operations are required to be recorded and standardized through regularly updated written instructions. All documents and records of activities relating to human biological material transport equipment should be readily available to the health authorities, upon request.The biological material must be packed in a form that will preserve its integrity and stability, and must be validated and approved by the supervisory technician.

According to ResolutionNo20, human biological material is classified as Category A or B infectious biological material, or Category Risk Minimum. Category A includes materials where exposure can cause permanent disability or fatal disease to humans and animals. Category B includes those materials not listed in Category A such as samples suspected or known to contain infectious agents causing diseases in humans. Category Risk Minimum or “exempt human specimens” include biological materials from healthy individuals. Human biological materials must also be classified according to the World Health Organization’s (WHO) risk classification diagram available in the WHO’s Guidance on Regulations for the Transport of Infectious Substances (Additional Resource (A)). Labeling should conform with the material type, risk classification, and specific requirements of the biological materials to be transported. The label for imported materials must be legible, understandable, and in English and Portuguese.

In addition to complying with ResolutionNo20, human biological material transport should be conducted in accordance with legislation from applicable regulatory bodies including the Ministry of Transport, the National Land Transportation Agency, the National Civil Aviation Agency, and the National Agency of Waterway Transportation. Refer to ResolutionNo20 for detailed import and export transport requirements.

See also the Clinical Trial Lifecycle topic, Submission Content subtopic for information on completing a clinical trial application.

ADDITIONAL RESOURCES

(A) (WHO Guidance) Guidance on Regulations for the Transport of Infectious Substances 2015–2016 (WHO/HSE/GCR/2015.2) (2015)
World Health Organization, Geneva, Switzerland

REQUIREMENTS

(1) (Regulation) Resolution RDC No. 9, of 20 February 2015 (ResolutionNo9 - English, unofficial translation) (Portuguese/Português) (February 20, 2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Section III) and Chapter III (Section I)

(2) (Regulation) Board Resolution - RDC No. 55 of 16 December 2010 (ResolutionNo55  - Portuguese/Português) (December 16, 2010)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (I (Article 2)) (II), and (III (Article 4)), Chapter II, and Chapter III

(3) (Regulation) Resolution – RDC No. 20 of 10 April 2014 (ResolutionNo20 - Portuguese/Português) (April 10, 2014)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I, Chapter II, Chapter III, Chapter IV, and Chapter VI

(4) (Guidance) Manual Submission of Drug Clinical Development Dossier (DDCM) and Specific Dossier Clinical Trial (Version 1) (G-DDCM Manual - Portuguese/Português) (2015)
ANVISA, Ministry of Health, Federative Republic of Brazil

Relevant Sections: 2 and 3

Specimens > Consent for Specimens
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Last content review/update: February 02, 2017. Submit updates or comments.
SUMMARY

Overview
In accordance with OrdinanceNo2201, ResolutionNo441, ResolutionNo466, and ResolutionNo340, prior to collecting, storing, or using a research participant’s human biological material, consent must be obtained from the participant or his/her legal representative in writing.

As per OrdinanceNo2201, ResolutionNo441, and ResolutionNo340, the informed consent form (ICF) must communicate the following information to the participant:

  • A clear explanation of the exams and tests that will be performed to identify genes, and to clarify the genetic materials to be studied and their possible correlation with the participant’s health
  • A guarantee of secrecy, privacy, and when necessary, anonymity
  • Free genetic advice planning and clinical surveillance by responsible people will be provided
  • The type and degree of access to results by the participant, wth the option to acknowledge this information or not
  • Measures to be taken to protect participant data, exam, and test results including limiting clinical report access to the involved investigators
  • Measures to be taken to protect the participant from any collective discrimination and/or stigmatization
  • The need for a separate ICF to be completed by each family member in the case of a family investigation
  • An explicit statement of the need for new consent for each study, or, an explicit waiver of consent for each new study


The participant may also consent to the use or disposal of his/her biological material, and provide names of individuals who may have access to his/her genetic information in the event of his/her death or any disabling condition. The investigator(s) must ensure the participant has free access to the results obtained with his/her stored biological materials, and provide guidance, including genetic counseling, if applicable.

In addition, per ResolutionNo441 and ResolutionNo340, investigators should explain the possibility of the participant’s stored genetic materials being used in a new research project. In this case, the participant will be contacted for further authorization or his/her waiver. If it is impossible to obtain either one of these documents, this fact shall be justified to the institutional ethics committee (Committee of Ethics in Research (Comitê de Ética em Pesquisas) (CEP)). The investigator(s) is also required to explain to the participant that the material will only be used upon approval of a new project by the ethics committee (CEP) and, when necessary, the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP).

As delineated in OrdinanceNo2201 and ResolutionNo441, the participant’s or his/her legal representative’s withdrawal of consent at any time must also be respected, and be valid from the date that the decision is communicated. The withdrawal must be formalized in a document signed by the participant or his/her legal representative. In addition, the transfer of human biological material to be stored at a biorepository or a biobank, or another institution, must be communicated to the participant. Please refer to Chapter IV of OrdinanceNo2201 and ResolutionNo441 for detailed requirements associated with storing human biological materials in a biorepository or a biobank.

(See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent).

 

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Ordinance No. 2201 of 14 September 2011 (OrdinanceNo2201 - Portuguese/Português) (September 14, 2011)
Ministry of Health, Federative Republic of Brazil

Relevant Sections: Chapter I (Article 3 (VI)), Chapter II, Chapter III, and Chapter IV (II (Articles 17 and 18)) and (III (Articles 24 and 25)

(2) (Regulation) CNS Resolution No. 441 of 12 May 2011 (ResolutionNo441) (Portuguese/Português) (May 12, 2011)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Article 1 (1 (VI)), (2 (II)), (3 (III)), (5), (6), (7), (8), (10 (I)), and (15)

(3) (Regulation) Resolution No. 466, of 12 December 2012 (ResolutionNo466) (Portuguese/Português) (December 12, 2012)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Section: Chapter III (3 (c))

(4) (Regulation) Resolution No. 340, 8th July 2004 (ResolutionNo340) (Portuguese/Português) (July 8, 2004)
National Health Council, Ministry of Health, Federative Republic of Brazil

Relevant Sections: Sections III, IV, and V

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OMB #: 0925-0668
Expiration Date: 2/28/2019