Human Research Standards in Latin America and the Caribbean by Country

General

Key Organizations

• Caribbean Public Health Agency (CARPHA)
• Pan American Health Organization (PAHO)

Relevant Standards

• PAHO — Regional Program on Bioethics (resources)

Drugs, Biologics, and Devices

Key Organizations

• PAHO

Relevant Standards

• PAHO Working Group on Good Clinical Practices — documents
• PAHO — Model Regulatory Program for Medical Devices (International Guide, 2001)

General

Key Organizations

• Ministry of Health

Relevant Standards

• Civil and Commercial Code (2015), Articles 26, 58, 59
• Ministerial Resolution 1480/2011 — Guidelines for Human Health Research & National Registry
• Resolution 1480/2011 — National Registry of Health Research

Drugs, Biologics, and Devices

Key Organizations

• ANMAT — National Administration of Drugs, Foods, and Medical Devices

Relevant Standards

• ANMAT Provision 6677/10 — Good Clinical Practice
• ANMAT Provision 12.792/2016 — Import Procedure
• ANMAT Provision 828/2017 — Expanded Access Programs
• ANMAT Provision 4008/2017 — Rules for National Research Committee
• ANMAT Provision 4009/2017 — Phase I/Bioequivalence site requirements
• ANMAT Provision 10017‑E/2017 — Oversight of research sites/investigators
• ANMAT Provision 969/97 — Clinical studies of medical technology

Clinical Trial Registries

Key Organizations

• National Registry of Health Research

Relevant Standards

• Resolution 1480/2011 — Creates National Registry

Privacy/Data Protection

Key Organizations

• National Directorate for the Protection of Personal Data

Relevant Standards

• Personal Data Protection Act No. 25.326 (2000)
• Decree 1558/2001 — Regulation of the Act
• Provision 60‑E/2016 — International transfers of personal data

Human Biological Materials

Key Organizations

• Ministry of Health

Relevant Standards

• Resolution 2940/2020 — Biobank guidelines (human biological samples)

General

Key Organizations

• University of the West Indies — Cave Hill / Ministry of Health

Relevant Standards

• Research Ethics Policy and Guidelines

General

Key Organizations

• Department of Health

Relevant Standards

• Research Governance Framework (2008)

General

Key Organizations

• Ministry of Health and Sport (MHS)
• National Bioethics Committee (NBC)

Relevant Standards

• Legal Decree No. 15.629 (1978), Arts. 147–148
• New Political Constitution (2009), Article 44
• MHS — Guidelines for Health Research & Ethical Norms (2002)

Drugs, Biologics, and Devices

Key Organizations

• AGEMED — State Agency of Drugs & Medical Technology

Relevant Standards

• Circular MS/AGEMED/CR/100/2020 — Use of investigational medicines
• Rule for Clinical Studies (2004)
• AGEMED — Regulations (various)

General

Key Organizations

• National Health Council (CNS)
• National Commission on Research Ethics (CONEP)

Relevant Standards

• Resolution CNS 196/96 — Rules on Research with Human Subjects
• Resolution CNS 240/97 — “Participating User” definition
• Operations Manual for Ethics Committees (4th ed., 2008)
• Resolution CNS 292/99 — Foreign cooperation
• Resolution CNS 304/2000 — Indigenous peoples
• Resolution CNS 346/2005 — Multicenter research
• Resolution CNS 466/2012 — Guidelines & rules for human research
• Normative 001/2013 — CEP/CONEP system
• Plataforma Brasil — submissions

Drugs, Biologics, and Devices

Key Organizations

• ANVISA — Brazilian Health Surveillance Agency
• CFM — Federal Council of Medicine

Relevant Standards

• CFM Code of Medical Ethics (Reg. CFM 2.217/2018)
• Law 9782/1999 — National Health Surveillance System
• CNS 251/1997 — New pharma products/vaccines/diagnostics
• CNS 301/2002 — Placebos
• ANVISA RDC 9/2015 — Clinical trials with drugs
• ANVISA RDC 548/2021 — Clinical trials with medical devices

Clinical Trial Registries

Key Organizations

• Brazilian Clinical Trials Registry

Relevant Standards

• Registry FAQs

Research Injury

Key Organizations

• CNS
• CONEP

Relevant Standards

• Law 6360/1976
• CNS 466/2012 — Adverse event reporting guidance linked

Privacy/Data Protection

Relevant Standards

• Law 13.709/2018 — General Data Protection Law (LGPD)
• Law 13.853/2019 — Amends LGPD; creates Data Protection Authority

Human Biological Materials

Key Organizations

• INCA — National Institute of Cancer

Relevant Standards

• Ordinance 2.201/2011 — National biobank guidelines
• CNS Resolution 441/2011 — Storage/use of human biological material

Genetic Research

Key Organizations

• CTNBio — National Biosafety Technical Commission

Relevant Standards

• Biosafety Law 11.105/2005
• CNS 340/2004 — Human genetics research

Embryos, Stem Cells, and Cloning

Key Organizations

• CTNBio

Relevant Standards

• Decree 5,591/2005 — Biosafety Law regulation
• ANVISA RDC 508/2021 — Good practices (human cells) for research/therapy

General

Key Organizations

• Ministry of Health
• Institute of Public Health (ISP)

Relevant Standards

• Law 20.120 (2006) — Research in human beings; genome; prohibits cloning
• Law 20.584 (2012) — Rights & duties in health care
• Law 21.331 — children/adolescents can refuse research; incapacitated adults excluded
• Law 20.724 (2014) — Health Code (pharmacies/medications)
• Decree 114/2010 (upd. 2013) — Regulation on Law 20.120
• Decree 30/2013 — modifies Decree 114/2010

Drugs, Biologics, and Devices

Key Organizations

• ISP — Institute of Public Health

Relevant Standards

• Decree 3/2010 — National control system for pharmaceutical products
• Exempt Resolution 2263/2015 — Guidelines for use control of pharmaceuticals in research

Research Injury

Relevant Standards

• Decree 3/2010 — pharmacovigilance & adverse events
• Technical Rule 140 (2012) — National Pharmacovigilance System
• Resolution 441 (2012) — AE notification in clinical research

Privacy/Data Protection

Key Organizations

• Ministry of the Secretary General of Government

Relevant Standards

• Law 19.628 (1999) — Protection of Private Life
• Law 20.584 (2012) — Rights/duties in health care
• Supreme Decree 41/2012 — Clinical records regulation

Genetic Research

Relevant Standards

• Law 20.120 (2006) — Human genetics research & cloning prohibition
• Decree 114/2010 — Regulation on Law 20.120

Embryos, Stem Cells, and Cloning

Relevant Standards

• Law 20.120 (2006) — Prohibition of human cloning
• Decree 114/2010 — Regulation

General

Key Organizations

• Ministry of Health & Social Protection
• INVIMA — National Institute of Drug & Food Surveillance
• MINCIENCIAS — Ministry of Science, Technology & Innovation

Relevant Standards

• Resolution 8430/1993 — Scientific, Technical & Administrative Regulations for Health Research
• Policy on Ethical Research, Bioethics & Scientific Integrity (2018)

Drugs, Biologics, and Devices

Key Organizations

• INVIMA

Relevant Standards

• INVIMA — Clinical study approvals/monitoring; AEs; safety reports
• Resolution 8430/1993 — Title III

Clinical Trial Registries

Relevant Standards

• Records of clinical research protocols — Colombia

Research Injury

Relevant Standards

• Resolution 8430/1993 — Title II, Art. 13

Privacy/Data Protection

Relevant Standards

• INVIMA website privacy policy (2018)
• Political Constitution (Article 15)
• Law 1581/2012 — Personal data protection regime

Human Biological Materials

Relevant Standards

• Blood bank standards — INVIMA
• Resolution 8430/1993 — Title II, Chapter VI
• Resolution 2640/2005 — Use of unclaimed cadavers for research (Art. 21)

Genetic Research

Relevant Standards

• Resolution 8430/1993 — Title III, Chapter II

General

Key Organizations

• Ministry of Health
• National Health Research Council (CONIS)

Relevant Standards

• CONIS — Legislation (various)

Drugs, Biologics, and Devices

Key Organizations

• CONIS

Relevant Standards

• Regulatory Law of Biomedical Research No. 9234 (2014)
• Regulatory Decree 39061‑S (2016) — Law No. 39533‑S
• Reforms to Decree 39533‑S (2016)
• Accreditation requirements
• Good practices in biomedical research

Clinical Trial Registries

Key Organizations

• CONIS

Relevant Standards

• Registered studies — CONIS

General

Key Organizations

• Ministry of Public Health

Relevant Standards

• Draft Public Health Law (2023) — Arts. 13, 16.1, 31, 48, 183–184

Drugs, Biologics, and Devices

Key Organizations

• CECMED — Center for State Control of the Quality of Medications

Relevant Standards

• CECMED — Approved regulatory dispositions (clinical trials)
• MSP Resolution 435/2017 — Regulation of Clinical Trials
• CECMED — Good Clinical Practice in Cuba

Clinical Trial Registries

Key Organizations

• Public Cuban Registry of Clinical Trials

Genetic Research

Relevant Standards

• Draft Public Health Law (2023) — Art. 155

Embryos, Stem Cells, and Cloning

Relevant Standards

• Draft Public Health Law (2023) — Art. 137

General

Key Organizations

• Ministry of Health

Relevant Standards

• Guidelines for the Conduct of Research on Human Subjects (2005)

General

Key Organizations

• SESPAS — State Secretariat of Public Health & Social Assistance
• CONABIOS — National Council on Health Bioethics

Relevant Standards

• Administrative Disposition No. 013620 (2000) — Creates SESPAS Bioethics Committee
• Resolution No. 0000012 (2008) — Establishes CONABIOS
• CONABIOS — Legal basis

General

Key Organizations

• Ministry of Public Health

Relevant Standards

• Constitution (2008)
• Organic Health Law (2006), Articles 207–208
• Ministerial Agreement No. 66 (2008) — Regulation on Health Research
• Regulation for Approval of Ethics Committees (2014)
• Regulation on Health Research Ethics Committees (2014)

Drugs, Biologics, and Devices

Key Organizations

• National Health Agency — Regulation/Control/Oversight

Relevant Standards

• Regulation — Approval/Oversight/Control of Clinical Trials (2017)
• Ministerial Accord No. 4889 (2014) — Approval of Ethics Committees
• Clinical Trials — process/info

Privacy/Data Protection

Relevant Standards

• Constitution (2008), Article 92
• Ministerial Agreement No. 5216 (2015) — Confidentiality in National Health System

Human Biological Materials

Key Organizations

• INDOT — National Institute on Donation & Transplantation

Relevant Standards

• Organic Health Law (2006), Articles 81–86
• Organic Law on Donation & Transplantation of Organs, Tissues, Cells (2011)
• Ministerial Agreement No. 0088 (2017) — Import/export of human biological samples

Genetic Research

Relevant Standards

• Organic Health Law (2006), Articles 209–210

Embryos, Stem Cells, and Cloning

Key Organizations

• Ministry of Public Health
• INDOT

Relevant Standards

• Organic Health Law (2006), Article 214
• Organic Law on Donation & Transplantation (2011)

General

Key Organizations

• National Health Research Ethics Committee

Relevant Standards

• Law on Duties and Rights of Patients and Healthcare Providers, Arts. 9 & 16 (2016)
• Regulations of the Law on Duties and Rights of Patients, Art. 12 (2018)
• Decree 927 (2024) — Reforms on Childhood & Adolescence Protection
• Decree 302 (2019) — Integrated National System of Health, Art. 28
• SOPs for Ethical Evaluation of Health Research (2015)
• Operating Manual — National Health Research Ethics Committee (2017)

Drugs, Biologics, and Devices

Key Organizations

• National Directorate of Medications

Relevant Standards

• Medication Law, Arts. 29 & 66 (2012)
• Guide on Good Clinical Practices (2016)
• Searchable Standards — National Directorate of Medications

General

Key Organizations

• St. George’s University / Windward Islands Office of Research
• U.S. 45 CFR 46

General

Key Organizations

• Ministry of Health

Relevant Standards

• Medical Research Involving Human Subjects Regulations (2007)

General

Key Organizations

• Ministry of Public Health & Social Assistance

Relevant Standards

• Accreditation for Ethics Committees

Drugs, Biologics, and Devices

Key Organizations

• Department of Regulation and Control of Pharmaceutical Products

Relevant Standards

• Ministerial Accord 206-2021 — Law Regulating Clinical Trials in Humans
• Governmental Accord 712-99, Arts. 91–94 (1999)
• Ministerial Accord 82-2019 — Rules for Regulation of Human Clinical Trials
• Clinical Trials — Forms & guidance

General

Key Organizations

• Secretariat of Health

Relevant Standards

• Health Code, Decree 65‑91, Arts. 175–176 (1996)

Drugs, Biologics, and Devices

Relevant Standards

• Regulation for Health Control of Products, Services & Establishments (2015)

Human Biological Materials

Relevant Standards

• Law on Donation & Transplantation of Anatomical Organs (2014)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Penal Code, Decree 130‑2017 (2019)

General

Key Organizations

• Ministry of Health & Wellness

Relevant Standards

• Guidelines for the Conduct of Research on Human Subjects (2010)

Drugs, Biologics, and Devices

Key Organizations

• Standards & Regulation Division — Ministry of Health

Relevant Standards

• Food and Drugs Act (1975)
• Food and Drugs Regulations (1975)

General

Key Organizations

• Ministry of Health
• General Health Council
• National Bioethics Commission (CONBIOÉTICA)
• COFEPRIS — Federal Commission for Protection Against Health Risks

Relevant Standards

• General Health Law — Title V, Ch. 1, Arts. 96–103 (Health Research)
• Regulation on the General Health Law in Health Research (2014)
• NOM‑012‑SSA3‑2012 — Criteria for Health Research Projects
• National Guidelines for Research Ethics Committees (2018)
• Reforms on Integration & Operation of Research Ethics Committees (2020)

Drugs, Biologics, and Devices

Relevant Standards

• NOM‑220‑SSA1‑2002 — Pharmacovigilance
• Guidelines of Good Clinical Practice in Health Research (2012)
• Guidelines for Protocol Amendments (2016)

Privacy/Data Protection

Key Organizations

• Federal Institute on Access to Public Information

Relevant Standards

• Personal Data Protection — National standards (various)
• Federal Law for Protection of Personal Data in Possession of Private Individuals (2017)

Human Biological Materials

Relevant Standards

• General Health Law, Title XIV, Arts. 313–342 (2021)
• Regulation of the General Health Law on Transplantation (2014)

Genetic Research

Key Organizations

• National Institute of Genomic Medicine

Relevant Standards

• Biosafety Law on Genetically Modified Organisms (2020; updated 2022)
• Regulations to the Biosafety Law (2009)

General

Key Organizations

• Ministry of Health (MINSA)
• Institutional Ethical Review Committee (CIRE)

Relevant Standards

• General Health Law No. 423 (2002)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health — Directorate of Sanitary Regulations
• National Committee on Research in Health

Relevant Standards

• Law of Medicines and Pharmacies, No. 292 (1998)
• Normative‑064 — Standard for Registration of Medical Devices
• Ministerial Agreement 491‑2020 — Rules of National Committee on Research in Health
• Ministerial Agreement 492‑2020 — Regulation of Clinical Trials on Drugs

General

Key Organizations

• Ministry of Health (MINSA)
• National Committee of Research Bioethics

Relevant Standards

• Law No. 84 on Research with Human Beings (2019)
• Executive Decree No. 1 (2013)
• Executive Decree No. 1843 (2014)
• Executive Decree No. 6 (2015)

Drugs, Biologics, and Devices

Relevant Standards

• Law 1 of 2001 — Drugs & Pharmaceuticals

Privacy/Data Protection

Relevant Standards

• Law 68 (2003) — Patient rights & data
• Law 81 (2019) — Personal Data Protection
• Executive Directive No. 1458 (2012)

Human Biological Materials

Relevant Standards

• Law 3 of 2010 — Organ & Tissue Transplantation
• Executive Directive No. 179 (2018)

Embryos, Stem Cells, and Cloning

Relevant Standards

• Law No. 3 (2004)

General

Key Organizations

• Ministry of Public Health — Research and Strategic Studies Directorate

Relevant Standards

• Resolution S.G. No. 905 — National Policy on Health Research Ethics
• Statute & Operating Procedures (2017)

Drugs, Biologics, and Devices

Key Organizations

• National Directorate of Health Surveillance (DINAVISA)

Relevant Standards

• Law 1119/97 — Health Products, Art. 30

General

Key Organizations

• National Institute of Health — DIIS

Relevant Standards

• General Health Law No. 26842, Art. 28 (1997)
• Ministerial Resolution 233‑2020 — Ethical considerations in health research
• Supreme Decree 011‑2011‑JUS — Bioethics as human rights

Drugs, Biologics, and Devices

Key Organizations

• Peruvian Registry of Clinical Trials (REPEC)
• DIGEMID — National Directorate of Medicines

Relevant Standards

• INS — Standards & documents
• Supreme Decree 021‑2017‑SA — Regulation of Clinical Trials
• Ministerial Resolution 655‑2019

Clinical Trial Registries

Relevant Standards

• REPEC — Clinical trials regulation

Research Injury

Relevant Standards

• Supreme Decree 021‑2017‑SA — Arts. 27–29

Privacy/Data Protection

Relevant Standards

• Law 29733 — Protection of Personal Information (2011)
• Law for Electronic Medical Charts (2013)
• Supreme Decree 003‑2013‑JUS — Data Protection Regulation

Drugs, Biologics, and Devices

Relevant Standards

• Clinical Trials Act (2016)

General

Key Organizations

• Ministry of Health
• University of the West Indies (UWI), St. Augustine

Relevant Standards

• UWI — Research Ethics

General

Key Organizations

• Ministry of Public Health

Relevant Standards

• Order 1.588/020 — Rules of Bioethics Commission (2020)
• Decree 189/998 — Good Clinical Practices in pharmaceutical research
• Decree 158/019 — Bioethics Commission project (2019)
• Decree 379/008 — Bioethics Commission project (2008)

Drugs, Biologics, and Devices

Relevant Standards

• Decree 189/998 — International agreements for GCP

Research Injury

Relevant Standards

• Decree 379/008 — Human subjects protections

Privacy/Data Protection

Relevant Standards

• Law 18.331 — Protection of Personal Data

Human Biological Materials

Key Organizations

• National Institute on Donation & Transplantation

Relevant Standards

• Decree 160/006 — Transplantation of human cells & tissues

General

Key Organizations

• FONACIT — Commission on Bioethics & Biosecurity
• IVIC — Venezuelan Institute of Scientific Research

Relevant Standards

• Constitution, Art. 46(3)
• Resolution No. 48 (1998)
• FONACIT — Code on Bioethics & Biosecurity (2002)

Drugs, Biologics, and Devices

Relevant Standards

• Medicines Act — Title III, Chapter II

Genetic Research

Relevant Standards

• Contract for Accessing Genetic Resources (2003)
• Revised Outline of the International Declaration of Human Genetic Data (2003)