Human Research Standards in North America by Country

General

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)
• National Defence and the Canadian Armed Forces
• Correctional Service of Canada
• Health Canada

Relevant Standards

• Tri‑Council Policy Statement (TCPS‑2), Ethical Conduct for Research Involving Humans (2018)
• DAOD 5061‑0 — Research Involving Human Subjects (1998)
• Commissioner’s Directive DCO09 — Research (2017)

Drugs, Biologics, and Devices

Key Organizations — Drugs

• Health Canada — Pharmaceutical Drugs Directorate
• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards — Drugs

• Food and Drug Regulations (1024 — Clinical Trials) (2001)
• Good Clinical Practices — Health Canada
• TCPS‑2, Chapter 11 — Clinical Trials

Key Organizations — Devices

• Health Canada — Medical Devices

Relevant Standards — Devices

• Medical Devices Regulations (SOR/98‑282) (1998)

Clinical Trial Registries

Key Organizations

• Health Canada Clinical Trial Database
• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards

• TCPS‑2, Chapter 11.D — Registries (2018)

Research Injury

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards

• TCPS‑2, Chapter 3 — Article 3.2 (2018)

Social‑Behavioral Research

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards

• TCPS‑2, Chapter 10 (2018)

Privacy/Data Protection

Key Organizations

• Office of the Privacy Commissioner of Canada (OPC)
• Interagency Advisory Panel on Research Ethics (PRE)
• Canadian Institutes of Health Research (CIHR)

Relevant Standards

• Privacy Act (1983), Sections 7–8
• PIPEDA — Articles 5 & 7 (2001)
• OPC SOR/2001‑6, SOR/2001‑7, SOR/2001‑8 (2014)
• TCPS‑2, Chapter 5 — Privacy & Confidentiality
• CIHR Best Practices for Protecting Privacy in Health Research (2005)

Human Biological Materials

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards

• TCPS‑2, Chapter 12 — Human Biological Materials (2018)

Genetic Research

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)
• Canadian Biotechnology Strategy
• Health Canada — Biologic & Radiopharmaceutical Drugs Directorate

Relevant Standards

• TCPS‑2, Chapter 13 — Human Genetic Research (2018)

Embryos, Stem Cells, and Cloning

Key Organizations

• Interagency Advisory Panel on Research Ethics (PRE)

Relevant Standards

• Assisted Human Reproduction Act (2004)
• TCPS‑2, Chapter 12 (Sections E & F)

General

Key Organizations and Relevant Standards

• Public Health Service Act
• Food and Drug Administration (FDA)
• HHS — Office for Human Research Protections (OHRP)
• 45 CFR 46 — Common Rule (Subparts A–E)
• OHRP — Human Research Protections Guidance (various)
• List of all Common Rule federal agencies
• USAID — Protection of Human Subjects in Research (2015)
• 22 CFR 225 — USAID
• 7 CFR 1c — USDA
• 28 CFR 22 — DOJ (Privacy)
• 28 CFR 46 — DOJ (IRB regulations)
• Executive Order 12333 — CIA adoption of 45 CFR 46
• DoD — Directorate of Human Research Protections
• 10 USC 980 — Limitations on Use of Humans as Experimental Subjects
• DoDI 3216.02 — Protection of Human Subjects (2011)
• PPRA — Protection of Pupil Rights Amendment (1974)
• FERPA (1974)
• DOE Order 443.1B
• EPA — Program in Human Research Ethics
• 40 CFR 26 — EPA Human Subjects Research
• NASA — Human Research Program
• National Science Foundation — Research Involving Human Subjects

Drugs, Biologics, and Devices

Key Organizations

• FDA — Drugs
• FDA — Vaccines, Blood & Biologics
• FDA — Center for Devices and Radiological Health

Relevant Standards

• FDA Guidance Documents (search portal)
• 21 USC 355 & 371 — Food, Drug & Cosmetic Act
• 42 USC 262 — Public Health Service Act
• 21st Century Cures Act — Section 3024 (2016)
• GCP & Clinical Trials Regulations (FDA)
• Clinical Trials & Human Subject Protection — FDA
• Drug Guidance Documents
• Biologics Guidance Documents
• Medical Devices Guidance Documents

Clinical Trial Registries

Key Organizations

• FDA — ClinicalTrials.gov Information
• NIH — ClinicalTrials.gov
• VA — Office of Research Oversight

Relevant Standards

• FDA Modernization Act — Section 113 (1997)
• FDA Amendments Act — Section 801 (2007)
• 42 CFR 11 — Clinical Trials Registration (2016)
• NIH Dissemination Policy (2016)
• ClinicalTrials.gov — FAQs
• VA Clinical Trials Registration FAQs (2015)
• OHRP — Informed Consent Form Posting (45 CFR 46.116(h))

Research Injury

Relevant Standards

• Common Rule — Sections 116(a)(6) and (7)
• 38 CFR 17.85 — VA Treatment of Research‑Related Injuries
• VA Directive 1200.05 — Appendix F, Paragraph 2a(11)

Social‑Behavioral Research

Relevant Standards

• 45 CFR 46 — HHS Common Rule
• All Common Rule agencies — per adoption of Subpart A
• NSF — FAQs & Vignettes on Human Subjects

Privacy/Data Protection

Key Organizations

• Various — agency‑specific jurisdiction

Relevant Standards

• Common Rule — 45 CFR 46.111(a)(7)
• Privacy Act — 5 U.S.C. § 552a (1974)
• HIPAA Privacy Rule — 45 CFR 160 & 164
• HIPAA Security Rule
• HIPAA Breach Notification Rule
• 21st Century Cures Act Research Guidance (OCR)
• CIPSEA — Confidential Information Protection and Statistical Efficiency Act (2002)
• HITECH Act (2009)
• NIH — Certificates of Confidentiality (2017)
• NIH — HIPAA Research Resources
• AHRQ — Confidentiality in AHRQ‑Supported Research (2018)
• E‑Government Act (2002)

Human Biological Materials

Key Organizations

• HHS — Office for Human Research Protections (OHRP)

Relevant Standards

• OHRP — Biological Materials & Data Guidance

Genetic Research

Key Organizations

• FDA — In Vitro Diagnostic Device Evaluation
• FDA — CBER
• HHS — OHRP
• NIH — Office of Science Policy
• HHS — OCR Genetic Information Guidance

Relevant Standards

• Genetic Information Nondiscrimination Act (GINA) (2008)
• Common Rule — 45 CFR 46
• FDA Guidance — In Vitro Diagnostic Device Studies Using Leftover Specimens (2006)
• FDA — IVD Device Studies FAQs (2010)
• FDA — Human Somatic Cell & Gene Therapy Guidance (1993)
• FDA — CBER Advanced Therapies Recommendations
• OHRP — Public Law 103‑43 (Fetal Tissue Research)
• OHRP — GINA Guidance (2009)
• NIH Guidelines for Recombinant or Synthetic Nucleic Acid Molecules (2019)
• OCR — HIPAA Privacy Rule provisions implementing GINA

Embryos, Stem Cells, and Cloning

Key Organizations

• National Academy of Sciences (NAS)
• NIH — Stem Cell Information

Relevant Standards

• Executive Order 13505 — Removing Barriers to Stem Cell Research (2009)
• Public Law 103‑43 — Fetal Tissue Transplantation (1993)
• NAS — Human Embryonic Stem Cell Research Guidelines (2010 Revision)
• NIH Guidelines for Human Stem Cell Research (2009)
• NIH — Human Embryonic Stem Cell Registry (2016)