Columbia University Human Research Protection Program

Regulations

Federal Regulations

Department of Health and Human Services (DHHS) Regulations, 45 CFR 46

• Excerpts from Subpart A:
  - Exempt Research Categories
  - Expedited Review Categories
  - Criteria for IRB Approval of Research
  - General Requirements for Informed Consent
  - Waiver of Elements of Informed Consent
  - Waiver of Documentation of Informed Consent

• Subpart B: Additional Protections for Pregnant Women, Human Fetuses & Neonates Involved in Research
• Subpart C: Additional DHHS Protections Pertaining to Biomedical & Behavioral Research Involving Prisoners as Subjects
• Subpart D: Additional DHHS Protections for Children Involved as Subjects in Research

FDA Regulations (Search CFR Title 21 Database)

• Protection of Human Subjects, Subchapter A, Part 50
• Institutional Review Boards, Subchapter A, Part 56
• Investigational New Drug Application, Subchapter D, Part 312
• Biological Products, Subchapter F, Part 600
• Charging for Investigational Drugs Under and Investigational New Drug Application
• Expanded Access to Investigational Drugs for Treatment Use
• Investigational Device Exemptions, Subchapter H, Part 812

Health Insurance Portability and Accountability (HIPAA)

U.S. Department of Education

• Family Educational Rights and Privacy Act (FERPA)

State Regulations

• Surrogate Consent Laws (by state)

New York Statutes and Regulations

• Article 24-A Protection of Human subjects
• Genetic Privacy Law, Article 7, section 79-l
• Autopsy and Dissection
• NYC Department of Education - Proposal Guidelines

New Jersey Statutes and Regulations

• Access to Medical Research Act
• Chapter 112 Privacy Act
• Chapter 364 School Surveys / Parental Consent
• Chapter 126 Genetic Privacy Act
• Patient Rights Title 26: Rights of Persons Admitted to a General Hospital