Laws and regulations

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Geisinger is committed to high-quality, ethical research for all participants. Find the latest laws and regulations to make sure you’re meeting these standards.  

Department of Health and Human Services regulations

Protection of human subjects: The common rule

• 45 CFR Part 46 – Subpart A: Basic HHS Policy for Protection of Human Research Subjects
• 45 CFR Part 46 – Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates in Research
• 45 CFR Part 46 – Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• 45 CFR Part 46 – Subpart D: Additional Protections for Children Involved as Subjects in Research 

Security and privacy: The HIPPA privacy rule

• 45 CFR Part 164 – Subpart E: Privacy of individually Identifiable Health Information

Food and Drug Administration regulations

Protection of human subjects

• 21 CFR Part 50 – Subpart A: General Provisions 
• 21 CFR Part 50 – Subpart B: Informed Consent of Human Subjects
• 21 CFR Part 50 – Subpart D: Additional Safeguards for Children in Clinical Investigations 

Institutional review boards

• 21 CFR Part 56 – Subpart A: General Provisions 
• 21 CFR Part 56 – Subpart B: Organizational Personnel 
• 21 CFR Part 56 – Subpart C: IRB Functions and Operations 
• 21 CFR Part 56 – Subpart D: Records and Reports
• 21 CFR Part 56 – Subpart E: Administrative Actions for Noncompliance

Investigational test articles

• 21 CFR Part 312: Investigational New Drug Application
• 21 CFR Part 812: Investigational Device Exemptions

Department of Defense regulations

• 32 CFR Part 219: Protections of Human Subjects
• DoD Instruction 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and Supported Research