1. Federal Regulation

• The Common Rule (45 CFR 46) governs human subjects research and includes requirements for IRBs, informed consent, and additional protections for vulnerable populations.
  • Read Frequently Asked Questions (FAQs) here.
• U.S. Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312) cover clinical investigations of drugs and devices, including investigator responsibilities, informed consent, and IRB review.
  • Part 50— Protection of Human Subjects
  • Part 56— Institutional Review Boards
  • Part 312— Investigational New Drug Application

• Health Information Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) protects patient privacy and governs the use of Protected Health Information (PHI) in research
  
  • Summary of the HIPAA Privacy Rule
  • Part 164—Security and Privacy

• The Minimum Necessary Rule (45 CFR Parts 164.502(b), 164.514(d) is a HIPAA standard that requires healthcare providers and researchers to limit the use and disclosure of PHI to the minimum amount necessary to achieve the intended purpose.                      

• NIH Guidelines for Clinical Research (National Institutes of Health) include policies on Certificates of Confidentiality, human subjects education, data and safety monitoring, and clinical trial registration.

2. State of Ohio 

• The Advance Ohio Education Act (SB 1) has broad requirements for programs, operations, and policies at Ohio’s public universities, including The Ohio State University.
  
  • Learn more about the bill from the SB 1 Summary and through Faculty FAQs.
• Ohio Revised Code
  • Research Ethics and Safeguards (Rule 4732-17-02) covers the general conduct requirements for conducting research in accordance with the approved research protocol. 

3. University Policies 

Read more about each of the policies below here.

• Enterprise for Research, Innovation and Knowledge (ERIK)
  • Animal Care and Use Program
  • Export Control
  • Human Research Protection Program
  • Individual Investigator Use of Controlled Substances in Non-Therapeutic Research
  • Institutional Biosafety
  • Intellectual Property
  • Research Data
  • Research Misconduct
• Office of Academic Affairs
  • Records Management
• Office of Human Resources
  • Whistleblower, 1.40
• Office of Technology and Digital Innovation
  • Digital Accessibility
  • Information Technology (IT) Security
  • Institutional Data
  • Responsible Use of University Computing and Network Resources
• Office of University Compliance and Integrity
  • Gift Acceptance
  • Outside Activities and Conflicts
• Wexner Medical Center Compliance and Integrity
  • Protected Health Information and HIPAA

• Office of Research Compliance (ERIK):
  • Conflict of Interest
  • Controlled substances and toxins
  • Research data
  • Research misconduct
  • Responsible Conduct in Research

4. The Belmont Report Summary (1979)

The Belmont Report is a foundational document in U.S. research ethics that outlines key principles for conducting research involving human subjects. It emphasizes:

1. Respect for Persons – recognizing autonomy and protecting those with diminished autonomy.
2. Beneficence – maximizing benefits while minimizing harm.
3. Justice – ensuring fair distribution of research benefits and burdens.

These principles guide informed consent, risk-benefit assessment, and subject selection through ethical research practices.