Human Subject Research Policies and Guidance

All Principal investigators (PIs) at The Ohio State University are ultimately responsible for the ethical conduct of human subjects research and for compliance with federal regulations, applicable state and local law, and university policies. These responsibilities are shared with investigators’ research staff and the Human Research Protection Program including the institutional review boards (IRBs) and the Office of Responsible Research Practices (ORRP). All co-investigators and key personnel will conduct research according to federal regulations, applicable state and local laws, university policies, and IRB standard operating procedures (SOPs) for the protection of human subjects in research.

The Huron IRB System Library serves as a comprehensive resource repository for human subjects research. The collection includes the Investigator's Manual, SOPs,  worksheets, reviewer checklists, and templates. This centralized resource supports efficient protocol development and regulatory adherence throughout the research oversight process.

U.S. Department of Health and Human Services (HHS)

• Office for Human Research Protections
• Considerations and Recommendations Concerning Internet Research and Human Subjects Research Regulations, with Revisions (SACHRP)
• FAQs, Terms and Recommendations on Informed Consent and Research Use of Biospecimens (SACHRP)
• Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
• Human Subjects Regulations Decision Charts
• Office of Human Research Protections Frequently Asked Questions
• Institutional Review Board Written Procedures
• International Compilation of Human Research Standards
• Fetal Tissue Transplantation Research - Public Law 103-43, Sec. 498A
• Policy for the Protection of Human Subjects, 45 CFR Part 46

Food and Drug Administration (FDA)

• Food and Drug Administration
• Institutional Review Boards Frequently Asked Questions
• Protection of Human Subjects, 21 CFR 50
• Institutional Review Boards, 21 CFR 56
• Clinical Trials Guidance Documents
• FDA's Role: ClinicalTrials.gov Information
• Investigational New Drug Application, 21 CFR 312
• Investigational Device Exemptions, 21 CFR 812
• Regulations: Good Clinical Practice and Clinical Trials
• Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable
• E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
• Device Advice: Comprehensive Regulatory Assistance

Department of Education

• U.S. Department of Education Protection of Human Subjects

National Institutes of Health (NIH)

• NIH Certificates of Confidentiality
• Instructions for Grant Applications using PHS 398

National Science Foundation (NSF)

• Research Involving Human Subjects 

State of Ohio

• Ohio Revised Code

• FERPA (Family Educational Rights and Privacy Act, U.S. Department of Education) – protects the privacy of student education records and establishes guidelines for accessing records.
• GDPR (General Data Protection Regulation, European Union (EU)) – GDPR protects the personal data of people located in the European Economic (EEA).

• American Society for Bioethics & Humanities (ASBH)
• Belmont Report
• Declaration of Helsinki (World Medical Association)
• Nuremberg Code
• Public Responsibility in Medicine and Research (PRIM&R)
• The President’s Council on Bioethics