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 investigators and key personnel will conduct research according to all applicable university policies and Human Research Protection Program standard operating procedures, as well as federal, state, and local laws and guidance for the protection of human subjects in research.

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
• Frequently Asked Questions Regarding Protection of Human Subjects of Research
• Human Subject Protection (Informed Consent), 21 CFR Part 50
• IRB Regulations: 21 CFR 56
• Clinical Trials Guidance Documents

• FDA's Role: ClinicalTrials.gov Information

• Investigational New Drug Application, 21 CFR Part 312
• Investigational Device Exemptions, 21 CFR Part 812
• Good Clinical Practice in FDA-Regulated 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)
• Medical Devices (Device Advice)

Department of Education

• Department of Education Human Subjects Protection

National Institutes of Health (NIH)

• NIH Certificates of Confidentiality
• NIH Grant Application (Form 398) – Instructions for Human Subjects Research (NIH)

National Science Foundation (NSF)

• Research Involving Human Subjects (NSF)

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)
• Ethics CORE (NCPRE)
• Nuremberg Code
• Public Responsibility in Medicine and Research (PRIM&R)
• The President’s Council on Bioethics