Policies, Procedures, Regulations 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 HRPP, 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 HRPP SOPs, as well as federal, state, and local laws and guidance for the protection of human subjects in research.
Ohio State Policies and Guidance
Human Research Protection Program (HRPP) Policies
Ohio State Research Policies and Procedures
- Outside Activities and Conflicts Policy
- Financial Conflict of Interest in Research SOP
- HIPAA and Human Subjects Research
- Institutional Data Policy
- Privacy and Release of Student Education Records
- Principal Investigator Status Appointments
- Research Data
Clinical Trials Registration Process
Special Types of Research Guidance
- Pregnant Women and Fetuses – Maternal-Fetal Welfare Committee Review
- Radiation – Human Subject Radiation Committee
- Human Gene Transfer
Federal Regulations and Guidance
OHRP
- 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)
- Human Subjects Regulations Decision Charts
- Human Research Questions & Answers (OHRP)
- Institutional Review Board Guidebook
- International Compilation of Human Research Standards
- Protection of Human Subjects: 45 CFR 46
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 Trial Guidance
- 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
- ICH E6: Good Clinical Practice: Consolidated Guidance
- Medical Devices (Device Advice)
Ethical Principles & Codes
- American Society for Bioethics & Humanities (ASBH)
- Belmont Report
- Declaration of Helsinki (World Medical Association)
- Ethics CORE (NCPRE)
- Nuremberg Code
- National Bioethics Advisory Commission (NBAC)
- Public Responsibility in Medicine and Research (PRIM&R)
- The President’s Council on Bioethics
HIPAA
Other Links
- Department of Education Human Subjects Protection (ED)
- Fetal Tissue Transplantation Research (Public Law 103-43, Sec. 498A)
- National Science Foundation – Human Subjects (NSF)
- NIH Certificates of Confidentiality
- NIH Grant Application (Form 398) – Instructions for Human Subjects Research (NIH)
- Ohio Revised Code
