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.
SOPs, Policies and Procedures
Human Research Protection Program
The Huron IRB System Library serves as a resource repository for human subjects research at Ohio State. The collection includes the Investigator's Manual, SOPs, worksheets, reviewer checklists, and templates which together represent Human Research Protection Program (HRPP) guidance for research conducted at Ohio State. This centralized document resource supports study development and ensures compliance with federal and local regulations governing Ohio State’s research portfolio throughout the research process. Investigators and study personnel must be familiar with the documents as they relate to human subjects research protection.
Note: the Huron library documents will eventually replace the previous Ohio State HRPP policies as the Huron documents are revised to incorporate Ohio State specific information contained in the previous policies. Refer to the Toolkit Document Crosswalk for help navigating the change in policies and documentation associated with the transition.
University Policies and Procedures
In addition to the HRPP-specific documentation associated with the Huron IRB library, researchers may find the following University-wide policies and procedures applicable to their particular research development and conduct.
Federal Regulations, State Statutes and Guidance
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
National Institutes of Health (NIH)
National Science Foundation (NSF)
State of Ohio
Data Protection
- 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).
Ethical Guidance
- 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