Regulations and Guidance
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
- IRB Review of Applications for HHS Support
- 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
- Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors
- Investigational New Drug Application: 21 CFR Part 312
- Investigational Device Exemptions: 21 CFR Part 812
Ethical Principles & Codes
- American Society for Bioethics & Humanities (ASBH)
- Belmont Report
- Declaration of Helsinki (World Medical Association)
- Ethics CORE (NCPRE)
- NIH Bioethics Resources on the Web
- Nuremberg Code
- National Bioethics Advisory Commission (NBAC)
- Public Responsibility in Medicine and Research (PRIM&R)
- The President’s Council on Bioethics
Good Clinical Practices
- Framework for Regulatory Oversight of Laboratory Developed Tests (FDA Draft Guidance)
- 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)
HIPAA
- HIPAA Research Authorization (at OSU)
- IRBs and the HIPAA Privacy Rule (NIH)
- NIH Guidance on Protecting Personal Health Information in Research (NIH)
- NIH Guidance on Research Repositories, Databases, and the Privacy Rule (NIH)
- NIH Guidance on Clinical Research and HIPAA Privacy Rule (NIH)
Other Links
- Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
- 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
- SMART IRB (Participating Institution)
