International
OHRP works to ensure that human subjects outside of the United States who participate in research projects conducted or funded by DHHS receive the same level of protections as research participants inside the United States. To that end, the OHRP International Activities program offers consultation services, disseminates pertinent reports, and provides research ethics training.
2013 Edition of the International Compilation of Human Research Standards
- Microsoft Word version (1.97 MB)
- Adobe PDF version (1.27 MB)
Ethical Codes
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Declaration of Helsinki
Research Standards
- 45 Code of Federal Regulations 46
- 21 CFR 50 (Protection of Human Subjects) and 21 CFR 56 (Institutional Review Boards)
- International Conference on Harmonization - Good Clinical Practice E6
- Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects (PDF - 1.55 MB)
- Canada: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
- Indian Council of Medical Research: Ethical Guidelines for Biomedical Research on Human Participants (PDF - 3.15 MB)
Equivalent Protections
- July 7, 2006 Notice on Interpretation of Assurance Requirements (PDF - 52 KB)
- March 25, 2005 Notice Soliciting Public Comment on Recommendations of HHS Workgroup (PDF - 71 KB)
- July 17, 2003 Report of Equivalent Protections Working Group (PDF - 135 KB)
- Appendix (PDF - 67 KB)