“Q: If local policy differs from the region’s regulations pertaining to the conduct of a clinical trial at a research site, what should be followed? A: The strictest requirements”. In response to this question one may ask, where can I find the local regulations for my study? A situation compounded in multinational trials. A helpful tool to reference is the OHRP’s International Compilation of Human Research Standards which was first published on 2005. The 2017 Edition of this tool is now available on-line here. The compilation features listings of over 1000 laws, regulations and guidelines on human subject protection in 126 countries as well as standards issued by a number of international and regional organizations.
Highlights in this new edition include:
- The addition of 6 new countries (Benin, Bermuda, Democratic Republic of the Congo, Dominican Republic, Guyana and Senegal).
- The countries of the Middle East are now found in a separate section beginning on page 136.
- Addition of many new rules, guidelines, laws and regulations enacted in 2016.
The standard is organized into 2 parts where countries are organized alphabetically and grouped by regions:
- Part 1: International and Europe (pages 1-105)
- Part 2: Asia/Pacific, Middle East, Latin America and the Caribbean, Africa, and Acknowledgements (pages 106-168)
The information on this standard is organized into 4 columns: