Clinical research continues to grow throughout the world, with researchers looking outside the US for new and diverse subject populations to help develop and improve investigational therapies. Requirements for research ethics review vary considerably country to country, and the regulatory variety can be daunting for a researcher new to working outside the purview of US regulatory agency requirements.
While it’s not possible to cover the many unique regulatory requirements of each nation in a single blog, I will discuss the basics of ex-US research ethics review for US-based researchers. For those seeking information on a particular country’s clinical research requirements, the International Compilation of Human Research Standards compiled by HHS is a good place to start.
Review by a Non-Local Ethics Committee
In many parts of the world, research ethics review is conducted locally by institutionally based ethics committees. Some countries may require additional layers of review at the local and/or national level, and most nations do not permit oversight by ethics committees that are not based in that country. Centralized research ethics review, like the US central IRB model where a single committee oversees research at multiple sites, is not common outside of North America.
There are some exceptions: for example, Canadian research regulations share similarities with US regulations and permit centralized non-Canadian research ethics committees to oversee some research, provided certain requirements are met (like including a majority of Canadian citizens as committee members).
Check with the country’s research ethics agency and/or the local institution to understand what is and isn’t possible. When non-local oversight is not permitted, researchers must work with local regulatory agencies and research ethics committees to ensure they comply with all local requirements.
How Can a US-Based IRB Help with Ex-US Research?
Research ethics committees do not exist in all countries, and when there are research ethics review requirements, not all local committees are alike. In some cases, it may be helpful to provide the local committee with a US-based IRB’s study review summary. While the regulations may not be the same, the perspective of a US-based ethics committee may be a helpful resource for the local committee’s own review deliberations. The ethical standards applied by the US-based ethics committee should be no less stringent than they would be for research conducted in the US.
Some ex-US research ethics committees may also accept dual oversight, where both the local ethics committee and the US-based ethics committee review the study and maintain oversight as the regulations permit. This may be an option for studies with sites in the US as well as in another country. Dual oversight may not work in every scenario, so check with the research ethics committee of record to understand what is possible.
Contact an Expert
Navigating a new set of regulatory requirements can be tricky, to say the least. Language and cultural barriers can exacerbate an already complicated situation. If you’re new to conducting research outside of the US, it may be beneficial to contact an expert for support. Some consulting groups and CROs may have resources based in the ex-US country who can help navigate the local requirements and processes.
Interested in learning more about international research? Watch our webinar, Lessons from the Trenches: Avoiding Common Legal Pitfalls in International Research.
Need auditing or quality support for an international study? Contact our consulting team.