Earlier today, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published the 2020 edition of the International Compilation of Human Research Standards, available here. The Compilation is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 133 countries and from many international organizations, classified into nine categories, including drugs and devices, clinical trial registries, research injury, privacy and data protection, and biological materials and genetic research.
As background, in the 1990s, the number of companies conducting research outside the U.S. began to increase dramatically for several reasons, as did the corresponding number of foreign investigators conducting FDA-regulated research. The number of research collaborations entered into with foreign entities by U.S. universities and hospitals followed a similar trajectory, as did the number of research projects being conducted directly by such institutions overseas. As a result of this globalization of research and in an effort to serve the research community, OHRP issued its first International Compilation of Human Research Standards in 2005 and has updated it several times since then.
This latest update includes at least two new countries, in addition to updated links and additional country-specific research. Drug and device companies, contract research organizations, universities, hospitals, and Institutional Review Boards (IRBs) that use the Compilation as a reference should be sure to check the latest Compilation with respect to any ongoing projects to ensure there have been no changes impacting those projects and to use the most recent version to analyze any new projects going forward. In addition, we are keenly aware that in-house counsel often face the question of whether to engage foreign counsel when considering whether and how to conduct research in another country. To address this topic, a short Insights article by the author of this alert will be published in Bloomberg Law on March 9.
If you have any questions about this alert or would like more information, please contact Clint Hermes or your regular firm contact.