Office of human protection assurance

Abstract

The Office for Human Research Protections (OHRP) offers an IRB Operational Assurance Programme which is mandatory to US and non-US institutions and organizations when the US Department of Health and Human Services is involved in funding their biomedical research. The list of OHRP Approved Assurances was downloaded on May 8, 2009 from its website to analyse the level of quality assurance by geographic representation, both within the US and internationally. The total number of OHRP Approved Assurances was 9,953 with the vast majority (79.0%) for US (n=7,631) and Canadian (n=235) institutions/organizations. Asia accounted for 566, followed by Europe (n=538), Latin America (n=340), East Europe (n=258), Africa (n=223), Oceania (n=130) and the Middle East (n=32). A total of 136 countries/regions had at least one OHRP Assurance; Canada, China, India, UK and Australia had the largest number issued outside of the US. The four BRIC countries – Brazil, Russia, India and China – were among the top ten, each outnumbering Germany, France, Italy and Spain. The four BRIC countries had 15% more assurances than the ‘big five’ European cities. In summary, the OHRP IRB operational assurance programme reaches out to 136 countries. A strong indication of the non-industry sponsored globalization process of clinical research is the four BRIC countries having more OHRP Assurances issued than Europe’s ‘big five’ cities. Also noteworthy is that Buenos Aires and Beijing account for the most Assurances among all non-US cities – even more than such established medical research cities as Toronto, London, Paris, Berlin, Rome, Madrid and Montreal.