ethica Clinical Research, a contract research organisation (CRO) based in Montreal, Canada, is expanding its ethics review services into South America through a joint venture with Blanchard y Asociados, a clinical research consulting firm with headquarters in Buenos Aires, Argentina.

At the same time, ethica has changed the name of its ethics review division to Veritas IRB, with the ‘IRB’ standing for Independent Review Board. The division’s Argentine office will offer the same services as Veritas IRB does from its Canadian base, “and in accordance with the same high ethical standards”, ethica noted. That includes re-investing any profits from the Argentine operation into local research-participant protection initiatives.

In extending its human research protection programme to Argentina and other South American markets, ethica will be able to call on Blanchard y Asociados’ “extensive” experience in training and its wide-ranging network of experts throughout South America, the Canadian CRO said.

Increased outsourcing of clinical research has inevitably raised questions about the vulnerability of study participants in countries where poverty, lack of education and limited access to healthcare may be a significant driver of recruitment.

“While clinical research has globalised and nearly half of the world’s clinical trials are now being conducted outside of North America and Western Europe, there is a need to develop a global approach to the oversight of research on humans,” commented Dr Janice Parente, founder and president of ethica. “We are proud to be playing a pivotal role toward achieving this goal.”

According to Anne Blanchard, founder and president of Blanchard y Asociados, both joint venture partners “believe that good research should never compromise the rights and welfare of research participants”.

By making sure the activities of trial investigators are “in accordance with the highest ethical standards”, and by providing participants with information and answers to questions about their rights, the venture will enable study participants to make informed decisions and take an active role in the research process, Blanchard added.

In 2006, ethica became the first CRO in the world and the first Canadian company to obtain full accreditation from the US-based Association for the Accreditation of Human Research Protection Programs (AAHRPP), it pointed out. To date, ethica remains the only AAHRPP-accredited CRO in the world and Veritas IRB the only AAHRPP-accredited research ethics board in Canada.