ethica Clinical Research, a Montreal, Canada-based contract research organization (CRO), has partnered with Argentina-based Blanchard y Asociados to provide ethics review services for clinical trials in Latin America.
The services will be run through ethica’s recently renamed non-profit independent review board (IRB),Veritas IRB,making this one of the first Latin American IRBs to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
“We’re already conducting trials in Latin America as a CRO. By opening our office in Buenos Aires,Veritas IRB becomes the first accredited IRB in Argentina ... and this provides us with the assurance that research participants’ rights and welfare will be protected in the studies that we and others participate in. We can now offer to investigators an IRB that is accredited and we can rest assured when we’re conducting the trials that risk management is being handled properly,” said ethica founder and president Janice Parente.
This recent partnership is not the first global move for ethica, which began conducting clinical trials in Brazil in 2002, but the company is approaching its global growth carefully to ensure that appropriate study standards are upheld, Parente said.
“What our industry fails to understand is that some of these countries aren’t ready for research,” Parente explained. “We’re trying to teach our industry that you can do it right. You can still do it quickly, and you can enter these countries and do the trials but without exploiting those populations. There’s a proper way to do it.”
ethica tailors the services it provides in each country based on the particular country’s needs and capabilities. In India, for example, where ethica expanded its clinical trial management operations last year, the CRO is working to establish basic standards and education before it will begin conducting clinical trials.
“We’re taking it very slowly. Our first entry into that market is training.We’re starting to train researchers on how to be researchers, and we’re starting to train physicians on how to be investigators.We’re building the infrastructure of research so that we can actually conduct the trials. Right now, we are cautious about what trials we are conducting in India,” Parente said.
South America is different, Parente said, because clinical trials have been conducted there for many years.
“We just want to make sure we’re doing it correctly,” Parente said. The recent partnership with Blanchard enables ethica to do that.
Founded in 2002, ethica is the first and only CRO to be AAHRPP-accredited. In 2007, ethica partnered with Columbia, Md.-based Chesapeake Research Review to deliver collaborative ethics review services for clinical research conducted in the United States and Canada. The CRO plans to eventually expand to other areas, but that expansion is a long way off, Parente said. “Right now, we’re where we want to be, and from Canada, South America, and Asia, being India, we seem to be able to control our growth.”