Ethical review firm enters Latin America

By Phil Taylor

- Last updated on GMT

Related tags: Clinical trials, Clinical trial

Canada’s Ethica Clinical Research has expanded into the emerging Latin American market via a joint venture with Argentinean contract research organisation Blanchard y Asociados.

The JV will focus on Ethica’s ethics review services, which the CRO has just renamed Veritas IRB. This non-profit division is staffed by both lay and professional people and reviews clinical trial proposals to make sure they are ethically acceptable and conducted responsibly.

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 Ethica founder and president Janice Parente.

Research into the conduct of human research studies in Latin America published in 2001 found that out of 20 research ethics committees assessed, only 45 per cent had standard operating procedures and concluded that members had little training.

Blanchard brings a network of clinical experts throughout South America to the joint venture, as well as established training expertise, and forms a base for Ethica to offer its human research protection services in Argentina and other South American countries.

Anne Blanchard, founder and president of the company, said that “both companies believe that good research should never compromise the rights and welfare of research participants.​”

The stance taken by both Ethica and Blanchard is to provide strict oversight of investigators so they conform to high ethical standards, and to make sure that trial participants are well-informed.

Profits generated by Veritas IRB are re-invested into local research participant protection initiatives.

Greater attention on ethics

This is very much in tune with efforts by the World Health Organization (WHO) to level the playing field for clinical trials carried out around the world to protect the welfare of research participants through attention to risks, benefits, and informed consent; and avoid exploitation of vulnerable individuals and populations.

As well as promoting the use of research ethics committees for all trials (known as institutional review boards in the US), the WHO called for the setting up of a register for all clinical trials in 2006 – a call that has been answered at least in part by the pharmaceutical industry.

And recent events show that oversight of human research should still be top of the agenda.

In August, concerns were being raised about the ethical conduct of clinical trials in India after 49 infants were found to have died during clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi, a contract manufacturer serving the pharmaceutical industry, since January 2006.

And just weeks earlier, criticisms were levelled at the reporting of clinical trials in China by researchers at the University of Birmingham, UK, and Guangzhou Medical Centre in China. The poor reporting practices meant that it was hard to gauge the quality of the studies, they concluded.

Alarmingly, less than 11 per cent of randomised clinical trials in the Chinese study mentioned ethical approval and only 18 per cent discussed​ informed consent, said the researchers.

Veritas IRB hopes that it can help tackle the issue with its ethics services, and that is one reason why Ethica is determined to expand the division into other territories.

The expansion into Latin America follows an earlier push into India for Ethica, which formed a joint venture with local firm Matrix Group a little over a year ago. In addition to ethics review services, the JV – called Ethicamatrix – carries out clinical study monitoring, data management, and investigator training

And last year, the firm forged a partnership with US Institutional Review Board (IRB) services firm Chesapeake Research Review Inc (CRRI) to deliver collaborative research ethics review services for clinical research conducted both in the US and Canada.

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