The Role of Contract Research Organizations in International Clinical Research

Charles Foster and Aisha Y. Malik are discussing the conduct of international clinical research in low and middle income countries. It seeks to highlight the role of contract research organizations (CRO) in the process. The article raised the issue that ethical theories should be more critical of researches conducted by CROs than those done by pharmaceutical companies because many of the researches performed by the CROs could not be justified by any of the four ethical theories.

Pharmaceutical companies want to reduce the price and costs of a research or a clinical trial, therefore they subcontract the research to CROs. Contract research organizations will act as negotiators (middle men) where they go to the locals and negotiate the terms of the trial, supervise the trial, pay the locals and return the results to the pharmaceutical companies. Contract research organizations are, therefore, more interested in getting the trial done rather than ensuring it fulfills the health needs of the locals and would be slow to recommend investment in local diseases.

The other issue that the article mentions is that for contract research companies, social justice is an irrelevant issue except in cases where it might affect the research which they are conducting. Assumptions made that contract research organizations speak for pharmaceutical companies that subcontracted them is untrue, these are independent bodies. Contract research companies operate in ways that pharmaceutical companies could not, like deal with corruption which is found in many low and middle class countries. Contract research organizations can get away with ethical problems and corruption which would be harder for pharmaceutical companies to get away with. In conclusion the article calls for contract research organizations to be held accountable for any ethical problems which might arise in researches subcontracted to them. Thank you, Sara Lavinia

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