The Elephant in the (Board) Room: The Role of Contract Research Organizations in International Clinical Research: A Review


The article is discusses the conduct of international clinical research in low and middle income countries, where it seeks to highlight the role of contract research organizations in the subject. The authors refer to a previous article by Pratt and coworkers (AJOB. 2012. 12:30-41)  where they claim that theories of justice 1) support the position that  international clinical research (ICR) should be a vehicle whereby for reducing health inequities in resource-limited countries and 2) provide guidance as to  what is owed by international clinical research (ICR) actors (e.g., researcher, organizations, and governments) to parties in low- and middle-income countries. These theories include —John Rawls’s theory of justice, the rights-based cosmopolitan theories of Thomas Pogge and Henry Shue, and the health capability paradigm offered by Jennifer Ruger.  While the authors of the previous article do demonstrate that how the theories help identify the ends of justice to which ICR is to contribute,  the theories fail to tell us how to organize ICR to promote these ends. Aside from Ruger’s health capability paradigm, the theories also lack a principle for assigning specific duties to specific actors.

According to Pratt and coauthors, the overarching hypothesis is that redressing the inequalities that exist in resource-limited countries is not the primary function of most ICRs, as the main objective is profit.  Essentially, pharmaceutical companies want to reduce the price and costs of a research or a clinical trial and one of the ways to do this is to subcontract the research to contract research organizations (CROs).    As such, when contract research organizations conduct a trial, they will do everything to give the pharmaceutical companies a good price, as the market for receiving contracts from pharmaceutical companies has become very competitive;  many CROs have been established in developing countries during the past 10 years.  Research that responds to the needs of justice will likely be a “casualty of competition.  Indeed, contract research organizations are therefore interested in getting the trial done rather than the health needs of the locals and would be slow to recommend investment is diseases.

The authors of the present article claim that ethical theories of justice would be even more critical of researches conducted by contract research organizations than those done by pharmaceutical companies.   For example, international companies might be unwilling to be seen as doing unethical or socially irresponsible research, as such conduct might make life difficult for such companies at home.  Also, it would be in the interest of pharmaceutical companies to at least to appear to be doing the right thing, as they will want to use a particular country repeatedly “as a laboratory” and might even want to sell its products in that country.  CROs might not be so inhibited and will strive to “use cheaper and less ethically sanitary practices” to be competitive.  Assumptions made that contract research organizations speak for pharmaceutical companies that subcontracted them is untrue, these are independent bodies.

In conclusion the authors  calls for contract research organizations to be held as accountable as pharmaceutical companies for any ethical problems that  might arise in researches.


Foster C and Malik AY.  The Elephant in the (Board) Room: The Role of Contract Research Organizations in International Clinical Research.  The American Journal of Bioethics. 2012. 12:49-50.

Bridget Pratt, Deborah Zion & Bebe Loff (2012): Evaluating the Capacity of Theories of Justice to Serve as a Justice Framework for International Clinical Research, The American Journal of Bioethics, 12:11, 30-41

No comments yet.

Leave a Reply

Designed & Developed by Web Ideations