Ethics of Outsourcing (Including Especially Clinical Research)

Outsourcing is an interesting topic, both economically and ethically. The outsourcing of entire pharmaceutical research projects — clinical trials — is particularly interesting, not to mention controversial.

(For those of you who don’t already know, “outsourcing” generally means when a company sends work to be done beyond its own walls. That might happen either because the company lacks the expertise to have the work done in-house, or simply because it’s cheaper to have someone else do it. And note that those 2 factors are not unrelated. “Outsourcing” can also mean sending work to be done overseas. In this particular case it refers to when companies that need research done — usually pharmaceutical companies — arrange to have that research done in another country, typically a less-developed one.)

Outsourcing of all kinds is subject to criticism. When companies with unionized workforces outsource work to cheaper, non-unionized companies, unions get upset. When North American companies outsource work (e.g., sewing clothes) to other countries, there’s always criticism — some of it rooted in concern for overseas working conditions, and some of it clearly rooted in bigoted protectionism if not downright xenophobia.

The source of much of the hullabaloo over outsourcing, of course, is that outsourcing involves a shifting of costs and benefits. When GM outsources assembly of engines (let’s say), that typically transfers work — income — from unionized employees to non-unionized employees. It also likely transfers money from employees to consumers, in the form of lower prices. Same goes for outsourcing overseas: it tends to transfer jobs from North Americans to people in less-developed nations, and typically results in a net transfer of wealth to customers and/or shareholders.

Whether the transfers of risks & benefits involved in particular cases of outsourcing are a good thing or not is hard to say. Some North Americans will argue that too many benefits are being transferred to foreign countries; others will argue that too many risks (e.g., environmental risks) are being pawned off on people who are already living, in some cases, difficult lives.

Take all of that complexity, and mix it with a) the passions aroused by anything having to do with medical research, and b) fairly-well-founded skepticism about the behaviour and motives of major pharmaceutical companies, and you’ve got a recipe for serious controversy.

Case in point: researchers at Duke University recently published a critique of the outsourcing of drug trials, in the New England Journal of Medicine. Here’s the full text of the paper: Ethical and Scientific Implications of the Globalization of Clinical Research (PDF). The paper raises a number of concerns, ranging from questions about the qualifications of clinician-researchers in developing nations to oversee complex trials, to concerns about potential injustices in access to the products that (hopefully) result from clinical trials.

Here’s the story as reported in the NY Times: Outsourcing of Drug Trials Is Faulted. The NY Times story raises good questions about the data used by the Duke researchers, but it remains true that there are good questions to be asked about the standards that get applied to clinical trials run in less-than-modern settings. I think the issue that is least-well-analyzed in this study is the issue of justice in access; I suspect that insight could be gained by comparing the outsourcing of clinical trials to other forms of outsourcing. How is outsourcing clinical trials different from outsourcing, say, customer support or manufacturing or assembly of electronics? Is the inability of the average Bangladeshi to afford major pharmaceutical products importantly different from the average Chinese factory worker’s inability to afford the Nokia cellphone she assembles? If so, how and why?
Addendum: for a Research Ethics perspective on this story, see today’s posting over at the Research Ethics Blog, here.

2 comments so far

  1. Jennifer on

    I think that is video would be of interest to you. “PARTNERSHIPS WITH CROs 2009 Presents A Workshop for CRO BD Execs CRO Strategies For Adapting To The Changing Tides In Pharma” an in-depth workshop provides CRO BD Execs with the strategies necessary to approach, interact and work effectively with your current and prospective biopharma clients.

  2. Danny King on


    Interesting article, thanks! I had not considered the ethics of outsourcing in pharmaceutical industry.

    I’d be interested to know if you have any opinions on the ethics of a small business offshore outsourcing to gain a competitive advantage?

    I wrote a short overview of the pros & cons of this at if you’re interested!

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