Do you see any ethical problems with the CRO’s plans?

A contract research organization (CRO) is planning to move its operations to a developing nation in Southeast Asia. The CRO specializes in conducting phase I trials (i.e., dosing studies) on healthy subjects for pharmaceutical companies. It is moving its operations to this country to save money on labor costs and to take advantage of a less burdensome regulatory system. The research subjects will be paid $5 per day for participating in research, which is about the average daily pay in that country. The CRO has no plans to compensate research subjects for injuries. Health care in the Southeast Asian nation is very limited. Most of the drugs tested by the company are likely to be used to treat chronic diseases that affect people in developed nations, such as hypertension, congestive heart failure, arthritis, and depression. Most of the drugs will be too expensive for patients in the country to afford, at least until their patents expire. The CRO is helping to establish an IRB to review the research at a local hospital. The CRO will conduct some educational and training activities for the IRB members and pay them the same wage as the subjects. Local leaders are delighted that the CRO has moved its operations to their vicinity, since this will create jobs and stimulate economic activity. They have reached a deal with the CRO that includes tax breaks.

• Do you see any ethical problems with the CRO’s plans?

• Is the local population receiving fair benefi ts from this deal?

• Is this situation exploitative? Unethical?

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