Informed Consent: Ethically necessary, or unnecessarily costly?

The question posed as part of the title of this blog post is designed to be rhetorical – suggesting that the obvious answer is that informed consent is ethically necessary – but amidst the commercialization of science and medicine, and the rise of Contract Research Organizations (CROs), what may strike many of us as the “obvious” answers, may not be so obvious to the CROs and the pharmaceutical companies that enlist their services. Informed consent is often considered one of the pillars of medical ethics; one can cite the Kantian ideal of not using persons as mere means, and only as ends in themselves as the foundation for informed consent.

The underlying idea is that it is only ethically permissible to conduct an experiment on a human subject (a person) if they are informed of the potential dangers/side effects, and they knowingly consent to the procedure/experiment. Only when subjects are capable of understanding the potential dangers can consent be truly considered “informed”. So what happens when people are incapable of providing informed consent, such as in cases where clinical research is conducted in developing nations? The result is that economics trumps ethics.

CROs willingly perform clinical trials on those who are incapable of providing informed consent for the sake of cost cutting measures. Clinical trials often involve large amounts of patients (making them costly) thereby encouraging CROs to conduct their human research in under-developed countries to keep costs down. The problem is that the value of a person’s life does not vary with their state’s GDP. Without suggesting that the FDA is sitting idly by while ethical violations are being committed against the world’s poor for the sake of economic costs, violations such as these ought to prompt greater regulations on foreign research on human subjects.

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