Human Subjects

Every year millions of Americans (no one knows exactly how many) volunteer to be human subjects in medical research that compares a new treatment with an old one—or when there is no existing treatment, with a placebo. By something like a coin toss, some volunteers are assigned to get the new treatment (the experimental group), while others get the old one (the control group). This type of research is termed a clinical trial, and at any given time there are thousands underway in the US. Most are sponsored by makers of prescription drugs or medical devices, but many are sponsored by the government, mainly the National Institutes of Health (NIH). A growing number are conducted offshore, particularly in countries with autocratic governments, where they are easier and cheaper to do.

The first modern clinical trial was published only sixty-seven years ago, in 1948. Sponsored by the British Medical Research Council, the trial compared streptomycin, a new antibiotic, with bedrest alone in patients with tuberculosis. (Streptomycin proved better, and became part of the usual treatment for this disease.) Before that, human experimentation was fairly haphazard; subjects were treated in one way or another to see how they fared, but there was usually no comparison group. Even when there was, the comparison lacked the rigorous methods of modern clinical trials, which include randomization to make sure the two groups are similar in every way except the treatment under study. After the streptomycin study, carefully designed clinical trials soon became the scientific standard for studying nearly any new medical intervention in human subjects.

Patients with serious medical conditions are often eager to enroll in clinical trials in the mistaken belief that experimental treatments are likely to be better than standard treatments (most turn out to be no better, and often worse).2 Healthy volunteers, on the other hand, are motivated by some combination of the modest payments they receive and the altruistic desire to contribute to medical knowledge.

Given the American faith in medical advances (the NIH is largely exempt from the current disillusionment with government), it is easy to forget that clinical trials can be risky business. They raise formidable ethical problems since researchers are responsible both for protecting human subjects and for advancing the interests of science. It would be good if those dual responsibilities coincided, but often they don’t. On the contrary, there is an inherent tension between the search for scientific answers and concern for the rights and welfare of human subjects.

Consider a hypothetical example. Suppose researchers want to test a possible vaccine against HIV infection. Scientifically, the best way to do that would be to choose healthy participants for a trial, give the vaccine to half of them, and then inject all of them withHIV and compare the infection rates in the two groups. If there were significantly fewerHIV cases in the vaccinated group than in the unvaccinated group, that would prove that the vaccine worked. Such a trial would be simple, fast, and conclusive. In short order, we would have a clear answer to the question of whether the vaccine was effective—an answer that might have enormous public health importance and save many lives.

Yet everyone today would agree that such a trial would be unethical. If asked why, most people would probably say that people should not be treated like guinea pigs—that is, they should not be used merely as a means to an end. (And, of course, no fully informed person would volunteer for such a trial.) There is an instinctive revulsion against deliberately infecting human subjects with a life-threatening disease, no matter how important the scientific question.

Adapted from http://www.nybooks.com/articles/2015/11/19/medical-research-dangers-human-subjects/

8 Comments


  1. MI; Clinical trial = ethical dilemma
    ex HIV

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  2. MI: Usage of humans in clinical trials is unethical.

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  3. MIP: CT= Risky + Ethical Concerns (neutral)

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  4. author tone = wary of clinical trials

    large dilemma : balancing ethical treatment and scientific advancement

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  5. human benefits should ALWAYS come before the desire to gain knowledge in science field

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  6. MIP: clinical trials = ethical debate (EX: HIV)

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  7. MIP: clinical trials improved but risky; tone = neutral

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  8. MIP: Clinical trials = unethical b/c science gets priority not subjects safety , Tone = Negative

    Reply

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