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Adil E. Shamoo is Professor of Medicine at the University of Maryland School of Medicine and Editor-in-Chief of the journal: Accountability in Research.

by Adil E. Shamoo

The media, legislators, and other organizations often raise concerns about human-rights violations and ethical breaches in clinical research. Such cases are legion. Human subjects are allowed to be bitten by 100 mosquitoes that could carry malaria in a study in Brazil. A French doctor performs a face transplant without the benefit of the usual research that would accompany such a high-risk procedure. An 18-year-old subject in a gene therapy trial dies, with numerous lapses in the clinical trial noted after his death.

The general public is aware of clinical research trials, but there is little awareness that the number of subjects enrolled in research is much larger than the number enrolled in clinical trials alone. While some research-related deaths reach the popular media, the actual number of deaths in research is higher. Even regulators and industry experts are not aware of the true numbers of deaths and adverse events, due to the lack of proper reporting.

The large numbers of human subjects in research are an outgrowth of the legitimate need for more and better health care throughout our ever-lengthening lifespan. No single entity keeps track of the real extent of the abuse of all human subjects engaged in research here in the United States or worldwide. I have estimated that in the US alone, there are more than twenty million subjects, half of whom represent drug trials. Worldwide, this number could exceed fifty million, with about half that number in drug studies. These staggering numbers present an awesome responsibility for our citizens and our governments alike.

The immediate ethical issue facing us is the real harm inflicted on unsuspecting subjects through a vast array of indignities, adverse events, injuries, and death. Many of those who are harmed are poor, uneducated, and politically powerless. Some are also impaired in their ability to give informed consent due to mental or cognitive disabilities, or are exposed to coercion, improper monitoring, and pervasive conflicts of interest. Moreover, the justice of the distribution of risks and benefits is questionable when research subjects are concentrated on a vulnerable segment of our society.

Bloomberg Market magazine recently published an extensive article on the unethical practices of the largest contract research organization conducting some clinical trials in Florida. Trial subjects from the Latin American illegal immigrant community were threatened with reporting of their status to the US Department of Homeland Security if they complained about the risks of the drug that they received.

That is only one example. The system of protections for human subjects worldwide is either non-existent or broken. In the US, this system has three levels: federal regulation, institutional oversight, and researchers’ ethical obligations. But there are serious shortcomings and gaps throughout the system. At the federal level, the protections apply to publicly funded research and those seeking a drug license, which probably covers 60-70% of all human subjects, although no one knows for sure. (Contrast this with the protection of animals in research, which since 1966 covers all animals, regardless of the sponsor.)

Further down the chain of supervision, research institutions are designated to “manage” their own conflicts of interests as well as those of their investigators. Yet many institutions and investigators have a financial stake in the clinical trials they are conducting. Most investigators have little or no training in ethics and regulatory compliance, for which there is no mandatory education.

Advocates in the US, such as the ten-year-old human rights organization, Citizens for Responsible Care and Research (www.circare.org), which I co-founded, have proposed a universal National Human Subjects Protection Act. However, there is no likelihood of passage anytime soon.

In the US, and most likely worldwide, opposition to serious reforms to protect human subjects in research comes from two groups: the pharmaceutical industry and universities. The objections of industry rest on the narrow issue of added financial cost. The objections of universities are more puzzling, as it is in their long-term interest to conduct research ethically.

In both cases, the effective protection of human subjects should receive much higher priority, thereby justifying the modest added expense, which probably would amount to no more than 1-2% of the overall cost of clinical studies. If such research is truly to serve the public good, the safety, health, and dignity of human subjects should not be compromised.

Copyright: Project Syndicate, 2006.
www.project-syndicate.org