New Scrutiny of Tests on 'Human Guinea Pigs' Today Congress Tackles Ethics of Drug Testing on Humans - a Fast-Growing Field

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The Brooklyn mother already had one son in trouble with the law. So when researchers at the New York State Psychiatric Institute said they wanted to study her younger boy to help understand what keeps kids "out of trouble," she jumped at the opportunity.

She thought they'd let her know if her son had any behavioral problems, she told the New York Daily News. And there would be some extra cash, too. The researcher proposed paying the family $125. Her son would get a gift certificate from Toys 'R Us.

She decided to do it, and so entered the ethically sensitive realm of human clinical drug trials. Little did she know at the time, the experiment would become a pivotal example of the growing weaknesses in the system that's designed to protect people who become, in essence, "human guinea pigs." At a hearing today on Capitol Hill, four government reports will call for reforms of the Institutional Review Boards (IRB). The ethics boards are supposed to ensure the benefits of any human research outweigh the risks and that people are fully informed before they agree to join any study. The most damaging report, subtitled "A System in Jeopardy," concludes the dramatic increase in research trials has outstripped and overloaded the IRB system; that too many research proposals are approved "too quickly" and with "too little expertise;" and that inherent conflicts of interests "threaten their independence." In need of ethics boost Some scientists and ethics experts contend that assessment is exaggerated, but all agree the system needs improving. "We can do more to ensure that review boards and patients are fully informed of all the ethical, legal, and scientific issues," says Belinda Seto, of the National Institutes of Health (NIH). The IRB system, a collection of local voluntary boards made up of scientists, academics, and at least one lay person, was developed in the 1970s. At the time, 85 percent of the clinical research on humans was done in prisons. People began to question the ethics of using captive populations, says the University of Virginia's Jonathan Moreno. And then the revelations broke that African-American men were unwitting subjects of a syphilis study in Tuskeegee, Ala. …