Monday, January 02, 2012

because animal studies were insufficient...,

From World War II until the end of the Cold War, the U.S. government performed military tests on large populations. While in their hospital beds, patients were injected with plutonium, along with many other amoral experiments, for the likes of which Nazi officers had been convicted during the Nuremberg Trials.

Soldiers were exposed to radiation to test their performance in a nuclear war. The Army released bacteria in the environment, making hundreds of thousands of Americans unwitting guinea pigs...

WaPo | IN 2010, THE FEDERAL government funded 55,000 experiments worldwide on human subjects. Ethical and operational controls adopted over four decades have eradicated the most abominable experiments, such as those in which U.S. researchers infected unwitting Guatemalans with sexually transmitted diseases during the 1940s. But the sheer number of ongoing projects and the absence of a centralized record-keeping system argue for additional safeguards.

Thousands of often desperately ill individuals volunteer each year to participate in experimental, federally funded medical programs. Thousands more participate in more mundane research with significantly less risk. And yet others take part in projects fueled by federal dollars that focus on social science and education research. The Department of Health and Human Services funds the most research on human subjects, but some 18 federal agencies play a role.

According to a recently released report by the Presidential Commission for the Study of Bioethical Issues, the government does not have a centralized database to keep tabs on these experiments. Even some agencies do not have a comprehensive database of the experiments they fund. The Defense Department, for example, took roughly seven months to compile data about research it sponsors on human subjects. The commission sensibly recommends creation of an online registry of all federally funded research on humans.

Another area of uncertainty: the number of individuals injured in medical experiments. “We don’t think it’s a big problem,” commission chair Amy Gutmann said, “but it’s perceived as a big problem because we’re one of the only developed countries that does not guarantee compensation for injured subjects.”

The commission encouraged the government to establish such a system. It did not endorse a particular approach but rightly pointed to the “no fault” program developed by the University of Washington. The university will pay up to $10,000 for medical care provided outside of the university system for individuals injured as a result of participation in a university research project. The school will pick up the tab for all post-injury medical services provided by university staff. Individuals who are treated through this program maintain the right to take the university to court. But one side benefit of the university’s morally responsible behavior is that it has seen the number of court cases and its litigation costs go down.