The presidential bioethics commission looked into the current protections for human subjects in a review triggered by evidence of unethical behavior in a 1940s experiment that deliberately infected Guatemalan prison inmates and mental patients with sexually transmitted disease.

The commission earlier this year concluded that U.S. government researchers must have known they were violating ethical standards at the time of the experiment, shortly after World War II. They have also called for a better system to compensate medical research subjects.

Nothing like the horrors of the Guatemala study could take place under U.S. government watch now, the panel said in a report released Thursday.

But the lags in how federal agencies collect and store data about their research involving human subjects offers no assurance that all unnecessary injuries or unethical activity are prevented.

U.S. government agencies last year supported more than 55,000 projects, mostly health-related, involving human subjects. The presidential commission asked 18 agencies that do most of such research to provide basic data about it, such as location of study sites, lead investigators, number of subjects involved and amount of funding designated.

What they found is that the information does exist, but in many cases is far from well overseen or readily available.

The Pentagon, for example, took more than seven months to get the basic data ready on research by the Department of Defense, which was found to have no public information system.

Some agencies had one public system tracking research and another tracking funding, but had trouble connecting them. Examples included the Department of Education and Department of Homeland Security, which could not provide the funding data saying "it would be overly burdensome, and in many cases not feasible," according to the commission's report.

"Because of the currently limited ability of some governmental agencies to identify basic information about all of their human subjects research, the Commission cannot conclude that all federally funded research provides optimal protections against avoidable harms and unethical treatment," said the report titled "Moral Science."

The panel called the Department of Energy and the National Institutes of Health examples of best examples of transparent and centralized systems tracking research on human subjects.

"There can be significant improvement in the assurance that can be given to human research subjects and the general public, significant improvements to what happens today. First step in those improvements, would be greater transparency and accountability of the experiments that are going on," said commission chairwoman Amy Gutmann.

"The Guatemala experiments remind us never to take ethics for granted," she said.

The United States apologized last year for the Guatemalan experiment, which was meant to test the drug penicillin. The research was uncovered decades later by a college professor.

Guatemala has called the incident a crime against humanity and conducted its own investigation. Its report released earlier this month showed that 2,082 people were affected.

The United States and Guatemala will now compare reviews and investigations and determine how best to compensate the victims and their families. Several of them have sued the United States.

The subjects of the Guatemala experiment were infected with venereal diseases, more than half of them with syphilis. They included inmates exposed to infected prostitutes brought into jails and male and female patients in a mental hospital. Some subjects had bacteria poured on scrapes made on their genitals, arms or faces.

The presidential commission plowed through thousands of pages of archives to find that U.S. and Guatemalan scientists at the time deceived the participants who were members of especially vulnerable groups, kept poor notes, did not try hard to protect the subjects from risks and conducted experiments in illogical order.

"This should not be just a moment of true regret and embarrassment on the part of our country," Gutmann said. "It should be an ongoing teaching moment."

SOURCE: 1.usa.gov/tW3DVZ The Presidential Commission for the Study of Bioethical Issues, December 15, 2011.

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