Protection of Human Research Subjects is a Must, Says US Panel

by Kathy Jones on  December 16, 2011 at 7:07 PM Clinical Trials News   - G J E 4
The US government has been urged to consider compensating victims who are harmed by participating in future research by a bioethics panel convened in the wake of a Guatemalan sex disease scandal.
 Protection of Human Research Subjects is a Must, Says US Panel
Protection of Human Research Subjects is a Must, Says US Panel

The President's Bioethics Commission was authorized by Barack Obama after revelations last year that 1,300 people were exposed to venereal disease as part of macabre research led by an American in Guatemala in the 1940s. Eighty-three people died as a result.

In its final report, the commission urged greater transparency, easy-to-understand warnings about the potential dangers of participating in studies, and a continued focus on high ethical standards in US federally funded research.

"The commission is confident that what happened in Guatemala in the 1940s could not happen today," said commission chair Amy Gutmann.

"We also are confident that there is room for improvement in protecting human subjects from harm -- avoidable harm -- and unethical treatment."

The United States last year was engaged in 55,000 research projects around the world involving human subjects, mostly for health and medical purposes.

Gutmann said there was a "strong ethical case" for compensating people who are hurt in research but stopped short of urging a payout for the victims in Guatemala, where five survivors of the experiments were recently found.

"We were charged by the president to make recommendations looking forward and we are strongly recommending that the government study and find a way, expeditiously, to assure people who volunteer for human subjects research that they will be compensated," she told reporters.

"We were not asked to make recommendations with regard to Guatemala."

The Guatemalan study, which was never published, came to light in 2010 after Wellesley College professor Susan Reverby stumbled upon archived documents outlining the experiment led by controversial US doctor John Cutler.

Cutler and his fellow researchers enrolled soldiers, mental patients, prostitutes, convicts and others in Guatemala for the study, which aimed to find out if penicillin could be used to prevent sexually transmitted diseases.

Initially, the researchers infected female Guatemalan sex workers with gonorrhea, syphilis or chancroid, and then encouraged them to have unprotected sex with soldiers or prison inmates.

The subjects were not told about the purpose of the research and were not warned of its potentially fatal consequences.

Cutler, who died in 2003, was also involved in a controversial study known as the Tuskegee Experiment in which hundreds of African-American men with late-stage syphilis were observed but given no treatment between 1932 and 1972.

Guatemalan President Alvaro Colom has called the 1946-1948 experiments "crimes against humanity" and earlier this month vowed to compensate the victims.

The Guatemalan government says it believes 2,082 people were infected, a higher number than the United States has acknowledged, in the research which involved 10 US and 12 Guatemalan researchers.

Obama personally apologized to Colom in October 2010 before ordering a thorough review of what happened. Secretary of State Hillary Clinton described the experiments as "clearly unethical."

The White House said on Wednesday, ahead of the commission report's release, that it could not comment on the matter of compensation to Guatemala.

"This matter is the subject of pending litigation that we cannot discuss at this time," a senior administration official told AFP. "We appreciate the work done by the commission and look forward to reviewing their recommendations."

Most other developed nations have policies that require researchers and sponsors to provide treatment or compensation for treatment for injuries suffered by research subjects, Gutmann noted.

Several national bodies have urged the United States to create such a system in years past, but it has never been put in place.

Source: AFP

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