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HHS strengthens global human research protection

The Department of Health and Human Services (HHS) has committed approximately $1.8 million to strengthen ethical training on global human research protection and to increase its efforts to improve the treatment and prevention of HIV and other sexually transmitted diseases (STDs) in Guatemala.

The 10 January announcement responded to revelations in October 2010 that HHS’ parent agency, the Public Health Service, funded research in the 1940s that involved intentionally infecting research subjects in Guatemala with STDs.

Under the HHS plan, the National Institutes of Health has pledged $1m to support research that will be used to evaluate the impact of the revisions to the HHS regulations governing human subject research that are currently under consideration.

“The US government considers the protection of human subjects in research to be of paramount importance and requires all federally funded research on human subjects to adhere to the most stringent ethical guidelines,” HHS said.

“There are currently numerous safeguards in place in the United States to prohibit these types of unethical practices, and the review of current regulations and standards is part of the administration’s effort to ensure we have the best possible human subject protection in the United States and around the world,” it said.

The HHS commitment came one day after the Justice Department moved to have a lawsuit against HHS dismissed in which Guatemalans sought restitution for the research project in question.

In its motion, the Justice Department agreed that this HHS research in Guatemala was “unethical” and constituted a “terrible wrong.” However, the agency also said the lawsuit was “not the proper vehicle” through which the consequences of this “shameful conduct” could be resolved.

“Non-consensual experimentation on human subjects is morally reprehensible,” the motion stated. “But the fact remains that Plaintiffs have chosen to seek monetary damages against federal officials in their personal capacities who had nothing to do with those studies and, indeed, may not have even been born when they took place,” it said.

The Justice Department concluded that the plaintiffs had no standing to bring their claims for equitable relief.