The federal government should develop a way to compensate volunteers who are harmed while participating in medical experiments, a presidential commission recommended Thursday.
In a 208-page report, the Presidential Commission for the Study of Bioethical Issues concluded that existing regulations are sufficient to protect people involved in federally funded research from suffering harm and unethical treatment, both in the United States and overseas. But the panel recommended 14 steps to improve protections, including establishing a compensation system for when harm does occur.
President Obama asked the commission to investigate safeguards for research subjects after revelations last year that the government had conducted unethical studies in Guatemala in the 1940s.
Those studies involved more than 5,500 men, women and children who were unwittingly drafted into tests involving the venereal diseases syphilis, gonorrhea and chancroid. The tests included deliberately — sometimes grotesquely — attempting to infect the people without their permissionor knowledge. n August, the 13-member commission released more disturbing details about the experiments and revealed that the researchers had obtained consent before conducting earlier, similar experiments on inmates in Terre Haute, Ind., and hid what they were doing in Guatemala. This, the commission said, clearly showed that the doctors knew their conduct was unethical.In its final report, the U.S. committee concluded that protections that have been put in place since the Guatemalan experiments would prevent such abuses from occurring today. For example, all research must now be approved and monitored by independent overseers.
The commission also discussed a report from a 14-member international subcommittee investigating whether current rules adequately protect people in medical studies from physical harm or unethical treatment worldwide.
“Nothing on the order of what happened in Guatemala could happen today with federally funded research,” the University of Pennsylvania’s Amy Gutmann, who chairs the committee, told reporters during a telephone briefing Wednesday.
But because information about government-sponsored research can be difficult to obtain, the panel said it could not guarantee that “all federally funded research provides optimal protections against avoidable harms and unethical treatment.”
The commission recommended that the government establish a central online registry of all government-funded research with at least basic details of the experiments, such as the title, the name of the lead researcher, the location and the cost.
The commission estimated that about 18 government agencies funded about 55,0000 projects worldwide in 2010, mostly involving health, but the ability to obtain information about those projects varied considerably from agency to agency.
The National Institutes of Health, for example, quickly provided the commission with details of the research it funded, while the Defense Department, by contrast, took seven months to respond because it did not have a central database.
“Sunshine is the best disinfectant,” Gutmann told reporters and editors at The Washington Post several days before the report was released.
The panel also recommended the creation of a system to guarantee that anyone injured by federally funded research receives appropriate care or is compensated for the cost of care.
The panel did not endorse a specific system, as some had urged, such as a fund similar to that used to compensate people injured by vaccines. However, it did cite a system implemented by the University of Washington as a good approach. That “no-fault” system caps compensation at $10,000.
Gutmann acknowledged that there is no way to know how much of a problem uncompensated injuries are.
“We don’t think it’s a big problem, but the truth is we don’t know how big a problem it is,” she said.
Gutmann noted that several other panels made similar recommendations that were never implemented. But she said she was hopeful that the government will act on the new recommendations, noting that the panel had specifically requested a response from the White House Office of Science and Technology Policy.
“While I can’t say I’m optimistic, I can say I’m not pessimistic,” she said.