Panel Urges Payment for People Hurt in Research
A group of international experts, reviewing American policies on protection of human research participants, has urged that the U.S. adopt a system to compensate individuals injured in the course of research.
The National Vaccine Injury Compensation Program is "a promising model," according to the panel, a subcommittee of the President's Commission for the Study of Bioethical Issues.
The panel included the recommendation in a report to the full commission on the adequacy of U.S. safeguards for research participants -- an outgrowth of the commission's probe of a 1940s-era study in which U.S. public health researchers deliberately exposed Guatemalan prostitutes, prisoners, and soldiers to sexually transmitted diseases.
Last year, a historian researching the infamous Tuskegee study of black men with syphilis who were left untreated stumbled across records of the Guatemalan experiment. It ran from 1946 to 1948 and was led by John C. Cutler, MD, who went on to become a widely respected public health researcher and teacher.
Cutler and colleagues intentionally infected female sex workers in Guatemala with syphilis, and then paired the prostitutes with male prison inmates. Some inmates as well as mental hospital patients and soldiers in Guatemala also were directly inoculated with the pathogens responsible for syphilis, gonorrhea, and chancroid. The experiments were performed without the individuals' full knowledge or consent.
The revelation prompted President Obama to publicly apologize for the study, and the directors of the CDC and the National Institutes of Health declared in a joint statement that it "should never have happened, and nothing like it should ever happen again."
Obama requested that the commission investigate the matter and make recommendations for policy changes necessary to prevent future research-related abuses.
In turn, the commission turned to bioethics and medical researchers from 10 nations around the world for their views on whether current U.S. policies are sufficient to protect research participants -- not only domestically but also abroad, where an increasing number of drug and device trials are conducted.
By and large, the subcommittee was satisfied with current safeguards.
"Over the past five decades, the U.S. has made significant progress in developing rules, standards, and practices for protecting human subjects in research," the panel wrote in a 48-page report.
The most significant recommended change is adoption of "a system to compensate research subjects for research-related injuries."
The report authors noted that many other nations already have such systems in place. For example, trial sponsors and investigators in some European countries must carry indemnity insurance to cover such injuries.
Other recommendations included:
Ongoing dialogue between U.S. and international bodies on research ethics
Relaxation of U.S. insistence that research procedures in foreign trials adhere to U.S. law when alternative safeguards may also be effective
More ethics training for clinical investigators and IRB members, funded by trial sponsors
Greater transparency and monitoring of ongoing research
Better enforcement and refinement of current rules instead of creating new ones
The full commission will consider the subcommittee's recommendations in making its final report to President Obama, due in December. Next month, the commission will issue its findings on the Guatemala study.
On Monday, the commission held a public discussion of its preliminary findings, which suggested that Cutler and colleagues knew that they were violating ethical standards prevailing at the time.
The Guatemalan government has commissioned its own probe of the study. Its findings have not been released. The investigation's leader -- the nation's vice president, Rafael Espada, MD, a former cardiothoracic surgeon -- was to make a presentation at the Monday commission meeting, but his travel was prevented by Hurricane Irene.