January 9, 2012
Commission calls for better oversight of human subjects research
The Presidential Commission for the Study of Bioethical Issues has released its report “Moral Science: Protecting Participants in Human Subjects Research,” recommending changes to better protect research volunteers.
Primary among the commission’s recommendations was to organize and make public the data on federally funded human subject research. The commission reports that in fiscal year 2010, the government funded more than 55,000 projects involving human subjects across 18 agencies and departments but was unable to readily access comprehensive information about this type of research.
“The commission’s work in mapping the type of research supported by the federal government is unprecedented and was an important initial step in conducting its work,” said Jeremy Sugarman, senior adviser to the commission and the deputy director for medicine at the Johns Hopkins Berman Institute of Bioethics.
President Barack Obama requested the report in response to the discovery in October 2010 that, from 1946 to 1948, the U.S. Public Health Service conducted experiments in Guatemala that intentionally exposed thousands of people to sexually transmitted diseases. The president asked the commission to “determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government,” as well as to conduct a thorough investigation of the experiments in Guatemala. The findings of the investigation were published in September 2011 in the report “Ethically Impossible: STD Research in Guatemala 1946 to 1948.”
“Although serious human rights abuses like the Guatemala and human radiation experiments are unlikely to occur today, the government must continue to be held accountable for the ethics of the research it funds on human subjects,” said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics and chair of the Presidential Advisory Committee on the Human Radiation Experiments, which led to the first presidential apology for unethical human subjects research, by President Bill Clinton in 1995. “The government can’t be held accountable for what it can’t count, which is why this report’s findings that there are major gaps in the extent and nature of the landscape of federally funded human research are of singular importance,” Faden said.
The commission also made recommendations regarding compensation for injuries sustained during research, the appropriate design of research and the need for education about the ethical underpinnings of the current regulations.
“The commission’s recommendations for a publicly accessible database of federally funded human subjects research is an important acknowledgment of the real lesson from Guatemala, which is that transparency and oversight are essential to the acceptable conduct of medical research,” noted Dan O’Connor, a faculty member at the Johns Hopkins Berman Institute of Bioethics, who specializes in the history of medicine and bioethics.
The commission also recommended that the federal government take steps to assess the effectiveness of the current systems used to protect human subjects. Sugarman notes that “such assessments will be essential going forward so that we can continue to improve how valuable research is conducted while maximally attending to the rights and welfare of those who volunteer to participate as research subjects.”
The full report is available online at bioethics.gov/.