March 15, 2013

The first comprehensive database of federally supported human subjects research went online today, but it is only an early ‘stepping-stone’ in assessing protections for human subjects, according to a concurrent commentary published by the Hastings Center journal IRB: Ethics & Human Research. 

Jeremy Sugarman

Michelle Groman, JD, Associate Director of the Presidential  Commission for the Study of Bioethical Issues, and Jeremy Sugarman, MD, MPH, MA, Senior Advisor to the Commission during its work on this issue, call the database a “solid starting point” for understanding the scope of human subjects research supported by the federal government. 

“Without such data, any assessment of the extent to which research participants are protected would be incomplete at best and biased at worst,” they write.

The Commission’s database comprises more than 250,000 project entries from 18 federal depart­ments and agencies for a five-year period (FY06-FY10).  In 2010 alone, the federal government supported over 55,000 human research projects. The Department of Health and Human Services (HHS) sup­ported the most projects, and, within HHS, the Nation­al Institutes of Health supported the most projects of any operating division, the authors report. In addition to HHS, the Depart­ment of Veterans Affairs, Department of Defense, Na­tional Science Foundation, and Department of Educa­tion comprised the top five human research supporters (by number of projects) in 2010. 

The database is “the most complete picture available of the landscape of U.S. government-supported human subjects research,” according to Groman and Sugarman.

“What is unique about this database is its breadth of coverage of the types of research supported across the U.S. government,” the authors write, clarifying that unlike the website ClincialTrials.gov, the Commission’s database extends beyond information about clinical trials to include other types such as social, behavioral and economic research.

Although the database is static and no updates are planned, the Commission recommended that federal departments and agencies make this sort of information publicly accessible in the future. In fact, some federal departments and agencies already have track­ing systems in place, while others are developing them, the authors note.

“It begins with accountability,” says Sugarman, the Harvey M. Meyerhoff Professor of
Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics.  “Federal government agencies and departments should account for and share basic information about the human subjects research they fund, project by project. If we know of all the federally funded research that is being conducted, we’ll be better able to provide appropriate ethical protections for research participants,” he says. 

Groman and Sugarman write that the Commission has “only scratched the surface” of the information-rich database, citing examples of further research to be done, including the involvement of vulnerable populations in research and comparison studies with non-federally supported research cataloged on Clinicaltrials.gov. 

The database is the result of a Commission investigation, the official report of which was published in December 2011, titled Moral Science: Protecting Participants in Human Subjects Research. President Obama requested the investigation 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 historical investigation were published in September 2011 in the report Ethically Impossible – STD Research in Guate­mala 1946 to 1948.

“Adequately protecting human subjects is a goal we can all support, but first we have to understand that there are many important, smaller steps along the way to achieving it,” says Sugarman.  “If we want to ensure human research subjects are protected, first and foremost we have to know about all the research being conducted with human subjects.”