U.S. Human Research Protections Are Adequate, Not Optimal, Bioethics Panel Finds

January 6, 2012 — A recent report from the Presidential Commission for the Study of Bioethical Issues concluded that current rules and regulations that apply to federally sponsored research involving human subjects adequately protect against avoidable harm and unethical treatment. 

However, the commission also recommended 14 ways to better protect research subjects through more transparency and accountability for research trials, said University of Virginia bioethicist John Arras, Porterfield Professor of Biomedical Ethics and Professor of Philosophy in the College of Arts & Sciences and a member of the presidential commission.

The commission addressed the lack of national policies to require treatment or compensation for injuries suffered by research subjects, a protection already in place in
most other developed nations and at many American universities and pharmaceutical companies. Several prior national commissions have recommended in vain that such policies be put in place.

"The U.S. government is a real outlier on that issue," Arras said.

Rather than follow prior national commissions and repeat that recommendation, the report called for further study of both the magnitude of the issue – how many people are injured annually and what are the likely costs involved – and how best to set up a compensation system.  

The 200-page report, "Moral Science: Protecting Participants in Human Subjects Research," issued Dec. 15, followed up the commission's Sept. 13 report on 1940s-era U.S. Public Health Service studies in Guatemala. Abusive practices in those studies were revealed by a Wellesley College historian in 2010, prompting a national apology from President Obama.

The September report found that from 1946 to 1948, U.S. Public Health Service researchers deliberately infected about 1,300 Guatemalans with syphilis, gonorrhea or chancroid, by inoculation or contact with prostitutes, without the subjects' consent. Fewer than 700 received any form of treatment and 83 participants died during the course of the studies.

President Obama charged the bioethics panel to both conduct a thorough investigation into the Guatemala research, and to ensure that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.

"Something like the 1940s Guatemala study would almost certainly never be possible again, given the rules and regulations that have grown up since then," Arras said, echoing the Dec. 15 report's central finding. For instance, institutional review boards, which independently review research, did not exist the 1940s, but are now well established in most countries and most medical centers.

In its latest report, the commission found that the federal government supported more than 55,000 projects involving human subjects around the globe in fiscal year 2010 – mostly health-related research – but no central source of information exists about the overall size, scope, and cost of the government's research involving human subjects.

The commission requested information from 18 government agencies that conduct most federal research involving human subjects, but discovered that many federal offices could not provide basic data about the research they support. The Pentagon, for example, required more than seven months to prepare information on specific studies supported by the Department of Defense. 

"Without access to a full data set, it's hard to say with assurance that everything is as it should be," Arras said.

To address this information deficit, the commission recommended that each federal department or agency supporting research with human subjects maintain a core set of data for their research programs that includes the title and lead investigator of each project, the location of each study and the amount appropriated for the research. Each office should aid the public in learning more about the government's research efforts by developing (or improving) publicly available electronic systems, or by releasing information through a government-wide system, such as ClinicalTrials.gov.

To support these efforts, the commission suggested that the Office for Human Research Protections or another office should administer a central, Web-based portal that links to each individual department or agency system. In addition, the government should consider developing a unified federal research database, which may ultimately be more cost-effective and efficient.

Another recommendation called for researchers to better engage the communities that host proposed research trials.

"This issue shows remarkable maturation on part of U.S. researchers in dealing with host populations," Arras said. "Not more than 15 years ago it would have been really rare for researchers to even bother consulting at length with a local population. They would usually just arrive with their study protocol, recruit and pay staff to run the trial, and get under way."

We are now seeing "this is changing dramatically, in very good ways," he said.

Better community engagement should offer dividends regarding the emerging international expectation that if research sponsored by those in the developed world is outsourced to developing countries, then the research should benefit the health priorities of the host country, Arras said.

When communities around the world have been engaged and consulted on proposed research, Arras said, they have a good record of determining what is best for them and standing up for themselves.

— By Brevy Cannon

Media Contact

H. Brevy Cannon

Media Relations Associate Office of University Communications