People who volunteer for federally funded research both in this country and abroad are well-protected by federal ethics rules, a high-level expert
panel has found. But there is room for improvement. The United States needs to do a better job of tracking human studies, the panel says, and it should
consider creating a system to compensate injured volunteers.
That advice comes from a report issued today by the Presidential Commission for the Study of Bioethical Issues. It began a probe last year after a
historian revealed that in the late 1940s, U.S. researchers deliberately exposed more than 1300 Guatemalans to syphilis and other sexually transmitted
diseases to study the effects and possible treatments. President Barack Obama asked for a fact-finding investigation, which the commission
completed in September; it found "unconscionable" ethical violations. The president also requested a
review of whether research subjects today are adequately protected.
In the decades since the Guatemala studies, the United States and other authorities have imposed many standards and rules on the use of human subjects,
the panel finds. In the United States, the 30-year-old federal Common Rule requires informed consent, independent ethics review, and the minimization
of risks. The Common Rule also applies to the growing proportion of U.S.-funded trials conducted abroad, where most countries now have similar rules.
As a result, "the commission is confident that what happened in Guatemala in the 1940s could not happen today," said commission chair Amy
Gutmann, president of the University of Pennsylvania, in a press teleconference on Wednesday.
However, in its 104-page report (plus endnotes and appendices), the commission finds some gaps
in transparency. When its staff members asked 18 U.S. agencies covered by the Common Rule to list the human studies they support, many could not easily
provide the information. Even the National Institutes of Health (NIH)'s grants database can't
readily be searched for only human research. And a federal database of drug trials, ClinicalTrials.gov, leaves
out many early-stage (phase I) trials and behavioral and social science studies, according to the report, titled "Moral Science: Protecting
Participants in Human Subjects Research."
The bioethics commission, which tallied 55,000 federally funded studies in 2010, says that federal agencies should be required to make public online
basic information about each project—including a study's title, investigator, location, and funding.
Another problem the commission flags is the need to treat or compensate injured volunteers. Most developed countries have compensation policies But in the
United States, it says, efforts are "piecemeal." Patients can sue if injured, but resolution can take years. Some agencies have their own compensation
systems for in-house research; drug companies usually have insurance. The University of Washington is "a wonderful case study," said commission
vice-chair James Wagner, president of Emory University: It provides up to $10,000 in out-of-pocket expenses and unlimited treatment through its health
care system for subjects who claim to need aid. The United States should consider whether to create a national compensation system for research
subjects, the commission concludes. Although there is a model for this--the National Vaccine Injury Compensation Program—it's not the only option. "Usually what succeeds in the United states is not a centralized uniform system, but a system by which, for example, the federal government could recommend or require all institutions of a certain size to make sure they have provisions for compensation," said Gutmann. "We want the government to get it right."
Among its 14 recommendations, the commission also focuses on the possibility that sponsors might chose to locate a study in a place for "worrisome"
reasons, for example because regulations there are not strong. For this reason, the panel concludes, funding agencies should make sure the study can be
done ethically in a proposed site. At the same time, it says the United States should consider allowing a foreign country's rules to supplant the
Common Rule when they are equivalent.
The commission also offers recommendations for an ongoing revamp of the Common Rule, including:
developing simple, standard informed consent forms; allowing multi-site studies to go through a central ethics review; and easing review requirements
for studies that pose minimal risk.
The report notes that earlier bioethics panels made similar recommendations—for example, in 2002 the Institute of Medicine urged that institutions
be required to compensate injured research participants. This time the White House Office of Science and Technology Policy or other agencies should
issue a response on why or why not the government plans to respond to the commission's advice, the report says.
Last week, Guatemala issued its own report on the 1940s syphilis study; it found that nearly 2100 people had been deliberately exposed to diseases, far more than
had been reported earlier, according to a press report. The
Guatemalan investigators drew on archived documents that the U.S. bioethics commission did not have access to, says commission executive director
Valerie Bonham. Her team is now reviewing the report, which it received in Spanish. It plans to fold the findings into a teaching guide for college
students about the Guatemala study.
Correction: This item has been modified to correct a statement suggesting that the report specifically recommends a compensation system along the lines of the National Vaccine Injury Compensation Program.