Safety for Research Subjects

Since 9/11, Congress has poured hundreds of millions of taxpayer dollars into developing drugs to defend against biological and chemical weapons. Given that such research is subject to only a veneer of regulation and oversight, the government should be equally eager to ensure that people are not hurt in the rush to protect the public. Instead, the Bush administration and Congress have been making moves that could weaken the protections of individuals who subject themselves to experimentation.

Last month, for example, the administration abruptly disbanded the National Human Research Protections Advisory Committee, the key board created to address what a 1995 federal report called “serious deficiencies” in the system for protecting human research subjects.

The administration says it plans to reconstitute the committee in the future, perhaps with a broader mission. But the committee’s chairwoman, University of Kansas bioethics professor Mary Faith Marshall, says the administration’s call to scrap her panel “came out of the blue.”

It’s unfair to blame the threat to human research subjects solely on the Bush administration. In an attempt to encourage more private investment in drugs aimed at countering bioterrorist threats, a top Democrat, Connecticut Sen. Joseph I. Lieberman, has introduced a bill that would reduce companies’ exposure to liability if patients were harmed by a drug intended to help them recover from a bioweapons attack.

George Painter is the president of a San Diego-based biotech start-up called Chimerix that hopes to develop a pill to combat smallpox. Capitalists, he notes, often fail to invest in companies tackling such important goals because they fear prohibitively expensive pain-and-suffering lawsuits.

The government needs to confront that obstacle. But first Congress and the Bush administration must fix obvious flaws in the Common Rule. That 1991 law lays out guidelines for research on human subjects, but only for publicly funded research conducted by 17 federal agencies. Inexcusably, institutions not receiving federal funds need not comply with any of the safeguards in the rule.

Legislators can find at least two sensible blueprints for reform. One is a 1995 report by a federal task force that suggested expanding protections to even classified research, “requiring the informed consent of all human subjects.” Another is a 2001 report from the National Bioethics Advisory Commission recommending that the Common Rule be applied without exception to “all government agencies, academe and the private sector.”

There is no reason why Washington can’t encourage more private investment in anti-terrorism research while demanding that scientists fully inform and offer strong protections to every human guinea pig who heroically volunteers to test lifesaving chemical and bioterrorism antidotes.