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doi: 10.1097/01.NT.0000407227.75007.13
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Legal-Ease: Lawsuit on Lead Poisoning Raises Questions About Informed Consent?

Valeo, Tom

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The harshly worded language used a decade ago by a judge to criticize a research project that tested ways to alleviate lead poisoning in children has found its way into a class-action lawsuit filed on behalf of one of the study subjects. And the vigorous denials of the accused and their supporters indicate that the debate over the ethics of volunteering children for scientific research remains far from settled.

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The lawsuit springs from a research project begun in 1993 involving the Kennedy Krieger Institute (KKI), a research and treatment facility affiliated with Johns Hopkins University. The US Environmental Protection Agency provided a $200,000 grant to KKI for the Lead-Based Paint Abatement and Repair & Maintenance study, which would attempt to curb widespread lead poisoning among children living in Baltimore's low-income housing by determining which of three successful lead abatement methods was most effective.

The study enrolled 108 African-American families, all of them already living in low-income Baltimore neighborhoods where buildings contained lead-based paint. The investigators compared three groups of families living in houses that used different types of lead abatement procedures, costing $1650, $3500, and $6500. They compared their blood levels with families who were living in houses that had already had lead removed and/or were lead-free because they were built after 1978.

Over six years researchers collected blood, dust, soil and water samples to determine which method of lead abatement was most effective. Blood levels of lead remained low for almost all of the children, but at the conclusion of the study two parents who participated in the research study filed suit, claiming researchers withheld test results that showed high levels of lead in the homes. The mother of one child, who was 10 months old when the family moved in the housing unit, claimed her daughter developed learning disabilities and cognitive impairment — two known outcomes of lead exposure in children. The other mother claimed researchers gave her “a false sense of security” by disclosing test results that showed only low levels of contamination.

Two Baltimore judges dismissed the lawsuit, agreeing there were no grounds for liability, but in August 2001 the Maryland Court of Appeals reversed the ruling and issued a scathing 96-page opinion that accused KKI and Johns Hopkins University of deliberately exposing poor children to lead-based paint. One of the judges, Dale R. Cathell, compared the research to the notorious Tuskegee syphilis experiment conducted from 1932 to 1972, in which the U.S. Public Health Service monitored black men with the disease but provided no treatment even after penicillin became widely available in the 1940s. He also said the children were “enticed” into the research project and used as “canaries in the mines.” His language was so inflammatory that another judge, Irma S. Raker, while concurring with the ruling, criticized her colleague for making such comparisons before any evidence had even been presented.

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THE NEW COMPLAINT

The new complaint filed recently in Baltimore Circuit Court on behalf of David Armstrong Jr., the father of one of the children included in the KKI study, evokes that language. “KKI anticipated that these child guinea pigs would accumulate lead in their blood … and thereby help researchers to determine the extent to which various partial abatement methods worked,” the complaint states. “KKI researchers intended that the children be the canaries in the mines, but never clearly told the parents.”

KKI president and CEO Gary Goldstein, MD, issued a statement pointing out that 25 years ago 95 percent of the housing in Baltimore's low-income neighborhoods contained lead paint, and 20 percent of the city's children were lead-poisoned. “Baltimore City had the highest lead poisoning rates in the country, and more children were admitted to our hospital for lead poisoning than for any other condition,” he said. It was the KKI study that demonstrated “landlords and building owners could make specific improvements to their properties that would reduce lead within homes.”

Don Ryan, co-founder and former executive director of the Alliance to End Childhood Lead Poisoning, regards the KKI study as an honorable and effective effort to reduce lead poisoning among children.

“I can hardly find words to express how unfounded and unfair the charges and criticisms of the study are,” said Ryan, currently a senior advisor for the National Center for Healthy Housing, affiliated with the Alliance. “To say children were lured into leaded housing and experimented on like guinea pigs turns reality on its head. The children in this study benefited from treatments that made their homes safer than surrounding properties.”

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ETHICAL CONSIDERATIONS

While Ryan and others focus on the KKI study's broad impact on curbing lead poisoning among children, medical ethicists, as well as the attorneys who filed the current complaint, find fault with some of the details of the study, especially the informed consent provided by the parents of the children, and the question of whether parents even have the right to enroll their children in research projects that offer them no direct benefit.

Thomas F. Yost, Jr., one of the attorneys filing the lawsuit, maintains that the parents involved in the KKI research never had a good understanding of the risks. “No one I've interviewed over the years has understood it,” he said.

He also argues that the children were used inappropriately to determine the effectiveness of the lead abatement techniques. “They were deliberately put in houses that were not safe to see how little effort could be expended and make a house safe,” he said. He suggested that the research could have been conducted by placing adults in the housing units along with dogs and cats whose blood could have been used to monitor lead exposure.

“You can't just deliberately expose children to lead and see what the outcomes will be,” Yost said.

Arthur Caplan, PhD, Emanuel & Robert Hart Director of the Center for Bioethics, and the Sidney D. Caplan Professor of Bioethics at the University of Pennsylvania in Philadelphia, echoed these concerns in discussing the ongoing influence of this case on bioethicists and public health experts.

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“In one sense the experiment had a good purpose — to find a way to get lead out of home environments where children are,” Dr. Caplan said. “I think the people doing the research could justify the study by claiming that whether they achieved a little lead abatement or a lot, they weren't making these children worse off than if they had left them alone.”

However, the informed consent was probably inadequate, in Dr. Caplan's opinion. The form was written in plain language that explicitly stated that “the purpose of the blood lead testing is to determine how well the abatement of the lead paint works in keeping young children's blood lead at low levels,” and it offered to provide parents with the results of the dust, soil, water, and blood samples taken. However, it did not clearly spell out the dangers posed to children by exposure to lead dust, according to the 2001 court ruling.

“It's likely that the people whose children were being monitored didn't understand fully the nature of the research,” Dr. Caplan said. “I wish they would have used quizzes and tests, and not just a signed form, to make sure the participants really understood.”

In addition, when blood lead levels went up in some of the children, action should have been taken immediately, according to Dr. Caplan, even if that meant breaking the double-blind structure of the study. “When you're dealing with kids, you have an obligation to shut the study down, or at least notify the IRB [institutional review board], when a health issue arises,” he said. “You can't just watch.”

In all likelihood the children would have been exposed to higher lead levels if they hadn't been enrolled in the study, since they probably would have lived in low-income housing that contained lead paint, but that's not an adequate justification for the research, according to George Annas, MPH, JD, William Fairfield Warren Distinguished Professor and chair of the department of health law, bioethics and human rights at the Boston University School of Public Health, School of Medicine and School of Law.

“The lead paint was there,” he said, “but the question is, how much can you take advantage of people's deprived situation? We face the same question when we do research in other countries where there is no decent medical care system, and people can get medical care only by participating in a research study. Is that fair? We've been having that debate for 15 years now.”

Living in the lead-abated housing may not even have been all that beneficial, according to Leonard Glantz, JD, professor in the department of health law, bioethics and human rights at the School of Public Health at Boston University, and associate dean emeritus of academic affairs.

“The purpose was not to benefit the children,” he said. “The children would stay in the housing regardless of what their blood levels were, and they would be tested on several occasions to see what their blood level was. The question of benefit isn't determined by whether the science is valid or socially useful. What the Court of Appeals ruled was that parents can't volunteer their children for risky, non-beneficial experiments.”

Glantz recalled being consulted when a physician wanted to do an unnecessary brain biopsy on a child with incurable brain cancer to gain a better understanding of the disease. “However, it was a non-therapeutic invasive procedure with potential for serious harm,” said Glantz, co-editor, with Michael Alan Grodin, MD, of Children as Research Subjects: Science, Ethics & Law (Oxford University Press). “Researchers might argue that the harm of a brain biopsy is rare, but you don't do that kind of procedure in the absence of benefit to the child. If they were doing a brain biopsy for diagnostic reasons and wanted to keep a piece for research, that would be a different question.”

There may not have been an entirely ethical way to conduct the KKI study, according to Paul Root Wolpe, PhD, Asa Griggs Candler Professor of Bioethics, and director of the Center for Ethics at Emory University in Atlanta.

“It can't be done,” he said. “Even though they tried to do everything ethically, this was a case of poorly conceived and designed research from an ethical perspective. Their motives were pure. They were trying to find a way to protect children from lead poisoning. But you simply can't know of an existing threat that you have some ability to mediate and, in the name of research, not mediate it, even if the threat was pre-existing.”

David E. Jacobs, PhD, research director of the National Center for Healthy Housing, believes the current lawsuit against KKI is “an aberration” brought about by the “incendiary language” of the 2001 Court of Appeals ruling.

“Similar studies have been conducted in 14 other cities, and the research has paid off,” he said. “The methods developed have produced a decline in blood lead levels. Had the research not been done, we in all likelihood would have continued to do open-flame burning of lead paint, power sanding, and other methods no longer practiced because they have been shown to cause greater exposure. The evidence that children were harmed by the KKI study doesn't exist. Children benefited, and facts bear that out. That why this case will probably go way of others.”

©2011 American Academy of Neurology

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