Air Date: Week of August 1, 2003

Working out the ethics of studies on human subjects is always a challenge. Host Steve Curwood talks to researcher Bruce Lanphear, medical ethicist Jeffrey Kahn, and advocate Kristin Joyner about the choices made in the new lead study Living on Earth reported on in the special, “The Secret Life of Lead.”

Transcript

CURWOOD: Earlier this year we aired a documentary called “The Secret Life of Lead” which focused on cutting-edge research about how lead affects developing children, especially its links to delinquent and criminal behavior. We received many letters thanking us for reporting on this topic. But a few listeners were concerned about the ethics of a new study involving about 400 children that, in part, tests whether home lead abatement is effective. Half the kids’ homes will be de-leaded. The other half will be fixed up to prevent household injuries. Some listeners were incensed that only half the homes were going to receive a lead clean-up.

Joining me to discuss the tough decisions to be made when conducting scientific research that involves human subjects is Bruce Lanphear, lead researcher in the new study and head of the Environmental Health Center at Children’s Hospital in Cincinnati. Jeffrey Kahn is director of the Center for Bioethics at the University of Minnesota. He also headed a national oversight group that Dr. Lanphear convened on this study. And Kristin Joyner, founder of United Parents against Lead of North Carolina. She, too, took part in the national oversight committee.

Bruce, let’s start with you. It wasn’t only some listeners who had ethical concerns. You first proposed this study to the Centers for Disease Control in Atlanta, and some folks there were also concerned that only half the group got lead assistance. How did you respond?

LANPHEAR: Well, in this case what we’ve done is we’ve set it up so that children in both arms of the study – that is, those who get the lead hazard reduction and those in the comparison group – potentially benefit from the study. The comparison group for the lead hazard group get an injury intervention, which we hope will also reduce injuries for that group of kids who don’t get the lead work.

CURWOOD: Now, you had to go through a review process at your own hospital. It’s called the Institutional Review Board, I think – every research organization has one when human subjects are considered for study. How did your own hospital evaluate this project?

LANPHEAR: With the exception that they raised one question, they approved the IRB that we originally submitted. The one concern they had when they spoke back to us was that we were going to be collecting dust from the comparison group homes, the control group homes, and not presenting it back to the family, but rather putting it in storage and not testing it for lead until after the study was complete. And so they asked us to change that. That information is very important to try to better understand why the intervention did or did not work.

CURWOOD: So, what in fact have you decided to do?

LANPHEAR: We proceeded with another aspect of our study, and that was to put together a national oversight committee. And we asked them to evaluate this study, and one part that we asked them to evaluate was that question of whether we should or should not collect environmental measures of lead from the homes of the comparison group.

CURWOOD: And how did that work out? How did this national group that you put together to help you think about this more, how did they respond?

LANPHEAR: Well, first let me tell you a little about the committee that we put together. This is very unusual. The reason we did it was that we recognized that, at least on the surface, this study was very challenging from an ethical perspective. And so we wanted a group of national experts, people who were recognized in bioethics and lead epidemiology, and advocates for children who were lead poisoned, to review this. They determined that the study was necessary to do, that it was an ethical study. They also, in their review of whether we should collect environmental lead samples from the comparison group homes, said that indeed we should. But we should make clear to the families that we were going to collect the data, but we were not going to analyze them until the end of the study, that they would not receive the results of those tests until the end of the study, and that in fact the research staff, including myself, would be blinded to the results. When we took those recommendations back to Children’s IRB, they approved the recommendations of that committee. And we are proceeding with collection of environmental samples of lead from the comparison group homes, but storing them, and certainly the families, in the informed consent process, are fully aware of that.

CURWOOD: Jeffery Kahn, you direct the Center for Bioethics at the University of Minnesota, and you were asked to head this independent national oversight committee that Dr. Lanphear set up. How did you solve these questions? What was the rubric of ethics that you used?

KAHN: Well, there’s a long-standing and well built up set of policy requirements for how research can be done in ethically acceptable ways in the United States. And when children are involved, there are even stricter standards, which require that there be no greater than minimal risk for the kids who are involved in the research unless there is some offsetting potential for direct medical benefit to them as individual subjects. So we use that as the starting point, and then the individuals who are part of this oversight committee, as Bruce already mentioned, came from a wide variety of disciplinary expertise. And so we asked a lot of questions. I think that’s probably the crux of the matter. We spent a number of hours listening to Bruce and then asking him to explain various aspects of this study, and I think everybody had a fair hearing about what they thought the issues were. And at the end I think we were satisfied that this was research that needed to be done, was appropriate in that way it was designed, and protected subjects sufficiently while also providing answers to important questions.

CURWOOD: Now, how did you solve or meet your requirement that the risk be relatively minimal, unless, of course, there was a great benefit for the individual? Where did you put in the benefit for the individual in this study?

KAHN: Well, the children who were subjects in the arm of the study who would have abatement in their house were obviously receiving some potential for direct medical benefit in that their lead levels were being reduced. In that arm of the study where that was not the case, where there was not abatement, there were cut-off points, where if there was exposure that was – by blood test – greater than a certain level, then there would be an intervention. The other pieces that we talked through with Bruce was this idea of information about what people could do to help reduce the risk to their children in their home whether or not they were receiving the actual abatement procedures.

CURWOOD: Let me turn to you, Kristin Joyner. You head a group called United Parents Against Lead, of North Carolina. I’m thinking now of the study of the study that was conducted in association with Johns Hopkins University in Baltimore, Maryland in which, in some cases, children ended up getting placed in housing where there was known to be lead, and it would be then very likely that they would be exposed to lead. This lead to – well, the thing wound up in court, I guess, to put it briefly, on ethics concerns. Now, you knew Bruce before he asked you to take part in this oversight committee. What were some of your most serious concerns about this new study?

JOYNER: One of the major concerns I had, Steve, was that it did not replicate the Baltimore study. That at no time were children going to be moved from what could potentially be a lead-safe environment into a potentially leaded environment, or a known leaded environment.

CURWOOD: So it was important to you that the study placed no one in any greater harm than they were before the study.

JOYNER: That was one of my major concerns, yes.

CURWOOD: And your other major concerns?

JOYNER: The other major concern was that at all times there was total understanding on the part of families of every bit of, you know, research that was going to be going on as far as what was going to be done with the families. That there was no enticement in the way of monetary amelioration, or additional medical assistance that they normally would not get. Anything given to them that would cause them to feel that they really were compelled to be part of this. I didn’t want anyone feeling compelled.

CURWOOD: How do you feel your concerns were addressed?

JOYNER: I was very pleased with it. You know, we had some wording concerns originally. Some of our main concerns were the reading level, so to speak, of how the consent forms were written out, that it was extremely understandable by anyone, and that all the things considered were going to be done. I really felt very confident going into it. You know, we were looking at Dr. Lanphear’s track record and the people that were working on the project with him, Dr. Dietrich and others. And we felt that they had a good history of performing ethical and, you know, really important research in the area of lead.

CURWOOD: Bruce Lanphear, as the lead scientist here, you believe that low levels of lead affect children profoundly. And you also understand that these effects are irreversible. So you understand that even in your own study, that any kid left behind could be left behind forever. How do you feel about that?

LANPHEAR: I feel bad about that. I think we, as a society, are dealing with one of the crimes of the last century, because we allowed industries to continue to use this toxin despite evidence that it was a poison. A number of countries in Europe banned the use of lead in house paint, for example, in the 1920s. And so when I look at that and I realize this epidemic was preventable, I feel terrible about it. I feel terrible that we don’t do anything for kids until after they’ve developed undue lead exposure. And so that’s really what this study’s about, is to try and demonstrate that we can do it differently, that we can protect children from lead hazards before they become poisoned.

CURWOOD: And for these particular kids in the study who might be left behind, what about them?

LANPHEAR: Well, I guess to some extent there’s two responses to that, Steve. The first is – just as happened when the CDC study that we tried to do five years ago was not approved, or was not, actually, funded – if we don’t proceed with this study, then these 400 children will neither receive changes in their home to reduce lead exposure or reduce injuries. It would be nice if I could wave a magic wand and homes would be safe for children. But that’s not going to happen overnight. And so, even though I’d like to do that, I recognize that public health is an incremental process. And you can’t help everybody all at the same time. And that’s what we have to deal with.

CURWOOD: I want to thank you so much. Bruce Lanphear, Director of the Environmental Health Center at Cincinnati Children’s Hospital; Jeffery Kahn, director of the Center for Bioethics at the University of Minnesota; and Kristin Joyner, founder of United Parents Against Lead of North Carolina. Thank you all.

LANPHEAR: Thank You.

KAHN: Thank You.

JOYNER: Thank You.

CURWOOD: For more on lead and lead research, go to our website, livingonearth.org. You’ll find an in-depth look at cutting-edge science on the connection between childhood lead exposure and criminal behavior later in life. This new research may hold the answer to why some young adults get into trouble. That’s “The Secret Life of Lead” on our website, livingonearth.org.

[MUSIC: Grand Master Flash & The Furious Five “The Message” Street Jams: Hip-Hop From the Top Part 1 Rhino 1992]

CURWOOD: Also this month on our web site listen to author Sy Montgomery read from her new book, “Search for the Golden Moon Bear”

MONTGOMERY: The golden bear lifts her head and opens her nostrils to our scent. She lives in a flood of odors. The area of her nasal mucosa is one hundred times ours. To her, the world is radiant with scent: she can smell the vapors rising from the soil, the ions escaping from the earth. Her nostrils quiver, pink and wet inside. She breathes in our identities; she reads the stories redolent in our sweat, our breath, our hair. She can smell the eggs in our stomachs. But of her story, we know next to nothing.

CURWOOD: It’s the “Search for the Golden Moon Bear” all this month at livingonearth.org. That’s livingonearth.org.

FEMALE ANNOUNCER: Funding for Living on Earth comes from the World Media Foundation. Major contributors include the Ford Foundation, for reporting on U.S. environment and development issues, and the William and Flora Hewlett foundation, for coverage of western issues. Support also comes from NPR member stations and Bob Williams and Meg Caldwell, honoring NPR's coverage of environmental and natural resource issues, and in support of the NPR president's council. And Paul and Marcia Ginsberg, in support of excellence in public radio.