Bioethics and Child Testing
JENNIFER LUDDEN, host:
To find out more about the guidelines for conducting clinical drug trials on children, we turn to Dr. Marjorie Spears. She's the executive director of the Association for the Accreditation of Human Research Protection Programs. She testified at the congressional hearing we just heard about.
Dr. Spears, welcome to the program.
Dr. MARJORIE SPEARS (Executive Director, Association for the Accreditation of Human Research Protection Programs): Thank you.
LUDDEN: Tell me, what is the normal procedure for choosing children to take part in the clinical drug trial, and what protections are there when children are used?
Dr. SPEARS: It begins with the development of the protocol, the document that describes the design, purpose and methods of the study. Once that protocol is developed, it's then submitted to an institutional review board to make sure that the risks are reasonable in relation to the potential benefits.
LUDDEN: Who decides that the child is going to take part? Are their parents consulted?
Dr. SPEARS: When research involving children is approved, it's approved with two requirements: One is that the child gives assent--assent means expressed agreement to participate in the study; second, to get permission from the parents.
LUDDEN: But if there's a foster child, do the foster parents play the role of the parent? Can they give permission?
Dr. SPEARS: Federal regulations allow for the guardian in the case of a foster child to give consent.
LUDDEN: How old does a child have to be to give consent?
Dr. SPEARS: There's no age stipulation in the federal regulations. Generally IRBs--that's the shorthand for institutional review boards--will want children who are around six, seven or eight to give their assent. The older the child is, then more is explained about the study to the child and then the more you want to get the permission from the child.
LUDDEN: So you mean the younger they are, the less they're actually told. And, I mean, how can a six-, seven- or eight-year-old even make that decision? I don't quite understand how they're supposed to understand the risk and benefits to them.
Dr. SPEARS: What you would explain to a younger child are the procedures, what's going to happen to them when they are participating in the research. With an older child, the researcher, in addition to explaining the procedure, would also explain the risks and the potential benefits. But the protection is complete by fully explaining the research to the parents or the guardian.
LUDDEN: What if the child says, `No, I don't want that shot. I don't want the pill'?
Dr. SPEARS: Then the researchers have to determine whether the research involves a prospect of direct benefit to the child. If there is a prospect of direct benefit, then the wishes of the parent can override the child. But that should occur in rare circumstances and be very carefully considered before a child who doesn't want to participate in the research would go forward with it.
LUDDEN: And is this done nationally? Are there national rules for this, or is it up to individual states? And are the rules the same?
Dr. SPEARS: There are a set of federal standards, regulations, that all investigators and all institutional review boards must follow. In addition to the federal regulations, there's very often state or local law that will apply. And it's incumbent upon the investigators and the institutional review boards to know the local and state law.
LUDDEN: The story we just heard about involves some clinical trials of children with AIDS back in the '80s and '90s. Have the guidelines covering children in clinical trials changed since then?
Dr. SPEARS: Since 1981, the federal regulations from the Department of Health and Human Services have been the same. In early 2001, the Food and Drug Administration added additional protections for children in research. But those additional protections are the same as those released by the Department of Health and Human Services.
LUDDEN: How do you read what Congress is investigating now? I mean, on the one hand, it sounds like these children were essentially guinea pigs. On the other hand, you know, you could say that the states were trying to do the right thing and provide these foster children with the best treatment at the time that was available. How do you look at what happened?
Dr. SPEARS: I think that researchers, IRBs, government officials, state agencies all have the best interest of children as their primary focus. And whenever children are involved in research, it presents an ethical dilemma just by the fact of their young age and developing cognitive abilities. But to exclude children from research means that they won't benefit from the findings of research. So one has to look very carefully and balance the risks and benefits to children.
LUDDEN: Dr. Marjorie Spears heads the organization that accredits institutional review boards for clinical research.
Thank you very much.
Dr. SPEARS: Thank you.