The role of children in clinical research

Episode # 104
Uploaded: July 24, 2012
Running Time: 3:00

CROWN: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.

The NIH Clinical Center, America's research hospital, has a long history studying diseases that affect adults and children. That's why some of the research studies conducted here include children as research participants, says Dr. David Wendler, head of the Clinical Center's Unit on Vulnerable Populations.

WENDLER: Because we give medical treatments to children and children get sick, and we want to figure out ways to treat children... help them...get them better. In a lot of cases the only way to do that is to do research. Since children in a lot of ways are different than adults in terms of the diseases they get, in terms of the way they react to medications, you often have to do the research on children if you want to figure out better ways to provide medical care.

CROWN: Research volunteers who enroll in the clinical studies at the NIH Clinical Center range from first-in-human trial participants hoping for a cure, to healthy volunteers who serve as a comparison for studying disease. Children fall into both categories, too. Adults who participate in studies are educated about the studies prior to providing their informed consents. Older children and teens provide a different type of agreement in research, says Dr. Wendler, which is called "assent."

WENDLER: Assent typically just means the agreement of the child. So the regulations define it not as a failure to protest, but it's actually an affirmative agreement. The idea is you explain what you are proposing to do -- to the extent and in a way that the child can understand it -- and then you ask them whether or not they are willing to go ahead.

CROWN: Dr. Wendler adds that parents are, of course, a critical part of the team, too. Whether a child has a condition and may benefit from participation, or whether a child is a healthy volunteer and is taking part to further science, it's important to discuss what participation means with the research team. It's also a really great idea, he says, to understand the general purpose of the study.

WENDLER: What's the purpose of the research or what's the goal of the research? A lot of times the research is being done to try to collect information to help others and so I think it's important for the parents to find out what that is and to make sure it is a kind of project or study that they think is appropriate for their child.

CROWN: To learn more about participating in studies at the NIH Clinical Center, go online to clinicalcenter.nih.gov/recruit. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Ellen Crown, at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

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