April 8, 2005

The subtleties of research ethics with children

Today comes the news that California Senator Barbara Boxer and Florida Senator Bill Nelson are holding up Stephen Johnson's nomination as EPA chief because of the EPA's Children's Health Environmental Exposure Research Study in Jacksonville. Designed as a study of the effects of normal pesticide use on young children, it may now be used to miseducate the public about research ethics. I'm not a medical or environmental research, but the politicizing of this concerns me.

From what I understand, the study had very poorly-written materials to inform parents about the study, problems which violate one of the basic principles of research ethics coming from the Belmont Report (1979): respect for persons, operationalized as informed consent. But Boxer's statements yesterday (you'll have to listen to the audio) implied that there should never be research about dangerous substances involving children, and that's also indefensible. The third Belmont principal is justice, or making sure that research includes appropriate populations. Years ago, publicly funded health studies generally studied men and ignored women. For years, drug companies failed to conduct pharmacological studies on children that really should have been required by off-label uses.

Research with children and other vulnerable populations requires special safeguards, but we still need such studies or we just won't have information about the effects of drugs or pollution on children.

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Posted in Random comments on April 8, 2005 1:12 PM |