In Brief

The Institute of Medicine released in April recommendations for ethically conducting research with children. The Best Pharmaceuticals for Children Act, passed by Congress in January 2002, authorized the report while also allocating $200 million for research on pediatric pharmaceuticals.

A team of 14 scientists, including psychologists Celia Fisher, PhD, director of the Center for Ethics Education and a psychology professor at Fordham University, and Diane Scott-Jones, PhD, a psychology professor at Boston College, helped author the paper.

The report provides broad procedural guidelines for conducting both federally and privately funded research and underscores the importance of conducting clinical studies with children--a message that Scott-Jones hopes gets heard.

"The motivation...is that for much of research that is done, children are not included," she says. "What may be perfectly fine for an adult may have a different effect or even a harmful effect on a child."

For example, a drug under development may generate side effects in children that are not found in adults, but if research is only done with adults, those potential risks may never be documented, says Scott-Jones.

But the benefits of conducting such research must be balanced with ethical concerns, Scott-Jones adds. In the case of children, who cannot legally decide for themselves whether to participate, special attention must be paid to potential harms, she notes. To conduct such research ethically, the report suggests that investigators:

  • Make consent an ongoing process. Asking the parent to sign a form does not equal informed consent, they say. Investigators should keep parents informed at every step in the study, giving them the opportunity to voice their concerns throughout.

  • Consider alternative forms of payment. Cash isn't automatically the best form of compensation. For example, parents who would have to miss work to drive their children to the research site might be more inclined to allow their children's participation if investigators use flexible scheduling or even provide transportation. In addition, sizable checks can blind parents to the potential harmful effects of research, the authors note.

  • Communicate with the child. Procedures and potential risks should be explained to children according to their age and cognitive development.

  • Request the participant's assent. Once the details have been explained, researchers should ask the child if he or she would like to participate in the study. However, the authors observe, investigators should be aware that some children are unwil ling to object to an authority figure's request.

--S. DINGFELDER

Further Reading

Access the report online at http://books.nap.edu/catalog/10958.html.