A teaching module using scenarios and other methods to facilitate discussion about the ethical issues that researchers face when research subjects are children.
Author(s): Eric Kodish, M.D.
Efforts to improve the health of children depend on clinical investigations that use children as research subjects. Children are a vulnerable population, however, and so are accorded special protection from research risks. Researchers in pediatrics may encounter conflicts between protecting the children who are vulnerable research subjects and developing generalizable knowledge to benefit children as a class. Furthermore, there are many pitfalls for the researcher in carrying out the communication with both parents and children that is required for responsible decision-making about participation by children or adolescents in experiments.
There is a long-standing moral and legal tradition that supports parents as the primary decision-makers for their minor children, including the right to make proxy decisions for children about participation in research. Parental decision-making is a critical factor in the study of pediatric research ethics, even though it is recognized that parents, as well as health researchers, may have interests that conflict with the best interests of the child.
Today, the legitimate role of the child in decisions about research participation is recognized. The ethical concept of assent provides a framework to assist investigators and parents with efforts to incorporate the views of children who are recruited as research subjects. Assent is analogous to consent where the subject has a reduced capacity to understand the matter to which they are assenting.
This course covers the key issues that arise when research is conducted with children as subjects.
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Distribution of scenarios to the students and faculty.
Panel discussion based on those scenarios and questions and any others that students or faculty wish to add.
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