Introduction and Purpose

Friends Research Institute, Inc. (FRI) has sponsored three national conferences on biomedical ethics. These conferences were held in Baltimore, Maryland - the headquarters of FRI. The first conference in 1995 was entitled: "Ethics in Neurobiological Research with Human Subjects." The second ethics conference, in 1998, was entitled: "Research and Decisional Capacity - Response to the National Bioethics Advisory Commissions (NBAC) Report." The third conference, in 2000 was entitled: "The Business of Human Experiments: Ethical, Legal, and Regulatory Issues." These three conferences were a great success in contributing to the national debate on important ethical issues in research in medicine. The conferences were well attended and the publications from the conferences were well received and used rather widely within the concerned community.

The 2002 fourth conference is entitled: "Ethics of Research with Children." This is an on-going important issue, as children are clearly a vulnerable population, both in terms of their lack of mature judgment and inability to offer legal consent and their being at high risk of injury from participating in research procedures due to their developmental stage. Prior to 1998, all drug-testing on children was on a "voluntary basis" and very little research was done. The pharmaceutical industry avoided extensive research with children for fear of liability. The ethical issues surrounding the use of children in research became more critical because of two actions taken in the past four years by our Federal government. In 1997, President Clinton ordered changes in testing drugs and biological products that are usually used for children. Drugs and biological products are normally tested on adults, despite the fact that some are used widely in children, without any tests conducted on children. Scientific literature clearly indicates that drugs affect children differently than adults, and the effects are not necessarily just related to dosage. Children are not "little adults." By the end of 1998, the Food and Drug Administration issued a ruling mandating that the pharmaceutical industry test drugs and biological products on children if they are to be used in treating children. The logic behind this regulation is the same as that used to require the inclusion of women and minorities in research trials.

The new ruling brought the ethical dilemma to a head. How do you provide justice to children by ensuring the efficacy of drugs used with this population, while protecting the well being of the children who participate in research? What are the safeguards for this vulnerable population?

This conference will address the following issues: Historical, philosophical, and ethical dimensions of the use of children in research; Current laws governing research with children; Degree and quality of risk in research protocols involving children; The ethics of the government mandate for inclusion of children as research subjects; How we define minimal risk for research with children; The ethics of the use of extra-vulnerable children (i.e. poor, minorities, behavioral issues, and foreign children); and How to improve the current practice.


Ethics Conference Information:


 

Ethics Conference
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