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.