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Meeting Summary
by Dr. LeRoy Walters, Director, Kennedy Institute of Ethics, Georgetown University and Dr. Christine Grady, acting Director, Department of Bioethics, NIH Clinical Center.
First, Dr. Grady discussed the seven ethical requirements that provide a framework for determining whether clinical research meets universal, necessary and sufficient ethical values. These seven criteria are:
- social or scientific value,
- scientific validity,
- fair subject selection,
- favorable risk-benefit ratio,
- independent review,
- informed consent, and
- respect for potential and enrolled subjects.
Dr. Walters then discussed the U.of Pennsylvania gene therapy experiment in which Jesse Gelsinger died. Dr. Walters suggested that because both gene transfer and xenograft research are in the early stages of their development, they require special oversight.