Chapter Four: Gene Therapy Regulations
When we talk about changing the biological make up of an individual, that must be something very dangerous. Our genetic make up makes us what we are, so changing this genetic composition should be highly regulated to avoid the long term risks. Ross Laframboise in his article "Gene Therapy Regulations: A Proactive Approach", explains the importance of regulating gene therapy researches in order to minimize the risks. He mentions that there are two main organizations now regulating gene therapy researches including US Food and Drug Administration (FDA) which makes sure of the safety during researches, and Recombinant DNA Advisory Committee (RAC) that is responsible of reviewing gene therapy protocols. Besides these two organizations, the author expresses the importance of the government regulation especially for germline gene therapy. Since germline gene therapy can affect the future generations, we need to take cautions on the specific genetic composition that we are going to change. The author also mentions that some organizations should be responsible of adopting the ethical issues regarding gene therapy to prevent any social problems.
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Gene therapy does seem like a practice that should be heavily regulated, so it is a good thing the FDA and that RAC committee are involved. And having another committee to deal with ethical issues may not be such a bad idea, either.
ReplyDeleteWhat specifically qualifies a person to be a member of the RAC? I wonder at what point would the ethical considerations of a certain gene therapy be outweighed by the benefits of treatment and who would have to decide that.
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