The ethics behind this sort of decisions are quite hard. If subjects are interested in research that has not been approved I think consent should be given only after they have been educated, informed, and fully capacitated of what the studies will involve and aware of what they will go through. I don’t see it as an attack on their freedom of choice. Even clinical trials that have been approved will include risks that the patient needs to be aware of. Some risk might be greater than others, yes, but if this doesn’t happen we could not make medical advancements. The individual who is interested should be in a good state of mind when making the decision of undergoing these type of trials and should be fully educated on the topic. If a patient is fully educated/assessed on the risks, dangers, etc. and willing to go under an unapproved clinical trial, is it ethical to deny consent?