I completely agree that you should not be aware of which drug you receive in order for the results to be valuable and unbiased. I beleive the contract for this particular treatment should include protection for the patient which should be the main ethic of the researchers. Therefore, I suggest that the contract should include a clause offering to remove the device and/or if the device causes damage to the patient some of the damage should be repaired by the researches either by surgically repair of the damage, if possible, or to compensate the family if a fatality occurs. It is only fair that if the Industry is going to profit from the risks of the patients participation, the Industry should take responsibility for any harm caused by their research of patient volunteers. The patient will then have assurance that his safety is of primary importance not just the result of the study. This assurance will cause the Industry to take on costs of the risks. I also believe the patient is entitled to all the results of the study, whether it is successful or a failure to make decisions on what further research they become involved in. All of this should fall under the category of research overhead for the pharmaceutical companies, and money put out should be taken out of profits and not passed on to the consumer as higher cost of therapies.

Vicky