The morning paper brought news of an AIDS vaccine that was found to be ineffective; which led me to the following question:
Are there ethical guidelines and standards about how to manage expectations in the subject of a clinical trial? Specifically, if a subject knows that he’s participating in a trial of an AIDS vaccine, how do you counter the (hypothetical) tendency to be less careful about safe sex?
This wouldn’t be a problem for, say, a smallpox vaccine–I doubt many participants would say “woohoo! I’m gonna expose myself to smallpox!” But if lifestyle is a contributing factor to the disease, I would think this might be an issue.
Granted that the participants are undoubtedly briefed that they might have gotten a placebo, or that the vaccine was ineffective (which it was, in this case). But if one person catches AIDS because he didn’t use a condom because he’d gotten the shot–that would be an awful price to pay.