> A different approach is therefore warranted What is the different approach? 1. Autonomy (informed consent), 2. beneficence, 3. non-maleficence ("do no harm"

> A different approach is therefore warranted What is the different approach? 1. Autonomy (informed consent), 2. beneficence, 3. non-maleficence ("do no harm"), 4. justice (distribution of treatment where it is limited) are the principles that bind doctors who are operating on patients. What principles would you expect an independent researcher to uphold beyond what a doctor currently upholds? All other factors considered, as long as these principles are upheld, a doctor is free to try a new surgery for the purpose of exploring its effectiveness, i.e. engage in research. This is not new; private doctors have been testing procedures of varying risk without an IRB since the time of these commissions. Any researcher who violates these principles--where there is a harm to a research subject--is almost certainly liable under criminal fraud and torts laws. It is not a "free-for-all", as you characterize it.