Eric, I must say that not only the patient's physician is unaware of all the risks and is unaware of whether the drug is beneficial but the same should apply to the researcher. After all, clinical studies to develop new and potent medications require statistical control to establish proof. Virtually all controlled studies require at least two "arms" of the study (unknown drug vs known drug or unknown drug vs placebo) and that at the outset that the experiment the assumption by the researcher should be that there is equipoise. Equipoise means that the investigator must assume for statistical analysis that one arm is no better and no worse in its beneficial effect than the other arm. That is,.the unknown drug is no better and no worse than the known drug or even a placebo (a chemical which is thought to have no therapeutic benefit). Have patients who are considering entering a study understand that such studies are to determine benefit or greater benefit and the assumption on entry is that there is no greater benefit, if any? And even the risks of the unknown drug are not fully known?
There is great demand for subjects in clinical studies but there is inadequate education and detailing of what the subject should understand and expect on signing the consent forms given to them. Even if the studies have been approved by the Food and Drug Administration and the plans reviewed by legally established review boards, bad thing have happened as examples noted in this
article "Major Gaps in Oversight of Human Medical Research"
http://www.huffingtonpost.com/2009/10/28/major-gaps-in-oversight-o_n_337399.html
What I am getting at with all these words is despite the fact that yes it is the professional duty to look to the best interest of the patient. Yes, it is a professional duty to inform the patient of all options which could provide benefit with limited risk to the patient. Yes, patient interest trumps self-interest of the physician. Yes, human medical research and development of treatment, at present, can't be accomplished without human subjects. Nevertheless, the physician should not assume that informing and then introducing a patient to a research study is always an ethical good, particularly if the patient is not near death from a terminal disease (where there might not be anything to lose unless the study prolongs the death with more symptoms!). Anyway, that is my opinion. ..Maurice.