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Colleagues I think Patricia raises an excellent point and I don't think our views are mutually exclusive. My main concern from an ethics perspective it that if there is risk it should be balanced by benefit. This is not my idea nor is it controversial. It appears in all international guidance on human research. It is also not up to me to determine of the benefits and risks are in the right balance. Review committees do that. And I think Patricia is right that if the case is made that the benefit to society or training etc outweighs any risk (which it could if the committee determined there was no risk), and that there is sufficient benefit without making any results available then the study would be ethical without sharing the results. Whether a student can really learn something without learning about sharing the results is a pedagogical question. Because this is an EB medicine list my comments were mainly focused on medical research which is usually associated with some risk though of course there can be low or even no risk health studies too. The issue of unpublished studies in medicine has been discussed extensively on this list (eg the influenza medication studies that had wordlwide implications-see BMJ on this) so I won't rehash that here. It would be interesting to gather empirical data from ethics committees to see what they would generally decide (approval vs not) if faced with studies that vary in risk from none, to minimal, to greater than minimal, that would never have results shared (I am assuming this is explicit in such proposal applications and not hidden). Patricia, thank you for providing a broader perspective. Best Rich Sent from my Verizon Wireless BlackBerry -----Original Message----- From: Patricia Lucas <[log in to unmask]> Date: Fri, 11 Mar 2011 07:39:54 To: Richard Saitz<[log in to unmask]> Reply-To: [log in to unmask] Cc: <[log in to unmask]> Subject: Re: unpublished research - is it ethical Dear all I completely disagree with the last writer. Our approach should be proportionate and take a measured approach to thinking about research. Student research is undertaken the world over with little expectation that the results will reach the publiv domain. The benefit is to the community of researchers or practitioners through the education of the next generation. This decision should consider the actual risk posed by the research. An awful lot of research poses no geater risk than the time taken to participate. Any research restricted to interviews, questionnaires or case review for example. So we should be comfortable with residents undertaking such low risk research as part of their learning. This balance would change if the risks were greater e.g. If treatment decisions were to be altered. Best wishes Patricia On 11 Mar 2011 01:12, "Richard Saitz" <[log in to unmask]> wrote: Seems to me the issue here is not about publication in journals. When research is done there are risks to participants. Those risks are only justified if there are benefits (to them or to science). If the research results are not available to anyone then they cannot benefit anyone (beyond those in the study). If they cannot benefit anyone else, then the risk of the study was not justified. (an internationally accepted ethical principle). One can make a solid case for peer review (not that it is perfect but it is difficult to argue that zero review is a better system for vetting scientific results). But the issue here is not (in my view) publication in peer review journals. The ethical issue is making the results available because if that is not done, the risk was not justified (and one could ask--why was it done if not to share it). One might imagine doing a study and telling participants---we will do this study but we will never publish the results. Anywhere. Because we don't think peer reviewed journals are good. We will keep them secret. Or, we wont share them because we are too busy to write them down... Would the participant agree? Should they? Is that ethical? And to return to the focus of the listserve, what is the impact on systematic reviews that try to determine the efficacy of interventions when such studies are not reported? (they become either useless or unknowingly biased...) Best Rich Saitz ______________________________________________________________________ This email has been scanned by the MessageLabs Email Security System. For more information please visit http://www.messagelabs.com/email ______________________________________________________________________