 |
 |
this is interesting, Amy. Most research projects that I am familiar with that involve students/residents/fellows have much lower risk to research participants compared to the risk to the patients when they are managed by the very same doctors in training! And, yet ethical standards seem to be so much different. Ben d From: "Dr. Amy Price" <[log in to unmask]<mailto:[log in to unmask]>> Reply-To: "Dr. Amy Price" <[log in to unmask]<mailto:[log in to unmask]>> Date: Sun, 13 Mar 2011 16:50:17 -0400 To: "[log in to unmask]<mailto:[log in to unmask]>" <[log in to unmask]<mailto:[log in to unmask]>> Subject: Re: unpublished research - is it ethical Very interesting farmer views! Educated farmers can provide more detailed data. I would like to add that students may need research with risk under supervision before their research skills are unleashed on the world. Surveys and systematic reviews may not bring them face to face with reality of research risks. I added some scenarios I have heard of below which the parties ended up resolving in their own ways but with supervised training in experiments with risk the new researchers would have been better prepared. Many unscrupulous predators mine young, bright but inexperienced researchers for their own purposes. Without adequate supervision and guidance lives can be ruined. In cell and genomic groups there is discussion about self publishing online or through research based social networks like Mendeley and Nature Blogs so they can learn from each other. Their view is that they learn as much from what doesn’t work as what does. No one can guarantee publication so responsibility for this could be a shared ethical issue. If each research training org was to host their own journals and access was shared with inter publication agreements perhaps that would increase research publishing. Some scenarios I have seen: · Student receives grant from equipment manufacturer to do survey /observational video study of surgery outcomes. As outcomes prove less favourable publishing is squashed. · fMRI study on impact based brain trauma and speed of recovery. Study is funded to first recovery point and withdrawn before secondary damage can be recorded research team has no funds to complete study · Human stem cell research, incubate all samples in growth medium and then keep them in freezer before reinjection in humans. They find out later after samples have been re-injected that a previous sample is positive for syphilis · Scrupulous attention is given to blood draw med procedure but no attention is given to preparing and sterilizing QEEG equipment and the population is HIV or HEP C positive/vulnerable · A Study is granted several million dollars...it isn’t working and is not likely too. Several colleagues finances depend on the study but it is now an unethical waste of money Best regards, Amy From: Evidence based health (EBH) [mailto:[log in to unmask]] On Behalf Of Dr. Carlos Cuello Sent: 12 March 2011 09:35 AM To: [log in to unmask]<mailto:[log in to unmask]> Subject: Re: unpublished research - is it ethical Loved the analogy, Stephen and group We have the same problem with residents and young doctor´s clinical research that does not seek publication of their work after they finish it (because they already passed the "exam") They (and many of my faculty staff) see clinical research as an obligation and a quality measure for a medical student; we are not taught to think in translational research. As in the farmers example, most doctors are not interested in doing clinical research (and I am fine with that). BUT, farmers are a to be a good source of questions about what should be investigated, what are the needs, and once it is surrogated to an interested researcher and published, (in an ideal world) the farmers must have the skills to ask: is it a good scientific work? is it valid and relevant to my farm? what else is needed to improve my crops? Cheers On Fri, Mar 11, 2011 at 08:34, Stephen Senn <[log in to unmask]<mailto:[log in to unmask]>> wrote: I am reminded of Michael Healy's bon mot. He moved from agricultural to medical research and was asked what the difference was. He replied, 'agricultural research is not done by farmers' Stephen Stephen Senn Professor of Statistics School of Mathematics and Statistics Direct line: +44 (0)141 330 5141<tel:%2B44%20%280%29141%20330%205141> Fax: +44 (0)141 330 4814<tel:%2B44%20%280%29141%20330%204814> Private Webpage: http://www.senns.demon.co.uk/home.html University of Glasgow 15 University Gardens Glasgow G12 8QW The University of Glasgow, charity number SC004401 From: Evidence based health (EBH) [mailto:[log in to unmask]<mailto:[log in to unmask]>] On Behalf Of Djulbegovic, Benjamin Sent: 11 March 2011 14:30 To: [log in to unmask]<mailto:[log in to unmask]> Subject: Re: unpublished research - is it ethical A number of years ago Doug Altman published a paper with memorable title “Scandal of Poor Medical Research” in which he essentially identified inadequate training of medical doctors in research methods as one of the major culprits for a dismal quality of published medical research. Doctors are trained to take care of patients and not to do research. Yet, most clinical research is conducted by medical doctors + many of medical doctors end up going to academia doing research without undertaking additional formal training in research methodology. This, along with the increasing recognition that practice and research intertwine has started a recent trend (at least in North America) that doctors in training are increasingly mandated to do “research”, which in the vast majority of cases will not be the Earth-shattering, to put it mildly. But, this raises serious ethical issues as the last exchange indicated. (I also believe that this is what Martin had in mind when he started this tread- not research aiming to undertake large scale RCTs etc. But, Martin can correct me here, if I am misreading his attentions). I should also mention that I have been struggling with a similar question for some time now, and I am quite interested in seeing how this debate will evolve. Ben Djulbegovic --- Well, it appears I clicked send before the reminder of what is in the Declaration of Helsinki (thanks Trish!). Patricia, I wonder if you wish to comment on how that squares with trainee human subjects research? It seems quite clear and doesn't make exceptions. Rich Sent from my Verizon Wireless BlackBerry From: Evidence based health (EBH) [mailto:[log in to unmask]<mailto:[log in to unmask]>] On Behalf Of Richard Saitz Sent: Friday, March 11, 2011 8:22 AM To: [log in to unmask]<mailto:[log in to unmask]> Subject: Re: unpublished research - is it ethical 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 ________________________________ From: Patricia Lucas <[log in to unmask]<mailto:[log in to unmask]>> Date: Fri, 11 Mar 2011 07:39:54 +0000 To: Richard Saitz<[log in to unmask]<mailto:[log in to unmask]>> ReplyTo: [log in to unmask]<mailto:[log in to unmask]> Cc: <[log in to unmask]<mailto:[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]<mailto:[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 ______________________________________________________________________ -- Carlos A. Cuello-García, MD Director, Centre for Evidence-Based Medicine Tecnologico de Monterrey School of Medicine Cochrane Collaboration Iberoamerican branch CITES piso 3. Morones Prieto 3000 pte. Col. Doctores 64710 Monterrey, NL. Mexico. ☎ +52.81.8888.2223 & 2154. Fax: +52.81.8888.2052 Skype: dr.carlos.cuello www.cmbe.net<http://www.cmbe.net> ⚫ Twitter<http://twitter.com/CharlieNeck> ⚫ Linkedin<http://mx.linkedin.com/in/drcuello> The content of this data transmission must not be considered an offer, proposal, understanding or agreement unless it is confirmed in a document signed by a legal representative of ITESM. The content of this data transmission is confidential and is intended to be delivered only to the addressees. Therefore, it shall not be distributed and/or disclosed through any means without the authorization of the original sender. If you are not the addressee, you are forbidden from using it, either totally or partially, for any purpose