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Patricia There may be cultural differences but as long as the main ethical tenets of patient autonomy,beneficence, non-maleficience and justice are met I think the study,any study can stand public scrutiny.The danger in not formulating broad principles before doing a study is that one might get fixated on the ideas& hypotheses and forget that clinical studies in Medicine have downstream results often not easily predicted. Madhu Singh Assistant Clinical Professor Medicine University of California San Diego USA Sent from my iPhone On Mar 13, 2011, at 8:49 AM, Patricia Lucas <[log in to unmask]> wrote: > Dear Colleagues > > Thanks Rich, I think that it would be very interesting to consider > what current practice in ethics committees will be. My guess cultural > differences will abound! > > The view I would like to propose is that there is a new kind of risk > introduced by a rigid application of procedures rather than principles > of ethical practice in research. I'm borrowing this argument from a > colleague and professor of professional ethics so feel it is at least > worth considering! The argument goes that in protecting people from > the worst kind of practice (as in the cases of Nazi human experiments > or Tuskegee or indeed from pharma companies burrying negative > findings) there is a new risk that we create a legislation that > excludes the possibility of research which doesn't follow these > models. Consider an medical anthropologist living in and being part > of a rural community in an under-developed country for 2 years. What > does informed consent to participate in this context mean? In a > clinical setting good practice might include time between informing > and consenting, signed consent probably indicating agreement with > various features of the research and including contacts for senior > staff who are scrutinising the ethical conduct of the research at the > outset and will certainly be an individual decision. This doesn't > seem to me to be the right way to inform and consent people in this > different research context, where perhaps extensive and ongoing > community consultation is more appropriate. In the same way, it seems > to me that in reviewing Martin's residents' work we should scrutinise > their research plans in the light of the context in which they take > place. For student projects with little to no risks to participation, > for the principle purpose of education, perhaps we should be testing > not 'likely to lead to publishable results', but 'likely to allow > learning to take place'. After all, a journalist is very likely to > publish the results of his/her research, but we don't think this > speaks to the ethics of their practice. > > I should add that I'm writing from a particular point of view. As a > UK social scientist involved in health research I already feel keenly > the flaws in the current system here that were recently pointed out in > the Rawlins Review > http://www.acmedsci.ac.uk/download.php?file=/images/project/129468115924.pdf. > It makes explicit reference to the needs for proportionality and > quotes the Canadian tri-council policy statement that: > > "the intention is to reduce unnecessary impediments and facilitate the > progress of ethical research" including the possibility of exempting > from full review "research in which the probability and magnitude of > possible harms implied by participation in the research is no greater > than those encountered by the participant in those aspects of his or > her everyday life that relate to the research" > > Ethical review should promote the best practice in protecting research > participants, but it it seems to unlikely to me that the model of good > practice for clinical trials can fit all research so it is a mistake > to always apply it. > > Patricia > > On 11 March 2011 13:22, <[log in to unmask]> wrote: >> 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]> >> Date: Fri, 11 Mar 2011 07:39:54 +0000 >> To: Richard Saitz<[log in to unmask]> >> ReplyTo: [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 >> ______________________________________________________________________ >> > > > > -- > Dr P J Lucas > School for Policy Studies, University of Bristol > http://www.bris.ac.uk/sps/