tag:blogger.com,1999:blog-525778292565554519.post5740065048929413636..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: Dreger on Naming NamesZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger6125tag:blogger.com,1999:blog-525778292565554519.post-42872097795319443362011-06-16T10:02:18.881-04:002011-06-16T10:02:18.881-04:00Thank you for your comment. It is always helpful t...Thank you for your comment. It is always helpful to quotes sources.<br /><br />I agree that the Belmont drafters did not intend research to be risk free. But that is not to say that they ever accepted the idea that some ethical researchers might deliberately harm their subjects. It seems that the <a href="http://www.institutionalreviewblog.com/2010/12/first-do-some-harm-part-iii-loosies-in.html" rel="nofollow">University of California-San Francisco IRB members</a> read the report differently from you, and I can't say I blame them.<br /><br />Indeed, your understanding of the Belmont Report appears to be at odds with that of some of its authors. In Belmont Revisited, Robert Levine writes, "The principle of beneficence, as interpreted by the National Commission, creates an obligation to secure the well-being of the individuals who serve as research subjects and to develop information that will form the basis of being better able to serve the well-being of similar persons in the future. However, in the interests of securing societal benefits, one should not intentionally injure any individual." This is not consistent with the ethics described by Dreger. <br /><br />Similarly, Albert Jonsen told me, "We really should have made much clearer distinctions between the various activities called research. The principles of the medical model are beneficence—be of benefit and do no harm. I simply don’t think that that applies to either the intent or the function of most people doing research."<br /><br />Then there is the reaction of sociologist Albert Reiss, who attended the Belmont conference and contributed a paper to the National Commission. Having unsuccessfully called for the drafters to recognize the value of "muckraking sociology," he later denounced the Belmont Report as "ethical malpractice." [Albert J. Reiss Jr., "Governmental Regulation of Scientific Inquiry: Some Paradoxical Consequences," in Carl B. Klockars and Finbarr W. O’Connor, eds., Deviance and Decency: The Ethics of Research with Human Subjects (Beverly Hills: Sage, 1979), 67]<br /><br />If you can find an explicit statement by any of the Belmont drafters calling for the "naming the names of those who didn't [do the right thing]," in Dreger's words, I would be grateful for the reference.<br /><br />What the drafters of the Belmont really wanted was for the federal government to answer questions like this rather than leaving folks like you and me to guess what they meant. As Jonsen explains in his contribution to Belmont Revisited, "my colleagues and I fully anticipated that an Ethical Advisory Board (EAB) would he established as a standing agency within the Department of Health and Human Services. We had so recommended in almost all of our reports. We expected that such a Board could be the living oracle of Belmont's principles. Just as our Constitution requires a Supreme Court to interpret its majestically open-ended phrases, and, if I may allude to my own Catholic tradition, as the Bible requires a living Magisterium to interpret its mystic and metaphoric message, so does Belmont, a much more modest document than Constitution or Bible, require a constantly moving and creative interpretation and application." <br /><br />Canada has revised its TCPS in the light of experience and debate, and in doing so it has explicitly recognized the value of critical inquiry. Australia has pledged to revisit its ethical guidelines periodically, giving researchers there the hope that they can amend the National Statement to match their principles. But in the United States, we are stuck with the Belmont Report, ambiguous in its language, inconsistent with federal regulations, in conflict with the ethics of social science, and impervious to change. It is time to rethink it.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-45339913360140731702011-06-13T23:43:53.474-04:002011-06-13T23:43:53.474-04:00Dr. Schrag, do not make this personal. I was readi...Dr. Schrag, do not make this personal. I was reading and teaching the Belmont Report before you were out of elementary school.<br /><br />The Belmont Report states that "do not harm" is only one part of two "complementary expressions" of the principle of beneficence, the other being "maximize possible benefits and minimize possible harms." It then goes on to explain, "The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks." Thus, it is clear that the drafters of the report did not intend research to be risk free.Jeffrey Cohenhttps://www.blogger.com/profile/06260329604710553905noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-90871347352162084232011-06-02T22:43:14.452-04:002011-06-02T22:43:14.452-04:00Please see the following two posts, including the ...Please see the following two posts, including the comments:<br /><br /><a href="http://www.institutionalreviewblog.com/2011/05/australian-political-scientist-causing.html" rel="nofollow">Australian Political Scientist: "Causing Harm . . . May Be the Whole Point"</a><br /><br /><a href="http://www.institutionalreviewblog.com/2010/12/first-do-some-harm-part-iii-loosies-in.html" rel="nofollow">First, Do Some Harm, Part III: Loosies in San Francisco</a>Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-38737146591717174932011-06-02T22:16:48.373-04:002011-06-02T22:16:48.373-04:00Come on Zack, if you are going to make an argument...Come on Zack, if you are going to make an argument, make it. Which part of the Report did you have in mind and why? Otherwise, let's just agree that Jeffrey is correct.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-87744655078247184932011-06-02T16:23:37.472-04:002011-06-02T16:23:37.472-04:00Dr. Cohen, what would it take to get you to read t...Dr. Cohen, what would it take to get you to read the Belmont Report?Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-40006921488207755042011-06-02T15:56:01.185-04:002011-06-02T15:56:01.185-04:00Just a note to remind everyone that there is no re...Just a note to remind everyone that there is no requirement that research does not harm subjects. The only requirements are that risks are minimized - that is, the research inflicts the least amount of harm necessary, and that risks are reasonable in relation to the benefits of the research - that is, there is no harm inflicted that is not necessary to obtain important information. Also, there is no requirement that research participation be anonymous, only that subjects are informed about how their identity will be protected, if at all. As long as subjects know that their identity will be revealed and give their consent, then an IRB should have no problem approving the research.Jeffrey Cohenhttps://www.blogger.com/profile/06260329604710553905noreply@blogger.com