tag:blogger.com,1999:blog-525778292565554519.comments2018-01-03T07:02:32.059-05:00Institutional Review BlogZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger338125tag:blogger.com,1999:blog-525778292565554519.post-49552449534946082032017-09-04T23:14:02.704-04:002017-09-04T23:14:02.704-04:00Interesting question re: repetitive behavior. Yes...Interesting question re: repetitive behavior. Yes, the FireWire may be an isolated and one-time incident; but when the repeated behavior is capricious and unrelated demands stipulated of researchers that hold up researchers and the research they are conducting (and possibly their career paths), such behavior can be viewed as repetitive. It may be Firewire vs. USB this time, and demanding an unnecessary form the next. Just as the particular insult uttered on the schoolyard may change from incident to incident (yet cumulatively reflects bullying), so too can the manifestation of repeated bullying acts by unchecked autonomous and abusive IRBs.Caleb T. Carrhttps://www.blogger.com/profile/11250930952010151175noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-61232181909038643382017-01-18T18:02:01.083-05:002017-01-18T18:02:01.083-05:00Thank you for all that you have done to support th...Thank you for all that you have done to support this movement to preserve oral history as a part of free speech! Well done.<br /><br />Mary Marshall Clark, Center for Oral History Research, Columbia University, senior member, Columbia University IRB Board.Anonymoushttps://www.blogger.com/profile/02578345616280504571noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-75914638327302151812017-01-18T17:56:12.045-05:002017-01-18T17:56:12.045-05:00Zach, thanks for your explanation of these changes...Zach, thanks for your explanation of these changes in human subjects regulations governing oral history - and other activities - and for YOUR advocacy of these changes for many years. We shall see how IRBs actually implement them - I have concerns, for example, about the failure to define an explicit "exclusion" category for oral history and other practices and the potential for some IRBs to decide what constitutes oral history, what does not, based on limited knowledge (and, I suppose, some researchers, too). But we shall see how it all shakes down. --Linda Shopes, Independent Historian Unknownhttps://www.blogger.com/profile/10123976511088898457noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-41433679130976357322016-12-19T10:17:33.479-05:002016-12-19T10:17:33.479-05:00Hi Zachary
Thanks for reading, and commenting. Yo...Hi Zachary<br /><br />Thanks for reading, and commenting. You say:<br /><br />"If your profession is research, aren’t research ethics a form of professional ethics?”<br /><br />Well, yes! As you and Stark (and Hedgcoe’s latest) show, for various reasons biomedical research ethics was deliberately created as something independent of the existing structures of biomedical professional ethics. Given the methodological and epistemic commitments in the biomedical (natural) sciences this was tenable. Part of the reason it has proved problematic in the social sciences is because this is not the case in these disciplines. Like medical practice, the social sciences are both science and art! Rethinking research ethics as a professional ethics does not necessitate a wholesale rejection of the former in favour of some wholly original creation in terms of the latter. Rather it requires the ethical terms of research to be restated and their meaning, purpose and logic to be reconsidered.<br /><br />You also question whether we can (or should) expect the social sciences to become institutionalised in the same way as medicine, law, the clergy (or the military). And if this will compromise a necessary ethical pluralism. First, i don’t think it is possible or desirable to institutionalise in this way - having a professional body to credentialise and disbar or defrock social scientists doesn’t seem likely or a good idea! There are too many sub-specialisms and we lack the requisite overarching unity. I’d rather see existing professional bodies articulate standards of professional research ethics and have research (and RECs) make actual use of them. <br /><br />Trust in social science is important, but at this point what is vital is that distrust is not allowed to take hold. Regardless of fault, the case of the Boston College Project and in the example of Marie-Ève Maillé show current promises of confidentiality are highly suspect. This needs to be addressed sooner rather than later, and preferable at a collective level. <br /><br />Nathannathanhttps://www.blogger.com/profile/09766849730535304890noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-36859360989551513322016-06-06T18:58:01.523-04:002016-06-06T18:58:01.523-04:00Thanks for posting this! Thanks for posting this! nathanhttps://www.blogger.com/profile/09766849730535304890noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-80682496733914667722016-06-06T10:04:30.017-04:002016-06-06T10:04:30.017-04:00Nice detective work. I've checked and have cor...Nice detective work. I've checked and have corrected this archived page of the President's Council on Bioethics listing former Bioethics Commissions and their published works to correctly note the Belmont Report as having been first published in 1978: https://bioethicsarchive.georgetown.edu/pcbe/reports/past_commissions/index.htmlMark Hakkarinen, M.A.https://www.blogger.com/profile/15070405199196578303noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-63870138917480956202016-05-25T23:24:23.947-04:002016-05-25T23:24:23.947-04:00Thanks for this comment.
The problem with the CIT...Thanks for this comment.<br /><br />The problem with the CITI Program is not that it's burdensome. Distinguishing the "correct" multiple choice answer from several obviously wrong ones is not hard, and if you happen to click wrong, you just do it again. The problem with the CITI Program is that it's mortifyingly stupid, and that's Anderson's complaint about these other programs as well. <br /><br />As it happens, I just recently completed my university's sexual harassment training. If anything, it was slightly less mortifyingly stupid than the CITI Program, in that at least there's case law behind most of the answers. Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-72312745561043771192016-05-24T15:05:56.809-04:002016-05-24T15:05:56.809-04:00I agree somewhat, but I think the Slate article is...I agree somewhat, but I think the Slate article is talking more about the sort of training my university has decided to require. It's from a group called Workplace Answers, and covers topics such as FERPA, Title IX, Clery Act, bullying, financial conflicts of interest, and so forth. We've been required to complete 9 modules so far this year. The CITI training is much less burdensome than the other courses I have gone through.Anonymoushttps://www.blogger.com/profile/02351836890907203224noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-8232913390459966872016-04-13T16:02:50.520-04:002016-04-13T16:02:50.520-04:00Thank you for your reply. The 2006 edition of Inst...Thank you for your reply. The 2006 edition of <a href="https://books.google.com/books?id=ZVByC6VVsl0C&lpg=PA83&vq=subcommittee&pg=PA84#v=snippet&q=subcommittee&f=false" rel="nofollow">Institutional Review Board: Management and Function</a> does mention subcommittees, but not for specific fields, such as ethnography.<br /><br />Putting ethics review in the hands of specialists is a good idea, as <a href="http://www.institutionalreviewblog.com/2016/04/wynn-calls-for-department-level-review.html" rel="nofollow">LL Wynn, an ethnographer, has argued</a>. Some universities did deploy more specialized subcommittees in the early 1970s, only to face scolding from federal regulators. (See <a href="http://www.institutionalreviewblog.com/2008/07/can-we-patch-this-flat-tire.html" rel="nofollow">Can We Patch This Flat Tire?</a>. <br /><br />The current system lacks provisions for review of ethnography by ethnographers.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-28740377670244843002016-04-13T15:30:27.902-04:002016-04-13T15:30:27.902-04:00Hi Zachary,
NC State does not have their internal...Hi Zachary,<br /><br />NC State does not have their internal list of topic consultants published online, as is the case with many IRBs (many do not even post their minutes online, which I feel is essential for transparency). I was employed at NC State for several years and can refer you (privately) to the names of ethnographers used to consult on ethnographic projects. I have reached out to the IRB Forum (moderated by PRIM&R) to see if there is a public list of IRBs with subcommittees that I can provide you with. I have also posted a question on the subject on an IRB Facebook page to see if anyone is willing to share their subcommittee information. I will pass along my findings to you.<br /><br />I can also assure you that there are published articles on the topic and that subcommittees are utilized. The Amdur and Bankert book is the "IRB Bible" for administrators and covers the use of subcommittees (chapter 3.7 in my ancient addition). <br /><br />My short article in Contexts and my professional efforts (as a researcher and IRB administrator) have always been to improve the IRB experience for social/behavioral researchers and to offer constructive suggestions. I enjoy Laura Stark's book because it provides a contemporary understanding of how IRB decisions are made. Unlike most critics of IRBs, Dr. Stark attends PRIM&R conferences and makes a committed effort to understand the perspective of both researchers and administrators.<br /><br />I certainly understand the frustrations of researchers and wish there could be less animosity and more productive communication and collaborative work between committees and investigators. Thank you. <br /><br />Abigail CameronCameronhttps://www.blogger.com/profile/03132940418387480859noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-59416600056173286812016-04-13T14:38:20.078-04:002016-04-13T14:38:20.078-04:00Thank you for this response. The NC State IRB webp...Thank you for this response. The NC State IRB webpage makes no mention of subcommittees, nor does Stark's book. I must question the accuracy of your claim that "some IRBs may have subcommittees assigned to review ethnographies."Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-45909700136184544122016-04-08T11:34:09.625-04:002016-04-08T11:34:09.625-04:00Hi Zachary,
Thank you for your blog post about m...Hi Zachary, <br /><br />Thank you for your blog post about my article. Contexts asked me to write the article for the ethics series as a general interest piece rather than an academic submission with citations. I also did not have the space to take my brief review of the debate back very far in time. I certainly feel your pain. I can tell you that at NC State, we were fortunate to have excellent anthropologists serve as ethnography experts for our committee there many years ago. Many IRBs are not as fortunate. I have also been to many PRIM&R conferences where anthropologists have presented about their collaborations with IRBs. If you are interested, Laura Stark from Vanderbilt, has written a great book about IRBs, "Behind Closed Doors: IRBs and the Making of Ethical Research," that you might be interested in. There certainly needs to be more research on contemporary IRB committees and how they are implemented differently across institutions with attention to the review of qualitiative work. Best, Abby CameronCameronhttps://www.blogger.com/profile/03132940418387480859noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-56058269947789951242015-10-12T14:29:20.500-04:002015-10-12T14:29:20.500-04:00The purpose of our article was not to analyse or i...The purpose of our article was not to analyse or interpret the US regulatory language at all, but to “report on research aimed at assessing why Public Administration research is eligible for research ethics review at all”. Our conceptual framework was never intended to be a replication of the US regulatory language, but a deduction from our reading of the Belmont Report and several scholarly works related to the report and research ethics review, including our evolving institutional policy on research ethics. In conclusion, we do not agree that the “article relies on a misunderstanding of U.S. regulatory language”. We developed three risk-associated categories (no involvement, indirect involvement and direct involvement) that are context-specific. We acknowledged as a limitation of this study that “a simplistic picture of research ethics risk is presented in the article” (see page 17). We also stated: “we are in the process of developing more refined risk categories for research in Public Administration in current research (see page 17). <br /> <br />It seems that your main concern is our equation of “more than minimal risk” to “direct involvement” as you perceive it as a misrepresentation of the meaning “more than minimal risk” as used in the US regulatory practice. We have deduced the risk categorisation used in this article from various discussions and interpretations of the principles as stated in the Belmont Report. In fact, we have developed for the purpose of this article only three risk categories founded on the notion of ‘human participant involvement’. On p 12 of our article we explicitly state that for “the purpose of this study, ‘minimal risk’ refers to the probability that harm or inconvenience anticipated in the research is not greater in itself than that encountered in ordinary daily life (OHRP, 1993); ‘more than minimal risk’ refers to research with the potential to harm or create inconvenience for human subjects. We stated explicitly on page 12 of the article that the risk category – ‘more than minimal risk’ reflect a potential to harm or to create inconvenience to human subjects. For the purpose of this research we regarded direct involvement of human participants through qualitative or quantitative methods as having that potential. Consequently, the conceptual framework presented in Table 2 has been used for the quantitative content analysis. We have deliberately decided to use for the purpose of this study a broad risk categoris action based on the nature of involvement of human participants. In fact, our current research focus specifically on a refined risk assessment framework as stated previously. We take notice of the practice in the countries such as the US and Canada. However, we do not regard these countries’ official risk categories and the definitions of these categories as the final word in this regard. <br /><br />As we categorised the use of secondary data (indirect involvement) as of minimal risk, it makes logically sense that direct involvement through interview- or survey-based research be classified as having the potential for more than minimal risk. It depends on the classification system <br /><br />Considering the definitions in our risk classification system the 26 percentage figure was not an over statement and indicates a “potential’ for more than minimal risk. In our discussion (on page 17) we acknowledged as a limitation of the study “the lack of information typically needed to determine the extent to which research procedures have met ethical principles …” We further acknowledged “our inability to assess the actual behaviour of researchers’ through the methods used”.<br />We never claimed that the findings indicated that real harm occurred during the research. The findings of case studies are contextual and a limitation of this type of research is that the findings are not generalizable. <br /><br />Kobus Wessels and Retha Visagie<br />University of South AfricaAnonymoushttps://www.blogger.com/profile/12643966401499567657noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-25546156714022591492015-09-03T09:40:51.150-04:002015-09-03T09:40:51.150-04:00This is a great breakthrough, and a real tribute t...This is a great breakthrough, and a real tribute to the enormous work which lots of people have done for a long time. However, it is imperative now that individuals and professional associations weigh in during the public comment period.<br /><br />Cliff Kuhn<br />Executive Director<br />Oral History AssociationOral History Associationhttps://www.blogger.com/profile/03181463815357877597noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-53004938520604764822015-06-25T09:16:12.909-04:002015-06-25T09:16:12.909-04:00God knows I disagree with a lot of what you write,...<br />God knows I disagree with a lot of what you write, but you are spot on about this. It seems daft to blame IRBs for ordering data-destruction when they don't actually order it.<br /><br /> Mark Lacour made the same excuse I think, even though the 'evidence' he presented included a letter from the chair of his IRB complaining about how he had carried out his research without submitting to the IRB.<br /><br />I guess IRBs are easy targets to hang blame on....<br /><br />Adam Hedgecoe, Cardiff UniversityUnknownhttps://www.blogger.com/profile/10706287966958638980noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-11889466389982091642014-12-08T09:06:50.825-05:002014-12-08T09:06:50.825-05:00See Li Abandons Suit, But Brown University Still ...See <a href="http://www.institutionalreviewblog.com/2012/04/li-abandons-suit-but-brown-university.html" rel="nofollow"> Li Abandons Suit, But Brown University Still Ponders IRB Reform</a> for the follow-up.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-36819249129035289532014-12-05T09:02:02.625-05:002014-12-05T09:02:02.625-05:00What is the status of this case?
Don Green, Col...What is the status of this case? <br /><br />Don Green, ColumbiaAnonymoushttps://www.blogger.com/profile/12880528691989652955noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-58939100192200395302014-08-30T15:12:49.247-04:002014-08-30T15:12:49.247-04:00I saw your piece in Wash Monthly. Even though I re...I saw your piece in Wash Monthly. Even though I read your blog, it was still nice to see everything presented clearly and concisely. Well done!PCMhttps://www.blogger.com/profile/13647097472236933108noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-21020965529130126702014-03-19T20:01:08.416-04:002014-03-19T20:01:08.416-04:00Thanks for this disturbing exposé. You are right t...Thanks for this disturbing exposé. You are right to call it “faulty memory and misinformation.”<br /><br />It is no surprise, however. Will van den Hoonaard has pointed out that IRB scholars and supporters live in a bubble in which genuine academic debate is not only absent but unwelcome. “No critical self-reflection about the work and nature of ethics committees. Participants of both conferences lived in a bubble of compliance. Unlike academic conferences, there were no voices of dissent, nor were any expected.” (<i>The Seduction of Ethics: Transforming the Social Sciences.</i> Toronto; Buffalo: University of Toronto Press, p. 285)<br /><br />Readers who want to learn more about the sordid history of McCarthy’s tenure at OPRR should check the meticulous reconstruction you provide in <i>Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009.</i> It is a shocking story of deceit and double-dealing by McCarthy and his federal colleagues. <br /><br />Ethics, indeed.<br /><br />Simon Whitney<br />Baylor College of Medicine, Houston, TX<br />swhitney@bcm.edu<br /><a href="http://suffocatedscience.com" rel="nofollow">Suffocated Science and Scholarship</a>Anonymoushttps://www.blogger.com/profile/15689234015656032781noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-77178949871538384312014-02-24T11:20:05.630-05:002014-02-24T11:20:05.630-05:00Thank you for this information.
The McMurtrie art...Thank you for this information.<br /><br />The McMurtrie article makes no mention of a proposed thirty-year embargo for the interviews. And while I can't claim to have read all that has been written about the Belfast Project, this is the first I have heard of such a proposal.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-50355884198040570042014-02-24T10:29:15.408-05:002014-02-24T10:29:15.408-05:00With reference to your penultimate paragraph, a li...With reference to your penultimate paragraph, a little background on the issue of publication and emabargos ref the boston college project might be helpful.<br />at the outset this was a point of contention between ourselves in belfast and boston college and i do believe beth mcmurtrie made some reference to this in her article which you may have missed.<br />as the former director of the project my initial demand was to impose an embargo similar to that decreed by most european governments, which is no publication for thirty years.<br />we were told by BC that this would not be acceptable and that the college normally expected to be able to publish material or make it available within a decade.<br />the final agreement, to keep interviews embargoed until the death of the interviewee was something of a compromise.<br />even so, we believe that the college's decision to axe the project in 2006 stemmed directly from a refusal by ourselves to bend on the embargo issue.<br />in january 2006, tom hachey, who headed the project overall, phoned me and travelled to belfast to meet the researchers to ask if we would agree to approach the interviewees and ask them to alter the terms of the contract to allow publication while they were still alive. the college wanted bangs for its bucks, it seems. we refused and five months later the project was closed.<br />i hope this sheds some light on this question.<br />regards<br />ed moloney<br />former director<br />belfast project<br />boston collegeEd Moloneyhttps://www.blogger.com/profile/11971666499303207728noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-43132984497756382542014-01-18T09:37:27.152-05:002014-01-18T09:37:27.152-05:00“Ms. Willingham had said a number of times that sh...“Ms. Willingham had said a number of times that she had identified data, and in fact had shared some pieces of it ... in connection with earlier investigations,” Dean said. “The (review board) had decided to look into her case before she finally turned the data set over to me.”<br /><br />He added that Willingham “did not have the authority to use identifiable data because to do so would have required (review board) ... approval, which she did not have.”Theresa Definonoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-28425349558525510302014-01-18T09:34:43.238-05:002014-01-18T09:34:43.238-05:00I believe they are claiming it was AFTER. She may ...I believe they are claiming it was AFTER. She may not have had IRB approval but may also have not really needed it...you know that story!Theresa Definonoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-72231387912268007252013-08-07T08:11:12.057-04:002013-08-07T08:11:12.057-04:00I doubt it, but Miller's claim raised some mil...I doubt it, but Miller's claim raised some mildly interesting issues about the definitional boundaries of human subjects research.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-14759775652198685122013-08-06T23:52:54.677-04:002013-08-06T23:52:54.677-04:00Honestly, does anyone really believe that this twe...Honestly, does anyone really believe that this tweet was part of a research project?Kevin Parsonnoreply@blogger.com