tag:blogger.com,1999:blog-525778292565554519.post5975139823591486738..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: New York Times Reports on ANPRMZachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-525778292565554519.post-66793908365729651282011-07-25T16:14:06.320-04:002011-07-25T16:14:06.320-04:00I agree with you about new procedures and guesswor...I agree with you about new procedures and guesswork. It seems to me that there is a high risk of practice turning out to be something other than expected.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-2910345195197260732011-07-25T14:44:28.420-04:002011-07-25T14:44:28.420-04:00I think the idea is that the exemption (or excusal...I think the idea is that the exemption (or excusal) criteria should be made clearer. Right now, no one knows what risk to reputation means, so researchers get in fights with IRB staff. The HIPAA criteria are clearer, so whether the review is done prospectively or retroactively, I would hope that the system would involve less guesswork.<br /><br />I take your point that retrospective audits could be "potentially more burdensome" than prospective review. I wish the ANPRM included a mechanism by which new systems of oversight could be tested and refined through experience. Instead, it asks us to guess how an untried system might work.Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-42465430405814641732011-07-25T14:21:46.622-04:002011-07-25T14:21:46.622-04:00I haven't worked my way through the whole docu...I haven't worked my way through the whole document but I think it is wishful thinking to assume that clarifications and some rule changes will get rid of institutional dysfunction. <br /><br />They are proposing a one page exemption registration. But that still leaves the problem that some researchers are not going to apply the criteria appropriately. They try to address this with "require random retrospective audits of a sample of exempt studies to assess <br />whether the exemptions were being appropriately applied." I think this is potentially more burdensome on everyone, and certainly opens the door to more dysfunction. I'd prefer sticking with a simple, independent check up front that asks what type of data is being collected, how, from whom and where to ascertain that the project involves no greater than minimal risk and meets at least one of the exempt categories. I guess that could be one page, plus attached instruments in some cases.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-51751011874916982332011-07-25T12:15:48.290-04:002011-07-25T12:15:48.290-04:00Thanks for this comment.
I am glad to learn that...Thanks for this comment. <br /><br />I am glad to learn that the exemption process is working at your institution, but the ANPRM recognizes that not all institutions function so well. It addresses the problem of institutions' overregulating by seeking to "clarify that routine review by an IRB staff member or some other person of such minimal risk exempt studies is neither required nor even recommended." This is an important reversal of current guidance. Other potentially helpful measures considered in the ANPRM include the gathering of data, and the requirement that institutions distinguish between federal requirements and their own rules.<br /><br />See "<a href="http://www.institutionalreviewblog.com/2010/12/menikoff-passes-buck.html" rel="nofollow">Menikoff Passes the Buck</a>."Zachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-52722265975694540392011-07-25T11:47:36.380-04:002011-07-25T11:47:36.380-04:00Our institution does a large amount of work on cur...Our institution does a large amount of work on curriculum evaluation of the sort referenced in the Carl Wieman quote above. Practically all of it is determined to meet the criteria for exemption under §46.101(b)(1). Where just teachers are involved it usually meets the criteria for exemption under §46.101(b)(2) as well. We often make recommendations about appropriate consent procedures but don't formally review or approve consent procedures and forms for exempt studies. <br /><br />The proposed revisions may in fact offer less than they appear with regard to social science research as most social science research can be treated as exempt under the current regulations but many institutions choose not to do so.Anonymousnoreply@blogger.com