tag:blogger.com,1999:blog-525778292565554519.post4693306898310512811..comments2018-01-03T07:02:32.059-05:00Comments on Institutional Review Blog: Can We Patch This Flat Tire?Zachary M. Schraghttp://www.blogger.com/profile/07101709506166167477noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-525778292565554519.post-36781073007457927312008-07-16T23:16:00.000-04:002008-07-16T23:16:00.000-04:00Thank you for your essay and for this helpful comm...Thank you for your essay and for this helpful comment. <BR/><BR/>I am glad your comment makes explicit your assumption that we are unlikely to achieve positive regulatory or legislative change any time soon. Perhaps I am the naive one, but I think such change is actually more likely than the kind of enlightened leadership you seek from OHRP. At today's meeting of the Secretary’s Advisory Committee on Human Research Protections, several committee members expressed their frustration with the current regulations, while also noting that OHRP's limited resources prevent it from leading reform efforts. Nor do OPRR/OHRP's actions in the past give me much hope. So I don't think I'm alone in thinking that we need at least to consider strategies for changing the regulations, and perhaps the statute which they claim to implement. <BR/><BR/>Of course, efforts at incremental and radical reform can proceed simultaneously, which is why I was glad to read your article. But I would like to know why you think your proposed reforms are any more likely to be adopted than those of the 2003 National Academies panel. As you note in your article, "good ideas . . . are yet to be tested or implemented on a wide scale." (502) That may be an understatement; in five years, has OHRP made any effort to implement any of the National Academies panel recommendations?<BR/><BR/>In sum, you two and I share some basic hopes for a reformed system. I think we would all like to see a greater role for review at the department level, ethical training for researchers tailored to their own methods and topics, and some way of holding IRBs to standards of procedural justice. And we may be equally pessimistic about achieving such outcomes nationwide. But while you direct your pessimism at Congress and the Common Rule signatories, I'll target mine at OHRP and the local IRBs.<BR/><BR/>ZachZachary M. Schraghttps://www.blogger.com/profile/07101709506166167477noreply@blogger.comtag:blogger.com,1999:blog-525778292565554519.post-14793654199977145592008-07-16T17:07:00.000-04:002008-07-16T17:07:00.000-04:00We appreciate your taking seriously, and commentin...We appreciate your taking seriously, and commenting on, the recommendations we offer for change. Unfortunately, short of significant regulatory reform (which is not likely) or other creative solutions, social scientists will find themselves at this same place years from now. Even Congressional action (e.g., at least one bill is being redrafted now) is not likely to help matters. Our approach was to attempt to identify areas in which institutional change could occur now without regulatory change. We are not insensitive to (or naïve about) the troubled relationships between social science researchers and IRBs. These troubled relationships have been present from the creation of the human research protections system in this country and have been the subject of much discussion over recent years. And historians, for one, have been particularly effective in raising their concerns. Despite these power dynamics, however, there is room for change. Our article is directed at trying to focus on some feasible changes and to move beyond problem specification to problem solving. Also, we do not see “education as a panacea,” but we do think that providing opportunities for the exchange of ideas around methodological or regulatory issues could lay the groundwork – at least at some institutions – for positive change. Our illustrations were not just empty calls for education, but steps that could change how IRBs come to understand their role (e.g., providing advice as protocols are developed). We cite research showing the benefits of a more transparent, open, and legitimate process. Indeed, a panel of social scientists assembled by the National Academies has also called for researchers and IRBs to seek a better understanding of the functions and constraints on each other as a way to improve the process.<BR/><BR/>Levine and SkedsvoldAnonymousnoreply@blogger.com