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href="../AboutSearch.html"><br>About Search</a></td> </tr> </table> </td> </tr> </table> <!-- Search Box End --> </td> </tr> <tr> <td valign="top" ><img src="../../graphics/titles/HFES_Bulletin.gif" alt="HFES Bulletin" longdesc="" width="200" height="86" border="0" /> </td> </tr> <tr> <td colspan="3" class="main" <!-- Content Area Begin--> <hr> December 2011<br> Volume 54, Number 12 <p><h3>Public Policy Matters</h3> <p><h2>An Uncommon Revision of the  Common Rule </h2> <br><i>By William C. Howell, Chair, HFES Government Relations Committee </i> <p>Whether those of you engaged in HF/E research realize it or not, you ve been operating under a set of federal regulations for the treatment of human participants and their data that are known collectively as the  Common Rule (for reasons that I ll get to shortly). What you may find more familiar is the fact that these regulations, and the Institutional Review Boards (IRBs) that enforce them, have created a lot of problems for researchers, ranging from seemingly irrelevant, time-consuming reporting requirements to unjustified mandates regarding the research itself and the handling of data. <p>Well, after two decades of complaints, the U.S. Department of Health and Human Services (HHS) and the administration s Office of Science and Technology Policy (OSTP) finally decided to undertake a revision of these regulations and, in doing so, to encourage comments from all those affected individuals, groups, and organizations on a draft of the proposed changes. Anyone interested in the actual draft can find it <a href="http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf" target="_blank">here</a>. <p>In what follows, I summarize the history of these regulations and what HFES has done in reacting to this draft and why. <p><b>Background</b> <br>For more than three decades, all federally funded research has been subject to a strict set of regulations governing the conduct of research with human subjects, including the requirement that an IRB review and approve research protocols. Promulgated and adopted in the 1970s because of some widely publicized abuses, the regulations created many problems for researchers, including the fact that different agencies and IRBs interpreted and applied them differently. Consequently, 17 major funding agencies got together sometime around 1991 to reach a common understanding, with HHS taking the lead in its Title 45, Part 46, of Code of Federal Regulations, thereafter known as the  Common Rule. <p>Although this resulted in significant improvements, including more clearly articulated lists of  exempted areas, it didn t fix everything. So complaints have continued over the two decades since, hence the aforementioned announcement by HHS and OSTP inviting comments on its draft revision of the Common Rule. In view of the number of HFES members engaged in research with human subjects, the HFES Government Relations Committee (GRC) felt that the Society should respond in some manner to this opportunity and so advised the president, who agreed. <p><b>The HFES Review and Response</b> <br>This document, like most federal regulations, was long and complex with a lot of  lawyer language. Moreover, in the solicitation of comments, HHS/OSTP posed some 74 specific questions relating to various provisions in which revisions were being proposed in the draft. Also typical of federal announcements, the original deadline for response was unrealistically short. Thankfully, complaints from a number of organizations resulted in a month s extension, enabling HFES to participate. However, based on a quick reading and consultation with other societies, it became clear to the GRC that HFES does not have the resources to do the kind of in-depth analysis that would be required for an informed set of comments. Given that other (much larger) organizations were in the process of doing this, it was decided that HFES would work with those groups rather than attempt a comprehensive review on its own. <p>Most important, the American Psychological Association (APA), whose research constituency is very similar to that of HFES (in fact, overlaps it to some extent), had been monitoring the whole regulation issue since the 1990s. In response to this announcement, APA had assigned several staffers full-time to the analysis of the document and appointed a committee of volunteer researchers to complement their efforts. <p>Similarly, the Federation of Associations in Behavioral and Brain Sciences (FABBS), of which HFES is a member and which is closely related to APA, was also investing heavily in a review. Following an all-day meeting of representatives of the 20 or so member organizations and other consortia, a committee was appointed to draft comments for the entire body. Based on the knowledge that APA and FABBS were undertaking in-depth reviews, the GRC recommended that HFES examine their comments and either sign on in support of one or both or, if there were any inconsistencies with the interests of HF/E researchers, submit a version of the comments revised in accordance with those interests. This recommendation was endorsed by the Executive Council, so the GRC proceeded accordingly. <p>The APA response consisted of a set of general comments addressing specific sections and subsections of the revised draft, whereas FABBS submitted a white paper that, rather than following the draft outline, addressed specific issues more broadly. The GRC reviewed both documents. Not surprisingly, though differing somewhat in emphasis and coverage, the two sets of comments had no substantive points of disagreement. Moreover, the GRC could find nothing in either for which there would be any concern within the HF/E research community. <p>Space does not permit nor do I expect that most readers would want a detailed account of either the changes proposed in the draft or the APA and FABBS comments. Suffice it to say that the revisions were aimed, for the most part, at streamlining the review process, enabling more minimal-risk research to qualify for exemption or expedited review, and eliminating some unnecessary requirements (such as multiple IRB reviews for studies conducted at multiple sites). <p>However, as was the case with the original version, the revision was heavily tilted toward biomedical research for which risks are substantially different in some areas than those posed by the behavioral kind. For example, the proposed data security and information protection requirements, though reasonable for biomedical data, would impose an unnecessary burden on anyone doing secondary data analyses a common practice in behavioral research. Both the APA and FABBS responses strongly opposed this one-size-fits-all provision. They also objected to a provision that would extend application of the Common Rule to <i>all</i> research being conducted at an institution that received <i>any</i> federal support, irrespective of sponsorship. (Currently only federally supported research is covered.) <p>Beyond these major objections, both the APA and FABBS comments dealt with a number of important details, such as the specific qualifications for expedited review and exempt classification, and the prescriptive language for the format and content of consent forms. In sum, both the proposed revisions to the Common Rule and the objections to specific provisions submitted by APA and FABBS would if implemented provide considerable relief for HF/E researchers. Furthermore, if the revised version were modified in accordance with the objections raised, nothing in it would impose additional burdens or pose new problems for this community. <p>Therefore, the GRC recommended that HFES sign on in support of both sets of comments. With the approval of the Executive Council, the president followed through. In the case of FABBS, we were advised that despite our being represented in its  corporate response as one of the member organizations it was useful to register independent support, so HFES joined the other member organizations in doing so. In the case of APA, it was simply a matter of endorsing the comments (as did several other organizations). <p>You might wonder what the purpose of this seeming duplication was. The simple answer is that sheer numbers matter, and also one never knows which set of comments is likely to attract the most attention where it counts. It s not like voting multiple times; rather, it s a matter of increasing the odds that HFES has an impact. <p>As I noted at the outset, I doubt that many HFES members are aware of the existence of the Common Rule, let alone the massive collection of very specific provisions it contains. But the Common Rule has had an important bearing on how they interact with subjects, conduct their research, and handle their data. If you are among those for whom the present regulations are a drag, you may find some relief soon provided the collective input from the behavioral and social science communities gets incorporated into the final revision. And you might be pleased to know that HFES was on top of it and may have had a small part in making it happen. <hr> <p>Back to the <a href="http://www.hfes.org/web/HFESBulletin/Dec2011Main.html">Table of Contents</a> for the December 2011 <i>HFES Bulletin</i> <p><a href="http://www.hfes.org/web/BulletinPdf/1211bulletin.pdf" target="_blank">Download a .pdf version of this issue</a> <p><a href="http://www.hfes.org/web/BulletinArchive.html" target="_blank">Archive of past <i>HFES Bulletin</i> issues</a> (in .pdf format) <!-- Content Area End --> </td </tr> </table> <!--Body Area End --></td> </tr> </table> <!-- Body Table End --></td> </tr> <tr> <td><!-- Footer Table Start --> <table cellspacing="0" cellpadding="0" border="0" width="100%" class="footer" summary="Footer Table"> <tr> <td colspan="2" class="Height_2px"><img src="../../graphics/invisible.gif" width="1" height="2" alt="" border="0" /></td> </tr> <tr> <td class="Width_1px"><img src="../../graphics/invisible.gif" width="1" height="1" alt="" border="0" /></td> <td class="footernav"><a href="../contact.html">Contact Us</a> &nbsp; | &nbsp; <a href="../sitemap.html"> Sitemap</a> &nbsp; | &nbsp; <a href="../privacy.html">Privacy Policy</a> &nbsp; | &nbsp; <a href="../legalnotices.html">Legal Notices</a> &nbsp; | &nbsp; <a href="../accessibility.html"> Accessibility Features</a></td> </tr> <tr> <td class="Width_1px"><img src="../../graphics/invisible.gif" width="1" height="1" alt="" border="0" /></td> <td> <p><a href="mailto:lois@hfes.org?subject=Tell us what you think about the new HFES Web site.">Tell us what you think about the new HFES Web site.</a></p> <p>Human Factors and Ergonomics Society, P.O. 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