Response to HHS-OPHS-2011-0005 by Members of the Field of Human-Computer Interaction October 25, 2011 Summary We the undersigned, consisting of academics and practitioners in the field of Human Computer Interaction (HCI), strongly support the goals of modernizing and revising current regulations for protecting human subjects who participate in research, as expressed in HHS-OPHS-2011-0005, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” We applaud the efforts to address the diversity of research practices and disciplines subject to IRB rules. We agree with the stated concern that, for the kinds of activities that are central to our practices, the current regulations are “not adequately calibrating the review process to the risk of research” and “some IRBs spend considerable time reviewing minimal risk research, and that some IRBs have a tendency to overestimate the magnitude and probability of reasonably foreseeable risks” and “[t]he nature of the possible risks to subjects is often significantly different in many social and behavioral research studies as compared to biomedical research, and … the difference is not adequately reflected in the current rules.” While we support the reforms proposed in the document, our comments below focus on the questions relevant to these points as they most directly impact our work. More precisely, we strongly support the proposed Excused category of research, and urge the addition of certain common activities used in human-computer interaction research to the list of activities that would qualify for this category, to be included explicitly alongside “educational tests, surveys, interviews, and similar procedures.” We also support the proposed revisions to regulations regarding expedited review and informed consent. Finally, we comment on the proposed changes regarding data security and information risk. Background HCI is a field of study that involves designing and evaluating computer systems, services, applications and interfaces. User interface design is critical to the successful use of technology, and a bedrock goal of HCI is to improve the interactions between computers and people, resulting in more successful and satisfactory experiences. Technology must be designed to take into account how people act and think, to reduce errors, and increase efficiency and enjoyment of work. Interface design is an iterative process, and requires working closely with prospective users, both to determine what they need and to determine how successfully a design meets those needs. Therefore, research in the field of HCI requires interaction with human participants to evaluate and improve the technology and the practices under study. 1 HCI research draws on software engineering practice, and many HCI studies incorporate user needs assessment, requirements analysis, design, prototyping, and usability testing. HCI is an interdisciplinary field that integrates theories and methodologies from computer science, information science, design, and social and cognitive sciences. It is closely related to the field of Human Factors. Two professional societies that are prominent in this field are ACM SIGCHI, www.sigchi.org, and the Usability Professionals Association www.upassoc.org . Although many of the undersigned are members of these organizations, we are signing as individuals and do not represent these organizations. The Excused Category of Research Question 14: This question asks: Are these expansions in the types of studies that would qualify for this Excused category appropriate? We strongly support the proposed Excused category. We believe these proposed changes are entirely appropriate and will improve the timeliness of research and reduction of paperwork without increasing risk to potential research participants. It is unlikely that the proposed changes would reduce protections for research participants or discourage individuals from participation. In particular: We support the suggested practice of having researchers who plan to do work that qualifies for the Excused category to submit a one page notice to their IRB board. More specifically, we support the proposed process for filing an Excused study. We agree that, “the proposed auditing requirement would provide institutions with information needed to assess their compliance with the new Excused category without unnecessarily subjecting all such research to either prospective review, or even routine review sometime after the study is begun.” This system appropriately puts more responsibility for identifying riskier studies on the researcher. Researchers should be expected to know and abide by their profession’s standards of ethical behavior, and understand when a particular research study has exceeded the limits of the Excused category. Additional training, code of conduct statements from professional societies, and ongoing review of emerging methods by a federal panel (see below) would support these standards. We support the proposed consent rules for Excused research and encourage that “user needs assessment, requirements analysis, design, prototyping, and usability studies” be added to the list of practices subsumed in this statement: “… oral consent without written documentation would continue to be acceptable for many research studies involving educational tests, surveys, focus groups, interviews, and similar procedures.” These additions are necessary because some institutional review boards may be unclear as to whether interacting with a computer or other common electronic devices should be considered a separate category of methods. Question 15: This question asks: Beyond the expansions under consideration, are there other types of research studies that should qualify for the Excused category? We believe that human-computer interaction studies involving user needs assessment, requirements analysis, design, prototyping, and 2 usability studies should be added to the Excused category. These are well-established practices that usually involve virtually no risk to participants. Question 17: This question asks which specific social and behavioral methodologies should be included in the Excused category. It also asks under what circumstances deception should be allowed. We support the following methods be included in the Excused category: Asking participants to use computer systems or other technologies that are intended to be used by end-users. This includes existing or experimental systems, prototypes, mockups, and sketches. Assigning participants tasks when using those technologies, or asking them to develop their own tasks. Asking users to analyze, critique or otherwise respond to these systems. Brainstorming and other creative techniques for eliciting or refining user needs, usage scenarios and system requirements; identifying trade-offs and benefits; exploring design alternatives; and exploring alternative solutions to design problems, etc. Monitoring or recording in conjunction with the above methods using a variety of capture technologies. These should include, but not be limited to, recording: audio, video, screen capture, interactions with the computer equipment such as mouse movements, touch screen taps, and tracking of eye movement using eye trackers. (Note that current eye tracking technology requires no physical connection with the participant.) This may be done locally or remotely. This assumes that monitoring is done with participants’ knowledge and consent in the context of a study. Observation, measurement and analysis of the responses, behaviors and views of people for the above methods. This assumes that observation is done with participants’ knowledge, or that standards for collecting and protecting public behavior are being followed. We feel that the above methods are appropriate for the Excused category because it is common for people to use (and critique) software programs, web sites and other technology in everyday life. Like surveys, focus groups, etc., these are “methodologies which are very familiar to people in everyday life and in which verbal or similar responses would be the research data being collected.” These methods involve benign interventions that pose virtually no risk to participants. These methods can be clearly defined and operationalized to ensure that researchers and IRB’s interpret them consistently. We support extending the mandate of the proposed standard federal panel (http://www.federalregister.gov/articles/2011/07/26/2011-18792/human-subjects-researchprotections-enhancing-protections-for-research-subjects-and-reducing-burden#p-77). In addition to reviewing and updating the list of research activities that qualify for Expedited review on a regular schedule, we propose that the same panel be charged with reviewing and updating the list of research studies that qualify for Excused status. This would provide a way for new techniques to be added to the list as they mature and become widely accepted and understood. 3 This panel should also be charged with articulating circumstances under which studies using these methods should not qualify as Excused due to psychological or information risks. Two such circumstances might be when particularly vulnerable populations are involved, or when devices are tested for possible negative physical effects. Use of deception is another circumstance where the panel might conclude that research using an ‘Excused’ method would warrant a higher level of review. Deception is occasionally used in human-computer interaction research. For instance, in order to develop a user interface for a web browser that will adequately warn a user if they are about to use a Web site that has been phished, it may be necessary to deceive users into believing they are viewing a legitimate web site when they are not. That said, we believe studies using deception should be approved under an Expedited review process rather than Excused. This panel is particularly encouraged to begin developing guidelines for research using public text and other data gathered on the Internet. IRB regulations have not kept up with the vast increase in research using this kind of public data, and ethical standards vary enormously between and even within institution. The issues in this area are numerous and complex, going well beyond the current ANPRM, and warrant a more concerted effort involving a broad representation of researchers and stakeholders. Question 19: This question asks if there should be a brief waiting period, such as one week, before a researcher may commence research after submitting the one-page registration form, to allow institutions to look at the forms and determine if some studies should not be Excused. We suggest that this be an option that is made available to institutions as an option should it suit their needs. It is useful to give the institutions flexibility, but within some short limit, e.g. 1 week. Without that constraint, they may feel the need to establish an arbitrarily long waiting period out of an overabundance of caution. The rules should make clear that this is not the intent. Question 22: We believe that a retrospective audit mechanism can effectively protect participants. A properly designed and implemented procedure is unlikely to result in a greater burden for either the researcher or the institution. Question 29: This question asks: “… IRBs sometimes engage in activities beyond those that are required by the regulations. For example, an IRB might review some studies for the purpose of determining whether or not they qualify for exemption (the new Excused category), or might review studies involving the analysis of data that is publicly available. Would it be helpful, in furtherance of increased transparency, to require that each time an IRB takes such an action, it must specifically identify that activity as one that is not required by the regulations?” We support requiring IRBs to report, in a public forum, each time it takes an action outside of those required by the regulations, in order to reduce occurrences of this to only those cases where there is a strong reason to depart from the regulations. 4 Expedited Review Question 7: This question asks which research activities should be added to the published list of activities that can be used in a study that qualifies for expedited review. We suggest that all activities covered under the Excused categories should be added here. Informed Consent Question 35: The question asks What factors contribute to the excessive length and complexity of informed consent forms, and how might they be addressed? We suggest that at least two factors contribute to the complexity and length of informed consent forms. First, institutional caution leads them to insert language that attempts to protect against even very low probability, low risk issues. Second, it's easier to get approval for a protocol from an IRB if it looks like one they previously approved, so investigators have an incentive to make as few changes as possible once they have an approved form. They add sections to address new issues, without removing outdated sections. This leads to more complex, less readable forms that are easier to get through IRB review. It might help to provide specific guidance that the form must balance readability and brevity with appropriate disclosure. Question 37 - The proposed changes appear likely to improve the overall quality of consent forms and we support them. Data Security and Information Protection In general, we support the proposal to strengthen data protections and reduce information risk. We support the idea of separating data security issues from the IRB approval process, as IRB experts are not necessarily data storage experts, nor are they intimately familiar with the evolving potential for recovering individual identities from de-identified data. Providing a consistent standard that is “scaled appropriately to the level of identifiability of the data” could improve protections for participants and reduce redundant review by IRBs. We do note several concerns, though. Question 59: The question asks in part, Are [HIPAA rules] appropriate not just for studies involving health information, but for all types of studies, including social and behavioral research? The use of HIPAA as a model may cause problems for HCI research because two data elements that are treated as personally identifiable information are URLs and IP addresses. It appears that HIPAA does not distinguish between URLs/IPs that could easily identify an individual (e.g. IP address of their computer) versus those that wouldn't (e.g., URL or IP address of a web site). There may be a need for separate guidelines for anonymization of electronically logged data from non-medical research. , We anticipate a need for more specific regulation regarding data sharing between research groups. It seems likely that the rules for data sharing will be harder to write than for data storage and protection. AOL's release of inadequately anonymized search data in 2006 illustrates the challenge of truly deidentifying data for public release. Although it is desirable to share data from HCI research, many studies do not need to do so, and could be inadvertently limited if data sharing standards and data release 5 standards are conflated. For that reason, we encourage HHS to clearly distinguish between data storage/protection and data release in its rulemaking. Signatures Name Title Affiliation 1 Bill Kules Assistant Professor The Catholic University of America, School of Library and Information Science 2 Nathan Bos Senior Research Associate Johns Hopkins University Applied Physics Laboratory 3 Scott Klemmer Associate Professor Stanford University 4 Marti Hearst Professor University of California, Berkeley 5 Ryan Aipperspach Director of Engineering and Design GoodGuide.com 6 Cecilia Aragon Associate Professor University of Washington 7 Martin Schedlbauer Clinical Professor Northeastern University 8 Louise Barkhuus Dr. 9 Juan Pablo Hourcade Assistant Professor University of Iowa 10 Mark W. Newman Assistant Professor University of Michigan 11 Dragomir Radev Professor University of Michigan Dean and Professor School of Information and Library Science, UNC-Chapel Hill 12 Gary Marchionini 6 13 Loren Terveen Professor University of Minnesota 14 Bradley Hemminger Associate Professor University of North Carolina 15 Zachary O. Dugas Toups Dr. TEEX/TCAT Crisis Response Innovative Technologies Lab 16 Thomas A. Finholt Professor and Associate Dean School of Information, University of Michigan 17 David Mendonca Ph.D. 18 Paul Conway Associate Professor University of Michigan 19 Terry Winograd Professor of Computer Science Stanford University 20 Hong Zhang Assistant Professor University of Kentucky 21 James (Bo) Begole Principal Scientist Palo Alto Research Center 22 Brad A. Myers Professor Carnegie Mellon University 23 Serge Egelman 24 Nicholas J. Belkin Professor Rutgers University 25 Doug Bowman Associate Professor Virginia Tech 26 Jeffrey Bigham Assistant Professor University of Rochester 27 Chris North Associate Professor Virginia Tech UC Berkeley 7 28 Susanne Jul President/CEO Amaryllis Consulting, LLC 29 Jacob O. Wobbrock Associate Professor University of Washington 30 Ed H. Chi Staff Research Scientist Google Research 31 Josh Tenenberg Professor University of Washington 32 Bjoern Hartmann Assistant Professor University of California, Berkeley - Computer Science Division 33 Sameer Patil Postdoctoral Research Fellow Indiana University 34 Andrea Kavanaugh Senior Research Scientist Virginia Tech 35 Harry Hochheiser Assistant Professor University of Pittsburgh 36 Mihaela Vorvoreanu Assistant Professor Purdue University 37 Joel Ross PhD Candidate University of California, Irvine 38 Dan Jurafsky Professor Stanford University 39 Clayton Lewis Professor of Computer Science University of Colorado 40 David Wagner Professor University of California, Berkeley 41 Ben Bederson Professor University of Maryland 42 Shumin Zhai 8 43 Ruy Cervantes University of California, Irvine 44 Jennifer Golbeck University of Maryland, Human-Computer Interaction Lab 45 Aditi Shrikumar Ph.D. Candidate University of California, Berkeley 46 Eelke Folmer Assistant Professor University of Nevada, Reno 47 Derek Hansen Assistant Professor Brigham Young University 48 Jon Froehlich Graduate Student University of Washington 49 Scott Robertson Associate Professor of Information and Computer Sciences University of Hawaii at Manoa 50 Clifford Nass Professor Stanford University 51 James D. Hollan Professor UCSD 52 Frank Ritter Prof. Penn State 53 Athena Hoeppner Electronic Resources Librarian University of Central Florida 54 Amy Bayes Human Systems Engineer/Training Systems Johns Hopkins University Applied Physics Laboratory 55 Janet Deery Usability Engineer Johns Hopkins University Applied Physics Laboratory 56 Elle He 57 Razvan Orendovici Research Assistant PSU 9 58 James Hays Assistant Professor Brown University 59 Mandy Natter Senior Professional Staff Johns Hopkins University Applied Physics Laboratory 60 S. Shyam Sundar Distinguished Professor Penn State University 61 Christine Robson Researcher IBM Research - Almaden 62 Al Liikkanen Stanford University 63 Helena Mentis Microsoft Research 64 Catherine Dumas PhD student SUNY Albany 65 James Lin Software engineer Google 66 Aaron Houssian 67 Janet Davis Assistant Professor of Computer Science Grinnell College 68 Paul Dourish Professor University of California, Irvine 69 William Fitzpatrick Senior Human Factors Scientist JHU/APL 70 Greg Boone MA Student Georgetown University 71 Celine Latulipe Assistant Professor UNC Charlotte 72 Wendy Kellogg Philips Research 10 73 Rebecca Fiebrink Assistant Professor Princeton University 74 Gregory Norcie Doctoral Student Indiana University 75 Steve Howard Professor The University of Melbourne 76 Jofish Kaye Senior Research Scientist Nokia Research Center, Palo Alto 77 Andy Dearden Professor of Interactive Systems Design Sheffield Hallam University, UK 78 Christopher Hoadley Assocate Professor and Program Director New York University 79 Matthew Bietz Project Scientist University of California Irvine 80 Matthew Bietz Assistant Project Scientist University of California Irvine 81 Yong Ming Kow Postdoctoral Researcher UC Humanities Research Institute 82 James Landay Professor CSE, University of Washington 83 Alan Wexelblat 84 Shaun Kane Assistant Professor University of Maryland Baltimore County 85 Bree McEwan Assistant Professor Western Illinois University 86 Lorrie Faith Cranor Associate Professor Carnegie Mellon University 87 Heather Leary Dr. University of Colorado-Boulder 11 88 A.J. Brush Senior Researcher Microsoft Research 89 Ed H. Chi Staff Research Scientist Google Research 90 Jeff Huang PhD student University of Washington 91 Michael Zarro Ph.D. Student Drexel University 92 Julie Kientz Assistant Professor University of Washington 93 Michael J Cole 94 Michael Bernstein Graduate Student MIT 95 Andrea Forte Assistant Professor Drexel University 96 Francisco Servant PhD Student University of California, Irvine 97 Edward Alan Fox Professor Virginia Tech 98 Nicholas F. Polys Director of Visual Computing Virginia Tech 99 Terry Winograd Professor of Computer Science Stanford University 100 Micah Lande Assistant Professor Arizona State University 101 Andreas Paepcke Senior Research Scientist Stanford University 102 Sara Kiesler Hillman Professor of Computer Science and Human Computer Interaction Carnegie Mellon University Rutgers University 12 103 Steven Dow Assistant Professor Carnegie Mellon 104 Justine Cassell Director, HCII CMU 105 Mark D Gross Professor Carnegie Mellon 106 Robert Capra Assistant Professor University of North Carolina at Chapel Hill 107 Daniel Horn Ph.D. 108 Maneesh Agrawala Associate Professor UC Berkeley 109 Dominik Kaeser Technical Director Berkeley Alumnus, Pixar Animation Studios 110 Peter Brusilovsky Professor University of Pittsburgh 111 Peggy Chi 112 Nicholas Kong 113 Kimiko Ryokai Assistant Professor University of California, Berkeley 114 Manas Mittal 115 Andy Carle PhD Candidate University of California, Berkeley 116 Celeste Roschuni Doctoral Candidate University of California at Berkeley 117 Gopinaath Kannabiran UC Berkeley 13 118 William Ryan 119 Elizabeth Buie Assistant Professor Ithaca College 120 Wesley Willett Ph.D. Candidate University of California, Berkeley - Computer Science Division 121 Joseph L Gabbard Assistant Reseach Professor Virginia Tech 122 Michael Christel Research Professor Carnegie Mellon University 123 Elizabeth Thiry PhD Candidate Pennsylvania State University 124 Mudit Mittal 125 Samantha Merritt 126 Melissa Rodriguez 127 Rachel K. E. Bellamy 128 Karl Fast 129 Tarun Gangwani 130 Bonnie E. John Professor Carnegie Mellon University 131 Reid Priedhorsky Postdoc Los Alamos National Laboratory 132 Alice Agogino Professor University of California at Berkeley Indiana University Graduate Student Indiana University Assistant Professor Kent State University Indiana University 14 133 Justin Donaldson Dr. Informatics 134 Laura Devendorf PhD Student UC Berkeley iSchool 135 Leif Berg Research Assistant 136 Tapan Parikh Assistant Professor UC Berkeley 137 Susan Dray President/CEO Dray & Associates, Inc. 138 Scott Hudson Professor Carnegie Mellon University 139 Ryan Allen Kirk HCI Researcher Iowa State University 140 Haakon Faste Visiting Assistant Professor 141 Karen Lin 142 Jason Hong 143 Ken Koedinger 144 Associate Professor Carnegie Mellon University Matthew Kam Assistant Professor Carnegie Mellon University 145 Noboru Matsuda Systems Scientist Carnegie Mellon University 146 Daniel P. Siewiorek University Professor Carnegie Mellon University 147 Kathleen Surfus 15 148 William E. Marsh Ph.D. Candidate Iowa State University 149 Roni Rosenfeld Professor Carnegie Mellon University 150 Jodi Forlizzi 151 Chung-Ching Huang 152 Sanjay Kairam Graduate Student Stanford University 153 James Herbsleb Professor Carnegie Mellon University 154 Robert Kraut Herbert A. Simon Professor of HumanComputer Interaction Carnegie Mellon University 155 Valkyrie Savage PhD Student UC Berkeley 156 Eric Paulos Associate Professor Carnegie Mellon University 157 Pablo Paredes PhD Student UC Berkeley 158 Kurtis Heimerl 159 Mike Kuniavsky CEO ThingM Corp 160 Stefan P. Carmien Staff Scientist ACM SIGCHI, RESNA 161 Ian Roberts Interaction Designer 162 Oriana Love Researcher UC Berkeley 16 163 Eric Bell NLP Scientist 164 Jean Scholtz Chief Scientist, HCI researcher 165 Russ Burtner Senior User Experience Research Scientist 166 Michael Madison Web Application Designer 167 Jennifer A. Rode 17