UNIVERSITY OF MARYLAND, COLLEGE PARK



SAMPLE IRB Application for Multi-dimensional In-depth Long-term Case Studies Also called MILC Studies 4/11/2010 – Catherine PlaisantSample IRB Application (p. 2)Sample recruiting email (p. 5)Consent Form (p. 6)Entry Questionnaire (p. 9)Exit Questionnaire and consent form (for publication permissions) (p. 11)NOTES:This sample application is from 2010. Rules may have changed in your jurisdiction so please adapt the sample application and consent form as neededAssociated scientific paper:Shneiderman, B., Plaisant, C. Strategies for Evaluating Information Visualization Tools: Multi-dimensional In-depth Long-term Case Studies. Proc. BELIV’06 – Beyond Time and Errors: Novel Evaluation Methods for Information Visualization 1-7 Title: Longitudinal Case Study Evaluation of Graphical User Interfaces Principal Investigators XXAbstractGraphical user interfaces have radically changed the way people access data on the personal computers, cell phones or the internet. Information visualization and visual analytics tools now allows users to gain insights, find patterns, identify outliers and make discoveries. In our research we are developing novel prototypes, techniques and interfaces. The reports of usability studies and controlled experiments are helpful to understand the potential and limitations of our tools, but we need other evaluation approaches that take into account the long exploratory nature of users’ tasks. We also need reports of successful adoption and demonstrated utility.We seek to recruit domain expert collaborators (our “study participants”) who will be involved in long-term studies to study how they utilize our prototypes. The study will mostly be qualitative. We seek to demonstrate the utility and effectiveness of our designs by collecting evidence of the use of the prototypes and documenting the value of the tools for users’ own professional work. Our collaborators will first undergo training sessions on how to use a prototype. The prototype will then be given to our collaborators for use in their professional environments. Periodic meetings to discuss the usage, utility, satisfaction (or lack thereof) of the interfaces will be conducted. The meetings may be face-to-face or virtual meetings. In addition, a history of collaborators’ actions using the interface will be automatically logged on their own computers. The logs will be accessed by the investigators only with the permission of the collaborators. The collaborators will fill out an entry questionnaire at the start of the study, and an exit questionnaire at the end to assess their subjective experience with the interface. Each participant in those studies will work with us for several weeks, with 4 to 8 weeks the expected average. Subject Selection During this project, we will recruit adult volunteer professionals (e.g. analysts, journalists, professors, medical researchers, etc.). They will be expert in their domain and have already have some knowledge of work and prototypes. They will be recruited via personal emails, among people who expressed interest about the tools we are developing. No specific characteristics (e.g. gender, age, ethnicity, etc.) are required of the participants. It is important to note that we see our subjects are collaborators who are interested in using advanced interfaces for their professional work. Because of the long-term, time-consuming, and detailed nature of this type of qualitative study, we intend to recruit only between 5 and 10 participants per year.ProceduresOur collaborators will first sign a consent form (attached), and receive training in the use of the user interface of the prototype. Collaborators will be informed of the type of data that is being collected prior to giving consent.Once the investigators feel that collaborators are trained and are competent in using the interface, a copy of the software will be given to the collaborator for him/she to install in their professional environment. Depending on the work environment, the investigators may be able to ask to observe collaborators in their work environments. The investigators and the collaborators will agree on a schedule of regular meetings (e.g., weekly or bi-weekly depending on the participant task and availability) to discuss problems, possible discoveries, or frustrations in using the interface in a real work environment. Each session in the regular meeting are expected to take a maximum of 1 hour each. Each collaborator can choose to spend as much time as they wish with the interface in their work.The regular meetings may be recorded in audio. To facilitate these meetings, collaborators may also be asked to write down their usage experiences in a journal. The goal is to obtain anecdotes of success and of failure when the prototype is put to use in a real environment.While in use, the interface will automatically log the usage (e.g. submitted queries, browsing strategies used) of a collaborator on the collaborator’s computer. Note that no personal or identifiable information will be collected in the log, only the actions performed within the interface are logged. The results of the logging are stored in the collaborators computer, and the investigators are only to access the log with the collaborator’s permission. The location of the log is made known to the collaborators, so they can delete or edit the log anytime they wish. During any part of the study, the collaborators are encouraged to ask questions about the interface or the study. The collaborators may choose to stop and terminate the study at any time.There will be no monetary compensation. The Informed Consent Form is attached.Risks and BenefitsThere are no risks involved in using the prototype. The study asks collaborators to use their own personal computer running our novel interfaces. While using the interface in their work environment, the collaborators are not forced to use the interface for a minimum amount of time. If the collaborator decides not to use the tool, we will interview them to ask them why (i.e. was the tool not useful? Not reliable? Too hard to use? Other reasons?) Collaborators will be asked whether their use of the prototype should be reported anonymously or if their participation should be acknowledged nominatively in the investigators’ scientific publications. When appropriate we will discuss possible joint papers reporting the results of our collaborations. No information about the collaborator’s work will be published without the collaborator’s consent. ConfidentialityAll results will be given to our collaborators prior to making them available or published. The collaborators can refuse the publication of certain personal or identifiable information, their narratives, their logs, or any combination of them. We do not collect private information beyond general demographic (gender, age group, professional background.)The logged data from collaborators’ actions using the interface will be stored only in each collaborator’s computer. The location of the log is shown to the collaborators, and they are made aware that they may choose to delete the log at any time. Furthermore, the logs are only to be accessed by the investigators with the corresponding collaborator’s permission.E-mail addresses obtained from volunteering collaborators will be kept during the study in the investigators regular email system.Interviews will be conducted in the setting chosen by the collaborators and they will choose the level of privacy needed to report on their work with the rmation and Consent FormsSubjects will be informed about the purpose of the research. The consent form will be presented and signed before the study starts. All participants will receive a copy of the consent form for their records. The procedures will be explained before the study, and our collaborators will be encouraged to ask questions at any time. At the end of the study an exit questionnaire will be provided, including an additional consent form section with specific questions about how we can report on their work (see Exit questionnaire). A copy of the exit questionnaire and consent form will be provided to the participants.Conflict of InterestNo potential conflict of interest.HIPAA ComplianceN/AResearch Involving PrisonersN/A.PERSONAL EMAIL TEMPLATE (to be sent to potential participants)Dear XXThank you for your interest in our research. To evaluate our work we are conducting multiple longitudinal case studies with participants who use our tools to conduct their own work (i.e. analyzing their own data, at their own pace).During our first meeting we will give you an entry questionnaire to record your plans and expectations. We will also setup a schedule of visits at regular intervals chosen by you, during which we will collect information about your use of the tool and the results of your ongoing analysis. We will let you install our software on your own computer and provide training and assistance during the duration of the study. You will be able to choose to have your name, institution and results mentioned in our papers and presentations (or not). Other current participants include XXX who is working on XXX and YYYYFor more detailed information about the tool please visit our website at cs.umd.edu/hcil/nameoftoolLet us know if you are interestedINFORMED CONSENT FORMStudy TitleLongitudinal Case Study Evaluation of Graphical User InterfacesPurpose of the StudyThis research is being conducted by Catherine Plaisant at the University of Maryland, College Park and her colleagues. We are inviting you to participate in this research study because you have expressed an interest in using a novel user interface system developed by the Human-Computer Interaction. The purpose of this research study is to evaluate the utility of the system and its interface. Name of the system(s) to be used: ProceduresAfter you fill a questionnaire and may participate in a training session you will use the interface in your normal tasks with your own data.? We will have a personal meeting with you (in person or electronically) at the start and end of the study to document your use of the tool, and - if appropriate - additional meetings at regular intervals chosen by you. Your actions on the computer may be logged and saved on your own computer for later data analysis.? Case studies may last 4 – 12 weeks, depending on your use of the system. An optional initial training session may take 1 to 3 hours. Each subsequent meeting will take less than an hour. Otherwise, you are asked to use the interface naturally in your own work environment, to conduct your normal work.. The actual committed time will depend on how much you use the system.Potential Risks andDiscomfortsThere are no risks associated with participation in this study.Potential Benefits The potential benefits are better user interfaces and information visualization techniques. This research is not designed to benefit you personally.? However, you may be acknowledged in our papers and presentations, and your use of the tool may be summarized.? You have the right to refuse being identified by name (name and/or institution) or to have the outcome of your analysis summarized in our papers. ConfidentialityAny potential loss of confidentiality will be minimized by storing notes and data in a locked location and/or on a password protected computer. If we write a report or article about this research study, your identity will be protected to the maximum extent possible unless you explicitly authorized us to do so (see Additional Choices on page 2). Your information may be shared with representatives of the University of Maryland, College Park or governmental authorities if you or someone else is in danger or if we are required to do so by law.Medical TreatmentThe University of Maryland does not provide any medical, hospitalization or other insurance for participants in this research study, nor will the University of Maryland provide any medical treatment or compensation for any injury sustained as a result of participation in this research study, except as required by law.Right to Withdraw and QuestionsYour participation in this research is completely voluntary. You may choose not to take part at all. If you decide to participate in this research, you may stop participating at any time. If you decide not to participate in this study or if you stop participating at any time, you will not be penalized or lose any benefits to which you otherwise qualify. If you decide to stop taking part in the study, if you have questions, concerns, or complaints, or if you need to report an injury related to the research, please contact the investigator: Catherine Plaisant, plaisant@cs.umd.edu., 2117C Hornbake South, University of Maryland, MD 20742Participant Rights If you have questions about your rights as a research participant or wish to report a research-related injury, please contact: University of Maryland College Park Institutional Review Board Office1204 Marie Mount, College Park, Maryland, 20742 E-mail: irb@umd.edu Telephone: 301-405-0678This research has been reviewed according to the University of Maryland, College Park IRB procedures for research involving human subjects.Statement of ConsentYour signature indicates that you are at least 18 years of age; you have read this consent form or have had it read to you; your questions have been answered to your satisfaction and you voluntarily agree to participate in this research study. You will receive a copy of this signed consent form.If you agree to participate, please answer the questions below and sign your name.You can change your answers at a later date if needed.Additional choicesI understand that if the results of this study are published, I will be asked in advance whether I choose to 1) be identified by name or not in the paper, and 2) see information about my work summarized in the paper or not. (please initial): __ Yes __ NoI give consent to have my name and institution mentioned as a research partner in this study in the researchers presentations about the system being evaluated. I am aware that can withdraw this authorization at any time by sending a written request to the PIs.(please initial): __ Yes __ NoI give consent to be recorded by audio or video during portions of the meetings with the researchers. The recording will be clearly announced before the start of the meeting. (please initial): __ Yes __ NoI give consent for my actions when using the system to be logged for research purposes. I have been told if logging will take place or not, and if it is taking place how to start and stop the logging, how and where the log data is stored, and how to delete it if I wish to):(please initial): __ Yes __ NoI have reviewed the entry and exit questionnaires which will be used at the start and end of the study.(please initial): __ Yes __ NoSignature and DatePARTICIPANT NAME[Please Print]PARTICIPANT SIGNATUREDATELongitudinal Case Study Evaluation of Graphical User InterfacesResearch being conducted by Catherine Plaisant (plaisant@cs.umd.edu) and colleagues at the University of Maryland, College Park ENTRY QUESTIONNAIREName:____________Institution: ____________ Date:____________System(s) to be tested: ___________________________ Summarize in a few words the question you have or the problem you are trying to solve: What data you will analyze (type, size, complexity):What prior analysis you or others have already conducted with that data:Give one or more examples of the type of discovery, finding, insight you HOPE to make during the data analysis.What would you consider to be a successful outcome of this analysis in your own profession work (e.g. a new drug discovered, money saved, a scientific paper submitted, a newspaper article published, a change in work practices, new hypotheses, improve confidence in data quality, better awareness, etc.) - Moderate success:- Significant success:Schedule of interviews and visitWhat is the estimated time duration of the analysis you plan to conduct (e.g. a day, a week; 3 months)What would be an acceptable schedule for one of our researchers to contact you for short interviews (e.g. never, once or twice max, weekly or monthly?) Any preferences regarding the method of communication: (e.g. personal visit, phone, skype, email only?) Other remarksThank you!Let us know if you wish a copy of the filled questionnaireCatherine PlaisantLongitudinal Case Study Evaluation of Graphical User InterfacesResearch being conducted by Catherine Plaisant (plaisant@cs.umd.edu) and colleagues at the University of Maryland, College Park.EXIT QUESTIONNAIREName:____________Institution: ____________ Date:____________Approximate time period of the case study: ______________________________Systems being used: to analyze the data ______________________________________Summarize in a short paragraph how you used the system(s) we provided (describe how there were used in conjunction with other tools if appropriate, and give indications of the amount of effort spent)Summarize the type of discovery made or the finding/insights gained during the data analysis with the system provided (you can remain vague if you want, or provide references to reports or publications)Could those discoveries/findings have taken place without the use of the system(s) provided?[ ] Yes[ ] Yes probably, but it would have been difficult[ ] Yes possibly, but it would have been extremely difficult [ ] Most likely No[ ] Definitively NoComments:Please rate the utility of the system in your data analysis For this particular case study the system was:Not useful at all: 1 2 3 4 5 6 7 Extremely useful In general the system is likely to be: Not useful at all: 1 2 3 4 5 6 7 Extremely usefulWould you be likely to use such a system in the future if it was available?[ ] Yes [ ] May be [ ] NoIf any, what features should be added or modified for you to use it on a regular basis?Can you give examples of other potential uses for analysis in your work?If a discovery was made or significant insight was gainedWhat professional output is likely to be produced (e.g. nothing, a scientific paper submission, a report produced, a presentation to colleagues, a white paper, a new direction of work, etc.)How does this compare to your original expectations before starting with the system. Well below my expectations 1 2 3 4 5 6 7 Well above my expectationsLongitudinal Case Study Evaluation of Graphical User InterfacesResearch being conducted by Catherine Plaisant (plaisant@cs.umd.edu) at the University of Maryland, College Park.CASE STUDY EXIT Questionnaire and Consent Form As researchers we hope to be able to report on your case study in our scientific papers and public presentations. Please specify how you want us to report on your case study:~~~I consent to have my case study described in generic terms that do NOT identify my name, institution or my discoveries and findings.(please initial) ___ Yes ___ NoI consent to have my case study described in scientific papers or presentations, with mention of my name and institution in the credits or in the body of the paper. Researchers will use the name and institution provided at the bottom of the form.(please initial) ___ Yes ___ NoI consent to have a general layman description of my discoveries and findings mentioned in scientific papers or presentations(please initial) ___ Yes ___ NoIf you answered YES to any of the above questions, please answer the following question:I request the right to review the materials before publication or presentation. I will provide consent by email within a week of receiving the materials.(please initial) ___ Yes I want to review the materials ___ No, this is not ments:A copy of this exit questionnaire and consent form should be sent to me: ___ Yes ___NoSIGNATURE _____________________________ DATE ____________Name (PRINT) ____________________________ Institution (PRINT)__________________________ ................
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