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<h1>INFORMED CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT</h1>
<h3><b>TITLE:</b> Examining User Experience in Data Analytic Operations</h3>
<h3><b>PRINCIPAL
<br>INVESTIGATOR:</b> Joshua C. Poore, Ph.D.; Draper Laboratory, Cambridge, MA.</h3>
<h3>AFFILIATED SITE
<br>LEAD RESEARCHER:</h3>
<p>In accordance with 45 C.F.R., Section 46.116, relating to the Protection of Human Subjects in
Research, you must provide your informed consent prior to taking part in any of the procedures described below. We ask that you carefully consider the information about this research provided below before giving your informed consent for participation. This consent form contains technical terms. Please ask the research staff to explain any words or information that you do not clearly understand.
<p><b>INVITATION TO PARTICIPATE</b>
<br>You are being asked to participate in a laboratory study investigating how you make sense of data and utilize user-interfaces, analytic tools, and visualizations as part of your analytic workflow. As part of this study you may be asked to engage with a variety of tasks, such as playing “table-top” games, pencil-and-paper tests, questionnaires and cognitive tests, as well as interactive tasks on a computer. You may be asked to engage in these experiences while you are monitored with physiological measurement equipment. The research team is conducting this study to determine whether certain types of analytic tools might change how people solve analytic problems and perform cognitive activities. This study is funded by the Defense Advanced Research Projects Agency.
<p><b>DESCRIPTION OF PROJECT</b>
<br>You have been asked to take part in this study because: 1) you have indicated that you have some formal training or experience in interpretation of data, hypothesis testing, or construction of reasoned argument such that you can complete of laboratory task and/or provide thoughtful considertation of questions regarding data analysis; 2) you have indicated that you are not currently taking any medication or substance that would interfere with physiological monitoring (only required for laboratory experiments, not online experiments). Individuals younger than 18 years of age, non-US citizens, incarcerated (i.e., prisoners) individuals, or members of another legally protected population (i.e., intellectually handicapped, children, etc.) are not eligible for participation. Pregnant women are eligible for participation and are therefore not counted in our definition of “protected populations”—pregnancy does not impair a woman's ability to provide legally effective informed consent and we do not anticipate that protocol tasks introduce disproportional risks for pregnant women beyond those posed to other eligible participant populations.
<p>In order to decide whether you wish to be a part of this research study you should know enough about its risks and benefits to make an informed judgment. This consent form gives you detailed information about the research study, which a member of the research team will discuss with you. This discussion should go over all aspects of this research: its purpose, the procedures that will be performed, and any risks of the procedures, possible benefits, and possible alternatives. Once you have reviewed the terms outlined in this form, and had all of your questions answered to your satisfaction, you will be asked to provide your consent to participate in this research. Your consent indicates that you understand the procedures, risks, benefits, and compensation associated with participation in this study, as well as your rights as a research participant.
<p>This form will first be presented to you in electronic form, preceding your Online Intake Questionnaire. After reading this version, and having all your questions answered to your satisfaction, you will be asked to indicate your assent to and comprehension of the procedures, risks, benefits, and compensation outlined in this form. This assent does not obligate you to participate in any other future component of this study. If you are solicited to participate in a (subsequent) laboratory session, you will be asked to review this document again and provide your signature on a “hard-copy” of this form as proof of your consent. At this time you are free to decline further participation or ask any additional questions you might have before providing your consent and signature. In either case, you are entitled to a copy of this form that is both signed and dated by research staff for your records.
<p><b>DESCRIPTION OF PROCEDURES</b>
<br>Your participation in this study may involve up to 9 hours of your time. However, no single component of this study will require more than 2 consecutive hours. All study components will occur on separate days and times to be negotiated between you and study personnel. If you have been recruited for an online experiment, these components will be distributed to you through an online portal that will direct you to the appropriate procedures. These components and the approximate time to complete each are listed below:
<p>Online Intake Survey: 30-60 minutes
<br>Online or Laboratory Task(s): 90-120 minutes
<br>Follow-Up Tasks I (Online or Laboratory): 90-120 minutes
<br>Follow-Up Tasks II (Online or Laboratory): 90-120 minutes
<br>Follow-Up Tasks III (Online or Laboratory): 90-120 minutes
<p>You will be (have been) notified at the time of your recruitment which procedures we are anticipating you to participate in, and whether your procedures are expected to take place exclusively online or in a laboratory, or some combination thereof. You will have the option to indicate you interest for being solicited for additional study components following your first at the bottom of this form. You may, at any time, indicate that you are NOT interested in further solicitation by submitting a request to study personnel via email or phone.
<p>If you are recruited for a laboratory session (or follow-up laboratory session(s)), it will take place at either be at the Charles Stark Draper Laboratory (Cambridge, MA), or an affiliated research site. You will be notified of your research site at the time of your recruitment. Your research site is also identified on the signature page of this document.
<p><b>Online Intake Survey</b>
<br>You will first be asked to complete questionnaires which gather information about your demographic information, education, personality, and analytic experience. This is estimated to take approximately 30-60 minutes of your time. Prior to completing these measures, you will be asked whether or not you agree and assent to the terms mentioned in this consent form. If you agree with and assent to these terms, you will proceed to the questionnaires, all of which can be answered online via a secure web-survey that is hosted through SurveyMonkey.com, a reputable company that hosts web-based surveys and allows for complete confidentiality through the use of sophisticated data-encryption techniques (all data submitted through SurveyMonkey.com is encrypted through secure socket encryption (SSL)). SurveyMonkey.com's data security and privacy statement will be made available to you upon request.
<p>If you are recruited for an online experiment, the online consent form and online intake survey will be made available to you via a web-based portal that will give you directions as to which tasks (see below) we are asking you to complete and the sequence with which we wish you to complete them. A link to this portal will accompany recruitment materials and will guide you through a brief registration that will provide you with a username and password for repeated access to the portal.
<p>If you are recruited for a laboratory experiment, the online consent form and online intake survey will be distributed to you as a link embedded in an email sent to you via study personnel.
<p>Following the completion of your online survey, you will be given instructions regarding a laboratory session, which constitutes part two of this study.
<p><b>Online Tasks</b>
<br>If you have been recruited for an online experiment, a web-based portal will direct you through a number of tasks that you may complete at your convenience on a computer that meets the minimum operating requirements described on the web-based portal. The tasks that you will be asked to complete may consists of up to 3 kinds tasks. No single session of tasks is expected to last more than 2 hours. First, you will be asked to complete cognitive assessments for pattern recognition, learning acumen, attention and fatigue. Second, you will be asked to engage in an analytic task, in which you will be asked to make sense of complex data/information. This task may be timed. Finally, you will be asked follow-up questionnaires pertaining to your analytic task, including your assessments of the difficulty of the task, how useful the tools you were provided to complete your task, how you arrived at your answers and how you felt while you were completing the task.
<p><b>Laboratory Tasks</b>
<br>If you have been recruited for a laboratory experiment, when you arrive at the laboratory, you will be given another opportunity to review a “hard-copy” of this form, which you will be asked to physically sign for our records and yours. At this time the procedures of this session will be explained to you verbally and you will have the opportunity to have any and all of your questions about your participation answered by research staff. At this time you will also be briefed about emergency exit procedures for the laboratory should there be an unexpected emergency.
<p>The Laboratory Session will take place at the Draper Laboratory or a satellite research laboratory and may consists of up to 3 kinds of tasks. No single session of tasks is expected to last more than 2 hours. First, you will be asked to complete cognitive assessments for pattern recognition, learning acumen, attention and fatigue. Second, you will be asked to engage in an analytic task, in which you will be asked to make sense of complex data/information. This task may be timed and may be presented to you in either paper-and-pencil or computerized format. Finally, you will be asked follow-up questionnaires pertaining to your analytic task, including your assessments of the difficulty of the task, how useful the tools you were provided to complete your task, how you arrived at your answers and how you felt while you were completing the task.
<p><b>Physiological Monitoring — For Laboratory Experiments Only</b>
<br>While you are completing cognitive batteries (Task 1) and analytic tasks (Task 2) we may wish to collect physiological data from you. To do so we may collect a number of physiological features from a suite of physiological sensors. These include: heart rate, your pulse amplitude, skin conductance, brain activity, as well as eye-movements and pupil dilation. We have selected this suite of physiological sensors because they are minimally invasive and will not interfere with your completion of laboratory tasks. Before measurements can be taken using these techniques, some preparation of the skin is necessary. In some cases, this may include cleaning the skin with alcohol pads and application of water-based gels that will improve the quality of signals detected by the electrodes. A member of the research team will help secure the electrodes in place, and both male and female research staff will be available to assist this preparation for male and female research participants, respectively.
<p>All of these physiological monitoring techniques are deemed safe for all participants by the American Psychological Association, American Medical Association and/or have been approved for use with human research volunteers by the US Department of Health and Human Services. Safety documentation for the sensors will be made available upon request. Furthermore, we have selected specific sensor kinds to reduce the likelihood of your discomfort. Please do not hesitate to ask the researcher describing these procedures to show you the physiological sensors if you have any concerns; they will answer any questions you might have about the kind of data they collect, how they collect data, and how they are applied.
<p>You will be told at the start of your laboratory session whether or not we wish to monitor your physiology, and if so, which of the physiological features described above we wish to measure.
<p><b>Debriefing</b>
<br>Following your tasks, we will tell you more about the specific aims of the research study as well as answer any and all questions you may have. If you are a laboratory experiment participant, you will receive monetary compensation for your participation.
<p><b>Follow-Up Session(s)</b>
<br>You may be asked if you are interested in participating in a follow-up session at a date after your laboratory session (laboratory experiments only), or given additional task-sets to complete via the web-based portal (online experiments only). These tasks will be identical to those you complete in your first session, with respect to procedures and time necessary to complete them (up to 2 hours). However, these sessions or task-sets may involve different analytic tasks and/or analytic tools that were not previously available for testing or were not permitted by time in your original laboratory session. You will NOT be solicited for follow-up sessions without you express permission to do so (see end of Informed Consent Form).
<p><b>CONFIDENTIALITY</b>
<br>Your privacy and the confidentiality of your data will be protected. Your research records and recordings will be kept as confidential as possible. At no time, will you be photographed, nor will your identity be shared as part of the study. However, if you are a laboratory experiment participant, your likeness may be incidentally captured by research facility security cameras. No study personnel will have access to security footage and in no way will that footage be tied to the information you provide through participation in this study. Only a code number will identify your research records. The code number will not be based on any information that could be used to identify you (for example, social security number, initials, birth date, etc.). The master list linking names to code numbers will be kept separately from the research data in a locked file at the site at which participated. This list will only be accessible the Principal Investigator (Draper), engaged investigators responsible for data collection at an affiliated research site, and regulatory bodies that oversee the compliance of this study with human-subjects research procedures for the sole purpose of protecting human-subjects (i.e., New England Institutional Review Board; Department of Defense (study sponsor)). All data on computers are password protected and limited to authorized research personnel, and contain no identifiers. Only your code number will accompany your data for analytic purposes, whether at the primary research site (Draper Laboratory), or at any other approved research sites—your name and/or other identifying information will not be included when data are securely sent to other sites for analysis. Only authorized research staff will have access to the information gathered in this study. All laboratory sites conducting analyses are required to follow the same privacy/confidentiality regulations we described above. Your identity will not be revealed in any reports or publications resulting from this study for any reason without your express, written consent for your identity to be released. We will retain your contact information should we wish to contact you for your written consent in the future, or should you wish to participate in additional study procedures (i.e., Part 2).Please note that by law we are required to disclose certain information about you without your consent that would identify you as a participant in the research project. Specifically, we are mandated to report information about child abuse, elderly abuse, intent to hurt yourself, or intent to hurt others.
<p>After the study is completed, the study data may be placed in a secure central storage location. The data will not include your name or other information that could identify you. The purpose is to make study data available to other researchers who must request permission to use it. Although the results of your research information will not be sold, the information obtained from the research may lead to the development of commercial products in the future. You will not receive any money from the use of your research information.
<p><b>RISKS AND INCONVENIENCES</b>
<br><i>Risks.</i> This study is associated with minimal risks. However, if the consent form is not read carefully, there could be a risk of not understanding fully the nature of the research being conducted, your responsibilities, and the safeguards to protect your confidentiality. Additionally, while most individuals tolerate all of the planned tasks, some may find them tedious and some individuals find it distressing or inconvenient to be monitored with physiological sensors. No procedures or materials (i.e., sensors/conductive gels/pastes) used in this study are deemed dangerous to any population (incl. pregnant women and fetuses). All gels/pastes used in this study are water-based and hypoallergenic. In very rare cases, participants with sensitive skin may feel some minor discomfort related to skin-preparation protocols, which include preparation with medical alcohol pads.
<p><i>Risk reduction.</i> To minimize any risk of not truly understanding the elements of this study, you will be provided several opportunities in which the purpose and procedures of the study will be presented, and you will be able to ask any questions and have those questions answered. Additionally, if at any time you feel uncomfortable with any study procedures you may discontinue your participation without penalty (you may be eligible to receive prorated payment or course credit). In addition, you can request to meet with our clinical psychologist on staff to discuss any stress or emotional distress you may experience related to your participation today.
<p>You will NOT be held responsible for any damages or mechanical failures that may occur to the equipment during the course of testing within the Draper Laboratory, nor will this affect your compensation.
<p><b>BENEFITS</b>
<br>There is no direct benefit to you for participation in the study.
<p><b>ECONOMIC CONSIDERATIONS</b>
<br>Participants recruited for laboratory experiments are eligible to receive monetary compensation. Participants recruited for online only experiments are not eligible to receive monetary compensation. Student populations that are recruited for laboratory experiments at university/college sites may be eligible to receive either monetary compensation or course credit as per their institutions' guidelines. US government personnel that volunteer to participate as government employees (not private citizens) may not be eligible to receive compensation for their participation.
<p>The total compensation possible for laboratory experiments is $135, which accounts for full participation in the online intake questionnaire, the laboratory session and all possible follow-up sessions. Completion of a given study component will result in maximum compensation possible for that component at the rate of $15/hour; this will be based on the maximum time estimate for that component (see above). Partial completion of a given study component will result in pro-rated payment for time spent in participation at the same rate of $15/hour. For example, completion of the Online Intake Questionnaire and the first Laboratory Session results in the payment of $45, full completion of the Online Intake Questionnaire and partial completion of Laboratory Tasks may result in a payment of $30. Payment for partial completion of the Online Intake Questionnaire participation will be mailed directly to participants in the form of checks with a cash value of $15. Payment for laboratory session (or follow-up session) participation will be given to participants, in person, directly following their session.
<p><b>ALTERNATIVES</b>
<br>Participation in the study is VOLUNTARY. The alternative to participating in this study is NOT participating in this study. If you decide to participate in this study, you may withdraw from the study at ANY time. You may choose not to participate at ANY time.
<p><b>IN CASE OF INJURY</b>
<br>Compensation may or may not be payable in the event of physical injury arising from this study under applicable federal law. If you have any questions about your rights as a participant, you may contact the Principal Investigator, Dr. Joshua C. Poore, at 617-258-4023, software-evaluation@draper.com.
<p><b>VOLUNTARY PARTICIPATION AND WITHDRAWAL</b>
<br>Your participation in this study is voluntary. You can refuse to participate in, or withdraw from this study at any time without penalty or loss of benefits to which you are otherwise entitled. If you decide to withdraw from the study, you can also request that all electronic data (including audio and video recordings) collected to that point be destroyed.
<p><b>Study Withdrawal</b>
<br>The principal investigator may end your participation in this study for any of the following reasons:
<br>1. If he feels that it is in your best interest to stop being in the study;
<br>2. If the study is cancelled by the sponsor, the New England Institutional Review Board or by Office of Human Research Protections (OHRP);
<br>3. For administrative reasons.
<p><b>QUESTIONS</b>
<br>We have used some technical terms in this form. Please feel free to ask about anything you don't understand and to consider this research and the consent form carefully - as long as you feel is necessary - before you make a decision. If you have any questions about your rights as a participant, or the study itself, you may contact the Principal Investigator, Dr. Joshua C. Poore, at 617-258-4023, software-evaluation@draper.com (email preferred).
<p><b>VOLUNTEER'S STATEMENT</b>
<br>I have been given a chance to ask questions about this research study. These questions have been answered to my satisfaction. I may contact the Principal Investigator if I have any more questions about taking part in this study. The Principal Investigator or the company he is employed by is being paid by the sponsor for my participation in this study.
<p>I understand that my participation in this research project is voluntary. I know that I may quit the study at any time without harming my future medical care or losing any benefits to which I might be entitled. I also understand that the investigator in charge of this study may decide at any time that I should no longer participate in this study.
<p>If I have any questions about my rights as a research subject in this study I may contact:
<p>New England Institutional Review Board
<br>Telephone: 1-800-232-9570</p>
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<a class="btn btn-lg btn-success btn-block" href="{% url 'op_tasks:register' %}" role="button">
I acknowledge that I have read the procedures described above and my questions have been answered to my satisfaction.
</a>
<br>
<a class="btn btn-lg btn-danger btn-block" href="{% url 'op_tasks:safety' %}" role="button">
I do not wish to participate in this experiment.
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