ࡱ> e ;bjbjJJ n(_b(_bn3%  $PJ>dE<(B)B)B) EEEEEEE$GJ2EB) ) )"B)B)2E@ GE,,,B)8 E,B) E,,6@@C iÍ)^AD]E0EB< K.*H K8@C K@CB)B),B)B)B)B)B)2E2Ev+*B)B)B)EB)B)B)B) KB)B)B)B)B)B)B)B)B) B L: Instructions: 1) The purpose of this template is to assist investigators and other research personnel in creating informed consent documents and to facilitate consistency and accuracy of informed consent language between human subject research protocols. 2) This template is intended to be a guide. However, all investigators must follow this format, order, and language where provided in each consent document. All of the elements required by Federal and Institutional statute are included. 3) Required fill-ins and instructions are italicized; bold headings and plain text indicate required language. Please delete all italicized or non-relevant text prior to submission. Please remember to proof read. 4) What is included here is a consent document, designed for adults. 5) For children (under 18), assent needs to be obtained as well as parental permission from the parent(s) or guardian(s). 6) Please note: If you are using Video or Audio Recordings of subjects in your research, you must clearly state each of the following in your Informed Consent Document: Who will have access to the recordings? Where the recordings will be stored? What will happen to the recordings after the project has terminated? How will the recordings be used in data analysis? If your document does not address all these items, the IRB will return the forms for revisions. 7) Please refer to the Guidelines for Informed Consent Forms for additional guidance. 8) This document should be submitted as a Word document. Upon approval the form will be stamped and converted into a pdf. ADDITIONAL COVID-19 INSTRUCTIONS: 1) This template includes additional verbiage that may be helpful to your study during COVID-19. 2) Recommendations regarding audio and video recording recorded via electronic web conferencing systems (e.g. Zoom, Microsoft Teams, etc.) or a separate recording device (e.g. audio recorder) will depend on the study. 3) Please be sure that the activities noted in the informed consent form are congruent with your protocol application (e.g. audio/video recording and recording methods, if applicable). University of Texas at El Paso (UTEP) Institutional Review Board Informed Consent Form for Research Involving Human Subjects  Protocol Title: Principal Investigator: UTEP [enter department]:  In this consent form, you always means the study subject. If you are a legally authorized representative, please remember that you refers to the study subject. Introduction You are being asked to take part voluntarily in the research project described below. You are encouraged to take your time in making your decision. It is important that you read the information that describes the study. Please ask the study researcher or the study staff to explain any words or information that you do not clearly understand. Why is this study being done? Insert simple explanation or purpose of study. Approximately, enter number of study subjects, will be enrolling in this study at UTEP (or other if not on campus). If this is a multicenter trial, enter the total number of people enrolled at the total number of sites. You are being asked to be in the study because enter the reason a subject qualifies for the study. List exclusion criteria, if applicable. If you decide to enroll in this study, your involvement will last about enter the length of the study (in days or weeks) for a single subject. List frequency, scheduling, and time commitment of each visit and/or research task. What is involved in the study? If you agree to take part in this study, the research team will: Describe ALL procedures, and any review of records, interviews, questionnaires, etc. that will take place. Where and when will the research activities occur? Audio/video recording should be addressed, if applicable. You will: Describe ALL research procedures. COVID-19 If transitioning to phone, video, or web conferencing AND you will be audio and/or video recording, please include the following statement, if applicable: Protocol ---- This study involves remote and/or virtual research interactions with participants by the research staff. Research activities will be audio AND/OR video recorded via web conferencing systems AND/OR by an independent device (e.g. audio recorder). Therefore, privacy and confidentiality is not guaranteed due to the nature of the research environment and the electronic conferencing platforms that will be used. Please note: Researchers should be mindful of the population and sensitivity of the data being collected (it is recommended that questions about criminal activity, civil liability, and/or any questions that could be damaging to their financial standing, employability, insurability, and reputation not be audio and/or video recorded or collected through electronic conferencing systems.) Informed Consent Form --- Please note that your participation in this study involves remote and/or virtual research interactions with our research staff. You will be audio AND/OR video recorded by the web conferencing system AND/OR a device that is separate from the online conferencing system. Therefore, privacy and confidentiality is not guaranteed due to the nature of the research environment. REMINDER: Please be sure that the verbiage in the informed consent form is congruent with the activities as listed in your protocol application. What are the risks and discomforts of the study? For minimal risk studies: The risks associated with this research are no greater than those involved in daily activities. There are no known or anticipated risks or discomforts associated with participation. (Alternatively, describe any known physical and nonphysical risks and/or discomforts.) The following risks or discomforts may occur as a result of your childs participation: If applicable, state: The study may include risks that are unknown at this time. The researcher may decide to stop your childs participation without your permission, if he or she thinks that being in the study may cause them harm, AND list other reasons that the study may be stopped. COVID-19 If transitioning to phone interviews and/or, phone, video, or web conferencing, please include the following statement: Due to the use of online conferencing systems, your privacy and confidentiality is not guaranteed. COVID-19 If transitioning to electronic survey software, such as UTEP licensed QuestionPro and Qualtrics and your study is NOT anonymous, please include the following: Your privacy and confidentiality is not guaranteed due to the nature of the research environment. What will happen if I am injured in this study? Required for greater than minimal risk The University of Texas at El Paso and its affiliates do not offer to pay for or cover the cost of medical treatment for research related illness or injury. No funds have been set aside to pay or reimburse you in the event of such injury or illness. You will not give up any of your legal rights by signing this consent form. You should report any such injury to (put the principal investigator's name and phone number here) and to the UTEP Institutional Review Board (IRB) at (915-747-6590) or irb.orsp@utep.edu. Are there benefits to taking part in this study? You are not likely to benefit by taking part in this study. (Add any educational or informational benefits as desired, such as: This research may help us to understand and enter a very brief description). Note, financial or grade compensation (extra credit) should not be referred to in this section-refer to remuneration section. Who is paying for this study? Optional-If not funded omit item. Internal Funding: Funding for this study is provided by UTEP Department of state the name of the department or UTEP grant. External funding: UTEP and list the names of the investigators are receiving funding from list the name of the sponsor or organization to conduct this study. What are my costs? There are no direct costs. Or If you choose to participate in this study, you will be responsible for insert. Will I be paid to participate in this study? If payment: You will be compensated for your participation in the form of insert dollar amount, gift certificate, savings bond, etc. If applicable, describe payment schedule consider using a table or graph format. If no payment: You will not be compensated for taking part in this research study. What other options are there? You have the option not to take part in this study. There will be no penalties involved if you choose not to take part in this study. What if I want to withdraw, or am asked to withdraw from this study? Taking part in this study is voluntary. You have the right to choose not to take part in this study. If you do not take part in the study, there will be no penalty or loss of benefit. If you choose to take part, you have the right to skip any questions or stop at any time. However, we encourage you to talk to a member of the research group so that they know why you are leaving the study. If there are any new findings during the study that may affect whether you want to continue to take part, you will be told about them. The researcher may decide to stop your participation without your permission, if he or she thinks that being in the study may cause you harm, AND list other reasons that the study may be stopped. Who do I call if I have questions or problems? You may ask any questions you have now. If you have questions later, you may call insert study contact(s) at insert office phone number and email address. If you have questions or concerns about your participation as a research subject, please contact the UTEP Institutional Review Board (IRB) at (915-747-6590) or irb.orsp@utep.edu. What about confidentiality? [Describe the way confidentiality of records identifying the subject will be maintained. Use words to the following effect, if appropriate:] Your part in this study is confidential. The following procedures will be followed to keep their personal information confidential [Describe the way] The results of this research study may be presented at meetings or in publications; however, your name will not be disclosed in those presentations. [Or, if the study involves information that legally must be reported to government agencies, then include the following:] Every effort will be made to keep your information confidential. Your personal information may be disclosed if required by law. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include, but are not necessarily limited to: The sponsor or agent for the sponsor, if applicable Office of Human Research Protections UTEP Institutional Review Board Because of the need to release information to these parties, absolute confidentiality cannot be guaranteed. All records will be [Describe how they are to be maintained]. Information regarding audio/visual recording records needs to be added, if applicable. Mandatory reporting If there is a reasonable chance that information may be elicited concerning child abuse or neglect, or potentially dangerous future behavior to others as part of the research protocol, the following disclosure must be made: If information is revealed about child abuse or neglect, or potentially dangerous future behavior to others, the law requires that this information be reported to the proper authorities. Authorization Statement I have read each page of this paper about the study (or it was read to me). I will be given a copy of the form to keep. I know I can stop being in this study without penalty. I know that being in this study is voluntary and I choose to be in this study. ______________________________________________ Participants Name (printed) ______________________________________________ ______________ Participants Signature Date ______________________________________________ ______________ Signature of Person Obtaining Consent Date COVID-19 If transitioning to electronic survey software, such as UTEP licensed QuestionPro and Qualtrics, please revise your existing authorization statement to the following. Authorization Statement I have read each page of this paper about the study. I know that being in this study is voluntary and I choose to be in this study. I will get a copy of this consent form now for me to keep. Please feel free to print a copy for your records.  FORMCHECKBOX  Yes, I agree to participate in this research project. I have read the following informed consent form and I understand what the research entails and understand that I will be audio and/or video recorded.  FORMCHECKBOX  No, I do not agree to participate in this research project. PIs wishing to store specimens for future study-related use, use A/V recordings in the future for education purposes, etc. can add additional verbiage here with another line to consent to such activities. Please be sure to delete all of the instructional language, including the instructional page, from the document prior to uploading the form for review.     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