ࡱ> Z\Y+ 0)bjbj {LܪDhܪDh Pp p $&&&PvLD&-.&UUU-------$S0 3h-!|U!!--%%%!j-%!-%%V0+H+y""x+ --0-.+Tq3"rq3++\q34,dUW%UUU--9$rUUU-.!!!!q3UUUUUUUUUp X : PROTECTION OF HUMAN SUBJECTS INSTRUCTION FOR COMPLETING THE 91 RESEARCH KEY INFORMATION AND DETAILED CONSENT FORMS Informed consent must begin with a concise and focused presentation of the KEY INFORMATION that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This document identifies the information that should be communicated to potential participants in the Key Information Consent Form and in the Detailed Consent Form. The bold headings should not be changed. Appropriate text is given in standard font. Type your information in the area enclosed in parenthesis with italics font. Omit the parentheticals and italics font when finalizing your consent form for inclusion in your application. You may add additional information as needed. After you complete the form and it has been approved by the IRB, print out the approved form and use it in your study. Do not substitute another form for the one that is approved. Be sure to save a copy of this form to your computer. Upload the form into your application. When you complete your consent form or cover letter, please delete these instructions before uploading file into your IRB application. 91 Consent for Participation in Research KEY INFORMATION FOR (Title of Research) You are being asked to be a participant in a research study about (add a brief description of the study). You have been asked to participate in the research because (explain how subject was identified) and may be eligible to participate. WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THE STUDY? (Briefly describe the purpose of the study and the procedures to be followed in lay terms. ) By doing this study, we hope to learn (complete_________________). Your participation in this research will last about (state in hours, days, months, years). WHAT ARE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? (State the most important reason(s) {i.e. potential benefit(s)} a person may want to volunteer to participate in this study?) For a complete description of benefits, refer to the Detailed Consent. WHAT ARE REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? (State the most important reason(s)/risk(s) why a participant may NOT want to volunteer for this study considering the participants perspective.) For a complete description of risks, refer to the Detailed Consent. (If applicable, discuss alternative treatments/procedures that might be advantageous to the subject.) DO YOU HAVE TO TAKE PART IN THE STUDY? If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any services, benefits, or rights you would normally have if you choose not to volunteer. (Add the following for student volunteers: As a student, if you decide not to take part in this study, your choice will have no effect on your academic status or class grade(s). ) WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? The person in charge of this study is (Principal Investigator, PI) of the 91 Department of (list department). (Add the following if the PI is a student: who is working under the supervision of {Faculty Sponsor}.If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study his/her contact information is: (PI and Faculty Sponsor contact information). If you have any questions, suggestions or concerns about your rights as a volunteer in this research, contact the Office of Research and Sponsored Programs Sharla Miles at 936-294-4875 or e-mail ORSP at sharla_miles@shsu.edu. 91 Consent for Participation in Research DETAILED CONSENT (Title of Research) Informed Consent My name is [PI Full Name], and I am [University Status] of the [Department] at 91. I would like to take this opportunity to invite you to participate in a research study of [Research Focus/Purpose]. I/We hope that data from this research will [results of research]. You have been asked to participate in the research because [why am I being asked?]. If you are collecting data that is protected by FERPA, you are required to include this information: Clarification of the specific records that will be disclosed to the researchers (e.g., student grades) The purpose of the data disclosure (i.e., how the data will be used in the research) The people or organizations that will have access to the student data How it will be stored, and when (and if) it will eventually be destroyed Participation is voluntary The research is relatively straightforward, and we do not expect the research to pose any risk to any of the volunteer participants. If you consent to participate in this research, you will be asked to [what participants will be asked to do in study]. Any data obtained from you will only be used for the purpose of [how data will be used]. Under no circumstances will you or any other participants who participated in this research be identified. In addition, your data will remain confidential. [ONLY include the following language if using a specific survey host for conducting your survey: Your survey responses will be kept confidential to the extent of the technology being used.[SURVEY HOST] collects IP addresses for respondents to surveys they host; however, the ability to connect your survey responses to your IP address has been disabled for this survey. That means that I will not be able to identify your responses. You should, however, keep in mind that answers to specific questions may make you more easily identifiable. The security and privacy policy for [SURVEY HOST] can be viewed at [INSERT SURVEY HOST PRIVACY POLICY URL].] This research will require about [approximate duration of subject participation] of your time. Participants will not be paid or otherwise compensated for their participation in this project. [If audio/video recordinginform participants that they can review recording, & when destruction of recording will occur]. Your participation in this research is voluntary. Your decision whether or not to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If you have any questions, please feel free to ask me using the contact information below. If you are interested, the results of this study will be available at the conclusion of the project. If you have any questions about this research, please feel free to contact me, [PI Full Name], or [Faculty Advisor Name]. If you have questions or concerns about your rights as research participants, please contact Sharla Miles, Office of Research and Sponsored Programs, using her contact information below. *If more than one Co-PI or if there are key research personnel, please include their contact information if they will be involved in the consenting process. [DELETE THIS NOTE BEFORE ATTACHING TO APPLICATION!] PI Full Name 91 Department 91 Huntsville, TX 77341 Phone: (936) 294-XXXX E-mail:Co-PI Full Name/Faculty Sponsor if PI is a student 91 Department 91 Huntsville, TX 77341 Phone: (936) 294-XXXX E-mail:Sharla Miles Office of Research and Sponsored Programs 91 Huntsville, TX 77341 Phone: (936) 294-4875 Email: irb@shsu.edu I understand the above and consent to participate.  I do not wish to participate in the current study. AUDIO/VIDEO RECORDING RELEASE CONSENT [DELETE IF NOT USING RECORDING PROCEDURES] As part of this project, an audio/video recording will be made of you during your participation in this research project for transcription purposes only. This is completely voluntary. In any use of the audio/video recording, your name will not be identified. [Inform participants that they can review recording & when destruction of recording will occur]. You may request to stop the recording at any time or to erase any portion of your recording.  I consent to participate in the audio/video recording activities.  I do not wish to participate in the audio/video recording activities.     A copy of this consent form is available for your records. ;xyz{ 4 5 _ ` G H I n w x - . 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