Sample/template SBS Consent Forms/Scripts Below are templates of consent materials for typical social & behavioral sciences research projects: Oral Consent Script (when IRB has approved waiver of written and signed Informed Consent Form); examples for Student Research and Non-student Research Informed Consent Form, requiring signature of participant – Outline Format to assure that all elements of Informed Consent are Captured Child assent form Parent/legal guardian consent form 1. Sample Oral Consent Script – SBS Student Project [Note that although the verbal consent is being sought, participants should be given a copy of the script that includes the researcher’s and IRB’s contact information.] Instructions are in red; bolded items must be included. Before submission to the IRB: remove instructions and any bold emphasis [Study Title] [PI Name] [Student Investigator Name] Hello. My name is [insert name]. I am a graduate student in the Department/School of [add department or School] at AUB. I would like to invite you to participate in a research study about [describe project in non-technical language; explain purpose of study]. Before we begin, I would like to take a few minutes to explain why I am inviting you to participate and what will be done with the information you provide. You will be asked to [describe procedure, such as “participate in a short interview” or “take several memory tests.” Include types of questions that will be asked; describe alternative procedures, if any] Please stop me at any time if you have questions about the study. I am doing this study as part of my studies at AUB. I will be [add what you will be doing as part of data collection, e.g. interviewing x number of people, asking y number of people to complete the tests, etc.] and will use the information as the basis for my [explain as course research requirement, thesis, dissertation.] I may also use this information in articles that might be published, as well as in academic presentations. Your individual privacy and confidentiality of the information you provide will be maintained in all published and written data analysis resulting from the study. [State any conditions for confidentiality of data here.] [If identities will be disclosed, provide details, e.g. with your permission your identity will be made known in the written materials resulting from this study, or pseudonyms will be used with any quotes attributed to an individual.] [N.B. If you will be sharing the information with other researchers or putting data in archives, etc, explain your plans here.] Your participation should take approximately [insert duration.] Please understand your participation is entirely on a voluntary basis and you have the right to withdraw your consent or discontinue participation at any time without penalty. [If you will be asking any personal or sensitive questions, state as much here.] [State any foreseeable risks to participants here, including steps you will take to minimize these risks. If the risks are minimal, state so.] The benefits which may reasonably be expected to result from this study are [state any potential direct benefits here. If there are no direct benefits, state as such.] You will receive [insert reimbursement or incentive for participation; explain any proration of payment if the subject withdraws for completing study, if any; where there is no payment or compensation, state as such] as payment for your participation. If at any time and for any reason, you would prefer not to answer any questions, please feel free to skip those questions [interview – say ‘skip this question’; paper form, just skip the question]. If at any time you would like to stop participating, please tell me. We can take a break, stop and continue at a late date, or stop altogether. You will not be penalized for deciding to stop participation at any time [if prorating payment, make clear impact of deciding to withdraw from participation.] [If you will be tape recording or videotaping the subject include the following:] I would like to tape record/video tape this interview so as to make sure that I remember accurately all the information you provide. I will keep these tapes in [state where you will keep them] and they will only be used by [state who will have access to the tapes]. [If you will be sharing taped data with other researchers and/or archiving data, state whether identifiers other than voice or face will be included.] [Explain what will happen to the tapes after the research done is completed.] [If participants may participate without being taped, state so.] If you have any questions, you are free to ask them now. If you have questions later, you may contact me at [add your contact information, including name, email address, phone number, etc.]. If you have questions about your rights as a participant in this research, you can contact the following office at AUB: [add contact information for SBS IRB/IRB Office, address, phone number, email.] Are you interested in participating in this study? Consent to Record Interview (Question should be posed before any recording begins) May I record this interview? Consent to Quote from Interview I may wish to quote from this interview either in the presentations or articles resulting from this work. [If a pseudonym will be used, include this statement: A pseudonym will be used in order to protect your identity, unless you specifically request that you be identified by your true name.] Do you all me to quote from this interview? Consent to Use Name There may be reasons for which you prefer that your true name be used in presentations and articles related to this research. Would you like your true name to be used in any oral presentations or written documents resulting from this research? [Note that if a participant agrees to have his or her name used, signed consent should be obtained, including a separate signature line for participation, taping (where applicable), and use of name. In such cases, add signature lines to this consent document. Remember to always give a copy of the Consent Form to the participant. 2. Sample Oral Consent Script – SBS Non-student Project [Note that although the verbal consent is being sought, participants should be given a copy of the script that includes the researcher’s and IRB’s contact information.] Instructions are in red; bolded items must be included. Before submission to the IRB: remove instructions and any bold emphasis [Study Title] [PI Name] Hello. My name is [insert name]. I am a researcher in the Department/School of [add department or School] at AUB. I would like to invite you to participate in a research study about [describe project in non-technical language; explain purpose of study]. Before we begin, I would like to take a few minutes to explain why I am inviting you to participate and what will be done with the information you provide. You will be asked to [describe procedure, such as “participate in a short interview” or “take several memory tests.” Include types of questions that will be asked; describe alternative procedures, if any] Please stop me at any time if you have questions about the study. I am doing this study as part of my research at AUB. I will be [add what you will be doing as part of data collection, e.g. interviewing x number of people, asking y number of people to complete the tests, take surveys, etc.] and this collected information will be used in published research as well as in academic presentations. Your individual privacy and confidentiality of the information you provide will be maintained in all published and written data analysis resulting from the study. [State any conditions for confidentiality of data here.] [If identities will be disclosed, provide details, e.g. with your permission your identity will be made known in the written materials resulting from this study, or pseudonyms will be used with any quotes attributed to an individual.] [N.B. If you will be sharing the information with other researchers or putting data in archives, etc, explain your plans here.] Participation should take approximately [insert duration.] Please understand your participation is entirely on a voluntary basis and you have the right to withdraw your consent or discontinue participation at any time without penalty. [If you will be asking any personal or sensitive questions, state as much here, e.g. some of the interview questions may ask about your personal behaviors; some of the pictures you will be asked to look at may cause some distress, etc.] [State any foreseeable risks to participants here, including steps you will take to minimize these risks. If the risks are minimal, state so.] The benefits which may reasonably be expected to result from this study are [state any potential direct benefits here. If there are no direct benefits, state as such. For example, there are no direct benefits to for participating in this research, but you may be helping others to better understand (fill in generalizable knowledge benefit).] You will receive [insert reimbursement or incentive for participation; explain any proration of payment if the subject withdraws for completing study, if any; if there is no payment or compensation, state as such] as payment for your participation. If at any time and for any reason, you would prefer not to answer any questions, please feel free to skip those questions [interview – say ‘skip this question’; paper form, just skip the question]. If at any time you would like to stop participating, please tell me. We can take a break, stop and continue at a late date, or stop altogether. You will not be penalized for deciding to stop participation at any time [if prorating payment, make clear impact of deciding to withdraw from participation.] [If you will be tape recording or videotaping the subject include the following:] I would like to tape record/video tape this interview so as to make sure that I remember accurately all the information you provide. I will keep these tapes in [state where you will keep them] and they will only be used by [state who will have access to the tapes]. [If you will be sharing taped data with other researchers and/or archiving data, state whether identifiers other than voice or face will be included.] [Explain what will happen to the tapes after the research done is completed.] [If participants may participate without being taped, state so.] If you have any questions, you are free to ask them now. If you have questions, concerns or complaints about this research study later, you may contact me at [add your contact information, including name, email address, phone number, etc.]. Are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about research or your rights as a participant, please contact the AUB Social & Behavioral Sciences Institutional review Board (SBSIRB) at AUB: [add contact information for SBS IRB/IRB Office, address, phone number, email.] Are you interested in participating in this study? Consent to Record Interview (Question should be posed before any recording begins) May I record this interview? Consent to Quote from Interview I may wish to quote from this interview either in the presentations or articles resulting from this work. [If a pseudonym will be used, include this statement: A pseudonym will be used in order to protect your identity, unless you specifically request that you be identified by your true name.] Do you all me to quote from this interview? Consent to Use Name There may be reasons for which you prefer that your true name be used in presentations and articles related to this research. Would you like your true name to be used in any oral presentations or written documents resulting from this research? [Note that if a participant agrees to have his or her name used, signed consent should be obtained, including a separate signature line for participation, taping (where applicable), and use of name. In such cases, add signature lines to this consent document.] Confirmation of Consent to Record Interview (Question will be posed once recording has begun) May I record this interview? 3. SBS SAMPLE CONSENT DOCUMENT – USING OUTLINE FORM AUB [Department/School] [Name of PI and researchers] Consent document We are asking you to participate in a research study. Please read the information below and feel free to ask any questions that you may have. A. Project Description 1. In this study, you will [describe tasks/procedures that the subject will be engaging in. If you will be asking any personal or sensitive questions, state as much here.] 2. The estimated time to complete this study is approximately [add expected time]. 3. The research is being conducted with the goal of publication in [e.g. academic journal, book,] and possibly presentation at academic conferences. 4. [Include any other additional information about the project and data collection here. For example, if you will be sharing the information with other researchers or putting data in public archives.] 5. [If subjects will be compensated, state the amount and terms of compensation. If payments will be prorated if a subject withdraws from the study, state the terms.] B. Risks and Benefits Your participation in this study does not involve any physical risk or emotional risk to you beyond the risks of daily life. [If risks are greater than minimal, please state those risks here.] You have the right to withdraw your consent or discontinue participation at any time for any reason. Your decision to withdraw will not involve any penalty or loss of benefits to which you are entitled. Discontinuing participation in no way affects your relationship with AUB. The benefits of this study include [state any potential direct benefits to subjects here.] [If no direct benefits so state: You receive no direct benefits from participating in this research; however your participation does help researchers better understand (fill in benefit to generalizable knowledge in field)] C. Confidentiality [State conditions for confidentiality of data here. For example, ‘Your name or other identifiers will not be attached to your answers so that your confidentiality can be maintained. Your privacy will be ensured in that all data resulting from this study will be analyzed, written, and published in aggregate form.’] Example: To secure the confidentiality of your responses, your name and other identifying information will never be attached to your answers. All codes and data are kept in a locked drawer in a locker room or in a password protected computer that is kept secure. Data access is limited to the Principal Investigator and researchers working directly on this project. All data will be destroyed responsibly after the required retention period (usually three years.) Your privacy will be maintained in all published and written data resulting from this study. Your name or other identifying information will not be used in our reports or published papers. D. Contact Information 1) If you have any questions or concerns about the research you may contact [list researcher’s contact information, including name, mailing address, telephone number, and email address]. 2) If you have any questions, concerns or complains about your rights as a participant in this research, you can contact the following office at AUB: Social & Behavioral Sciences Institutional Review Board [add address, telephone, email for administrative contact] E. Participant rights Participation in this study is voluntary. You are free to leave the study at any time without penalty. Your decision not to participate is no way influences your relationship with AUB. Do you have any questions about the above information? Do you wish to participate in this study? [If written consent is required, please add a line below for the subject to sign and date.] Example: I have read and understand the above information. I agree to participate in the research study. Participant: ____________________________ Date: _____________________ 4. SBS Child Assent Form Template AUB Social & Behavioral Sciences Assent to Participate in Research Study Title: Researcher: Sponsor: [if any] You are being asked to be in a research study. Studies are done to find better ways to treat people or to better understand how kids think about things or how kids and adults may behave at different times. This form will tell you about the study to help you decide whether or not you want to participate. You should ask any questions you have before making up your mind. You can think about it and discuss it with your family or friends before you decide. It is okay to say “No” if you don’t want to be in the study. If you say “Yes” you can change your mind and quit being in the study at any time without getting in trouble. If you decide you want to be in the study, an adult (usually a parent) will also need to give permission for you to be in the study. 1. What is this study about? 2. What will I need to do if I am in this study? 3. How long will I be in the study? [Insert expected duration of test, survey, interview, etc. If there is a follow up portion of the study, make it clear there are several sessions involved in this study.] 4. Can I stop being in the study? You may stop being in the study at any time. [If there are limitations, such as you may discontinue completing the test/survey at any time, but you must remain at your desk in this room until the survey period ends.] 5. What bad things might happen to me if I am in the study? [MAKE RISK DESCRIPTION APPROPRIATE TO LEVEL OF UNDERSTANDING/AGE OF CHILD] 6. What good things might happen to me if I am in the study? [IF NO DIRECT BENEFIT, SAY THAT] 7. Will I be given anything for being in this study? [IF ANY INCENTIVE, MAKE CLEAR WHETHER IT IS GIVEN TO CHILD OR TO HIS PARENT/GUARDIAN] 8. Who can I talk to about the study? For questions about the study you may contact ___________________. To discuss other study-related questions with someone who is not part of the research team, you may contact the AUB Social & Behavioral Science Institution Review Board at [INSERT PHONE NUMBER OR EMAIL ADDRESS] Signing the assent form I have read (or someone has read to me) this form. I have had a chance to ask questions before making up my mind. I want to be in this research study. AM/PM Signature or printed name of subject Date and time Investigator/Research Staff I have explained the research to the participant before requesting the signature above. There are no blanks in this document. A copy of this form has been given to the participant or his/her representative. Printed name of person obtaining assent Signature of person obtaining assent AM/PM Date and time This form must be accompanied by an IRB approved parental permission form signed by a parent/guardian. 5. AUB Social & Behavioral Sciences Parental Permission Template Permission for Child to Participate in Research Study Title: Researcher: Sponsor: [If applicable] This is a permission form for your child/child for whom you are legal guardian to participate in a research study. It contains important information about this study and what to expect if you decide to permit your child/child for whom you are legal guardian to participate. Your child’s participation is voluntary. Please consider the information carefully before you decide to allow your child to participate. If you decide to permit participation, you will be asked to sign this form and will receive a copy of the form. Purpose: [describe in nontechnical terms the purpose of the research project, include the types of questions or activities that the child will be asked to perform, observe.] Procedures/Tasks: [describe the procedures involved, mention audio or video taping, if applicable and what will happen to the tapes after the study, e.g. shown at scientific meetings, archived for a period of time and then responsibly destroyed, etc.] Duration: [Insert the length of time the child will be involved in the study; if there is more than one session, describe how many sessions and the length time for each session.] Your child may leave the study at any time. If you decide to stop your child’s participation in the study, there will be no penalty to you, or your child and you will not lose any benefits to which you are otherwise entitled. Your decision will not affect your future relationship, or that of your child, with AUB. Risks and Benefits: [insert a description of all foreseeable risks to the child participating in the research.] [Insert a description of any direct benefits that the child might receive or gain by participation. Example: during this research your child will be shown how to play a simple board game involving two people. Your child will be permitted to keep this game as a thank you for participating in the research. ] Confidentiality: [Insert full description of how privacy of information and data collected will be preserved; how confidentiality of child’s participation will be protected. Explain what will happen to the research data after the study is complete. If data will be shared with other researchers at AUB or elsewhere disclose that information.] Example: Efforts will be made to keep your child’s study-related information confidential. All data from this study will be maintained in a secure locked drawer in a locked office or on a password protected computer. Data will only be reported in the aggregate. No names of individual children will be disclosed in any reports or presentations of this research. However, there may be circumstances where this information must be released. For example, personal information regarding your child’s participation in this study may be disclosed if required by law. Also, your child’s research data may be reviewed by the following groups (as applicable to the research): U.S. Office for Human Research Protections or other federal, state, or international regulatory agencies, required; The AUB Institutional Review Board or Office of Human Research Protections; The sponsor, if any, or agency supporting the study. After the conclusion of the study, the Principal Investigator will retain all original study data in a secure location for at least three years to meet institutional archiving requirements. After this period, data will be responsibly destroyed. Incentives: [insert description of reimbursement or recruitment incentive or participation incentive. If payment is prorated for partial participation in the research, be clear about what payment schedule is. If there is no payment, state as such. Make clear whether payment is made directly to the child e.g. your child will be able to select a toy of nominal value from the study toy box for participating in the project; or payment made to parent/legal guardian: you will receive $3.00 for your child’s participation in the study.] Participant Rights: You may refuse to allow your child to participate in this study without penalty or loss of benefits to which you are otherwise entitled. If you are a student or employee at AUB, your decision about whether or not you allow your child to participate in this research will not affect your grades or employment status. If you choose to allow your child to participate in the study, you may discontinue his/her participation at any time without penalty or loss of benefits. By signing this form, you do not give up any personal legal rights you or your child may have as a participant in this study. The Social & Behavioral Institutional Review Board responsible for human subjects research at AUB has reviewed this research project and found it to be acceptable, according to applicable Lebanese and U.S. federal regulations and AUB policies designed to protect the rights and welfare of participants in research. Contacts and Questions: For questions, concerns, or complaints about the study you may contact [Insert name of PI/Investigator and phone or email where this person may be contacted.] For questions about your child’s rights as a participant in this study or to discuss other study-related concerns or complaints with someone who is not part of the research team, you may contact the AUB Social & Behavioral Science Institutional Review Board [INSERT PHONE AND EMAIL CONTACT INFORMATION] Signing the consent form I have read (or someone has read to me) this form and I am aware that I am being asked to give permission for my minor child (or child under my guardianship) to participate in a research study. I have had the opportunity to ask questions and have had them answered to my satisfaction. I voluntarily agree to give permission for my child/child under my guardianship to participate in this study. I am not giving up any legal rights by signing this form. I will be given a copy of this form. Printed name of subject Printed name of person authorized to give permission for minor subject/participant Signature of person authorized to give permission for minor subject/participant (when applicable) Relationship to the subject Date and time AM/PM Investigator/Research Staff I have explained the research to the parent or legal guardian of the child subject/participant before requesting the signature(s) above. There are no blanks in this document. A copy of this form has been given to the parent/legal guardian of the child participant/subject. Printed name of person obtaining permission Signature of person obtaining permission AM/PM Date and time