ࡱ>  0PbjbjBqBq 7 ~_ ~_G;+ + + + + ? ? ? 8w k!|? dZ!!(%"%"%"###YYYYYYY$6]_ Z+ ##### Z+ + %"%"Z%%%#+ %"+ %"Y%#Y%%3OXR,zG#6P(Y4Z0dZP ~`$"~`PRRL~`+ S##%##### Z Z%###dZ####~`######### : 911 525 West 120th Street New York NY 10027 212 678 3000 Adult Consent Form to Participate in a Research Study Instructions for Consent form Preparer: Fill in the information requested in italics or delete as applicable. Include a version date in the footer. If your study has more than one consent form, clearly identify the individual forms in the footer. Please be sure to delete all parts that are inapplicable to your research prior to saving. This form may be used as an adult consent form only. Title of research study and general information. Study title: [insert title as detailed on IRBManager protocol submission] Study number: [insert IRBManager and all external protocol numbers] IRB of Record: [insert information pertaining to the IRB of record for this project] Participation duration: [e.g. participants will partake in 10 sessions over the course of 2 months, averaging 2 hours per session] Anticipated total number of research participants: Sponsor/Supporter: [insert names of funding agencies if any] 2. Researchers contact information. Principal Investigator: [name, institutional affiliation (e.g. Professor, Yale University), and degree(s) of the Researcher conducting the study] Phone Number: Email Address: [institutional addresses required] Co-Investigator/Study Coordinator: [name(s), institutional affiliation (e.g. Study Coordinator, Columbia University Medical Center), and degree(s), as applicable] Phone Number: Email Address: Faculty Advisor: : [name, institutional affiliation] Phone Number: Email Address: 3. What information is on this form? We are asking you to take part in a research study. This form explains why we are doing this study and what you will be asked to do if you choose to be in this study. It also describes the way we (Researchers) would like to use and share information about you. Please take the time to read this form. We will talk to you about taking part in this research study. You should ask us any questions you have about this form and about this research study. You do not have to participate if you dont want to. 4. Why is this study being done? Choose one or more of the following: We are doing this research study to find out if [insert specifics] can help people who have [insert condition]. Or/and We are doing this research study to better understand how people think about [insert specifics]. Or/and We are doing this research study to learn more about [insert specifics]. Or/and We are asking you to take part in this study because [choose one of the following options as appropriate] -you have [insert condition]. -you are scheduled to have [a routine intervention, standardized test, educational intervention, etc.]. -you are part of [some organization/event] and we would like information about people in this group. Add if applicable: We also want to find out if [insert specifics]. 5. Who is being included? You are being asked to participate in this study because we have determined that people who [detail inclusion criteria] will help us answer our research question(s). The following people will not be included because [detail exclusion criteria]. If specific schools are included/excluded: We have selected the following schools to participate in this research because [detail inclusion and exclusion criteria/justification]. 6. What will I be asked to do if I choose to be in this study? Choose as appropriate: We will ask you to come to [insert location]. or We will come to [insert location] to see you. Choose as appropriate and as many as apply: We will ask you to complete [number] survey(s) / answer questions [explain how and where, e.g. using MTurk]. And/Or We will ask you to participate in [number] of interviews [explain how and where]. And/Or We will ask you to participate in [number] of focus groups [explain how and where]. And/Or We will contact you in [insert specific] month[s]/week[s] by telephone to [insert specifics]. And/Or We will conduct observations of [insert specifics] And/Or We will get information from your [insert student, personnel, administrative, or specify other] records such as [insert specifics]. 1a. If data request/obtainment is an optional procedure, add the following: Please write your initials next to the choice you make below: ______ (initial) YES, I agree to the data or records release as described above ______ (initial) NO, I do not want my data or records to be released to the study team for research purposes Or The following tests and procedures will be done on scheduled visits: [Describe simply what the research participant will do or experience in chronological order. If some procedures are optional, it should be clearly noted and statements should be added to the consent form so that permission from the research participant can be obtained for the optional procedures (i.e. i agree and . i do not agree-). If many procedures will be performed, a table can be used instead of or in addition to a paragraph.] Additional language for describing procedures should be added here if not captured by any of the fields above. This study will last [insert total length of study period]. If the research will involve mandatory audio/video recording or photography of research participants, please add the following: Recordings: Audio/video recording or photography We are asking for you to allow us to [include all recording procedures such as audiotape (voice recording), videotape (movie), photograph (picture)] you as part of the research study. The recording(s) will be used for [include purpose of recording; e.g., analysis by the research team, possible use as a teaching tool to those who are not members of the research staff (i.e., for educational purposes), commercial purposes. If the tapes will be used for commercial purposes, the consent form must specifically state whether or not the subject would be compensated for this use.] The recording(s) will include [indicate whether the subject's name or any other identifier will be recorded. If videotaping will be utilized, indicate the extent to which the subject's identity would be masked, e.g., facial features partially blocked out, recording will not include facial pictures, recording will include full facial pictures.] The recording(s) will be stored [include measures taken to protect subject's privacy, e.g., in a password protected database; in a locked file cabinet with no link to subject's identity, in a locked file cabinet and linked with a code to subject's identity, in a locked file cabinet and labeled with subject's name or other identifiable information] and will be [indicate the length of time the recording(s) will be retained, e.g., destroyed upon completion of the study procedures, destroyed upon publication of study results, retained indefinitely.] 1a. If recording is an optional procedure, add the following: Please write your initials next to the choice you make below: ______ (initial) yes, I agree to recording as described above ______ (initial) no, I do not want to be recorded 1b. The statement below is applicable for any other optional procedures and should be added immediately after the full description in lay language of the optional procedure. Please write your initials next to the choice you make below: ____ (initial) yes, I agree to [insert optional procedure] ____ (initial) no, I do not agree to [insert optional procedure] If recordings are not optional, add the following language: Recordings are required for participation. If you do not consent to the recordings described above, you cannot participate in this research. Please sign here to confirm that you agree to all recordings described above: ____________________________________________________________ Signature Date 7. Are there any risks? Risks [physical, social, financial, psychological, privacy, or other] and possible discomforts need to be described. Depending on the study, there can be risks related to confidentiality of information, risks from procedures, risks from privacy breaches, and discomforts (physical, emotional, psychological, etc.) from the procedures. Choose one or more of the following, as applicable: We do not think that the risks associated with taking part in this study are greater in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests. And/or You may feel uncomfortable when [insert specific]. And/or You can choose to skip questions if they make you uncomfortable. And/or There may be risks or discomforts if you take part in this study. These include: [describe any reasonably foreseeable risks, discomforts or side effects and the likelihood of the occurrence] If the study involves collection or use of private information: Loss of confidentiality A risk of taking part in this study is the possibility of a loss of confidentiality or privacy. Loss of privacy means having your personal information shared with someone who is not on the study team and was not supposed to see or know about your information. The study team plans to protect your privacy. Their plans for keeping your information private are described in section 9 of this consent form. 8. Are there any benefits? You will not benefit from taking part in this study, but your participation may help people who have [insert condition] in the future. And/Or You will not benefit from taking part in this study, but your participation will contribute to our understanding of [insert explanation for why youre doing this research]. And/Or You may or may not receive personal [direct] benefit from taking part in this study. The possible benefits of taking part in this study include: [insert specifics such as contributions to general knowledge]. 9. What about my privacy? Every effort will be made to keep your personal information confidential. However, we cannot guarantee total privacy. Describe the steps that will be taken to maintain confidentiality of subject data/participant privacy: Suggested procedures/text: The data collected will be given a code number, and separated from your name or any other information that could identify you. The research file that links your name to the code number will be kept in a [Choose as appropriate: password protected database or locked file cabinet or describe other]. Only the Principal Investigator and the study staff will be able to see this file. Or All collected research data will be immediately stripped or all identifiers and maintained in a de-identified format in a password protected database or locked file cabinet or describe other. Only the Principal Investigator and the study staff will be able to see this file. Or We will collect and store identifiable information [insert specific details regarding how this data will be safeguarded and how long identifiers will be retained]. If information from this study is published or presented at scientific or professional meetings, your name and other personal information about you will/will not be used. The following people and/or agencies will be able to look at, copy, use and share your research information: - The investigator, [add your institution of affiliation and the NYC DOE] staff and other professionals who may be evaluating the study; - Authorities from [add your institution of affiliation and NYC DOE], including the Institutional Review Board ('IRB'). An IRB is a committee organized to protect the rights and welfare of people involved in research. - The Federal Office of Human Research Protections ('OHRP') - [If this study is sponsored (money or supplies are being provided)] The sponsor of this study, [name sponsor], including persons or organizations working with or owned by the sponsor may review your data for accuracy but may not copy information with your name on it. - [List other entities that may receive and process Data or Research Findings, such as transcription firm or a secondary data analysis partner and detail all applicable confidentiality agreements that will be in place]. Focus Groups [include if applicable] All participants will be asked not to share the information discussed during the group discussion with anyone outside of the group. However, complete confidentiality cannot be guaranteed. Future Use/Data Storage [include if applicable]: Describe either a particular type of specified research or a wider scope of research to be performed in the future, and, where applicable, describe the identifiable private information that will be stored, maintained, and used in secondary research. Indicate whether or not the information will be shared with other researchers and what the nature of the secondary institutions and investigations will be. Please be sure to explicitly specify the length of storage of identifiable information. On the checklist below, please indicate if you would permit the researchers to store and/or share your [describe data to be stored/shared] for future research. ______ I agree to allow my [insert data type] to be stored for future research by the researchers of this study. ______ I agree to allow my [insert data type] to be shared with other researcher for future research. ______ I do not agree to allow [insert data type] to be stored or shared for future research. You may change your mind and revoke (take back) this consent at any time and for any reason. To revoke this consent, you must contact the Principal Investigator, [Insert contact information]. However, if you revoke your consent, you will not be allowed to continue taking part in the Research. Also, even if you revoke this consent, the Researchers and the Sponsor (if applicable) may continue to use and disclose the information they have already collected. 10. Will I get paid or be given anything to take part in this study? Choose as appropriate: You will not receive any payment or other reward for taking part in this study. or If compensated: We will give you [insert specifics i.e. amount given in cash or gift cards] to pay you for your time. [If more than one study visit] You will receive [insert specifics] at each visit. If applicable, i.e., a series of subject payments will result in total compensation greater than $600, please add: According to the rules of the IRS, compensation payments totaling more than $600 in a calendar year are considered taxable income and will be reported to the Internal Revenue Service (IRS). or If reimbursed for travel expenses: We will reimburse you up to $ [insert amount] per visit for reasonable travel and parking expenses. 11. Will I incur costs if I take part in this study? There will be no costs to you for being in this study. or If there will be costs to the participant, specify and itemize anticipated costs. 12. What are my rights if I take part in this study? Taking part in this study is your choice. You can decide not to take part in or stop being in the study at any time. If you decide not to participate, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. For students: Your participation or non-participation in this study will in no way affect your grades, your academic standing, or any other status. If applicable, please add: Please tell one of the Researchers listed in Section 2 of this consent form if you decide to leave the study before it is finished. If applicable, please add: Your participation will also end if the Researchers or the study Sponsor stops the study earlier than expected or if you do not follow the study procedures. 13. Who can I call if I have questions? You may call [insert name of Principal Investigator or study contact] at telephone # [insert phone number] or email [insert email] if you have any questions or concerns about this research study. If you have any questions about your rights as a research participant, or if you have a concern about this study, you may contact the Institutional Review Board listed below. Institutional Review Board 911 525 W. 120th ST New York, NY 10027 Telephone: (212) 678-4105 IRB@tc.edu Institutional Review Board New York City Department of Education 52 Chambers Street, Room 310 New York, NY 10007 Telephone: (212) 374-3913  HYPERLINK "mailto:MAzar@schools.nyc.gov" MAzar@schools.nyc.gov 14. Statement of consent and signatures When finalizing this document, please make sure the statement of consent and signatures are on the same page. Statement of consent I have read this consent form. The research study has been explained to me. I agree to be in the research study described above. A copy of this consent form will be provided to me after I sign it. By signing this consent form, I have not given up any of the legal rights that I would have if I were not a participant in the study. Signatures Omit signature lines that do not apply to your study. If the signature line remains, the expectation is that it will be used at the time of each enrollment. ___________________________________________________________________ Research Participant Date ___________________________________________________________________ Print Name of Research Participant ------------------------------------------------------------------------------------------------------------------------------------------------ ____________________________________________________________________ Person Obtaining Consent Date ____________________________________________________________________ Print Name of Person Obtaining Consent ---------------------------------------------------------------------------------------------------------------------------------- ____________________________________________________________________ Witness Date ____________________________________________________________________ Print name of Witness The signature of a witness is only required for minimal risk studies when obtaining consent from: a Non-English Speaking Research participant using the short form process, or a person who is physically not able to read, talk or write.     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