ࡱ>  |bjbj~~ 8{{AD KK8l~:)(QQQ{ { { ,dC]{ Y "{ { { CI!KKQQI!I!I!{ K8QQI!{ I!I!t|!C!:gwH0wI!|I!|&|@ { { { CCI!{ { { { { { { { { { { { { { { { + :    SHAPE \* MERGEFORMAT   Research Participant Information and Consent Form Study Title: Principal Investigator and Title: Department and Institution: Address and Contact Information: (If applicable) Sponsor: You are being asked to participate in a research study. This form gives you important information about the study including the purpose of the research study, expected duration of participation, expected risks/discomforts and benefits, exams/tests/procedures, etc. involved, and alternative treatment options if you choose not to participate in this research study. Research is voluntary; therefore, read this form carefully and if there is anything you do not understand, please ask questions and take your time in making a decision about whether or not you wish to participate in this research study. (If applicable) Your child may be eligible to take part in a research study. For parents or legal guardians, who are giving permission for a child to participate, the term you in this form refers to your child. KEY INFORMATION ABOUT THIS RESEARCH STUDY PURPOSE OF THE RESEARCH (Insert description of purpose or why the study is being conducted.) From this study, the researchers hope to learn [] DURATION (Describe duration of participation.) Participation in the study involves you visiting [name/address] for [insert number of] visits over a period of [insert number of days/weeks/months.] Each study visit will last about [insert number of] minutes/hours. There will be [#] phone calls, each lasting about [timeframe.] PROCEDURES (Outline in chronological order (i.e. the order in which the exams, tests, and procedures will be encountered by the subject) the procedures to be followed. Give sufficient detail for the subject to understand the full extent of his/her participation.) If you agree to participate in this study, you will do the following: POTENTIAL RISKS/DISCOMFORTS (Give details of all reasonably foreseeable risks, stresses, and discomforts including physical, social, economic, etc. List risks in order of severity and frequency and provide a clear explanation of how these risks, stresses, and discomforts are monitored or reduced.) If you agree to participate in this study, you may experience the following potential risks or discomforts: The researchers have taken steps to minimize the risks of this study. You may still have problems or unintended consequences, even when the researchers are careful to avoid them. Please tell the researchers about any injuries, side effects, or other problems you have during the study. As with any research study, there may be additional risks that are unknown or unexpected. Examples (If applicable for Loss of Confidentiality if dealing with identifiable and potentially sensitive information) [There is the risk of a breach of confidentiality, despite the steps that will be taken to protect your identity. Specific safeguards to protect confidentiality are described in a separate section of this document.] (If applicable for Focus Groups) [Others in the Focus Group will hear what you say, and it is possible that they could tell someone. The researchers cannot guarantee what you say will remain completely private, but the researchers will ask that you, and all other group members, respect the privacy of everyone in the group.] (If applicable) [Risks of reporting illegal or compromising activities (e.g. sexual behavior).] (If applicable) [Availability of referrals, counseling, or other services (e.g. suicide counseling).] (If applicable) [Discomfort associated with procedures.] (If applicable for Sensitive Questions) [The [interview/survey/questionnaire] includes some questions about [describe generally] that may be sensitive or personal. You are free to skip any question for any reason.] (If applicable, please note that you must include in the consent, any experimental procedures that are being used for the research study outside the study focus.) [An experimental procedure that is being used to conduct this research study (outside the study focus) includes [describe experimental procedure and any associated risk(s) in detail.]] POTENTIAL BENEFITS (NOTE: Financial or other compensation is not considered a benefit. Describe the benefits to subjects or others that may be reasonably expected.) (If applicable) Taking part in this study is not likely to benefit you personally. However, this research may help researchers understand [insert brief explanation, being careful not to inflate the importance of the study.] or (If applicable) You may benefit from participating in this study by [insert brief description.] ALTERNATIVE OPTIONS (For applicable Greater than Minimal Risk Study, include the statement below.) (If applicable) If you choose not to participate in this study, you could receive other treatment(s) for your condition. The standard therapy for your condition is [insert standard therapy treatment.] or (If applicable) The other option would be to choose not to participate in the study. Participation is voluntary. (If applicable) [If students are required to obtain research credits, inform them of the equivalent, non-research assignment which may be done in place of research participation] EXPANDED INFORMATION RELATED TO PURPOSE OF RESEARCH (If your study involves incomplete disclosure or deception, contact ͷapp IRB for additional guidance.) You are being asked to participate in a research study about [] You have been selected as a possible participant in this study because [] In the entire study, [#] people are being asked to participate. Include additional detail as appropriate, for example: [Description of how researcher got subjects name] (If applicable) [If you are under 18, you cannot be in this study without parental permission.] This study is being conducted collaboratively by [Institution A] and [Institution B.] EXPANDED INFORMATION RELATED TO STUDY PROCEDURES AND RESPONSIBILITIES [Delineate clearly what is being done for research, what is experimental, and whether subjects will receive any results or findings.] Examples [Schedule of events or process flow chart] [ͷapp setting, describe what is research and what is routine class work.] Randomization: You will be placed into one of the study groups by chance [like flipping a coin/rolling a dice.] Neither you nor the researcher is allowed to choose which group you will be in. You have a one in [#] chance of being placed in [either/any] of the study groups. As a participant in this research study, you have certain responsibilities, [such as attending your scheduled appointments.] [For studies that collect identifiable private information , delineate clearly whether:] Examples [Identifiers will be removed from private information] [De-identified information may or may not be used or shared for future research] PRIVACY AND CONFIDENTIALITY (Describe safeguards that will be implemented to protect confidentiality. If researchers plan to hold data for future research or submit data to a data registry for secondary research, you may need to consider the Opt-in/Opt-out consent template question. Where will the data be stored and how will it be protected? [Describe all procedures that will be followed to keep subject information secure and confidential, including whether the data are being sent somewhere else (e.g. central data base, another institution) and/or whether data are being coded and a key maintained separately.] Examples Research records will be kept in a separate research file that does not include names, registration numbers, or other information that is likely to allow someone other than the researchers to link the information to you. Information about your study participation may be included in your medical record. The data for this study are being collected anonymously. Neither the researchers nor anyone else will be able to link data to you. Who will have access to the data? Researchers and Research Staff The staff who are taking care of you Person(s) at ͷapp with responsibilities for oversight of research Agencies of the federal, state, or local government (including the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) and the Office for Human Research Protection (OHRP), as applicable) (If applicable) Research teams at [other collaborating institutions list participating hospitals, clinical, universities, etc.] (If applicable) Sponsor of the study and/or its agents The results of this study may be published in an article or presented at a scientific meeting, but would not include any information that would let others know who you are. (If applicable) If [actual or suspected child and/or adult abuse] may be revealed during this study or we learn that others have been or may be harmed, we may be required to report that information to the appropriate agencies. (if applicable) [Describe any potential for mandated reporting of communicable diseases.] (If applicable) This study involves the collection of [video recording/audio recording/photograph] of you. The researchers will ask for your separate written permission to use the [video recording/audio recording/photograph] of you in articles or presentations. (If applicable) [Discuss how instructors/teachers cannot access identifiable data.] (If applicable) [If data are being collected via the internet, discuss if the data are being collected anonymously or with identifiers. Tell the subject if you are collecting IP addresses or not.] Your rights to participate, say no, or withdraw Participation is voluntary. You have the right to say no. You may change your mind at any time and withdraw. You may choose not to answer specific questions or to stop participating at any time. Refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. You may discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled. If you decide to withdraw from the study before it is finished, please notify one of the study team members [specify who and what type of notification is required.] If you decide to withdraw from the study, the researcher will stop collecting new data, but the data already collected will be retained. Additional text, if appropriate: (If applicable) [Your participation, non-participation, and/or withdrawal will not affect your grades or your relationship with your professors or WMU/ͷapp. If research credit is required for successful course completion, other alternative means for obtaining credit is available and you may discuss these options with your course instructor.] Could the researcher make me leave the study? Yes, there are reasons why the researcher or study team may need you to end your participation in the study. Some examples include: The Researcher believes that it is not in your best interest to stay in the study. You become ineligible to participate. You are unable to follow the study schedule or instructions from the researcher or study team. The study is suspended or cancelled. NEW INFORMATION (If Greater than Minimal risk Study involving medical treatment, include the statement below.) If the researchers learn of new information during the course of the research study that could impact your willingness to continue participating, you will be notified (unless the study is limited to a single session). COSTS (Any additional costs that may result from participation in the study must be listed.) (If applicable) There will be no costs to you for participating in this study other than possible costs related to transportation to and from the research site. COMPENSATION FOR BEING IN THE STUDY Will I be paid? (If applicable) You will not be paid for participating in this study or (If applicable) You will be paid [insert amount and type of payment] for participating in this research study. If you do not complete the study, you will receive [insert prorated amount] for each study visit. (If applicable) [Description of method of payment] (Required statement if you will pay participants) ͷapp will keep a record of any money you are paid, your name, address and social security number. If ͷapp pays you more than $600 in a calendar year (or if you are a foreign citizen who is not here as a permanent resident), we must report the payment to the IRS (Internal Revenue Service) and will send you a 1099 Miscellaneous Income form. WHAT HAPPENS IF I AM INJURED AS A RESULT OF PARTICIPATING? (Only required if study is more than minimal risk. If applicable, see section 15 of the biomedical consent template.) Conflict of INterest (Only include this section if applicable.) [Disclosure language as required by ͷapp conflict of interest management plan, if any.] 16. Contact Information If you have concerns or questions about this study, such as scientific issues, how to do any part of it, or to report an injury, please contact the researcher: [complete contact information for business hours contact, and a 24-hour contact, including: name, mailing address, e-mail, phone number.] If you have questions or concerns about your role and rights as a research participant, would like to obtain information or offer input, or would like to register a complaint about this study, you may contact, anonymously if you wish, the ͷapp Institutional Review Board (IRB) office at 269-337-4345 or email  HYPERLINK "mailto:wmedirb@med.wmich.edu" wmedirb@med.wmich.edu or regular mail at 1000 Oakland Drive, Kalamazoo, MI 49008. If you are concerned about a possible violation of your privacy or are concerned about a study, you may also contact, anonymously if you wish, the ͷapp Compliance Hot Line at 269-337-6505 or  HYPERLINK "mailto:compliance@med.wmich.edu" compliance@med.wmich.edu. 17. Documentation of Informed consent I have had the opportunity to read this form or have had it read to me. I have had a chance to ask questions and have had them answered to my satisfaction. I have been told that people listed in this form will answer any questions that I have in the future. By signing below, I am volunteering to participate in this research study. (If applicable) Audio/visual media: _____ Yes, I give permission for my [video recording/audio recording/photographs] to be kept for future use in research studies and educational purposes. Initials____________ _____ Yes, I give permission for my [video recording/audio recording/photographs] to be kept for future use in publications and presentations resulting from this research study. Initials____________ _____ No, I do not give permission for my [video recording/audio recording/photographs] to be kept for future research studies, educational purposes, publications, or presentations. Initials____________ Printed Participant Name: ______________________________________________________________ ________________________________________ _____________________________ Signature Date You will be given a copy of this signed Informed Consent Form to keep. Additional Signatures (Include as applicable.) Legally Authorized Representative (LAR): (Delete unless use of LAR included in IRB application.) Name: _________________________________________ ______________________________________________ ________________________ Signature Date Relationship: &Parent / &Spouse / &Child / &Sibling / &Legal Guardian / &Other: _____________ Reason participant is unable to consent: ________________________________________________ Impartial Witness: (Required if participant/LAR have low literacy or other challenges that might impact ability to read, communicate, or sign consent.) Name: _________________________________________ ______________________________________________ ________________________ Signature Date Relationship: &Parent / &Spouse / &Child / &Sibling / &Legal Guardian / &Other: _____________ Second Parent Permission: (Always required if study involves minor subjects with no prospect of direct benefit to the minor subject and the risks are assessed by IRB to be greater than minimal. May also be required by IRB.) 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