Statement of Consent



INFORMED CONSENT DOCUMENT[Insert title of study]PLEASE DELETE THIS BOX, ALL [ITALICIZED TEXT], and OTHER TEXT THATDO NOT APPLY TO YOUR STUDY BEFORE SUBMITTING YOUR FINAL DRAFTSYou are being asked to participate in a research study about [insert general statement about study]. Researchers at Case Western Reserve University are conducting this study.KEY INFORMATION[The purpose of this section is to provide concise and focused information that a reasonable person would want to have to make an informed choice about whether to participate. This should be presented in sufficient detail and organized and presented in a way that facilitates why one might or might not want to participate.]PurposeThe purpose of this research is [explain research question and purpose in lay language].Procedures and Duration[Briefly describe the procedures to be followed in lay terms; indicate expected duration of participation.] [If applicable, add:] Please refer to the Detailed Consent for a complete description of the study procedures.Reasons You Might Choose to Volunteer For This Study[State the most important reason(s) (i.e., potential benefit) a person may want to volunteer for this study]. [If applicable, add:] Please refer to the Detailed Consent for a complete description of the anticipated benefits.Reasons You Might Choose Not to Volunteer For This Study[State the most important reason(s)/risks why a person may NOT want to volunteer for this study considering the participant’s perspective]. [If applicable, add:] Please refer to the Detailed Consent for a complete description of the foreseeable risks and discomforts.[If applicable, discuss alternative treatments which may be beneficial to the subject.]Voluntary Participation:If you decide to participate in the research, it should be because you want to volunteer. There is no penalty or loss of benefits for not participating or for discontinuing your participation.[Note: If the information included in the Key Information section also satisfies the elements of informed consent (45 CFR 46.116(b) and (c)), then this information does not need to be repeated later in the Detailed Consent section of the document.]DETAILED CONSENTYou were selected as a possible participant because [explain how participant was identified] and [list any specific inclusion or exclusion criteria]. We hope to recruit [insert total number of subjects] people to volunteer for this research. Please read this form and ask any questions that you may have before agreeing to participate.ProceduresIf you agree to participate in this research, we would ask you to do the following things: [Briefly describe the procedures to be followed (including audio/video recording); indicate expected frequency and duration of participation, and identify any procedures that are experimental.]You can choose to stop participating for any reason at any time. However, if you decide to stop participating in the study, we encourage you to tell the researchers. [If applicable, add:] You may be asked to complete some study termination activities, but you may choose not to participate in these activities.Foreseeable Risks and DiscomfortsAll treatments and procedures may involve some level of risk to you, whether foreseeable or not. [For minimal risk studies]There are no known risks, harms or discomforts associated with this study beyond those encountered in normal daily life. Some of the activities we will ask you to complete might make you feel uncomfortable. You may refuse to answer any of the questions, take a break, or stop your participation in this study at any time. The possible risks and/or discomforts associated with the procedures described in this study include: [Categorize the risks by severity and include the likelihood of the risk/discomfort occurring. Make sure to consider all types of risks – psychological, social, economic, legal and physical. Examples of risks/discomforts – Keep all statements that apply to this study and remove/revise as applicable]: Examples: anxiety, embarrassment, and invasion of privacy.] [If there are significant physical or psychological risks to participation, the participants should be told under what conditions the researcher will terminate the study without regard to the participant’s consent.][Describe how the study design and procedures will prevent and/or minimize any potential risks or discomfort. Potential risks and discomforts must be minimized to the greatest extent possible by using procedures such as appropriate training of personnel, monitoring, withdrawal of the subject upon evidence of difficulty or adverse event; referral for treatment, counseling or other necessary follow-up.][For greater than minimal risk studies]Some of the activities we will ask you to complete might make you feel uncomfortable. You may refuse to answer any of the questions, take a break, or stop your participation in this study at any time. The possible risks and/or discomforts associated with the procedures described in this study include: [Categorize the risks by likelihood and severity of the risk occurring. Make sure to consider all types of risks – psychological, social, economic, legal and physical.] [If there are significant physical or psychological risks to participation, the participants should be told under what conditions the researcher will terminate the study without regard to the participant’s consent.][Describe how the study design and procedures will prevent and/or minimize any potential risks or discomfort. Potential risks and discomforts must be minimized to the greatest extent possible by using procedures such as appropriate training of personnel, monitoring, withdrawal of the subject upon evidence of difficulty or adverse event; referral for treatment, counseling or other necessary follow-up.][Describe whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.]Anticipated Benefits[If direct benefit to the subject is anticipated] The possible benefits you may experience from the procedures described in this study include [Complete this sentence – the description of subject benefits should be clear and not overstated. Examples: increase reading comprehension; improved writing skills; learning about ways to improve your memory.][If no direct benefit to the subject is anticipated]You will not directly benefit from participation in this study.[Insert a statement about possible benefits to science or society here. Examples: greater understanding of how grassroots organizations contribute to eco-awareness, greater understanding of how stress influences memory.][Explain benefits of participation that will be gained by the participants or others. If there are no benefits, state such. The description of benefits to the participant should be clear and not overstated. If no direct benefit is anticipated, then that should be stated. If these benefits may be materially relevant to a participant’s decision to participate, the benefits should be disclosed in the informed consent document.][Compensation is not considered a benefit.] CompensationThere will be no costs to you for study participation. [If there is a cost, please delete the previous sentence and explain the cost to subjects.][If subjects will not be compensated]You will not be compensated for your participation in this research study.[If subjects will be compensated]You will receive the following compensation/reimbursement: [Insert amount of payment information, payment method (i.e., class credits, gift cards, cash, check, etc.), as well as when payment will occur. Add information if compensation will be altered if a subject chooses to withdraw.] [If subjects will be compensated through the social science lab]You will receive extra course credit for an eligible course through the CWRU Psychological Sciences human subjects’ pool. You will receive ____ unit of course credit for each ____ hour of participation in this study. Total amount of credit you may earn is [Enter total # of credits]. [If subjects will be compensated with extra course credit: The course instructor offering extra course credit for participation in research must provide alternatives to earn extra course credit. The alternative assignment must require equal or less time and effort for the same amount of earned extra credit that you can earn through participation in research.][If subjects will be compensated for one session]You will receive _____ for your participation in this study. [Example: a $5 gift card to a local merchant, or: you will be entered into a raffle to win 1 of 10 Amazon gift cards worth $100; chances of winning are approximately 1 in 100.][If subjects will be compensated for multiple sessions]You will receive _____ for each _____ you complete. [Example: you will receive $5 for each survey you complete]. There are [Enter # and type of study components.] Total compensation for participation in this study is [Enter total compensation for completion of the study.] If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits that you have completed.[If subjects will be reimbursed for multiple sessions][Insert amount of reimbursement information (i.e., parking fees, transportation fees), as well as when reimbursement will occur.] [If no reimbursement will be provided]You will not be reimbursed for any out of pocket expenses, such as parking or transportation fees.[Explain how such withdrawal will be pro-rated (i.e., half of the money or extra credit if discontinue participation half-way through).]Alternative(s) to ParticipationYou have the option to not participate. [If there is an alternative, then delete the previous sentence and explain alternative(s).][If subjects will be compensated with extra course credit: The course instructor offering extra course credit for participation in research must provide alternatives to earn extra course credit. The alternative assignment must require equal or less time and effort for the same amount of earned extra credit that you can earn through participation in research.]Voluntary Nature of the StudyYour participation is voluntary. If you choose not to participate, it will not affect your current or future relations with the University [or with other cooperating institutions (insert names)]. There is no penalty or loss of benefits for not participating or for discontinuing your participation.You are free to withdraw from this study at any time. If you decide to withdraw from this study you should notify the research team immediately. The research team may also end your participation in this study if you do not follow instructions, miss scheduled visits, or if your safety or welfare are at risk.[If applicable, add:] If you withdraw or are removed from the study, the researcher may ask you to [Complete this sentence], but you may choose not to participate in these activities. [Examples: return for a final visit or evaluation; if you are interested in continuing long-term follow-up procedures; complete a voluntary exit telephone interview that will not be included with the data previously collected.] [When research is not subject to HIPAA regulations]If you elect to withdraw or are withdrawn from this research study, the researchers will discuss with you what they intend to do with your study data. Researchers may choose to analyze the study data already collected or they may choose to exclude your data from the analysis of study data and destroy it, as per your request.[When research is subject to the HIPAA Privacy rule]If you elect to withdraw or are withdrawn from this research study, you may choose to terminate the continued use or disclosure of your protected health information (PHI) for research purposes. The request to end the use or disclosure of your PHI must be made in writing to the Responsible Investigator.Privacy of Protected Health Information (PHI)[To be used only when the research project involves PHI, must use verbatim. This can also be removed from the informed consent document and presented as a separate HIPAA Authorization document for the subject to sign.]The Health Insurance Portability & Accountability Act (HIPAA) is a Federal law that helps to protect the privacy of your health information and to whom this information may be shared within and outside of Case Western Reserve University [and insert affiliate(s) associated with study]. This Authorization form is specifically for a research study entitled “[insert name of research study]” and will tell you what health information (called Protected Health Information or PHI) will be collected for this research study, who will see your PHI and in what ways they can use the information. In order for the Principal/Responsible Investigator, [insert Principal/Responsible Investigator’s name], and the research study staff to collect and use your PHI, you must sign this authorization form. You will receive a copy of this signed Authorization for your records. If you do not sign this form, you may not join this study. [If applicable, list affiliate(s) involved: ____.] Your decision to allow the use and disclosure of your PHI is voluntary and will have no impact on your treatment [at affiliate(s)]. By signing this form, you are allowing the researchers for this study to use and disclose your PHI in the manner described below.Generally, the Principal Investigator and study staff at Case Western Reserve University [and if applicable affiliate(s)] who are working on this research project will know that you are in a research study and they will see and use your PHI. The researchers working on this study will collect the following PHI about you: [list in a specific and meaningful fashion the PHI that will be collected for the purposes of this research]. This PHI will be used to [insert a description of each specific purpose of the research study in lay terms]. Your access to your PHI may be limited during the study to protect the study results.Your PHI may also be shared with the following groups/persons associated with this research study or involved in the review of research: [insert specific names of ALL entities and persons by whom PHI will be disclosed or used (e.g., sponsor, CRO, other sites/ investigators). If PHI will not be disclosed, indicate such]; other staff from the Principal Investigator’s medical practice group; [insert if applicable affiliate and any entities within the affiliate that are appropriate to be identified]; Government representatives or Federal agencies, when required by law.Your permission to use and disclose your PHI does not expire. However, you have the right to change your mind at any time and revoke your authorization. If you revoke your authorization, the researchers will continue to use the information that they previously collected, but they will not collect any additional information. Also, if you revoke your authorization you may no longer be able to participate in the research study. To revoke your permission, you must do so in writing by sending a letter to [insert name and mailing address for Principal Investigator]; If you have a complaint or concerns about the privacy of your health information, you may also write to the University’s Director of Privacy Management, Lisa Palazzo at lisa.palazzo@case.edu or 216-368-4286 [and, if appropriate, insert affiliate’s contact] or to the Federal Department of Health and Human Services (DHHS) at DHHS Regional Manager, Office for Civil Rights, US Department of Health and Human Services, 233 N. Michigan Ave., Suite 240, Chicago, IL 60601.The researchers and staff agree to protect your health information by using and disclosing it only as permitted by you in this Authorization and as directed by state and Federal law. Case Western Reserve University [and if appropriate, insert affiliate associated with study] is [are] committed to protecting your confidentiality. Please understand that once your PHI has been disclosed to anyone outside of, Case Western Reserve University [and if appropriate, insert affiliate associated with study], there is a risk that your PHI may no longer be protected. ConfidentialityThe records of this research will be kept confidential. Any time information is collected, there is a potential risk for loss of confidentiality. Every effort will be made to keep your information confidential; however, this cannot be guaranteed.In any sort of report we might publish, we will not include any information that will make it possible to identify a participant. Research records will be kept in a locked file and access will be limited to the researchers, the University review board responsible for protecting human participants, regulatory agencies, and [add, only if applicable, sponsors and funding agencies].[Certificate of Confidentiality language to be included for all NIH-funded studies.]Certificate of ConfidentialityFor Adults[“This research is covered by a Certificate of Confidentiality (CC) from the National Institutes of Health. This CC adds special protection for the research information about you. The CC will protect the investigators from being forced, even under a court order or subpoena, to release information that could identify you. We may release identifying information in some circumstances, however. One example is if you agree that we can give out research information with your name on it. Other examples may include, disclosing medical information in cases of medical necessity related to your care, or taking steps (including notifying authorities) to protect you or someone else from serious harm, including child abuse or neglect, or disclosing auditing information required by the agency or entity funding the research. In addition, we may use certain information in future research as permitted by law.”]For Vulnerable Populations[“This research is covered by a Certificate of Confidentiality (CC) from the National Institutes of Health. This means that we will not tell anyone what you tell us even if a judge tries to force us to identify you as a person in the study unless you give us permission. You should know, however, that we may tell local authorities if harm to you, harm to others, or if child abuse or neglect becomes a concern. Also, the government agency that has provided the money for this project may see your information if they ask for our records to ensure we were conducting the project correctly. In addition, we may use certain information in future research as permitted by law.”][For non-NIH funded studies that use identifiable, sensitive information, please include language that states you will be obtaining a Certificate of Confidentiality. You may use the language provided above or specific language provided by the agency.]Subject Identifiable Data – [Keep all statements under this heading that apply and remove others as needed.][Explain whether subject identifiers will be linked to the research data.][All/some] information that identifies you will be removed from the study data.[All/some] information that identifies you will be removed and replaced with a code. A list linking the code and your identifiable information will be kept separate from the research data. [Explain why personal identifiers will be retained.][All/some] information that identifies you will be kept with the research data. [Explain why personal identifiers will be retained.]Data Storage – [Keep all statements under this heading that apply and remove others as needed.][Describe how the data will be maintained.] Research data will be maintained in a secure location at CWRU. Only authorized individuals will have access to it. Research data will be stored electronically in an encrypted file [and is password protected].The [audio/video recordings] that can identify you will be:Stored in a secure location; Transcribed and erased [as soon as possible OR at the end of the study]. [Select one and delete the other.];The recordings will be retained with the other research data for _____ [If identifiable, insert finite amount of time. If completely de-identified (no codes/master list), then such data can be kept indefinitely.]Data Retention – [Retain the longest option that applies and remove/revise as applicable.][Explain how long the research data will be maintained.] The researchers intend to keep the research data: [Select all that apply and delete those that do not apply.]Until analysis of the information is completed;Until the research is published and/or presented;For approximately ______ years;[If identifiable private information or identifiable biospecimens will be collected during the research, add one of the following statements:]Your identifiable [information or biospecimens] which are collected for this research may have the identifiers removed and be used for future research studies or distributed to another investigator for future research studies without your additional informed consent.ORYour information or biospecimens that are collected as part of this research will not be used or distributed for future research studies, even if all of your identifiers are removed.[If biospecimens will be collected during the research, add one of the following statements:]Your biospecimens will not be used for commercial profit.ORYour biospecimens may be used for commercial profit even if identifiers are removed. If this is the case you will share in the commercial profit as follows [describe the profit sharing arrangements. If there are none, please indicate that they will not share in the commercial profit.]This research [insert does OR does not] include whole genome sequencing.[Include in the consent if this is applicable]Significant New FindingsIf any significant new finding develop that may affect your decision to participate these will be provided to you.[Include in the consent if this is applicable]Significant Financial InterestThe responsible investigator and/or other members of the research team have a significant financial interest in the sponsor of this research OR the product being investigated in this study. If you have any questions about this interest, please discuss it with the responsible investigator.Contacts and QuestionsThe researchers conducting this study are [Responsible Investigator] and [Co-Investigator(s)]. You may ask any questions you have now. If you have any additional questions, concerns or complaints about the study, you may contact them at [contact information – phone number and/or email address].If the researchers cannot be reached, or if you would like to talk to someone other than the researcher(s) about: (1) questions, concerns or complaints regarding this study, (2) research participant rights, (3) research-related injuries, or (4) other human subjects issues, please contact Case Western Reserve University's Institutional Review Board at (216) 368-4514 or write: Case Western Reserve University; Institutional Review Board; 10900 Euclid Ave.; Cleveland, OH 44106-7230.You will be given a copy of this form for your records.[Include in the consent if this is applicable]Permission to Record[If audio or video recording, indicate that recording is an integral part of the study and that if the participants do not wish, they should not participate in the study.][OR][Insert yes/no checkboxes, if applicable. In the procedures paragraph of the consent forms, state that you will take notes if they refuse to be recorded, if that is an option for this study.]YES, I CONSENT to being audio/video recorded. I also understand that I can change my mind.NO, I DO NOT CONSENT to being audio/video recorded.Statement of ConsentYour signature below certifies the following:You are at least 18 years of age. [If creating an assent form, please delete “I am at least 18 years of age.”]You have read (or been read) the information provided above.You have received answers to all of your questions and have been told who to call if you have any more questions.You have freely decided to participate in this research.You understand that you are not giving up any of your legal rights.Printed Name of ParticipantDate: Signature of Participant: [Include the next two lines in the consent only if a Legally Authorized Representative is applicable]Printed Name of Legally Authorized Representative: Date: Signature of Legally Authorized RepresentativeDate: ____________Signature of Person Obtaining Consent: ................
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