Sample Consent Form s3
Total Page:16
File Type:pdf, Size:1020Kb
Modify to fit your study.
Department of 9201 University City Boulevard, Charlotte, NC 28223-0001 t/ XXX-XXX-XXXX f/ XXX-XXX-XXXX www.
Informed Consent for (Title of Project)
Project Title and Purpose: You are invited to participate in a research study entitled (give title of project). This is a study to (state purpose of study)
Investigator(s): This study is being conducted by (provide UNCC Department of the Principal investigator. If the Principal investigator is a student, you should also provide the name of the responsible faculty.)
Description of Participation: You will be asked to [Think of the consent form as a tool. Give details of what subject will be asked to do: for example, will be assigned to a group, fill out surveys, complete questionnaire, participate in an activity, participate in interviews or focus groups, will be observed by the investigator, and so on. If applicable, mention audio/video taping - how and when it will be used during the study and the plans for the recordings (e.g. transcribe and destroy, share in academic meetings/conferences, or research purposes only). It is important also on this part to explain what kind of data will be collected, e.g. identifiable information? publicly available data?].
Length of Participation Your participation in this project will take (state the expected length of the subject’s participation. Include the number and frequency of any research sessions and how long each is expected to last; e.g. hours, days, or minutes e.g. Interview will take 45 minutes; survey will take 15 minutes, observation will take 30 minutes). “If you decide to participate, you will be one of (insert # to be enrolled) subjects in this study.
Risks and Benefits of Participation: The risks associated with this study are (list any risks OR if there are no known risks, state) There are no known risks to participation in this study. However, there may be risks which are currently unforeseeable. The benefits of participation in this study are (Be sure that your language does not guarantee any benefits, e.g. use the word “may.” Payment and incentives are not considered “benefits” to a participant and should be discussed within this section). If there are no direct benefits, state: There are no direct benefits to participants in this study (But societal benefits must be discussed. List any reimbursements for participation if applicable and list any costs if applicable).
Alternatives: (List appropriate alternatives to participation, if any)
Possible Injury Statement: (If there is the possibility of injury to the subject, include this wording. Do not include any exculpatory language.)
1 All research involves a chance that something bad might happen to you. This may include the risk of personal injury. In spite of all safety measures, you might develop a reaction or injury from being in this study. If such problems occur, the researchers will help you get medical care, but any costs for the medical care will be billed to you and/or your insurance company. UNC Charlotte has not set aside funds to pay you for any such reactions or injuries, or for the related medical care. You do not give up any of your legal rights by signing this form.
Conflict of Interest: The investigator has a financial interest in the company sponsoring this research. (Describe financial interest).
Volunteer Statement: You are a volunteer. The decision to participate in this study is completely up to you. If you decide to be in the study, you may stop at any time. You will not be treated any differently if you decide not to participate or if you stop once you have started.
Confidentiality: Any information about your participation, including your identity, will be kept confidential to the extent possible. (If there is any audio or video recording, include the statement) “Because your voice will be potentially identifiable by anyone who hears the tape/digital recording, your confidentiality for things you say on the tape cannot be guaranteed although the researcher will try to limit access to the tape/digital recording as described below. (Or if there is focus group, include the statement) Please note that if you choose to take part in the focus group, the researcher(s) cannot promise absolute guarantee of privacy and confidentiality. As researcher(s), we will do everything we can to keep your information confidential (refer to Confidentiality Statement section). However, given the nature of focus groups, we cannot make guarantees about how others in the group might use your information. We ask that you respect the privacy and confidentiality of the group and group members to keep the discussion private and confidential.
The following steps will be taken to ensure this confidentiality: (Provide an explanation of how confidentiality will be maintained – data security, access, coding, etc. Include a statement that reads - all information obtained in this study will be held confidential unless disclosure is required by law. (If applicable, the researcher must add a description of any legal duty to report abuse that might supersede these confidentiality promises). For Internet Research, include this wording): Absolute confidentiality of data provided through the Internet cannot be guaranteed due to the limited protections of Internet access. Please be sure to close your browser when finished so no one will be able to see what you have been doing. (Alternatively, add security statement from commercial survey tool used for the study).
Fair Treatment and Respect: UNC Charlotte wants to make sure that you are treated in a fair and respectful manner. Contact the Office of Research Compliance at 704.687.1871 or [email protected] if you have any questions about how you are treated as a study participant. If you have any questions about the project, please contact (insert Principal Investigator name and contact number. If PI is a student, include Responsible Faculty name and number also).
This form was approved for use on Month Day, Year for a period of one (1) year.
2 Participant Consent (For subjects 18 years of age or older, the following language must be included in the area above the signature lines) I have read the information in this consent form. I have had the chance to ask questions about this study, and those questions have been answered to my satisfaction. I am at least 18 years of age, and I agree to participate in this research project. I understand that I will receive a copy of this form after it has been signed by me and the Principal Investigator.
______Participant Name (PRINT)
______Participant Signature DATE
______Investigator Signature DATE
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