Consent Information
Instructions:Studies involving survey research usually qualify for a waiver of documentation of consent, meaning that a signed consent form is not required. Under the regulations, “an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research” (45 CFR 46.117[c]).
· Enter all information below as it relates to your study.
· Change the font color to black, and delete these and all other instructions before submitting this form to the IRB.
Study Title: Insert the full title of the study.
Investigator: Insert the investigator’s name and his/her hospital/clinic/organization.
If the PI is a student, indicate that the study is being conducted as part of an undergraduate project, graduate student project, thesis, or dissertation.
Funding: If funded, identify the funding agency. Include a conflict of interest statement if necessary. If there is no funding, then delete this section.
The researchers are inviting you to take this survey in order to obtain your opinions about explain the study’s purpose in a few words. If appropriate, include information about how the subject was selected—for example, “As you may recall, you gave us your contact information at ___.”
About the Survey
· The information you provide for this study will help us briefly explain what the information is being used for.
· The survey will take about approximate amount of time to complete.
· There are no known risks if you decide to take this survey. You may skip any question that you do not wish to answer.
· Taking the survey may not benefit you directly, but we hope that the information we collect helps us learn more about describe the research question.
· There is no cost to you for participating in the study.
· If you are compensating subjects, describe the compensation; if not, delete this bullet point.
· Your participation in this study is voluntary. By submitting or returning the completed survey (e.g., by mail, put in a box in a specific location, etc.), you are voluntarily agreeing to participate.
About Confidentiality
Include this information only if the survey is completely anonymous:
This survey is anonymous. Do not include your name on the survey. No one will be able to identify you or your answers, and no one will know whether or not you participated in the study.
If this is a web-based survey, indicate how you will provide anonymity (e.g., not collect IP addresses). Also include the following statement, “Please note that absolute anonymity cannot be guaranteed over the Internet.”
Include this information if the survey results will be linked to subjects:
Any information that we collect for this study and that can be identified with you will remain confidential and will be disclosed only with your permission or as required by law. Confidentiality will be maintained by means of describe coding procedures and plans to safeguard data, including where data will be kept, who will have access to it, etc. Individuals from give the name of the funding agency, if any, and the Allina Health Institutional Review Board may inspect these records. If the data are published, no individual information will be disclosed.
Contacts for Questions
If you have any questions about the study, please contact name, phone number, and/or email address of the PI (and faculty advisor if the PI is a student).
The Allina Health Institutional Review Board (IRB) has reviewed this research study. If you have any concerns about your rights in this study, please contact the Allina Health IRB at 612-262-4920 or .
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