Appendix 11 Letters and Consent Forms - University of Michigan 2025

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A consent form is a document that is signed by a person (or on behalf of the person whom they are a guardian) to show that they are in agreement with the contents of the document.
Instructions for Developing an Informed Consent Document General Information. Describe the purpose(s) of this research study in lay terms. Purpose of the Study. Procedures. Risks. Benefits. Compensation, Costs and Reimbursement. Withdrawal or Termination from Study. Confidentiality.
Example: All information taken from the study will be coded to protect each subjects name. No names or other identifying information will be used when discussing or reporting data. The investigator(s) will safely keep all files and data collected in a secured locked cabinet in the principal investigators office.
Examples of giving verbal consent include: Yes That sounds great That feels awesome
An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116) provide the framework for the type of information (i.e., the elements) that must be included as part of the consent process.
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All consent forms for non-Exempt research should include these elements: Title of the Research Study, Invitation to Participate, Basis for Subject Selection, Purpose of the Study, Explanation of Procedures, Potential Risks and Discomforts , Potential Benefits to the Subject, Potential Benefits to Society, Assurance of

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