Sample informed consent document - IRB - University of Pittsburgh - irb pitt 2025

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The elements needed for the documentation of the informed consent discussion include: The nature of the procedure or intervention. The risks and benefits of the procedure or intervention. Reasonable alternatives. The risks and benefits of alternatives. An assessment of the patients understanding of these elements [10][11]
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.
I have read and understand the information in this form. I have been encouraged to ask questions and all of my questions have been answered to my satisfaction. I have also been informed that I can withdraw from the study at any time. By signing this form, I voluntarily agree to participate in this study.
Elements of an Informed Consent Form A statement that the study involves research. Purpose(s) of the research. Expected duration of the subjects participation. Explanation of the procedures to be followed. Attendant risks or discomforts. Expected benefits (money, course credit, free physical examination).
Unless the Institutional Review Board (IRB) determines that the requirements for obtaining informed consent can be waived, the investigators should seek and obtain the legally effective informed consent, as described in 45 CFR 46.116, for the now-adult subject for any ongoing interactions or interventions with the

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The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.
Elements of Informed Consent Title of the Study. Names and Affiliations of the Primary Investigator. If a student is conducting the study, state the students information first. Purpose of the Study. Subject Selection Criteria. Study Procedures. Potential Risks and Discomforts. Potential Benefits. Cost and Compensation.

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