Required Elements of Consent
- A statement that the study involves research
- An explanation of the purpose of the research
- A description of the procedures to be followed
- The expected duration of the study
- Identification of any procedures that are experimental
- A description of any foreseeable risks or discomforts
- A description of the benefits to the subjects or others that may result from the research
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- A explanation that participation is voluntary and that the subject may discontinue at any time
- Terms of payment and conditions under which subjects will receive partial or no payment
- An explanation of whom to contact with questions about the research
- A explanation of whom to contact with questions about subjects’ rights
- A description of appropriate alternative procedures or courses of treatment that might be advantageous to the subject
- For research involving more than minimal risk, an explanation about whether any compensation is offered and/or whether medical treatments are available if injury occurs, and where further information may be obtained
- For research involving more than minimal risk, an explanation of whom to contact in the event of research-related injury
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Campus IRB Guides