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FormatThe format of the Consent Form depends on the type of research and level of risk posed to research subjects
The format of the Consent Form depends on the type of research and level of risk posed to research subjects
If the research is Exempt but requires written informed consent (for example, an educational study requiring parental consent) or if the research involves procedures which are clearly less than minimal risk, a narrative Consent Form format may be used. This means that all the necessary elements of informed consent should be present on the Consent Form but they need not be identified by subheadings. The concluding consent statements may be simplified for Exempt/less than minimal risk research.
For research that is minimal risk or greater, the format of the Consent Form should use the elements of informed consent, according to federal law. All required elements must be identified by the appropriate subheadings. The concluding consent statements (link to Documentation) for research that is minimal risk or greater must be used.
