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The key objective of obtaining informed consent from a clinical trial participant is to ensure that the participant fully understands the nature and risks of the clinical trial. The informed consent form, itself, is an important foundational component in the informed consent process. A well-drafted informed consent form addresses both substantive and style issues.
Consider any state-specific requirements for the content of the form, including Power of Attorney or Medical Directives. Additionally, all informed consent forms must comply with Food and Drug Administration (“FDA”) requirements. (See “FDA’s Requirements for Informed Consent Forms” in the Risk Management 101 series.) Consider whether the regulations of any other regulating entities, such as the Department of Health and Human Services, come into play. Finally, remember that the rules imposed by regulating entities serve only to establish the minimum requirements for an informed consent form.
Style issues include but are not limited to the wording, readability, and formatting of the document. Style is important because it can impact whether a potential clinical trial participant fully understands the nature and risk of the clinical trial. Consider the following when drafting an informed consent form:
A well-drafted informed consent form is vital to the informed consent process. It aids in making sure that the potential clinical trial participant understands the nature of the consent and can mitigate against potential litigation.
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