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Guidance on Informed Consent & Assent Office of Research Integrity & Compliance Version 2 Updated: June 23, 2017This document is intended to educate researchers and reviewers on the elements of informed

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What is guidance on informed consent?

Guidance on informed consent is a set of instructions or rules provided to individuals to ensure they fully understand the risks and benefits of participating in a study or experiment before giving their consent.

Who is required to file guidance on informed consent?

Researchers, medical professionals, or institutions conducting studies or experiments that involve human subjects are required to file guidance on informed consent.

How to fill out guidance on informed consent?

Guidance on informed consent should be filled out by providing clear and detailed information about the study or experiment, potential risks and benefits, and ensuring that the individual fully understands before giving their consent.

What is the purpose of guidance on informed consent?

The purpose of guidance on informed consent is to protect the rights and well-being of individuals participating in studies or experiments by ensuring they are fully informed before giving their consent.

What information must be reported on guidance on informed consent?

Information such as the purpose of the study, potential risks and benefits, alternative treatments, confidentiality measures, and the right to withdraw at any time must be reported on guidance on informed consent.

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