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Informed Consent Information Sheet Guidance for IRS, Clinical Investigators, and Sponsors DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions

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What is consent information sheet?

The consent information sheet is a document that outlines the details of an individual's consent to participate in a study or research project.

Who is required to file consent information sheet?

Researchers and study organizers are required to file the consent information sheet.

How to fill out consent information sheet?

The consent information sheet can be filled out by providing all necessary details of the study, risks, benefits, and the consent process.

What is the purpose of consent information sheet?

The purpose of the consent information sheet is to ensure that participants understand the nature of the study, their rights, and provide informed consent.

What information must be reported on consent information sheet?

The consent information sheet must include details about the study objectives, procedures, risks, benefits, confidentiality, and contact information.

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