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EFS Adult ICF Template 11/20/20Patient Initials: IMPORTANT NOTE: This Informed Consent Form Template is based on FDA Guidance “Investigational Device Exemptions (IDEs) for Early Feasibility Medical

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How to fill out informed consent to participate

01

Read the informed consent form thoroughly to understand the purpose of the study, the procedures involved, risks and benefits, and your rights as a participant.

02

Ask any questions you may have about the study or the informed consent form to the research team.

03

Discuss the study with your family or friends if desired, to ensure you are making an informed decision.

04

If you are willing to participate, sign and date the informed consent form.

05

Keep a copy of the signed informed consent form for your records.

Who needs informed consent to participate?

01

Anyone who is going to participate in a research study or clinical trial needs to provide informed consent.

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What is informed consent to participate?

Informed consent to participate is a process where individuals are provided with information about a research study or program and voluntarily agree to take part.

Who is required to file informed consent to participate?

Researchers or organizations conducting a research study or program are required to file informed consent to participate.

How to fill out informed consent to participate?

Informed consent forms typically include information about the study, risks and benefits, confidentiality, and the participant's rights. Participants are asked to read the form and sign it if they agree to participate.

What is the purpose of informed consent to participate?

The purpose of informed consent to participate is to ensure that individuals have the necessary information to make an informed decision about participating in a research study or program.

What information must be reported on informed consent to participate?

Informed consent forms must include details about the study, risks and benefits, confidentiality, participant's rights, and contact information for questions or concerns.

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