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CCI Committee on Clinical Investigations Page 1 of 16 **FOR CCI USE ONLY** Approved by the Beth Israel Deaconess Medical Center Committee on Clinical Investigations: Administrator: Lily May/WC APPROVED

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What is informed consent form to?

The informed consent form is a document used to provide detailed information about a research study or medical procedure to individuals, explaining its purpose, risks, benefits, and alternatives, and obtaining their voluntary agreement to participate or undergo the procedure.

Who is required to file informed consent form to?

The individual conducting the research study or performing the medical procedure is required to obtain and file the informed consent form from the participants or patients.

How to fill out informed consent form to?

To fill out the informed consent form, the research study or medical procedure provider needs to provide all the necessary information, including the study or procedure details, potential risks and benefits, alternatives, and ensure that the participant or patient understands the information by allowing them to ask questions. The participant or patient then needs to sign and date the form, indicating their voluntary agreement to participate or undergo the procedure. Each section of the form must be completed accurately and clearly.

What is the purpose of informed consent form to?

The purpose of the informed consent form is to ensure that individuals are fully informed about the nature of a research study or medical procedure, enabling them to make an autonomous decision about whether or not to participate or undergo the procedure. It also serves to protect the rights, safety, and well-being of the participants or patients, promoting ethical practices in research and healthcare.

What information must be reported on informed consent form to?

The informed consent form must include comprehensive information such as the purpose and objectives of the study or procedure, the expected duration, any potential risks, benefits, or discomforts, confidentiality measures, any compensation or incentives, contact information for questions or concerns, and the participant's rights and ability to withdraw from the study or procedure at any time.

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