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2243 Main Ave. Suite 4 #20, Durango, CO 81301 9704227334ADDENDUM TO INFORMED CONSENT Electronic Forms of Communication I/We,,, understand that electronic forms of communication such as email, texting,

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How to fill out addendum to informed consent

01

To fill out addendum to informed consent, follow these steps:

02

Start by clearly identifying the document as an addendum to the informed consent form.

03

Include a title that accurately reflects the purpose of the addendum.

04

Provide a brief summary of the changes or additions being made to the original informed consent form.

05

Clearly outline the specific sections or elements of the original form that are being modified or supplemented.

06

Include clear instructions for the participant on how to acknowledge and consent to the addendum.

07

Provide space for the participant to sign and date the addendum.

08

If applicable, include space for a witness to sign and date the addendum as well.

09

Make sure to provide a copy of the completed addendum to the participant and keep a copy for your records.

10

Ensure that the addendum is securely attached to the original informed consent form, preserving the integrity of the document.

11

If necessary, consult with appropriate legal or ethical guidelines to ensure compliance with all regulations.

12

Remember to carefully review the completed addendum before finalizing and implementing any changes.

Who needs addendum to informed consent?

01

An addendum to informed consent may be needed in various circumstances, including but not limited to:

02

- When there are significant changes or updates to the research study, treatment plan, or procedures that were not covered in the original informed consent form.

03

- When new risks or benefits are identified that require additional consent from the participant.

04

- When modifications are needed to ensure compliance with regulatory guidelines or ethical standards.

05

- When participants request or require specific modifications or clarifications to the original informed consent form.

06

It is important to consult with relevant institutional or legal authorities to determine if an addendum is required in specific situations.

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What is addendum to informed consent?

An addendum to informed consent is a supplementary document that provides additional information or updates regarding a study or procedure that participants need to be aware of after the original informed consent has been obtained.

Who is required to file addendum to informed consent?

Researchers or organizations conducting studies that experience significant changes to the protocol, risks, or any other relevant information that affects participants' decisions are required to file an addendum to informed consent.

How to fill out addendum to informed consent?

To fill out an addendum to informed consent, one should clearly state the changes or additional information, provide context for why these changes are being made, and ensure that participants can understand how the changes may affect their participation.

What is the purpose of addendum to informed consent?

The purpose of an addendum to informed consent is to ensure that participants have the most current and relevant information regarding a study, enabling them to make informed decisions about their participation.

What information must be reported on addendum to informed consent?

The addendum must report any new risks, changes to the study protocol, new procedures, or additional information that might affect participants' willingness to continue their participation.

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