Get the free SUPPLEMENTAL INFORMED CONSENT - Varble Orthodontics

Zachary L. Marble DMD, MSD Patients Information Patients Full Name: Name you like to be called: Date of Birth: Gender (circle one): Male / Female Patients Address: Primary Phone: Secondary #: Email:

How to fill out supplemental informed consent

How to fill out supplemental informed consent

1. Begin by reviewing the original informed consent form that the participant has already signed.
2. Identify the specific information or procedures that require additional consent.
3. Create a separate section in the supplemental informed consent form for the additional information or procedures.
4. Clearly explain the purpose and nature of the additional information or procedures to the participant.
5. Provide any necessary details, risks, benefits, alternatives, and any other relevant information related to the additional information or procedures.
6. Allow the participant to ask questions and clarify any concerns they may have.
7. Give the participant enough time to make an informed decision.
8. Ensure that the participant voluntarily signs and dates the supplemental informed consent form.
9. Keep a copy of the signed supplemental informed consent form for record-keeping purposes.

Who needs supplemental informed consent?

1. Supplemental informed consent is typically required for research studies or medical procedures that involve additional information or procedures beyond what was initially covered in the original informed consent form. It may be necessary when there are changes to the study protocol or when new information becomes available that could affect the participant's decision to continue participating.

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What is supplemental informed consent?

Supplemental informed consent is a document that provides additional information to participants in a research study, ensuring that they understand new risks, changes, or other modified aspects of the study that may arise after the original consent was obtained.

Who is required to file supplemental informed consent?

Researchers or institutions conducting studies that undergo significant changes or that have new findings with implications for participant safety or understanding are required to file supplemental informed consent.

How to fill out supplemental informed consent?

To fill out supplemental informed consent, researchers must provide clear, concise information about the new aspects of the study, ensuring that participants understand what they are agreeing to. This typically includes detailing the changes to the study and obtaining the participants' signatures.

What is the purpose of supplemental informed consent?

The purpose of supplemental informed consent is to protect the rights and well-being of research participants by ensuring they remain fully informed about the nature of the study and any potential changes that may affect their participation.

What information must be reported on supplemental informed consent?

The supplemental informed consent must report any new risks, benefits, procedures, or changes in study design, as well as provide participants with updated contact information for questions or concerns.