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SUPPLEMENTAL
INFORMED CONSENT
Orthodontic Treatment in the Era of COVID-19
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How to fill out supplemental informed consent
How to fill out supplemental informed consent
01
Step 1: Begin by explaining the purpose and importance of the supplemental informed consent form to the participant.
02
Step 2: Provide a detailed description of the specific procedures or interventions being added to the original study.
03
Step 3: Clearly outline any potential risks, benefits, or alternatives associated with the supplemental procedures.
04
Step 4: Ensure that the participant understands that their participation in the study is voluntary and they have the right to withdraw at any time.
05
Step 5: Answer any questions or address any concerns the participant may have regarding the supplemental procedures.
06
Step 6: Have the participant carefully read through the supplemental informed consent form.
07
Step 7: Allow the participant sufficient time to consider their decision and ask any additional questions.
08
Step 8: Once the participant is ready, have them sign and date the supplemental informed consent form.
09
Step 9: Provide the participant with a copy of the signed form for their records.
Who needs supplemental informed consent?
01
Supplemental informed consent is needed for participants who are already enrolled in a study but will be receiving additional procedures or interventions that were not originally part of the study protocol.
02
This can include participants who are eligible for a new experimental treatment, participants who have experienced a change in their medical condition that requires additional procedures, or participants who are being asked to participate in additional assessments or surveys.
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What is supplemental informed consent?
Supplemental informed consent is additional consent obtained from research participants after initial consent has been given.
Who is required to file supplemental informed consent?
Researchers or investigators conducting studies that require additional information or changes in consent forms.
How to fill out supplemental informed consent?
Supplemental informed consent forms should be filled out by providing all necessary details and obtaining signatures from participants.
What is the purpose of supplemental informed consent?
The purpose of supplemental informed consent is to ensure that participants are fully informed of any changes or additional information related to the study.
What information must be reported on supplemental informed consent?
Any new information, changes in procedures, risks, benefits, or any other relevant updates should be reported on supplemental informed consent forms.
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