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ISARIC/WHO Clinical Characterisation Protocol IRAS Ref. 126600 INFORMATION SHEET AND ASSENT FOR CHILDREN YOUNGER THAN 12 YEARS OLD DATA ONLY 30th August 2022. Version 10.2 Local lead investigator:
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How to fill out informed consent and assent

01
Read the informed consent and assent form thoroughly.
02
Make sure you understand the purpose, procedures, risks, and benefits of the study.
03
Ask any questions you may have to the researchers before signing the form.
04
If you agree to participate, sign the informed consent form as the participant or as the legal guardian.
05
If the participant is a minor, they may need to provide assent by signing a separate assent form.
06
Keep a copy of the signed form for your records.
07
Remember that you have the right to withdraw your consent at any time during the study.

Who needs informed consent and assent?

01
Anyone who is being asked to participate in a research study needs informed consent.
02
Informed consent is especially important for participants who may be considered vulnerable, such as minors, individuals with cognitive impairments, or those who are not able to make independent decisions.
03
Assent is typically required for minor participants, in addition to obtaining informed consent from their legal guardians.

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Informed consent is a process by which a participant voluntarily confirms their willingness to participate in a research study after understanding all aspects of the study. Assent is a concept similar to informed consent but is specifically used for minors or individuals who may not be able to provide full legal consent.
Researchers conducting studies that involve human participants are required to file informed consent and assent.
Informed consent and assent forms should be filled out by providing clear and comprehensive information about the study, ensuring participants understand the risks, benefits, and their right to withdraw at any time.
The purpose of informed consent and assent is to ensure that participants are fully educated about a study's procedures, risks, and benefits, allowing them to make informed decisions about their participation.
Informed consent and assent must include the purpose of the study, potential risks and benefits, confidentiality measures, voluntary participation, and contact information for questions.
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