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CONSENT PROCESS CHECKLIST Subject Initials or ID:___Protocol: ___ Initial Consent Assent Re consent/assent PhoneInitial below. If the statement below is not applicable, indicate N/A and capture explanation
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Informed consent is the process by which a patient or participant voluntarily confirms their willingness to participate in a study or medical procedure after being informed of the relevant facts, risks, and benefits. Assent is the agreement of someone who is not able to give legal consent (typically minors), where they are provided information in a manner that they can understand.
Researchers and healthcare providers who conduct studies or medical treatments that involve human participants are required to file informed consent and assent, ensuring that all participants are adequately informed and agree to the procedures.
To fill out informed consent and assent forms, the individual conducting the study should provide clear and comprehensive information about the study, including its purpose, procedures, risks, benefits, and the right to withdraw. Participants and their guardians should then sign the form to indicate their understanding and agreement.
The purpose of informed consent and assent is to protect the autonomy and rights of participants, ensuring that they are fully aware of what participation entails and that they consent to it voluntarily, without coercion.
Informed consent and assent forms must report information such as the study's purpose, procedures, potential risks and benefits, confidentiality measures, and the participant's right to withdraw at any time without penalty.
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