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Insert Department CONSENT/PARTICIPANT INFORMATION Form Insert Title of Study Note to investigators: this template encompasses all the required and some additional elements of informed consent, as
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How to fill out informed consent - only

01
Step 1: Begin by explaining the purpose of the informed consent form to the participant.
02
Step 2: Provide a clear and concise description of the study or procedure that the participant will be involved in.
03
Step 3: Ensure that the participant understands the risks and benefits associated with their participation.
04
Step 4: Answer any questions the participant may have regarding the study or procedure.
05
Step 5: Have the participant read the informed consent form carefully and sign it to acknowledge their understanding and agreement.
06
Step 6: Make a copy of the signed informed consent form for both the participant and the research team's records.

Who needs informed consent - only?

01
Anyone who is participating in a research study or a medical procedure that involves potential risks or benefits needs to provide informed consent.

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Informed consent is the process through which a participant voluntarily confirms their willingness to participate in a research study after being informed of the relevant facts, risks, benefits, and alternatives.
Researchers and institutions conducting studies involving human subjects are required to file informed consent.
Informed consent should be filled out by providing clear, comprehensive information about the study, ensuring participants understand the content, and obtaining their signature to indicate consent.
The purpose of informed consent is to protect participants' autonomy, ensure they are well-informed about the study, and to provide legal protection for researchers.
The information that must be reported includes the study's purpose, procedures, risks, benefits, confidentiality assurances, and the right to withdraw without penalty.
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