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SUMC COMMON SOP11 Obtaining Informed Consent Attachment B Subject Initials or ID: Initial ConsentCONSENT PROCESS CHECKLIST Protocol: Re consent PhoneInitial below, if the statement below is not applicable
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How to fill out sop-11 obtaining informed consent
How to fill out sop-11 obtaining informed consent
01
Start by explaining the purpose of the study and the procedures involved in simple and understandable language.
02
Provide detailed information about any potential risks or discomfort that the participant may experience during the study.
03
Clearly explain the benefits and potential alternatives to participating in the study.
04
Ensure that the participant has the freedom to ask questions and clarify any doubts.
05
Obtain written consent from the participant or their legal representative, ensuring that they have fully understood the information provided.
06
Clearly outline the participant's rights, such as the right to withdraw from the study at any time.
07
Document the process of obtaining informed consent, including the date, time, and signatures of the participant and the person obtaining consent.
08
Provide a copy of the informed consent form to the participant for future reference.
09
Regularly review and update the SOP-11 obtaining informed consent to ensure compliance with ethical guidelines and regulations.
10
Train all relevant staff members on the proper procedures for obtaining informed consent.
Who needs sop-11 obtaining informed consent?
01
Researchers conducting human subjects research that require informed consent.
02
Medical professionals and institutions involved in clinical trials or experimental procedures.
03
Ethics committees and institutional review boards responsible for reviewing research protocols.
04
Any organization or individual involved in studies that involve human participants and require ethical approval.
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