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SOP #501.5
Revision 5
Approved By:
ORB Director
Approved By:
IRB ChairStandard Operating Procedures
TITLE: Informed Consent
Signature
SignatureEffective Date:
3/1/2019
Date
3/1/2019
Date
3/1/2019PURPOSE
To
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How to fill out sop obtaining informed consent
How to fill out sop obtaining informed consent
01
Step 1: Identify the purpose and scope of the Standard Operating Procedure (SOP) for obtaining informed consent.
02
Step 2: Include a brief introduction on the importance of informed consent and its role in ethical research.
03
Step 3: Specify the key personnel responsible for obtaining informed consent and their roles.
04
Step 4: Outline the step-by-step process for obtaining informed consent, including how to explain the study or procedure to the participant.
05
Step 5: Include instructions on how to address any concerns or questions raised by the participant regarding the informed consent process.
06
Step 6: Detail the documentation requirements for informed consent, such as consent forms and participant information sheets.
07
Step 7: Explain the process for obtaining consent from participants who may have limited capacity to understand the study or procedure.
08
Step 8: Provide guidelines on how to handle situations where a participant withdraws consent.
09
Step 9: Include information on how to ensure the privacy and confidentiality of participant information obtained during the informed consent process.
10
Step 10: Conclude the SOP with a section on training and ongoing monitoring of the informed consent process.
Who needs sop obtaining informed consent?
01
Researchers conducting any form of research involving human participants or subjects need a SOP for obtaining informed consent.
02
The SOP helps ensure that participants are adequately informed about the study or procedure, understand the potential risks and benefits, and voluntarily agree to participate.
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What is sop obtaining informed consent?
SOP obtaining informed consent is a standard operating procedure that outlines the steps and guidelines for obtaining consent from individuals before they participate in a research study or medical procedure.
Who is required to file sop obtaining informed consent?
Researchers, healthcare professionals, and institutions conducting research or medical procedures are required to file SOP obtaining informed consent.
How to fill out sop obtaining informed consent?
SOP obtaining informed consent should be filled out following the outlined steps and guidelines provided in the standard operating procedure document.
What is the purpose of sop obtaining informed consent?
The purpose of SOP obtaining informed consent is to ensure that individuals have a clear understanding of the risks and benefits associated with participating in a research study or medical procedure.
What information must be reported on sop obtaining informed consent?
SOP obtaining informed consent should report details about the study or procedure, potential risks and benefits, the voluntary nature of participation, and how to withdraw consent.
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