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Guidance Memo1705August 3, 2017
Effective Date: January 1, 2003,
To: IRB Directors
Subject: Surrogate Consent for Research
Note: This guidance was originally issued in 2003 in a different format by
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What is to irb directors?
to irb directors oversee the institutional review board and ensure compliance with ethical guidelines for research involving human subjects.
Who is required to file to irb directors?
Researchers conducting studies involving human subjects are required to file reports to irb directors.
How to fill out to irb directors?
Researchers can fill out and submit reports to irb directors electronically or through a designated platform.
What is the purpose of to irb directors?
The purpose of filing to irb directors is to ensure that research involving human subjects is conducted ethically and in compliance with regulations.
What information must be reported on to irb directors?
Reports to irb directors must include information on the study design, informed consent process, risks and benefits to participants, and plans for data management.
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