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Under federal regulations (Title 45 Code of Federal Regulations, Part 46 §46.116), informed consent must be documented by the use of a written form approved by the HSRB and signed by the subject or their legally authorized representative. The consent form may be one of the following; in either case, a copy must be given to the research participant or their representative.
The HSRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
In cases in which the documentation requirement is waived, the HSRB may require the investigator to provide subjects with a written statement regarding the research.