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Procedure for the Informed Consent Process and Documentation of Informed Consent - IRB PRO113

This procedure outlines the responsibilities of the Investigator, OIRB and IRB regarding the informed consent process and documentation of informed consent.

Procedure for Waiver to Informed Consent Process in Research Planned for Emergency Settings - IRB PRO119

This procedure lists responsibilities of the investigator, IRB, OIRB, and sponsor for waiver to the informed consent process in research planned for emergency settings.

Procedure for Observation of the Informed Consent Process in Ongoing Research - IRB PRO129

This procedure outlines responsibilities of the investigator, OIRB and IRB for observation of the informed consent process in ongoing research.

Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process - IRB PRO131

This procedure outlines the responsibilities of the investigator, ORIB, and IRB to facilitate questions and concerns as part of the Informed Consent process.

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