Exception from Informed Consent Requirements for Emergency Research: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Information

Type

Guidance

Regulated products

Biologics, Drugs, Medical Devices

Topics

Good Clinical Practice (GCP)

Published

April 1, 2013

Last updated

April 21, 2020

Description

This document provides guidance on exceptions to informed consent requirements for emergency research, focusing on Good Clinical Practice (GCP).

Organization

Country / Region

United States

License

Other (Public Domain)

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