The Process of Informed Consent

Published: August 2013

Every investigator and clinical research coordinator (CRC) should recognize the importance of obtaining valid and appropriate informed consent as an important protection of the rights and welfare of human subjects. The purpose of this ACRP guidance document is not to provide a literature review or summarize the recommendations of various working groups. Instead, the Association decided it would be helpful to our members if we provided short and focused guidance which describes how to best structure the informed consent process in accordance with best practices.

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The Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. Our Mission: To provide global leadership to promote integrity and excellence for the clinical research profession.