The informed consent process is essential to the ethical conduct of research on new medicinal products, therapies, and approaches to improving healthcare. The investigator can use various tools to optimize this process, but the most important feature of informed consent is the investigator’s commitment to high standards in its conduct. This article looks at the institutional review board’s (IRB’s) perspective on the informed consent process, and how electronic informed consent is propelling human research forward.
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About the Author
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC, has over 30 years of clinical experience, a Bachelor of Science degree in Nursing and a Master of Science degree in Education with a Specialization in Training and Performance Improvement. She has served many roles in clinical research, including site study coordinator and manager, sponsor and CRO monitor, quality assurance auditor, risk manager, trainer, and performance management consultant. SAM has held clinical research industry certifications for over 15 years by the Association for Clinical Research Professionals (ACRP). She is a current member of the ACRP Academy Board of Trustees, and Regulatory Affairs Committee (RAC). SAM is a frequent subject matter expert for GCP regulation and speaker at industry conferences. Sam has authored many competency-based curriculums for various clinical research stakeholders.More Content by Sandra "SAM" Sather