Slide 1Office for Human Research Protections 1 Updating the Common Rule Governing Human Subjects Research Protections Jerry Menikoff Slide 2 Office for Human Research Protections…
Slide 1Is it Research? Slide 2 Is It Research? 2 Elements –The project involves a systematic investigation –The design (meaning goal, purpose, or intent) of the investigation…
Slide 1SACHRP Strauss Flynn 7-08 Subcommittee on the Inclusion of Individuals with Impaired Decision- making in Research [SIIIDR] Presentation to SACHRP July 15, 2008 David…
Slide 1Protection, Over-Protection, and Pseudo Protection Alan Wertheimer Senior Research Scholar Department of Bioethics Clinical Center National Institutes of Health May,…
Slide 1 Identify consent process requirements Distinguish between IRB, PI/Designee consent process responsibilities Identify with what went wrong? Summarize…
Slide 1 Part 1 of 3 Part Series: Informed Consent: The Document Wendy Lloyd, BA, LPN, CIP, CCRP Regulatory Affairs and Compliance Specialist Process Improvement Team Slide…
CSI ICD: Investigating the Missing Pieces within Informed Consent Documents Part 1 of 3 Part Series: Informed Consent: The Document Wendy Lloyd, BA, LPN, CIP, CCRP Regulatory…
Procedure Of Taking Informed Consent How will we take consent Written Oral Video The Consent Process: The subject/representative must enter the date of signature on the consent…
Susan Bailey, PhD Fall 2010 Lecture 1 Learning Objectives Understand components of the syllabus My Responsibilities Course Objectives Materials Your Responsibilities Assignments…