HIPAA & Research
View: HIPAA & Research (40 minutes)
Provides an overview of:
- The Health Insurance Portability and Accountability Act (HIPAA)
- The intersection of HIPAA and research
- The role of the IRB and other University offices
- Useful tips for drafting HIPAA authorization agreement forms
Informed Consent: Supporting Participant Understanding
View: Informed Consent: Supporting Participant Understanding (60 minutes)
Learn about approaches for improving informed consent and supporting participant understanding of the studies they are asked to join.
Information Session on the Notice of Proposed Rulemaking
View: Information Session on the Notice of Proposed Rulemaking (NPRM) (30 minutes)
Describes the major changes to the proposed rule that may affect the research community.
Keep Calm & Carry On: Preparing for FDA Inspections of Clinical Investigations
View: Keep Calm & Carry On: Preparing for FDA Inspections of Clinical Investigations (45 min)
Provides an overview of how to prepare for the FDA Bioresearch Monitoring (BIMO) inspections of investigators at the University of Minnesota.
You will learn reasons FDA inspects investigators, what to prepare in advance of the FDA inspection, what to expect during and after the FDA inspection.
Introduction to Clinical Research Methodology
This series of online courses from CTSI provides an interactive orientation for health professions students, fellows, and practitioners.