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
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
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
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.
Protocol Development Series
The protocol development series, done in collaboration with the Clinical and Translational Science Institute’s Clinical Research Preparation Group and the Masonic Cancer Center, wrapped up in March.
The series, facilitated by university experts, includes discussions of the essential elements, core components, and development process of a research protocol.
- Essential Elements of a Social/Behavioral Research Protocol
- Essential Elements of a Biomedical Research Protocol
- Developing Endpoints
- Defining Study Procedures
- Defining, Collecting, Monitoring, and Reporting
- Developing a Site-Supplement
- Engaging Research Participants
- Ancillary Reviews
Introduction to Clinical Research Methodology
This series of online courses from CTSI provides an interactive orientation for health professions students, fellows, and practitioners.