How does HIPAA apply to clinical researchers?

Every year, Tufts Medicine workforce members must complete HIPAA privacy and general compliance annual education. This annual education focuses on clinical settings, but it is important to understand that these requirements also apply to clinical research. In this course, you will learn how to adhere to HIPAA’s Privacy rule and the related IRB requirements as a clinical researcher. We will use case studies and real-world examples to highlight key considerations.

Learning Objectives

By the end of this session, you will be able to:

• Identify HIPAA regulations that apply specifically to research.
• Describe the impact of HIPAA and privacy regulations on research.
• Describe at least 3 strategies to operationalize compliance and privacy policies into your day-to-day operations.
• Apply HIPAA regulations to research processes.

Digital Badges

Learners who complete this course can earn digital badges to demonstrate their understanding of the following core competencies created by the Joint Task Force for Clinical Trial Competency (JTF) and the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center):

• 2.3 Apply relevant national and international principles of human subject protections and privacy throughout all stages of a clinical study.
• 4.7 Describe how global regulations and guidelines assure human subject protection and privacy during the conduct of clinical studies.

These competencies are licensed under CC BY-NC-SA 4.0.