Program Overview

Human Research Protections Required Training

The University of Maryland, Baltimore (UMB) requires ongoing education and training in the protection of human subjects for all individuals engaged in human participant research. This training is a federal requirement, and the Human Research Protections Office (HRPO) takes a proactive approach to provide ongoing education and training.

Required Education and Training

• Protection of Human Subjects Training: All individuals, including IRB members, engaged in human participant research at UMB are required to complete this training.
  • The training is provided by the University of Miami's Collaborative IRB Training Initiative (CITI) and includes a comprehensive selection of educational modules.
  • Individuals must affiliate with "University of Maryland Baltimore" to access the correct course.
  • A refresher course must be completed every three years to continue conducting human participant research at UMB.
• Good Clinical Practice Training: NIH-funded investigators and clinical trial site staff responsible for the conduct, management, and oversight of NIH-funded clinical trials are required to be trained in Good Clinical Practice.
  • GCP training must be refreshed at least every three years to remain current with regulations, standards, and guidelines.
  • Accepted courses include CITI Good Clinical Practice and ICH, CITI Good Clinical Practice (US FDA Drug and Device Focus), and CITI GCP-Social and Behavioral Research Best Practices for Clinical Research.
• HIPAA Training: All individuals employed at UMB must take HIPAA 125 (HIPAA 101 and HIPAA 120), regardless of whether they are engaging in research.
  • Additionally, all individuals engaging in research at UMB are required to complete HIPAA 201.
• Required Principal Investigator Training: Principal Investigators (PIs) are required to take training on their responsibilities as it relates to maintaining IRB approval and the consequences for allowing IRB approval to expire.
  • The training is provided through a Blackboard site and includes a pre-test, training video, and post-test.

Optional Education and Training

• Additional CITI Courses: Responsible Conduct of Research (RCR) and Conflicts of Interest (COI) courses are available.
• On Being a Scientist: A Guide to Responsible Conduct in Research is also available.

University of Maryland, Baltimore

The University of Maryland, Baltimore is the founding campus of the University System of Maryland. It is committed to providing a safe and respectful environment for all individuals engaged in human participant research.