May 2004, Issue 2

New IRB Education Requirements for Tufts Health Sciences and Tufts-NEMC

The IRB Executive Committee has revised the IRB human subjects protection education requirements for Tufts University Health Sciences and Tufts-NEMC. The baseline requirement is the online course, Investigator 101, which takes approximately two hours to complete but allows users to stop and start as often as they choose. Anyone who's already taken either the NIH or the University of Rochester course does not have to take Investigator 101, unless you are new to Tufts or are interested in foundational information for dealing with human subjects research

Investigator 101 touches on all areas that are subject to regulation. Researchers must pass the online test to be credited as having taken the course.

Building on this core requirement is a second layer of education provided in four online lectures presented by attorney Mark Barnes:

1. Research compliance: basic requirements and accurate record keeping,
2. Recognizing and reporting adverse events during a clinical trial,
3. The impact of HIPAA on clinical research, and
4. What researchers need to know about investigational drugs and devices under FDA regulations (INDs/IDEs)

The PI, and any co-PI, must view all four lectures to the extent that they apply to the research protocol and complete the post-test and evaluation form for each lecture. The PI must then decide who in the research group should view any or all of the lectures. For example, only researchers who will be working with drugs and devices will need to take module 4 on investigational drugs and devices. The HIPAA module only applies to people who are doing research within a covered entity or who interface with a covered entity,* such as Tufts-NEMC or the Dental School clinics.

For more information on these education requirements, go to

* "Covered entity" means a health plan (as defined by HIPAA and the HIPAA
regulations), a health care clearinghouse (as defined by HIPAA and the HIPAA
regulations), or a health care provider (as defined by HIPAA and the HIPAA
regulations) who transmits any health information in electronic form in
connection with a transaction covered by the HIPAA regulations.



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