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New Compliance Training Requirements for participation in Human Subjects Research

July 19, 2010

Dear Colleagues:

Effective August 1, 2010, the Johns Hopkins Medicine Institutional Review Boards (JHM IRB) will implement new compliance training requirements for participation in human subjects research.  Our intent is to make it easier for investigators and study team members to determine which courses they are required to take, register for the courses, and have access to their course completion information. The compliance training will be tracked using the Hopkins myLearning website at http://www.hopkinsmedicine.org/interactive_learning/my_learning/.

Following are the significant changes in our compliance training requirements:

  • We are moving to CITI (Collaborative Institutional Training Initiative) for basic Human Subjects Research (HSR) and Conflict of Interest (COI) training.  Registration for these courses, along with HIPAA & Research and other JHM IRB courses, is available at myLearning.

  • If you have already completed the JHU SOM HSR or JHU SOM COI courses, you do not need to take the basic CITI courses.  If you have registered for the JHU SOM HSR or COI courses, but have not completed them, you must complete them by September 1, 2010.  After that date, you will be able to obtain your certificates for completed courses at https://secure.lwservers.net, but access to the courses will be disabled.

  • The JHM IRB will not track completion of General Privacy Issues (GPI).  Completion of GPI will be monitored by individual departments.

  • The Course on Research Ethics (CORE), or its equivalent, is still required for all principal investigators within one year from the date of their first eIRB submission.  Fellows must complete CORE by the end of their fellowship.

  • If there will be billing for study procedures, Clinical Research Billing Orientation (CRBO) is still required for PIs, and for study team members who will consent participants. When a new research application is submitted in eIRB, you will be notified by Clinical Research Support Services (CRSS) if you are required to take CRBO.  The PI and study team members responsible for entering data in the Clinical Research Management System (CRMS) will also be required to take CRMS training.

  • Although there are no recertification training requirements at this time, we anticipate that we will implement recertification requirements later this fall.  Registration for the recertification courses will be available at myLearning.  We’ll provide an update on any recertification requirements well in advance of implementation.

Please contact the Office of Human Subjects Research at (410) 955-3008 or jhmirb@jhmi.edu, if you have any questions about the revised training requirements.

Sincerely,

Daniel E. Ford, M.D., M.P.H
Vice Dean for Clinical Investigation