December 15, 2004

Revised Training Requirements for Human Subjects Resarch

Dear Colleagues:

I am writing to inform you of a simplification in the JHU SOM training requirements for human subjects research. After much discussion with colleagues, I have determined that requiring non-Hopkins investigators to complete Hopkins training is an unnecessary impediment to research that does not contribute to protection of research participants. For study team members (investigators, consent designees and others listed on a study) who are not affiliated with Hopkins, the JHM IRB will accept research compliance training certification from their local institution or another institution, such as NIH. The link to the NIH training site is: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp. A copy of the research compliance training certification from the outside institution should be submitted with the application to the JHM IRB. We will also assume their local institution has conducted all requisite HIPAA training and we will not require any HIPAA training certifications.

JHU SOM faculty (full-time and part-time), fellows, students and staff listed as study team members must still complete our four required training courses (see chart). The four courses are: JHU SOM Human Subjects Research (HSR); JHU SOM Conflict of Interest and Commitment (COI); Johns Hopkins HIPAA General Privacy Issues (GPI); Johns Hopkins HIPAA Privacy Issues Relating to Research (IRR).

* Bloomberg School of Public Health module

The Bloomberg School of Public Health and the Schools of Nursing, Engineering and Arts and Sciences determine the overall training requirements for their institutions. From the JHM IRB perspective for JHUSOM studies, however, Schools of Nursing, Engineering and Arts and Sciences faculty, staff and students are required to complete HSR, GPI and IRR. School of Public Health faculty, staff and students are required to complete BSPH compliance training, GPI and IRR.

Research Compliance Training Courses and HIPAA Compliance Training Courses are available online at https://secure.lwservers.net. If you have any questions about the training requirements, please contact the Office of Human Subjects Research regulatory team at 410-955-3008 or via e-mail at jhmirb@jhmi.edu.

As a reminder, all faculty are required to complete the Course on Research Ethics (CORE) or its equivalent by June 30, 2006. Fellows must complete the CORE course before the end of their training period.

Sincerely,

Michael J. Klag, MD, MPH
David M. Levine Professor of Medicine,
Epidemiology, and Health Policy and Management
Vice Dean for Clinical Investigation