January 2009 JHU SOM faculty (full-time and part-time), fellows, students and staff listed as study team members on a human subjects research application must complete our four required training courses (see chart below). 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 and Research or Privacy Issues Relating to Research (IRR). The HIPAA and Research course was implemented in September 2007 and replaces the HIPAA IRR course. Affiliation | HSR | COI | HIPAA GPI | HIPAA and
Research (1) | CORE | Clinical Research Billing | | Principal Investigators (PIs) | X | X | X | X | X (2) | X | School of Medicine faculty, fellows, staff, and students | X | X | X | X | Fellows Only (2) | X (5) | School of Nursing Faculty | X | X | X | X | | X (5) | | School of Nursing staff and students | X | | X | X | | X (5) | Engineering and Arts and Sciences faculty, staff and students | X | | X | X | | X (5) | School of Public Health faculty, staff and students | X (3) | | | | | X (5) | Non-Hopkins study team members | X (4) | | | | | X (5) |
(1) The Johns Hopkins HIPAA General Privacy Issues (GPI) is a pre-requisite for the HIPAA and Research course. (2) All PIs of active IRB protocols are required to complete the Course on Research Ethics (CORE) or its equivalent. Individuals who were not active PIs as of October 1, 2006 have one year from the date of first submission to complete the CORE requirement. Fellows must complete CORE by the end of their fellowship.(for exemption information please click here) (3) Bloomberg School of Public Health or CITI module (4) NIH, CITI, or local institution human subjects research module (5) PIs and study team members who have a role in billing for services provided to participants enrolled in clinical trials are required to complete this course. When a new research application is submittd in eIRB, you will be notified by PRA (Prospective Reimbursement Analysis) staff if you are required to take the Clinical Research Billing Course.
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, COI, GPI and HIPAA and Research (or IRR). School of Public Health faculty, staff and students are required to complete BSPH compliance training, or the CITI Basic Course for Research Investigators. 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. The Human Subjects Research course, Conflict of Interest and Commitment course, HIPAA General Privacy Issues course and certificates for the IRR course are available online at https://secure.lwservers.net. IRR certificates are also available on there, for those that have already completed the IRR course. The HIPAA and Research course is available online at http://www.jhminteractive.com/ . As of July 1, 2008, a new course must be completed by clinical researchers to meet the new JHM billing training requirements. The “Clinical Research Billing Orientation” course is available at http://www.jhminteractive.com/. The course must be completed by the Principle Investigator and his/her study team who will bill for services provided to participants enrolled in clinical trials. Training should be completed before the first participant is enrolled. The courses will be required for all clinical faculty by October 1, 2008, regardless of whether they are currently participating in an active study. The requirement is because all clinical faculty who bill professionally will potentially submit bills for services provided to research participants. Questions about the courses should be directed t0: Karen Roz, Associate Director of Support Services, 410- 955 7682, rozka@jhmi.edu
Mike Amey, Associate Dean for Research Administration, 410- 955 1566, mamey@jhmi.edu
Daniel Ford, Vice Dean for Clinical Investigation, 443 287 4234, dford1@jhmi.edu
Pat Travis, Associate Director of Contracting, 410-502 0233, ptravis2@jhmi.edu
Martha Weiner, Senior Director of Billing Quality Assurance, 410-502 0780, mweiner3@jhmi.edu
Kenneth Wilczek, Associate Dean for the Clinical Practice Association, 410-955 2600, kwilcze1@jhmi.edu For more information on training requirements go to http://www.hopkinsmedicine.org/Research/ora/training/compliance_reqs.html
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