September 2007 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* | CORE | | Principal Investigators (PIs) | X | X | X | X | X** | School of Medicine faculty, fellows, staff, and students | X | X | X | X | Fellows Only** | Schools of Nursing, Engineering and Arts and Sciences faculty, staff and students | X | | X | X | | School of Public Health faculty, staff and students | X*** | | | | | Non-Hopkins study team members | X**** | | | | |
* The Johns Hopkins HIPAA General Privacy Issues (GPI) is a pre-requisite for the HIPAA and Research course. Individuals who have already completed IRR are not required to take HIPAA and Research. ** 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) *** Bloomberg School of Public Health or CITI module **** NIH or local institution human subjects research 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, 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/INT/ . For more information on training requirements go to http://www.hopkinsmedicine.org/Research/ora/training/compliance_reqs.html
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