All New Research Protocol Submissions Must Now Be Submitted Electronically

Our informatics tool, eIRB, must now be used for new protocol submissions effective September 1, 2005. eIRB is accessible at http://e-irb.jhmi.edu and from a link on the main JHM IRB website.

Our hope is that this new system will improve the IRB's efficiency and ability to serve the faculty. If you have any questions about eIRB, please contact the Office of Human Subjects Research eIRB Help Desk at 410-955-3008 or via email at jhmeirb@jhmi.edu. Thank you.

Clinical Trials Registration

The International Committee on Medical Journal Editors (ICMJE) concerning publication of clinical trials have agreed to only publish clinical trial reports if the study has been registered on a database that is electronically searchable to the public at no charge, open to all registrants, not for profit, and has a mechanism to ensure the validity of the registration data. One of the sites where registration of trials can be completed is http://clinicaltrials.gov. Each trial only has to be registered once, so anyone involved in a multicenter clinical trial needs to discuss responsibility for registration with their colleagues.

Clinical trials starting now need to complete registration before the enrollment of the first patient.

For more details important links include: http://www.insidehopkinsmedicine.org/news/leadershipcorner/2005/071605.cfm http://www.icmje.org/clin_trialup.htm
http://prsinfo.clinical trials.gov

Course on Research Ethics (C.O.R.E) Offered October 17, 2005

The next Course on Research Ethics (C.O.R.E) will be offered on October 17th, 2005. Faculty who participate in clinical research must complete C.O.R.E. or its equivalent by June 30, 2006. Fellows who participate in clinical research must complete C.O.R.E. training before completing their fellowship. In addition, completion of both the morning and afternoon sessions of C.O.R.E. fulfills Kirschstein-NRSA responsible conduct of research training requirements.

Registration for CORE is handled by the Office of Continuing Medical Education (CME). Registrations must be received 10 days prior to the course. To register, please visit CME's C.O.R.E. webpage at: http://www.hopkinscme.net/etrakwebapp/Meeting Detail.
aspx?MeetingCode=06-511418&SessionCode=

For additional information regarding the School of Medicine Research Compliance Training requirements, please visit: http://www.hopkinsmedicine.org/Research/training/
compliance_reqs.html

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