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Update June 27, 2015
If you have any questions, please contact the JHM eIRB at firstname.lastname@example.org or 410-955-3008.
As part of scheduled updates, the following changes will be made in eIRB2:
- Section 6 – Protocol Information, Q10 – the question has been modified to specify “JHH” and “JHBMC”: "If your study is occurring at JHH or JHBMC, check all of the below that apply:"
- Section 8 – Conflict of Interest, Q5 – if answered “Yes”, the Conflict of Interest committee will be notified to perform a concurrent ancillary review of your application.
- Section 17 – Assent and Waivers – Children, Q3 – an issue related to Q3 not appearing when required has been resolved.
- Section 20 – Supplemental Study Documents – additional instructions have been added to assist investigators with determining whether documents being uploaded are appropriate: "You are not required to submit standard and recognized questionnaires or tests if they have not been altered for specific use in this study."
- Section 30 – External Radiation Exposure Worksheet, Q1 – the “Update” button was missing, preventing investigators from modifying existing answers.
- Section 34 – SKCCC CRO, Q6 - an issue related to Q6 not appearing when required has been resolved.
- Protocol Event, Section 2 – Protocol Event Report, Q14 – the question has been modified. Old: Should currently enrolled participants be notified about this protocol event? New: Should participants be notified about this protocol event?
- Administrative issues preventing the submission of a small population of applications, as well as hide/show problems, have been resolved throughout the New Application and Further Study Actions.
- Study Expired Notification – the boilerplate language has been revised to state: “If you believe it is in the best interest of participants already enrolled to continue on the study until IRB re-review occurs, you must request permission from the JHM IRB to allow these participants to continue. With this request, you must provide a rationale as to why it is in the participants' best interests and ethically justified to continue study interventions during the re-review period. Send an email requesting permission to email@example.com to the attention of the Compliance Team.”
- Pre-IRB Reviews – issues related to skipping pre-IRB reviews and notifications to the department reviews have been resolved.