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Update June 7, 2008
As part of quarterly scheduled updates, the following changes have been made to the eIRB new application:
- Screen 4 – Exempt Research – question 4.0 has been revised to describe how and when specimens or data will be deidentified, whether any links will be kept and whether the PI or study team may have access to the links. It is important to address each of these points in the text box provided.
- Screen 8 -Conflict of Interest - includes the instruction to click Edit to indicate a conflict of interest for each study team member. This must be completed before the application can be successfully submitted.
- Screen 12 – Participant Information – a new question has been added at 7.0. Will you enroll healthy volunteers? A healthy volunteer is defined as a participant with no known significant health problems who participates in research.
- Screen 13 – Recruitment Information – question 2.0 has been revised to include telephone scripts. If you are submitting recruitment materials and/or telephone scripts for review indicate YES and upload the materials at question 4.0
- Screen 21 – Drug Information – a new question has been added. If the sponsor holds the IND, the IRB must confirm the IND number. The study team is asked to indicate the method for confirmation (sponsor protocol is imprinted with IND, written communication from FDA documenting IND number has been uploaded, written communication from sponsor documenting IND number has been uploaded).
- Screen 23 – Devices – new questions have been added at 2.0 and 3.0. For studies where an investigational or marketed medical device(s) will be studied, you must indicate whether there is a separate supply of the device(s) used only for the study and where the device(s) will be stored.
If you have any questions, please contact the JHM eIRB at email@example.com or 410-955-3008.