December 3, 2007 As part of quarterly eIRB application updates, changes have been made to the following application pages: General Information - Question 7.0, “progress report for an expired application,” is no longer a required field. If a terminated, withdrawn or disapproved application is being resubmitted, a progress report is not applicable. However, please note that if the resubmission is related to an expired application, a progress report should be uploaded. Study Team Compliance – The compliance table has been revised to include HIPAA and Research (H&R) compliance course. In addition, the "CORE Required" field has been removed and replaced with "Date CORE Completed." Study Location - The check box for “Multicenter sites” has been replaced with “Multicenter sites where another PI will conduct the research.” Also, the check box for “Other non-Hopkins sites (U.S. and International)” has been replaced with “Non-Hopkins sites where you will conduct the research." Additional guidance has also been added to the IRB Help link. Human Biological Samples - The pathology review form is no longer required. If question 3.0 is checked to indicate that samples will be obtained from JHH or JHBMC Pathology Department, you will be prompted to answer additional questions related to the pathology review rather than upload a separate document. Investigational Drug Service – Question 1.0 has been revised from “Is there a study-specific supply of the material (drug) identified in this study?” to “Is there a separate supply of the drug(s) used only for this study?” Additional guidance has also been added to the IRB Help link. Data Confidentiality - Rather than checking the procedures to be used to protect the confidentiality of data and samples, you must confirm as "Yes" or "No" that all the procedures will be used. If you answer "No," you must explain why. Data Confidentiality - The Certificate of Confidentiality upload is exposed whether the certificate is held by Hopkins faculty, a cooperative group, or another institution. Devices, investigational or marketed device information window - Question 8.0 has been revised to include electrical or battery powered devices. Additionally, if the sponsor holds the IDE, a copy of the signed Investigator Agreement is no longer required.
If you have any questions, please contact the JHM eIRB at jhmeirb@jhmi.edu or 410-955-3008. |
