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Update September 14, 2009
As part of quarterly scheduled updates, the following changes have been made in eIRB:
- Paper Conversion – You now have the option to convert paper studies (those originally submitted on paper forms) to eIRB applications. This step will allow use of the eIRB system by all JHM components that must track approved research. You are encouraged to convert your paper study at the time of continuing review. Please submit your application at least 8 weeks prior to your study expiration date to allow sufficient time for the IRB review. On January 1, 2011, the IRB will stop accepting paper continuing reviews or changes in research; all paper studies must be converted in eIRB prior to this date.
- Convert Paper Studies to eIRB Instructions and Tutorial
- New Application – 1 General Information – the department list has expanded to include approximately 70 departments and divisions within the School of Medicine.
- Department and Division Chairs will receive a notification from the system when a new application is submitted from their Department or Division without an identified funding source.
- The Department of Neurosurgery will now conduct a departmental pre-review.
- New Application – 27 Imaging/Radiation – the page previously titled Radiation/MRI has been renamed as Imaging/Radiation and the questions have been revised.
New Application – 28 Incidental Findings – an additional page has been added to the application to report incidental findings for studies that involve imaging procedures.
- New Application – 29 Data and Safety Monitoring Plan – question 1.0 has been revised to indicate the methods for monitoring that will be used in the study rather than the primary method.
- New Application – 12 Participant Information – a new question has been added to indicate if the investigator will enroll foster children in the state of Maryland.
- New Application – 10 Study Location – Suburban Hospital has been added as a study site.
- New Application – 21 Drug Information – a copy of prescribing information (e.g., package insert) is no longer required for FDA-approved products used according to FDA-approved indication.
- The administrative approval letter has been revised to indicate that the application is approved but requires administrative changes prior to the release of approval documents.
- Minor changes have been made to the instructions on the New Application and Continuing Review final pages.
- Instructions not to DELETE documents have been added to all fields with a document upload. Deleted documents cannot be retrieved. If you delete a document, you will also delete the version history of the uploaded document, including all prior versions of the document uploaded in that spot.
- Click ADD to upload new document(s).
- Do not DELETE existing documents.
- Click EDIT to upload revised versions of existing documents.
- Always upload track changed versions of documents when submitting revisions.
- Clean versions of the consent forms are not necessary.
- New language has been added to the Agree to Participate and Submit activities to instruct the PI and study team members not to submit individually-identifiable information about research participants in eIRB.
If you have any questions, please contact the JHM eIRB at firstname.lastname@example.org or 410-955-3008.