1. What are the procedures for studies that will be reviewed at WIRB?
WIRB and the HSRO require that two (2) printed copies of all submissions to be reviewed at WIRB be delivered to the HSRO. When submitting a new study for WIRB review, users must also complete an eProst SmartForm. Once the user indicates that the study will be reviewed at WIRB, eProst will generate “Short Form” which will only ask questions required for UM’s records. Continuing Reports, Final Reports or Reportable Events should be submitted using only the appropriate WIRB form. Amendments will also only require the submission of a WIRB form but the user is asked to update the eProst “Short Form” if necessary.
2. I have a study that is currently being reviewed at WIRB. Will this study now be reviewed by the UM IRB?
The UM IRB’s are currently in the process of reacquiring some UM studies from WIRB. If your study is being reacquired, PI’s and study contacts will receive an email from a member of the HSRO staff at the time of continuing review letting them know. A Continuing Report should be submitted via eProst. Study teams should contact the HSRO at 305-243-3195 if you have any questions regarding the reacquisition of their studies.
3. What occurred on November 1st, 2006 with the eProst system?
The full workflow was implemented for the Department of Ophthalmology only. The workflow is a fully electronic process where the study report submission will go through various electronic stages until they are approved: These stages are: a) PI submission; b) department approval c) ancillary committee approval (if applicable); d) review by HSRO; e) review by IRB Board; and f) Approval/Disapproval. These steps ensure that all issues and concerns are adequately addressed. As eProst issues were discovered and corrected, the Department of Opthalmology beta test was considered successful and other departments have subsequently been included within the eProst workflow. Workshops are being held within each department prior to its going on-line into the eProst system.
4. When will my department be activated on the electronic workflow?
The HSRO is currently activating all departments on an individual basis. The goal is to have all department on-line by December 31st, 2007. The HSRO may be contacted at 305-243-3195 for specific dates or information.
5. What are the requirements when submitting a Continuing Report or Amendment?
When submitting a new Continuing Report or Amendment, the system will verify that the new protocol form has been completed. If this step has not been carried out, the user will receive a message requiring him/her to complete this form. Users should be proactive and complete the new protocol form before a Continuing Report or Amendment is required.
Please contact the HSRO Help Desk at 305-243-3195 when completing a Final Report to bypass this requirement.