Released June 4, 2016
The following changes apply to the IBC Application:
“The Needles/Sharps Injury or Exposure Guide will be posted” can now be selected as an option for Question 8 on the Risk Mitigation - Lab Practices for BSL2 Work section of the IBC Application. A link to download the Needle/Sharps Injury or Exposure Guide has also been added to the help for question 8.
In Question 3.6.1 (Adenovirus Types), vector type Type 5 has been changed to Type 2/Type 5 and two new selections have been added: Mouse adenovirus (MAV) and Canine adenovirus (CAV).
Question 6-1.1 (Biological Substances Administered to Animals) sub-question 3 (animal housing containment levels) has been updated to allow for the ability to select more than one animal housing level.
The following NIH Guideline questions have been modified:
1-3.19 has been replaced with a new guideline: Generation of transgenic rodents, in which the animal's genome has been altered by stable introduction of rDNA, or DNA derived therefrom, into the germ line (Section III-E-3).
1-3.20 is now a combination of 1-3.20 and the previous 1-3.19: EITHER breeding/crossbreeding experiments in which one or both parental rodents, or the offspring, contain more than 50% of the genome of an exogenous eukaryotic virus from a single family (all viruses in the family are considered equal);
ORbreeding experiments in which one or both parental rodents contain a transgene that is under the control of a gammaretroviral long terminal repeat (LTR). (Section III-E-3).
Question 6.1 (Animal Species) sub-question 4.1 (describe transgenic animals) is now required for all Transgenic Animals, previously it was required only for Transgenic Rodents.
Both the Initial Approval Date and the Last Amendment Date (if applicable) now display in the Approved Application Summary.
The following changes apply to the Human Subjects Application (HUM):
A new question (5.7) has been added in Section 5 (Research Design) to ask if the study will be conducted according to ICH-GCP E6 guidelines. This question will only be asked for studies that are clinical trials and that route through IRBMED.
The Mobile Medical Device questions added to sections 7-2 and 7-3 now display on the Printer Friendly Version.
An error allowing execution of the Notify Study Team Members to Accept Roles activity on Not Regulated studies has been corrected. Study Team members are not required to accept their role on Not Regulated studies.
An error preventing documents uploaded in application question 16.2.15 from displaying on the Documents tab in the application workspace has been fixed.
For applications with vulnerable populations indicated, a problem that impacted appropriate smartform routing has been fixed.
The Action Deferred Pending Core Committee motion and activity have not previously been available while a study is in Core Committee Staff Contingency Review. Staff now have the ability to issue this motion and execute the activity rather than needing to request that ITS manually perform this action via contacting the ITS Service Center.
Direct sponsors entered manually (i.e., not selected from the list) now display on the agenda.
The Unassign Reviewer activity has been removed from the Reviewer Checklist. The Manage Reviewers and Unassign Expedited Reviewers activities on the parent study should be used to manage this.
The Edit Open Issues activity is no longer available when the application is in the state of Pre Submission.
In cases where the parent study is Not Regulated and Exempt Approved (Initial or Transitional), the “Approve” motion on Amendment was not checking for whether an Expiration Date had been entered before transitioning the application to “Approved”. This led to the possibility of studies becoming “Approved” with no Expiration Date.
The following changes apply to IRB MED:
Applications and Amendments which require Biomedical Engineering Unit (BEU) review will now have an auto-generated contingency that IRBMED must clear before Approval can be issued. Creation of this contingency will be based on the same criteria that drives whether BEU review is required on the particular submission in question. IRBMED business policies will determine when the contingency can be cleared. In the contingency text, “BEU” is now referred to as UMHS Clinical Engineering (formerly BEU).
The following changes apply to PRC:
An error causing the incorrect notification letter to be sent for No Review Required has been fixed.
Several textual updates have been made to the PRC letter templates.
The following change applies to OHRCR:
OHRCR will now receive email notifications for submitted application with an IND or IDE.