Integration with Kuali Coeus awards system for IRB and IACUC research projects
IRB Changes
Form Changes
2.1 Study Staff: Human Subjects certificate is required to be added to the study personnel list
2.1 Study Staff: (USC only) selecting the "Other" role will result in that person being used for the dept/div review calculation
2.1 Study Staff: CHLA studies will not use sub-investigators for the dept/div review calculation
2a: when filling out 2a.1 for collaborators from other institutions, all the questions will require an answer
New page, 6c, for CHLA study locations
6c Other Study Sites: has been renamed to 6d Other Study Sites
Exempt studies that only select category 4 will no longer be presented with page 9.
26.5: Option "The NIH requires that the records be retained for three years following the completion of the study" added.
28.1: The first option, "There are no direct benefits to some or all of the research participants" has been deprecated. In its place will be "There are no direct benefits to research participants."
38.2 & 38b.2: The options have changed. The FDA and NIH options have been removed, since they are pertinent to 26.5, but not to 38.2 or 38b.2.
39b: Official changes to this page to support CHLA's use of the diSClose conflict of interest disclosure system.
Reportable Events: For CHLA, committee member review will no longer automatically send out a letter, instead requiring the assigned IRBA to format and send the letter.
Returning a study to pre submission clears any existing contingency flag from before, thus avoiding a manual reset.
Upon Amendment, when a study changes from being Exempt to Expedited, the IRB is given the option of changing the study status from Exempt to Approved.
A facility for HSC to flag a particular study as requiring scrutiny by LAC has been added to the reviewer forms to enable an automatic email to LAC.
When a Continuing Review has been submitted, reminder notices regarding the imminent expiration of the study stop.
For Expedited studies on Continuing Review, when they have been found to have exceeded their target accrual, the form gives the study staff the option of requesting a change to the target accrual, which goes into effect following approval of the continuing review.
IACUC Changes
Committee Agenda reorganized
Upcoming Meetings now appear in IACUC Member and IACUC Specialist pages
Required Fields:
Am2.1 now required if other is selected in Am2.
Am3 now required.
R1.2.1 now required if R1.2 is answered yes.
R2.1 & R2.2 now required if R2 is answered yes.
R3.1 now required if R3 is answered yes.
R4.1 & R4.2 now required if R4 is answered yes.
R5.1 now required if R5 is answered yes.
IBC Changes
Committee Agenda now displays Expedited Review applications
Upcoming Meetings now appear in IBC Member and IBC Staff pages
RSC Changes
Form Changes:
1.6.2 & 1.6.3: New questions have been added for Research with Humans (IRB)
2.1: Personnel table now sorted by role
AD1.1: MicroPET CT changed to MicroPET. Added MicroCT as an option.
Committee Agenda reorganized
PI / Permit Holder will be reminded if the requested changes have not been addressed for a specified amount of days.
