Platform updated to latest Click version (Click Portal 8.0)
New User Interface - fonts have changed, larger; color scheme altered
Navigation streamlined
New Header & Footer
New buttons and Icons
IRB Changes
New Rule changes (beginning Jan 19th)
New Exempt categories
Continuing Review no longer required for minimal risk studies
New waiver of written informed consent criterion (native peoples)
Form Changes
Page 5b: Type of Study Review - Exempt: Changes to the Exempt Categories for new studies (part of new common rule that goes into effect on Jan 19th, 2018)
Page 11: Study Data (Coded): The coded specimens page gets ability to attach a BUA and edits to the abstract question to make it more clear that tissue sources have to be accounted for
Page 22b: Employees/Students: A new question, 22b.2, asks whether anyone on the study team has a supervisory relationship with potential participants. If yes, a warning shows up that says that it is against USC policy for a supervisor to consent or collect data from people he or she oversees.
Page 22e: Minors: A new question, 22e.4 asks whether the research will require regular continuous or recurrent communication with minors. If so, a warning that explains that the researchers are mandated reporters shows up.
Page 24: Subject Recruitment and Informed Consent: A new option for the waiver of signed informed consent (24.4) shows up (following the new rule), that allows a waiver of signed informed consent in the event that the participants are members of a cultural group for whom signing forms in not the norm.
Page 36: HIPAA Analysis: Now the HIPAA Authorization forms upload (36.2.2) only shows up if the HIPAA forms are said to be modified in 36.2.1.
