Human Research Protections
IRB Protocol Transcription is Complete!
;widows: auto;-webkit-text-size-adjust: auto;-webkit-text-stroke-width: 0px;word-spacing:0px”>***Please read and forward to your researchers*** Dear Colleagues, This email is to inform you that the protocol transcription project for IRB protocols is now complete. This excludes exempt protocols which will still need an adhoc transcription. The Temporary Transcription Team (TTT) has transcribed 1500+ protocols from our previous system(s)…
Read MoreHRP Spring Update: Tips on Informed Consent
HRP Spring Update: Tips on Informed Consent View this email in your browser Keep in mind the following when considering the research informed consent process at UCI: Use the latest UCI Institutional Review Board (IRB) and Single IRB (sIRB) Consent templates. Effective April 1, 2022: Use of the most recent consent templates will be required…
Read MoreSpring QRAM 2022 03/23 – Agenda and Zoom Info
Dear Colleagues, Next Wednesday, 03/23, is our Spring QRAM. It is scheduled via Zoom from 10-1130 AM. See below for the agenda and the Zoom info. March 23, 2022 Agenda Welcome and Housekeeping Oracle Cloud Financials – Exploratory Phase Area Updates: Sponsored Projects Administration Research Engagement and Compliance Contracts & Grants Accounting Human…
Read MoreImportant Compliance Tip: Management of Investigational Medications
UCI Health policy requires that investigational medications are under the control of Investigational Drug Services (IDS) Pharmacy. View this email in your browser An Important Compliance Tip from Compliance + Pharmacy: Management of Investigational Medications In order to promote a commitment to compliance with FDA regulations and Good Clinical Practice (GCP) guidelines, UCI Health policy…
Read MoreChina’s Personal Information Protection Law (PIPL)
View this email in your browser China’s Personal Information Protection Law (PIPL) China has a new Personal Information Protection Law: the PIPL. The PIPL applies to the processing of personal information of individuals living in mainland China on or after November 1, 2021 UC is required to comply with PIPL if conducting any activity in…
Read MoreKRP: Department Chair (DC) or Organized Lead Unit Director (OLUD) Sign Off
Institutional Review Board Human Research Protections (HRP) – Feb 28, 2022 – Kuali Research Protocols (KRP): Department Chair (DC) or Organized Lead Unit Director (OLUD) Sign Off Effective March 1, 2022, the IRB will require DC or OLUD sign off before releasing final protocol approval. This is the same requirement the IRB had…
Read MoreKuali Research Protocols (KRP): Administrative Determination vs a Protocol for IRB Review
There are 3 types of applications in KRP. Keep this reference on hand when navigating human subject research at UCI. Non-Human Subjects Research (NHSR) Self-Determination Exempt Self-Determination UCI allows Exempt Self-Determination for Categories 1-4ii. There are exceptions for certain populations and procedures. Exempt Research that Requires IRB Approval Exempt research that is not eligible for…
Read MoreERA Office Hours Wednesday (2/9) 11am-12pm – Department Chair Sign Off in KR Protocols
Dear Colleagues, The next ERA Virtual Office Hours will be this coming Wednesday (2/9) from 11am-12pm. Starting this session, we will be providing a demo on how Department Chairs can access, review and sign off on protocol applications – a requirement before final IRB approval can be released which will resume March 1, 2022. Please…
Read MoreKuali Research Protocols (KRP): Department Chair Sign Off
Kuali Research Protocols (KRP): Department Chair Sign Off Coming March 1, 2022, Department Chair (or their designee) sign off will be required before final IRB approval can be released. As a reminder, this is the same requirement the IRB had prior to migration to KRP. Why is Department Chair Review Needed? The IRB, in conjunction…
Read MoreUPDATED! Winter QRAM Agenda and Zoom Info
Dear Colleagues, We have an updated (still light) agenda for Wednesday’s QRAM below. Looking forward to “seeing” you all! Welcome and Housekeeping IACUC News Property / Equipment Procedure SPA Updates C&G Accounting Updates ERA Updates Closing Barbara Barbara Inderwiesche, CRA Director, Electronic Research Administration image001.png@01D78AA3.370D2670″> From: OR-IRB-HRP <or-irb-hrp-bounces@department-lists.uci.edu> On Behalf Of Office of Research Human…
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