OR Human Research Protections

Updated IRB and hSCRO Forms

Human Research Protections (HRP)   Updated IRB and hSCRO Forms    Version July 10, 2023   Updated IRB and hSCRO forms will be released after 5pm on July 14, 2023   The Institutional Review Board (IRB) and Human Stem Cell Research Oversight Committee (hSCRO) forms in Kuali Research Protocols (KRP) have been revised to incorporate regulatory requirements […]

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Using Inclusive, Gender-Neutral Language in the IRB Consent Templates.

Institutional Review Board Human Research Protections (HRP)   Using Inclusive, Gender-Neutral Language in the IRB Consent Templates   Version June 15, 2023 Effective June 1, 2023, new human research studies that involve an informed consent process will be required to use the latest IRB consent templates.  The updated IRB consent templates include the use of

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UPDATED ZOOM LINK – QRAM Agenda and Zoom Info – 03/22 10AM

Hello everyone,   Please try this link for this morning’s QRAM: https://zoom.us/j/9498244789   Thank you!   Barbara   Barbara Inderwiesche, CRA Director, Electronic Research Administration     To learn more about ERA and to stay connected with the latest project developments, please sign up for the OR-ERA listserv by sending a blank email to: or-era-join@department-lists.uci.edu.

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QRAM Agenda and Zoom Info – 03/22 10AM

Dear Colleagues,   Please join us next Wednesday, March 22, from 10AM-11:30AM for our Spring QRAM!   Below is our agenda and Zoom info:   C&G Accounting Updates Federal Updates Research Administrators United (RAU) Award Setup Process Consent addendum for the 2023 DMS requirements CT.gov Compliance CT Contracting Team Updates 700U PowerForm in DocuSign REC

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Certificates of Confidentiality (CoC): NIH and FDA

  Institutional Review Board Human Research Protections (HRP)   Certificates of Confidentiality (CoC): National Institutes of Health (NIH) and Food and Drug Administration (FDA) Version December 7, 2022   New Resource Update!!!!   HRP has released a NEW EQUIP Tip, which provides a comprehensive step-by-step on how to obtain a CoC for a non-Federally supported study.

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Clinical Trials.Gov Webpage Updated

Institutional Review Board Human Research Protections (HRP) – August 26, 2022 – HRP has updated the Clinical Trials.Gov Webpage to simplify content.   In addition, we have included further resources.  Please review this webpage to confirm if your study meets the one or more of the following registration requirements, and for how and when to update this record;

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SAVE THE DATE: Fall QRAM

;widows: auto;-webkit-text-size-adjust: auto;-webkit-text-stroke-width: 0px;word-spacing:0px”>  SAVE THE DATE!    The 2022 Fall Quarterly Research Administration Meeting (QRAM) is scheduled for: Wednesday, September 28, 2022 from 10AM to 11:30AM.   Zoom info and agenda will be sent the week prior.   If you have any request for QRAM topics – or have an interesting topic you’d like to

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New Standard Operating Procedure (SOP): Clinical Research Subject Injury

Institutional Review Board   Human Research Protections (HRP) – August 2, 2022 – __________________________     New Standard Operating Procedure (SOP): Clinical Research Subject Injury   A new standard operating procedure (SOP) addresses the provision and reimbursement of medical costs to human research participants for injuries and illnesses resulting from participation in research.   The

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Kuali Protocols Performance Update

 ***Please read and forward to your researchers***     Dear Colleagues,   Please see below message from Kuali regarding the latest performance issues. As the first priority outlined below, Kuali is temporarily scaling back previously published validation enhancements. If you run into any problems with validations in your protocols, please contact era@research.uci.edu and someone from

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