Human Research Protections

NIH 2023 Data Management and Sharing Plan (DMSP) Guidance and Resources!!!!

A message from Pramod Khargonekar National Institutes of Health (NIH) 2023 Data Management and Sharing Plan (DMSP) Guidance and Resources!!!!   Background: Effective January 25, 2023, the NIH will require all researchers seeking grant funds that result in the generation of scientific data to submit a data management and sharing plan (DMSP) as part of …

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National Institutes of Health (NIH) Data Sharing Plan Requirements Coming in 2023

+ UCI Library Resources + UCI Office of Research and Libraries January   Webinar (Save the Date) New NIH Requirements Coming: Starting January 25, 2023, the NIH will require all researchers seeking grant funds that result in the generation of scientific data to: For more details about the new data management and data sharing policy, read the …

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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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