Updated IRB and hSCRO Forms

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Human Research Protections (HRP)

 

Updated IRB and hSCRO Forms 

 

Version July 10, 2023

 

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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 and to address feedback from the research community. Below is a list of notable updates.

 

IMPACT: 

 

  • Drafts transactions that are not submitted by the above deadline will be automatically converted to the updated version. This may result in additional prompts that must be addressed.
  • Transactions that are already approved will remain on the prior version of the KRP form.

 

UPDATES: 

 

Self-Determination Forms:

Email confirmations will no longer be sent for Non-Human Subjects Research and Exempt Self-Determination. The intructional text has been revised to explain that sucessful submission of the self-determination will serve as confirmation. 

IRB Forms:

 

 

HRP Regulations Incorporated

·         California Information Protection Act (CIPA)

·         China’s Personal Information Protection Law (PIPL)

·         European Union General Data Protection Regulations (GDPR) 

·         NIH Data Management and Sharing (DSM)

 

New Application Protocol Sample Size

  • New prompt to estimate/anticipate the prescreening sample size, as applicable
  • Terminology defined: prescreen vs maximum vs expected 

 

Amendment Form

New option to report Sponsor suspension of trial involving investigational radiopharmaceuticals

hSCRO Forms:

 

 

 

hSCRO Regulations Incorporated

Assurance for the use of Fetal Tissue (Federal 42 U.S. Code § 289g–1 and Amend 17 California Code of Regulations section 100085)

 

New Application

New prompt for the type(s) of hSCRO activities invovled

 

Renew&Amend Form

  • New prompt for the type(s) of hSCRO activities invovled
  • Status prompt simplified 

 

Amendment Form

New prompt when study team change indicated


For IRB questions or regulatory/institutional guidance, please contact
HRP Staff or visit  Office Hours.

For KRP technical questions or issues, please contact era@research.uci.edu.”>ERA.

 

 

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