Artificial Intelligence and Human Subject Research

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Artificial intelligence (AI) is an evolving, fast paced topic.  It includes chatbots, algorithms, deep learning, machine learning/ intelligence, predictive analytics, and more. The purpose of this guidance is to share current legal considerations, as well as best practices when conducting human subject research at UCI. Please consider the following before submitting a human subject research…

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UCI as Relying IRB 2

UCI as the Relying IRB (External sIRB) Relying IRB will rely on the review of the Reviewing (external) IRB. The IRB may refuse, on a case-by-case basis, to rely on the review of another IRB. External sIRB Eligibility UCI Serves as HIPAA Privacy Board External sIRB Agreements Submit an External sIRB Request Post-Cede Responsibilities External…

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UCI as Reviewing IRB

UCI as the Reviewing IRB Reviewing IRB: The “IRB of record” to which authority for IRB review and oversight has been ceded by another institution for an instance of research under an institutional authorization agreement or individual investigator agreement. The Reviewing IRB is responsible for reviewing all IRB transactions for the Relying Institution. This includes,…

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How To Register and Update Your Study

How To Register and Update Your Study The following is a quick start users guide on how to carry out some of the most common functions on ClinicalTrials.gov when registering a study. For a general overview of the registration process and requirements, see the ClinicalTrials.gov page How to Register Your Study.  Want this information in…

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UCI IRB Metrics Dashboard

UCI IRB Metrics This will house the IRB Metrics Dashboard. This is updated at the end of each day, so this information reflects previous days’ studies.

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I-GREAT

I-GREAT in Human Research Protections (HRP) I-GREAT is our internal cultural agreement.  HRP serves to facilitate human subject research at UCI.  We don’t just want to facilitate, however, our goal is to Shine Brighter! We strive to maintain a positive work environment and thereby an equally positive IRB submission experience. If at any time HRP…

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IRB Committee Calendars

IRB Committee Meetings & Deadlines IRB Full Committee meetings are held monthly for Biomedical and Social-Behavioral greater than minimal risk research. All full committee documentation must be provided in KRP by the specified deadlines. Minimal risk protocols and related transactions (e.g., amendments, renewals, closings) are reviewed on a rolling basis, at weekly subcommittee meetings. Greater…

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China’s Personal Information Protection Law

China’s Personal Information Protection Law (PIPL) China’s PIPL applies to the processing of personal information of individuals living in mainland China on or after November 1, 2021.  Per Article 4 of PIPL: “Personal information” refers to various information related to an identified or identifiable natural person recorded electronically or by other means, but does not include…

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UCI as the Reviewing IRB

UCI as the Relying IRB Current UCI policy requires that all faculty, staff, and students must have UCI IRB approval before they begin research with human subjects. This requirement applies regardless of the source of funding and even when no funds are involved, regardless of the site of the study activities. UCI will consider relying…

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