Required Elements Of Informed Consent 45 CFR 46.116   General requirements for informed consent. (Note: UCI will not be implementing broad consent.) (b) Basic elements of informed consent. Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized…

Informed Consent Process Informed Consent is not synonymous with simply obtaining a subject’s signature on the consent form. Informed consent involves providing a potential subject with adequate information, facilitating comprehension of that information, providing ample opportunity for questions from the subject, and continuing to provide them information as the clinical investigation progresses. This page and…

Training & Education Individuals at UCI engaged in human subjects research must complete one of the following to meet the basic human research protections training requirement: – CITI Basic HRP Course for Biomedical Investigators, or – CITI Basic HRP Course for Social and Behavioral Investigators Completion of one of these CITI tutorials. Is required for…

Assessing Risks and Benefits The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake…

Levels of Review Full Committee Research Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review.  Please see the Committee Calendar for submission deadlines and meeting dates for all IRB Committees. Exempt Research Although the category is called ‘Exempt’, this type of…

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IRB Frequently Asked Questions What Activities Need IRB Approval? Does my study need IRB review? We cannot make an official determination of whether a study requires IRB approval via email or over the phone. Step 1: Use the Non-Human Subject Research Determination form on KRP to determine if IRB review is required. See Definition of…

Exempt Self-Determination & UROP The UCI HRP allows Exempt Self-Determination (i.e., IRB review not required) for Categories 1-4i, with exceptions noted below. All UCI faculty, staff, and students, must log into Kuali Research Protocols (KRP) and submit an Administrative Determination-Exempt Self-Determination. UCI Undergraduate Research Opportunities Program (UROP) UROP Research Protections Instructions Exempt Category 1: Research…

Quality Improvement Projects vs  Quality Improvement Research Activities In general, a quality improvement (QI) project does not need to be submitted to the IRB. The comparison chart below is intended to help you determine whether an activity is a “Project or “Research” Additional Guidance! EQUIP Tips: QI Project vs. QI Research EQUIP TIPS Definitions Definition…

Case Reports Case Reports typically involve retrospective medical record reviews (of three or less patients) and the only interaction with the patient has been for purposes of treating the patient, and not for the purpose of gathering research data. Case reports or case series of three or less individuals are not considered Human Subject’s Research…