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 protocol progresses. This page and its…

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 the CITI tutorials listed above (individuals…

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 The Levels of Review reflect the risk level to the subject. From lowest to highest risk, the Levels of Review are: Exempt < Expedited < Full Committee. Exempt and Expedited are collectively considered as the Minimal Risk categories; Full Committee is considered the Greater Than Minimal Risk category. What is minimal risk…

Protocol Preparation Checklist Download this PDF

IRB Frequently Asked Questions What Activities Need IRB Approval? Does my study need IRB review? TIP! Refer to EQUIP’s updated Do You Need IRB Review as a quick-start guide for what IRB review and documents apply to your research! We cannot make an official determination of whether a study requires IRB approval via email or over…

Exempt Self-Determination The UCI IRB allows Exempt Self-Determination (i.e., IRB review not required) for Categories 1-4 as described below, exceptions apply. The majority of Undergraduate Research Opportunities Program (UROP) projects register a self-determination. Registration Process When an activity qualifies for Exempt Self-Determination, IRB approval is not required and will not be provided. Instead, the Principal…

Ethical Guidelines, Regulations and Statutes Ethical Guidelines   Nuremberg Code Developed in response to the Nuremberg Trials of Nazi doctors who performed unethical experimentation during World War II, the Code was the first major international document to provide guidelines on research ethics. It made voluntary consent a requirement in clinical research studies, emphasizing that consent…

HRP Office Hours Office Hours are NOT held on UCI holidays and may be canceled due to unexpected absences. Monday Time: 9a – 10a Frequency: 1st & 3rd Monday of the month HRP Staff: Cheree DuBose, IRB “B” Administrator and Compliance Manager Type of Research: Biomedical – Greater Than Minimal Risk Zoom Link Monday Time:…