Drafting the Informed Consent Form Format and Style of Informed Consent Documents (Key Points) The IRB strongly encourages Investigators to use the standard UCI IRB consent template, which is available on the HRP Toolkit page. The template is written in the 2nd person. IRB requires that the consent and assent documents be written in the 2nd…

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 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. TIP! Exempt research may…

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. Need to register an Exempt Self-Determination? IMPORTANT! The registration process is different than the IRB submission process. Review the IRB Researchers Guide…

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…