The Common Rule Explained - Key 45 CFR 46 Definitions for IRBs

The Common Rule Explained: Key 45 CFR 46 Definitions for IRBs covers the definitions that decide whether an activity is human subjects research at all. Human subject, research, minimal risk, and legally authorized representative are tested word for word on the CIP exam, and every IRB determination depends on them. This is Lesson 4 of 26 in IRB and HRPP Administration: From Coordinator to CIP, taught by Angel Reyes, MPH, MCHES, PMP, a public health doctoral candidate and research methodologist. Every lesson is built on PRIM&R's public 2025 CIP Body of Knowledge and Exam References and cites the regulation it teaches, so you can verify it yourself. 5 Key Facts from This Lesson: 1. Under 45 CFR 46.102(l), research is a systematic investigation designed to develop or contribute to generalizable knowledge, so internal quality improvement alone is not research. 2. Minimal risk compares the probability and magnitude of harm to daily life or routine physical or psychological examinations. It does not mean no risk. 3. The 2018 Requirements added four activities deemed not to be research. These are not exemptions, because exempt activities are still research. 4. Since the 2018 Requirements, a legally authorized representative may be designated under institutional policy when no applicable law addresses the question. 5. The Federalwide Assurance is signed by the Institutional Official, not the IRB chair. Chapters: 0:00 The Common Rule definitions 0:54 CIP as a PRIM&R certification mark 3:03 How research is defined 4:20 When quality improvement becomes research 6:22 Three kinds of exam question 7:45 What conducted means 8:26 Funding and the federalwide assurance 9:47 Otherwise subject to regulation 13:42 Federal Register notices 18:37 Why paraphrases cost exam points Visit https://www.subthesis.com for the full course, more free research and public health courses, and practical research tools. Disclaimer: This video is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.