4. The Common Rule Explained: 45 CFR 46 Definitions That Decide Everything
After this lesson you can
- State to whom and to what 45 CFR 46 applies and how the FWA extends it
- Recite and apply the definitions of research, human subject, minimal risk, and the related terms
- Name the four activities deemed not to be research
- Walk Subpart A section by section, 46.101 through 46.124
- List the major changes made by the 2018 Requirements
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.
5 Key Facts from This Lesson
- 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.
- Minimal risk compares the probability and magnitude of harm to daily life or routine physical or psychological examinations. It does not mean no risk.
- The 2018 Requirements added four activities deemed not to be research. These are not exemptions, because exempt activities are still research.
- Since the 2018 Requirements, a legally authorized representative may be designated under institutional policy when no applicable law addresses the question.
- The Federalwide Assurance is signed by the Institutional Official, not the IRB chair.
Exam traps
The distinctions exam questions on this topic are most often built to test. Know them cold.
Minimal risk compares to daily life or routine examinations of the general population; it is not no risk
Research requires design to contribute to generalizable knowledge; internal quality improvement is not research
The four deemed-not-research activities are not exemptions; exemptions are research
Since 2018 an LAR may be designated under institutional policy when no law applies
The FWA is signed by the Institutional Official, not the IRB chair
Practice quiz
- Question 1Under 45 CFR 46.102, which is NOT one of the activities deemed not to be research?
- Question 2Minimal risk means the probability and magnitude of harm are not greater than those ordinarily encountered in:
- Question 3The general compliance date of the 2018 Requirements was:
- Question 4An institution is engaged in human subjects research when its employees or agents:
- Question 5The document by which an institution commits to comply with 45 CFR 46 for HHS-supported research is the:
Recap
- Applicability: conducted, supported, or regulated by twenty signatory agencies; extended by the FWA
- Definitions: research, four deemed-not-research activities, human subject with two prongs, identifiable, minimal risk, clinical trial, LAR
- Structure: 46.101 through 46.124 and where every rule lives
- Engagement: intervene or interact, obtain identifiable information, obtain consent, or receive a direct award
- 2018 changes: definitions, exemptions, broad consent, key information, posting, continuing review, single IRB, checkbox
Coming next
Lesson 5, FDA Human Subject Regulations.
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This course 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.