Please note: This lesson will take approximately 1 hour and 35 minutes to complete. Use the next and previous buttons to advance through the course. You will
be able to print a completion certificate for your records at the end of this training. OHRP does not collect information about who accesses it. Do not refresh your browser. Refreshing your browser will restart the lesson. This lesson will explain how the Common Rule regulations define “research” and “human subjects” and explain what it means to be exempt from the regulations. This lesson focuses on the Revised Common Rule (or 2018
Requirements) that became effective in 2018. Lesson OverviewThis lesson contains four parts:
You will answer quiz questions throughout each part to test your knowledge. A correct response is required to advance in the lesson. Learning ObjectivesAfter completing this lesson, you will be able to:
Content created by Office for Human Research Protections (OHRP) What makes a research study exempt?Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects, but is still considered research requiring an IRB review for an exemption determination.
How does the IRB define human subjects?A human subject is defined by Federal Regulations as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.”
What defines research with human subjects?Human subjects research is any research that systematically collects data or information about living individuals through intervention, interaction, or the use of identifiable private information with the intent of developing or adding to generalizable knowledge.
Where should a researcher go to inquire whether something qualifies as an exemption?Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.
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In an institution, who usually determines whether a research study is non-exempt human subjects?
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