Defining Human Research

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Defining Human Research

  1. 1. When Performance Matters1601 Fifth Avenue, Suite 1000 | Seattle, Washington 98101T 206.448.4082 | F 206.448.4193 | QuorumReview.comDefining Human ResearchIs an Activity defined as “Research InvolvingHuman Subjects” under 45 CFR 46?¹Is the activity a systematic investigation designed todevelop or contribute to generalizable knowledge?If no, activity is not research. IRB review is notrequired under 45 CFR 46.If yes, activity is research. Does the researchinvolve obtaining information about livingindividuals?YESIf yes, does the research involve interventionor interaction with the individuals?YES NO If no, the research is not research involvinghuman subjects. 45 CFR 46 does not apply.IRB review is not required.NOIf yes, the activity is researchinvolving human subjects.YESYES NOIf no, is the information individuallyidentifiable (i.e. the identity of the subject isor may readily be ascertained by theinvestigator or associated with theinformation)?NOIf no, the research is notresearch involving humansubjects. IRB review is notrequired under 45 CFR 46.If yes, is the information private? (About behavior that occurs in a context inwhich an individual can reasonably expect that no observation or recordingis taking place, or provided for specific purposes by an individual and whichthe individual can reasonably expect will not be made public.)NOIf yes, the activity is research involvinghuman subjects, but may not require IRBreview if exempt under 45 CFR 46.101(b)(1)-(6).If no, the research is notresearch involvinghuman subjects. 45 CFR 46does not apply.IRB review is not required.YES¹Adapted from OHRP Human Subject Regulation Decision Charts, Chart 1, Is an Activity Research Involving Human Subjects Covered by 45 CFR part 46? September 24, 2004,available at: http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1.

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