Defining Human Research
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This document provides a decision tree to help determine if an activity constitutes human subjects research under 45 CFR 46. It involves asking a series of yes or no questions to evaluate if the activity is a systematic investigation designed to develop generalizable knowledge, involves obtaining private information about living individuals, and involves intervention or interaction with those individuals. If the answers indicate it is research involving human subjects, it may require IRB review unless an exemption applies under 45 CFR 46.101(b)(1)-(6).
Defining Human Research
- 1. Q When Performance Matters Defining Human Research Is an Activity defined as “Research Involving Human Subjects” under 45 CFR 46?¹ 1 Is the activity a systematic investigation designed to develop or contribute to generalizable knowledge? NOIf no, activity is not research. IRB review is not required under 45 CFR 46. If NO If YES If NO If YES If NO If YES If no, the research is not research involving human subjects. 45 CFR 46 does not apply. IRB review is not required. If yes, the activity is research involving human subjects. and may require IRB review unless exempt under 45 CFR 46.101(b)(1)-(6). If NO If YES If NO If YES NO YES 2 If yes, activity is research. Does the research involve obtaining information about living individuals? 3 If yes, does the research involve intervention or interaction with the individuals?² 4 If no, is the information individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information)? 5 If yes, is the information private? ³ ¹Adapted 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. ² Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102(f)) ³Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102(f)) 1601 Fifth Avenue, Suite 1000 | Seattle, Washington 98101 T 206.448.4082 | F 206.448.4193 | QuorumReview.com