Non-Human Subjects Research

Are you are unsure whether or not you are conducting human subjects research? OR you are certain you are not conducting human subjects research but your sponsor or a publication requires certification… Please use the following Self Certification form: (instructions are found in the form)   http://irb.med.nyu.edu/files/irb/attachments/non_human_subects_form.doc

Federal regulations require IRBs review only research involving human subjects.  Federal Regulations under 45 CFR 46.102 provides the following definitions that guide human subjects research:

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.  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. Private 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.