IRB Definitions & Resources
Definitions
Research
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject
Human subject is a living individual from whom a researcher—whether professional or student—collects data through interaction or intervention, or obtains identifiable private information.
Institutional Review Board (IRB)
The IRB is an independent administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
Minimal Risk
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during routine physical or psychological examinations or tests.
Generalizable Knowledge
Generalizable Knowledge means that findings of the research will be made public (e.g., presented at conferences, or published in a journal or book).
Intervention
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction
Interaction includes communication or interpersonal contact between the investigator and the subject.
Private Information
Private information is 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 (e.g., in 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.
Research Data
Research data include laboratory notebooks and any other primary records necessary for the reconstruction and evaluation of reported research results and the events and processes leading to those results, including subject-informed consent forms, regardless of the medium on which they may be recorded.
Privacy
Privacy means being free from unsanctioned intrusion.
Confidentiality
Confidentiality means keeping all information relating to an individual secret, unless the individual gives consent permitting disclosure.