IRB: Important Definitions

All definitions are from the Federal Policy for the Protection of Human Subjects (the “Common Rule” as revised in 2018)

 

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

 

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

 

(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).

 

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

 

(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

 

Human subject: a living individual about whom an investigator (whether professional or student) who is conducting research:

 

(1) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

 

(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

 

 

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

 

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

 

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

 

An Adverse Event is anything that occurs during the course of a research protocol that either causes physical or psychological harm, or that increases the risk of physical or psychological harm, or that results in a loss of privacy and/or confidentiality to a participant or others (e.g., the participant’s family members).

 

An Unexpected (or Unanticipated) Problem is an incident not listed as a risk in the protocol application and/or consent form, or not previously documented at the intensity or frequency that was observed in your study population. The event places the participant at greater risk than was previously known, recognized, or anticipated. Risks that are documented in the protocol application and consent form (e.g., “participants may experience motion sickness or nausea during virtual reality”) are not unexpected problems unless the participant experiences the problem at an intensity, frequency, or duration that was not anticipated.