There are two main questions that determine whether an activity is reviewed by the HSRO.
- Is it research, and
- Is it research with humans
“a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” (ref. 45CFR46)
The key word in the definition is designed. The HSRO looks at the primary intent of an activity. If the intent is to generate new or generalizable knowledge – information that can be applied in other settings - the activity is considered research.
Human subject means:
“a living individual about whom an investigator (whether professional or student) conducting research:
(i) Obtains infromation or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes that information or biopsecimens, or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Intervention includes both physical procedures by which information or biospecimens are gathered 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).
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 activity that meets the above criteria would be considered research and the responsibility of the HSRO. Often people believe that since they don’t plan to publish their results they don’t need review by an HSRO. This is incorrect; intent to publish has no part in determining whether an activity needs review.
General attributes of research
Produces generalizable knowledge
Benefits extend beyond the participants
General attributes of non-research
Intent is to identify and control a specific problem or improve a program or service
Benefits are primarily or exclusively for the participants or their community
Data are used to assess and/or improve the program or service
Knowledge doesn’t extend beyond the scope of the activity
For purposes of 45CFR46 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.