On January 21, 2019 the final revisions on the Common Rule will take effect. These changes may affect how the IRB reviews your research. Please read below for an overview of the changes in the definitions.
What is Research?
The definition of research has changed to mean a “systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” With this definition, HHS has provided guidance on what is no longer research including
“Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
Public health surveillance activities;
Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
Certain activities in support of intelligence, homeland, security, defense, or other national security missions.
As before, however, please check with the IRB to determine whether your research falls within the definition of research.
What is a Human Subject?
A living individual about whom an investigator conducting research obtains
information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Use the drop downs items below to browse relevant definitions.
A human subject a living individual about whom an investigator conducting research obtains (1) information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Interactions that are brief harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.
Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons (45 CFR 46.303(d)).
Generalizable studies are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study population), inform policy, or generalize findings.
Systematic can be defined as any activity that involves a prospective research plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question.
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).