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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

  1. “Scholarly and journalistic activities (e.g. oral history, journalism, biography, literary criticism, legal research, and historical scholarship);
  2. Public health surveillance activities;
  3. Collection and analysis of information, biospecimens, or records for criminal justice or criminal investigative purposes; and
  4. 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

  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

Use the drop downs items below to browse relevant definitions.

Research

A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Human Subjects

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.

Clinical Trial

A research study in which human subjects are prospectively assigned to interventions to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

Interaction

Any communication or interpersonal contact.

Intervention

A physical procedures/environmental manipulations by which information or biospecimen are gathered.

Benign Behavioral Intervention

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

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

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

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.

Private Information

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

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

Identifiable Biospecimen

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

Vulnerable Populations

Vulnerable to coercion/undue influence.

Legally Authorized Representative:

Individual/judicial/body authorized under applicable law to consent on behalf of prospective subject