Definitions

Approval
Research that is approved outright requires no further revisions and may be initiated as soon as the investigator receives the IRB's decision.

Assent
The active affirmation of a desire to participate in the research.

Child
In the State of Connecticut, a child is defined as anyone under 18 years of age.

Conditional Approval
Often the IRB will require specific revisions to the protocol an/or consent form before the research will be approved. When the IRB asks for specific revisions, the investigator must submit the revised protocol to the IRB for the changes to be reviewed.

Decisionally Impaired Individuals
Those who have a diminished capacity for decision-making and who may be unable to fully understand the risks of research.

Deferral
Sometimes the IRB will require additional information about the research before the protocol can be approved. This usually happens because the protocol does not contain enough information to allow the IRB to fully review and understand the nature of the research. In these cases the IRB will ask the investigator to revise the protocol and submit it for re-review.

Intervention
Includes both physical procedures by which data are gathered (for example, 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 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.)

Human Subject
"A human subject is a living individual about whom an investigator (professional or student) conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information."
(45 CFR 46.102(f))

Minimal risk
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. (45 CFR 46.102(i))

Prisoners
A prisoner is defined by federal regulations as any individual involuntarily confined or detained in a penal institution and/or individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to incarceration.

Private Information
Information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

Research
"Research means 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."
(45 CFR 46.102(d))

Risk
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only "minimal risk." (See also: Minimal Risk.)

Secondary Data
Data, documents, records, or specimens that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis) and are in existence prior to the beginning of the study. (see Secondary Data section)