Glossary

any change that does not meet the definition of a minor change or modification to previously approved research, or a modification which fundamentally alters the judgments relied upon to make determinations on any of the criteria for IRB approval under 45CFR 46.111 and/or involves modifications which would not be eligible for expedited review.

penetrates and exposes a body cavity or produce substantial impairment of physical or physiologic function OR involves extensive tissue dissection or transection

someone who has not reached adulthood as defined by state law, but who may be treated as an adult for certain purposes (e.g., consenting to certain types of medical care).

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

either a psychiatric disorder (e.g., psychosis, neurosis, personality, or behavior disorder), a developmental disorder (e.g., mental handicap), or a neurological disorder that affects cognitive or emotional functions to the extent that it results in an Impaired Decision-Making Ability.

The probability and magnitude of harm or discomfort anticipated in the 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 VA studies the determination includes tangible or intangible risk. For DOD research the determination does not include the inherent occupational risks that certain subjects face in their everyday life.

an IRB determination when the research uses procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, the research uses procedures already being performed on the subjects for diagnostic or treatment purposes.

a modification to research which in the judgment of the reviewer does not fundamentally alter the judgments relied upon to make determinations on any of the criteria for IRB approval under 45CFR 46.111 does not adversely impact the overall risk-benefit relationship for the subjects of the research (based on new or modified risk information). For studies originally approved by expedited review, a minor change is a modification that does not change the study's eligibility for expedited review (considering risk and expedited review categories 1-9).

does not expose a body cavity and causes little or no physical impairment

When an animal is in the state of dying, or at the point of death. Moribund animals may experience pain and distress during progression to a moribund condition.

research conducted at more than one location and under the jurisdiction of more than one IRB.

research conducted at more than one location and under the jurisdiction of only one IRB.