Glossary
Major Change or Modification
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.
See also:Major Survival Surgery
penetrates and exposes a body cavity or produce substantial impairment of physical or physiologic function OR involves extensive tissue dissection or transection
See also:Mature Minor
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).
See also:Medical Device
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 USP脨NF, 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.
Mentally Disabled
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.
See also:Minimal Risk
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.
See also:Minimizing Risk
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.
Minor Change or Modification
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).
See also:Minor Survival Surgery
does not expose a body cavity and causes little or no physical impairment
See also:Morbund Condition
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.