Glossary
New Drug Application
an application filed with the FDA to obtain approval to market a new drug.
See also:Non-Assured Institutions
an institution that does not hold an OHRP-approved Federalwide Assurance.
See also:Non-Exempt Human Subjects Research
research that meets the regulatory definition of human subjects research that does not qualify for exemption. Includes clinical trials, non-clinical trial research and research data or specimen repositories.
See also:Non-Human Research
research that does not involve "human subjects" as defined by the regulations.
See also:Non-Interventional Research
non-exempt human subjects research that does not meet the criteria to be considered a clinical trial (i.e., observational or repository).
See also:Non-Pharmaceutical Grade Compound
Non-pharmaceutical grade agents refer to chemical compounds that have not been formulated for production of medicine. Agents obtained from chemical supply companies, novel compounds, and or agents prepared in a research laboratory are of reagent and not pharmaceutical grade.
Non-Pharmacologic Measures
Measures such as acclimation training, fluids, warmers, heating pads, or bedding that are used to minimize distress, discomfort, suffering or pain.
Non-Surgical Procedure
All non-invasive procedures or invasive procedures limited to entering a preexisting orifice that does not involve cutting with a scalpel, scissors, biopsy forceps, punch biopsy, laser, cautery, direct tissue damage by cold (liquid nitrogen) or any comparable device or technique.
Non-Survival Surgery
Any surgical intervention in which the animal will not recover from anesthesia (euthanized before waking).
Non-Therapeutic Research
research that has no likelihood of intent of producing a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit subjects with a similar condition in the future.
See also:Noncompliance
conducting research in a manner that disregards or violates applicable federal regulations, failure to follow the requirements and determinations of the IRB or IACUC (as applicable), or applicable institutional policies and procedures (in the case of VA research it includes noncompliance with the requirements of the VA Handbook as applicable).
See also:Nonsignificant Risk Device
a device that does not meet the definition for a significant risk device.
See also:Nonviable Neonates
an infant, in the first 28 days after live birth, who cannot survive outside the womb.
In research federal regulations require, after delivery, there must be a determination as to whether the neonate is viable (viable means being able to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. Additionally, there are limitations on determining viability of neonates - individuals engaged in the research may not have any part in determining the viability of a neonate being considered for inclusion in a study. In addition, after delivery, nonviable neonate may not be involved in research unless there is scientific justification for their inclusion, legally effective informed consent of both parents (exceptions apply, see IRB Form U - Research Involving Pregnant Women, Human Fetuses And/Or Neonates) and all of the following additional conditions are met:
(1) Vital functions of the neonate will not be artificially maintained;
(2) The research will not terminate the heartbeat or respiration of the neonate;
(3) There will be no added risk to the neonate resulting from the research;
(4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and
(5) The legally effective informed consent of both parents of the neonate is obtained (waiver or alteration of consent is not allowed). However, there are some exceptions