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NCI

National Cancer Institute

NCRC

North Campus Research Complex

NCT Number

The protocol identifier assigned by clinicaltrials.gov.

Neonate

A newborn up to four weeks old.

NIAAA

National Institute on Alcohol Abuse and Alcoholism

NIDA

National Institute on Drug Abuse

NIH

 National Institutes of Health

NIMH

National Institute of Mental Health

Non-Affiliated Member

To be eligible for participation on IRBMED as a community representative/non-affiliated member, neither the member nor any member of his/her immediate family may otherwise have a direct affiliation (i.e., as an employee, contractor, student in a degree program, or active emeritus faculty member) with the University. Immediate family includes spouse, parents, grandparents, children and grandchildren, brothers, sisters, mother-in-law, father-in-law, brothers-in-law, sisters-in-law, daughters-in-law, sons-in-law, adopted, half, and step members.

Non-Compliance

Failure (intentional or unintentional) to comply with applicable federal regulations, state or local law, the requirements or determinations of the IRB, or University policy regarding research involving human subjects. Non-compliance can result from action or omission. Non-compliance may be non-serious (minor) or serious, and may also be continuing.

Non-Financial Conflict of Interest

An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultant’s) obligation to protect research participants and potentially compromises the objectivity and credibility of the research review process.

Non-physiological Adverse Event

An Adverse Event involving social or psychological trauma, insult or injury rather than physiological or biomedical harm.

Non-Scientist

An individual appointed to the IRB who (due to training, background, and/or occupation) is inclined to view research activities from the standpoint of someone outside the scientific or scholarly discipline of the IRB on which he/she serves.

Non-Serious or Minor Non-Compliance

Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human subject protection program. Examples of minor noncompliance may include, but are not limited to: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.

Non-Significant Risk Device (NSR)

An investigational medical device that does not present significant risk. The determination that a device presents a non-significant risk is first made by the sponsor. If the IRB agrees with the sponsor’s finding that a device presents non-significant risk, the device is considered a non-significant risk device.

Non-Therapeutic Research

Research that has no likelihood or 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.

Non-Viable Fetus

An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy [45 CFR 46.203 (d) and (e)]. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams [Federal Register 40 (August 8, 1975): 33552], a specific determination as to viability must be made by a physician in each instance. See also: Viable Infant.

Normal Subject

Subjects used in study of normal physiology and behavior, or subjects who do not have the condition under study in a particular protocol used as comparisons with subjects who do have the condition. “Normal” does not necessarily connote normal in all respects. For example, patients with broken legs may serve as normal volunteers in studies of metabolism, cognitive development and the like. Similarly, patients with heart disease but without diabetes may be “normal” in a study of diabetes complicated by heart disease.

Notice of Outcome

Written acknowledgement from the IRBMED, faxed to the study coordinator and/or investigator at the fax number provided in the submission application, regarding the outcome of the review of that application. Outcomes may be "approved", "acknowledged", or "disapproved". Adverse Event and ORIO reports are generally acknowledged, but if accompanying changes to the protocol or consent form are requested these require approval in order to take effect.

Null Hypothesis

The proposition, to be tested statistically, that the experimental intervention has "no effect," meaning that the treatment and control groups will not differ as a result of the intervention. Investigators usually hope that the data will demonstrate some effect from the intervention, thereby allowing the investigator to reject the null hypothesis.

Nuremberg Code

A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.