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National Cancer Institute


North Campus Research Complex

NCT Number

The protocol identifier assigned by clinicaltrials.gov.


A newborn up to four weeks old.


National Institute on Alcohol Abuse and Alcoholism


National Institute on Drug Abuse


 National Institutes of Health


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.


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.


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.

Noninvasive procedures

Noninvasive procedures do not involve tools that break the skin or physically enter the body. Noninvasive procedures for research purposes are usually deemed to pose minimal physical risk, though this is also dependent on other contextual factors.

OHRP's list Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) includes many examples:

#3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

#4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing....
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

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.